chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme soreness / Achiness; Swelling; Feeling down  for a couple of days; Didn't feel well; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, swelling, feeling down and feeling unwell. On an unknown date, the outcome of the pain, swelling and feeling unwell were unknown and the outcome of the feeling down was recovered/resolved.   It was unknown if the reporter considered the pain, swelling, feeling down and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient's age group was not reported but captured as adult as per vaccine indication. The reporter was a floater pharmacist. She worked in a lot of different pharmacies and tons of patients had told her that, they had issues after getting Shingrix.  Those patients had experienced extreme soreness, achiness, swelling, feeling down for a couple of days, did not feel well after getting one or both Shingrix vaccines. The reporter did not have specific details regarding product or patient(s) to provide at time of report, and did not want to be contacted regarding events reported. The reporter did not consent to follow-up.
Went to ER on 11/26/21, ultrasound done on left leg and found blood clot from groin to knee long. Leg pain, aches, cramps Partial DVT identified within the left common, superficial, and popliteal veins.   Went back to ER on 12/4/21 due to additional symptoms  Ultrasound done on right arm, right and left leg and blood clots were found in all 3. Pain, aches, cramps Right arm:  Nonocclusive DVT in the right basilic vein. Right leg: There is nonocclusive acute DVT in the right common femoral vein and   superficial femoral vein and popliteal vein.     Left leg: There is nonocclusive acute DVT in the left common femoral vein and   superficial femoral vein and popliteal vein
racing heart around 6:00 pm, lasted a few minutes.  have had anxiety over it.  I went to my doctor.  all my vital signs were good.  could be anxiety caused it?
10/8/21 PATIENT ADMITTED TO MEDICAL CENTER aCUTE ON CHRONIC lv SYSTOLIC HEART FAILURE. PATIENT REPORTING SOB , CARDIAC CATH SHOWED NORMAL, ACUTE RENAL FAILURE NOTED .imPELLA DEVICE PLACED.  COVID + ACUTE RESP FAILURE.  10/9/21 PATIENT HAD CARDIOPULMONARY ARREST.  PATIENT INTUBATED . PATINET  PROGRESSIVELY MORE HYPOTENSION AND BRADYCARDIC. ON 10/9/21 PATIETN DIED.
do not remember whether they got the 1 and/or 2 doses / got vaccinated was 3-4 years ago.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 or 4 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient's husband. The age at vaccination was not applicable for this report. The health care professional reported that the patient wanted to have it might be a 3rd dose of Shingrix as she did not remember whether she got the 1st and/or 2 doses of the vaccine which led to incomplete course of vaccination.  The reporter called to have more data regarding getting re-vaccinated. The reporter consented to follow up. The case had been linked with US2021149594 reported by same reporter. Note: This case was conservatively kept valid with event incomplete course of vaccination as it was not clear if patient had received 2nd dose of Shingrix or not. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021149594:Same reporter
This is a spontaneous report from a contactable consumer (patient reported for herself). A 70-year-old female patient received PREVNAR 13 via unspecified route of administration in the right arm on 03Feb2018 at 0.5 ml, single dose for immunization. Medical history included thyroid issue. Concomitant medications included ongoing thyroid medication and vitamins. The patient received the vaccine almost two weeks ago and since then has been unable to move her right arm; she woke up the next morning and couldn't move her arm, it hurt so bad (started to experienced on 04Feb2018). It's even worse today than it was yesterday. She can't sleep on unspecified date in Feb2018. It was reported that the patient can't eat due to she's unable to lift her hand up to her mouth. She's lost 7lbs on Feb2018; she was 111lbs when she got the vaccine and was now 103lbs. She has to sit in a recliner to sleep, she has tried using heat and cold on her arm but it doesn't help any and the cold hurts worse. She has to use her left arm to move her right arm because she can't move her right arm by itself. She can't use the bathroom by herself; her husband has to help her with her pants. It was reported that she has always gotten her flu shot like she's supposed to and never had this problem before. It feels like the shot is still going into her arm, like someone is twisting a knife in her arm, it hurts so bad. She has called her regular doctor and was told to go to the ER, but she can't afford to be going to the emergency room every day for this pain. She confirmed that she has not been to the ER yet. She has been living on TYLENOL, (Exp: Apr2018) and MOTRIN; (Lot: 7FE1339A, exp date: Apr2019) and it's not doing any good at all. The patient some pain pills left from when she was in the hospital in Dec2017. Pain pills are oxycodone 10-325mg, generic for PERCOCET. She has been taking these and they don't phase the pain either, they aren't helping. They only let her sleep for a couple hours. The patient went to an orthopedist and had an X-ray done. They didn't find anything wrong with her arm. The patient stated it has to be the vaccine that is causing all this pain and her not being able to move her arm. Therapeutic measures were taken for the event. Outcome of the event unable to move her right arm and Right arm hurts so bad was not recovered; outcome of other event was unknown.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. Medical assistant reported that the patient received first and second dose (dosing information, route of administration and lot number were not provided) of GARDASIL "3 years ago) (approximately 2010/2011) and received third dose (dosing information, route of administration and lot number were not provided) today, on 13-JAN-2014. No adverse effects were reported. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Additional Details: PATIENT HAD A FAINTING EPISODE WITHIN ABOUT 2 MINUTES OF THE VACCINE. RECOVERED AFTER LAYING HIM ON BACK AND ELAVATING HIS LEGS. HAD ANOTHER FAINTING EPISODE ABOUT 5 MINS LATER, THIS TIME WAS SHAKING. RECOVERED AFTER AGAIN BUT THIS TIME SWEATING A LOT. PARAMEDIC CALLED. DECLINED TO BE TAKEN TO HOSPITAL. BENADRYL 25MG TABLET GIVEN.
Headache, 2 day rash neck - upper chest, unsteady and shaky, fell headlong, hurt shoulders, hands, knees, BP up 175/82 - got physical therapy for injury.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received BOOSTRIX (batch number BF252, expiry date 13th September 2020). Co-suspect products included HAVRIX (batch number TB995, expiry date 25th October 2020) and STAMARIL (batch number M53121V, expiry date unknown). On 15th May 2018 10:15, the patient received BOOSTRIX (intramuscular) .5 ml. On 15th May 2018, the patient received the 2nd dose of HAVRIX (intramuscular) and STAMARIL (subcutaneous). In May 2018, less than a week after receiving BOOSTRIX and not applicable after receiving HAVRIX, the patient experienced injection site pain, pain in arm, tingling and neck pain (with radiation). On 15th May 2018, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site pain, pain in arm, tingling, neck pain (with radiation) and wrong injection technique were unknown. The reporter considered the injection site pain, pain in arm, tingling and neck pain (with radiation) to be related to BOOSTRIX. It was unknown if the reporter considered the tingling and neck pain (with radiation) to be related to HAVRIX. Additional details were provided as follows. This case was previously reported to a doctor. The patient received BOOSTRIX vaccine on left deltoid, HAVRIX in right deltoid and a dose of STAMARIL in the left arm. The patient experienced left arm soreness for three or four days. Around day five or six, the arm soreness progressed into left arm pain and tingling that radiates down the arm and up into her neck. It was unknown if the reporter considered injection site pain, pain in arm, tingling and neck pain (with radiation) to be related to STAMARIL. The reporter did not have the expiration dates for the vaccination and were obtained lots for GSK products with lot recall locator.
This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 16-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced swelling arm, erythema of extremities and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities and pain in arm were unknown. It was unknown if the reporter considered the swelling arm, erythema of extremities and pain in arm to be related to BEXSERO. Additional details were provided as follows: Within 24 hours of administration of BEXSERO, the patient's arm got swollen, red, and sore. The patient returned to the office the day after the vaccine to see the doctor.
This spontaneous report as received from a consumer refers to a 70 year old female patient. The patient had no pertinent medical history and no known drug reactions and allergies. In approximately 2009, 5 years ago, the patient was vaccinated with a dose of ZOSTAVAX, one time vaccine to prevent shingles (route, lot #, expiration date were not provided). There was no concomitant medication. The patient received ZOSTAVAX vaccine 5 years ago but on 18-FEB-2014, the patient developed shingles. On 19-FEB-2014, the patient went to doctor and received acyclovir, 800 mg table, 5 a day for 7 days. There were no laboratory diagnostic studies performed. At the time of the report, the patient's status was unknown. Additional information has been requested.
About five minutes after the vaccine patient reported that "he wasn't feeling well.".  When I went to evaluate the patient he was very warm and was breaking out in sweats. He said his vision was very blurry. The patient lost consciousness and had convulsions/lower extremity rigidity for about 30 seconds to a minute. Patient regained consciousness and did not have any more convulsions. Patient was drenched it sweat but slowly regained color and he said his vision was returning to normal. Patient did not remember losing consciousness. EMS was called during the episode and patient was taken for further evaluation by EMS.
HEALTHY, DEVELOPMENTALLY NORMAL 6 MONTH INFANT DEVELOPED 2 UNPROVOKED SEIZURES SHORTLY AFTER RECEIVING HIS 6 MONTH IMMUNIZATIONS (NON FEBRILE)
Initial report received from healthcare professional on 24 September 2014. A 76-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number U5019AA, intramuscular in left deltoid) on 19 September 2014. The patient has no known allergies and illness at the time of vaccination was unknown. It was reported that on 23 September 2014, 4 days after receiving FLUZONE HD vaccine, the patient experienced stabbing pain at the arm lasting 30 minutes and goes on and off for 5 seconds each time. It was reported that, once she gets up the pain goes away and did not come back until the next morning. The patient's corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA331476, 2018SA331166 and 2018SA331478. This case involves a seven years old patient (age not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (formulation Suspension for injection in pre-filled syringe) lot number, Exp. Date, route and administration site not reported. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration and overdose. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
About 15 minutes after receiving the vaccine patient stated that she was dizzy and that her head hurt. Patient was advised to sit for 15 minutes and was monitored by pharmacist. After about 10 minutes patient complained of nausea and was advised to sit for 15 more minutes and was monitored by the pharmacist. After about 45 minutes following initial complaint patient stated that nausea subsided but she was dizzy and her head still hurt. Patient was given a note to call out of work upon request and took a cab home. Pharmacist contacted patient evening of 6/24/21 and patient stated that symptoms were gone after resting for the day.
Cannot move arm without severe pain. Pain radiates to shoulder and neck.  Injection site was high:  Barely below shoulder.
Administered 1st dose of Moderna at 10:06 , Within 5 minutes after receiving the vaccine she developed  hives, SOB and vomiting.  Administered 0.5ml of Epi at 10:12.  Within 3 minutes of administering epi, Pt self reported she was starting to feel better.  Ambulance called and transported to local ER for further evaluation.
Muscle aches, fever, swelling and redness at injection site and surrounding areas, fast heart beat, and difficulties breathing.
I HAVE A COMPLAIN ON YOUR VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced i have a complain on your vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of i have a complain on your vaccine was not reported. This report was non-serious.
Received DTaP/IPV/Varicella on R arm and MMR on L arm on 3/16/10. Presented on 3/18/10 with swelling and redness to L deltoid.  Of note, when vax done on L arm, pt. struggled and knocked needle before safety could be employed and this needle hit the administrator.
Idiopathic hypersomnia, fevers when exerting self too much (still currently),  tachycardia.
now both legs are acting like I have peripheral neuropathy; I got the second shot almost 8 weeks later; having a hard time just walking; very painful; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-year-old male patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 2021 as dose 2, single (Age at Vaccination:70) for covid-19 immunisation. He received bnt162b2 (BNT162B2, Batch/Lot number: EW0176) via an unspecified route of administration, administered in right arm on 3May2021 at 10:00 AM as dose 1 single, for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing if covid prior vaccination: Yes, drug hypersensitivity from an unknown date and unknown if ongoing known allergies as Penicillin. Concomitant medication included finasteride (5mg daily) and metoprolol (25mg daily). Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 2021, The patient reported now his both legs were acting like i had peripheral neuropathy, got the second shot almost 8 weeks late, had a hard time just walking, very painful. After received the first shot, On 06May2021 at 01:00AM he started had a pain in my right calf and hamstring muscle. Like a pulled muscle. He had not been doing any heavy exercise other than walking. It was hard to walk because his right leg felt heavy. He got second shot almost 8 weeks later and now both legs was acting like he had peripheral Neuropathy. He was having a hard time just walking and it was very painful. He received treatment for the adverse event (testing pending). The outcome of the events were not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Case number PHEH2014US023262, is an initial spontaneous report from a pharmacist received on 18 Nov 2014. This report refers to a 15-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 1413701) intramuscularly on 05 Nov 2014. On an unknown date, after vaccination, she experienced pain at the injection site. Outcome of the event was unknown. Seriousness and causality of the event was not reported.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 14-AUG-2014 the patient was vaccinated with one dose of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous (lot number not reported) that was stored improperly. No adverse effects were reported. Additional information has been requested.
Headache, joints and muscles pains, rush from tummy and neck spreading out everywhere else.
On December 3, 2021, I went to ER with heart palpitation, sore chest and arm. They found that my lymph node was swollen. I was referred to a breast doctor for assessment. It was over 7 weeks the lymph node became larger had surgery on March 9, 2022 at Surgery Center. The biopsy results shows I now have Castleman disease which is extremely rare. I am currently seeing a Oncologist for bloodwork and upcoming PET scan.
Beginning ~ 14 days after 2nd dose (Mid-March), patient began experiencing cognitive impairment which included inability to remember names, dates and confusion with simple tasks. On 5.1.2021, as the cognitive impairment continued, patient could not "string words together" to form sentences and began experiencing extreme fatigue, sleeping > 12 hours/day. On 5.5.21, spouse took patient to ER due to increased cognitive impairment and fatigue.
This spontaneous prospective pregnancy report as received from a physician refers to a 19 year old female patient. No pertinent medical history, drug reactions or allergies were reported. On an unknown date the patient was vaccinated with GARDASIL (strength, formulation, dose, dose number, route, lot number and expiration date were unspecified) and afterwards it was determined that the patient was pregnant (unspecified date). Concomitant therapies were not reported. Laboratory diagnostic studies performed were unspecified. The patient sought medical attention (unspecified). The patient became pregnant with last menstrual period of 26-JUN-2014 (reported as 3-4 weeks of gestation) and estimated delivery date of 02-APR-2015. The pregnancy outcome was pending. The outcome of the event was unknown. Additional information has been requested.
My unvaccinated family members are sick with covid. Im having symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of SUSPECTED COVID-19 (My unvaccinated family members are sick with covid. Im having symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (My unvaccinated family members are sick with covid. Im having symptoms). At the time of the report, SUSPECTED COVID-19 (My unvaccinated family members are sick with covid. Im having symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had 2 doses of Moderna and had a booster. No concomitant medication were provided. No treatment information were given.  This case concerns a patient of unknown gender and age with no relevant medical history, who experienced the non-serious adverse event of special interest of suspected COVID-19. The event occurred on an unknown date after the third dose of mRNA-1273. The rechallenge was assessed as not applicable since the AE occurred after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.; Sender's Comments: This case concerns a patient of unknown gender and age with no relevant medical history, who experienced the non-serious adverse event of special interest of suspected COVID-19. The event occurred on an unknown date after the third dose of mRNA-1273. The rechallenge was assessed as not applicable since the AE occurred after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.