chrisvoncsefalvay/vaers-outcomes huggingface dataset:
random severe muscular and joint pain; random severe muscular and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (random severe muscular and joint pain) and ARTHRALGIA (random severe muscular and joint pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0l0m20A) for Prevention.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced MYALGIA (random severe muscular and joint pain) and ARTHRALGIA (random severe muscular and joint pain). On 03-Aug-2021, MYALGIA (random severe muscular and joint pain) and ARTHRALGIA (random severe muscular and joint pain) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.
It started that same day after getting my vaccine. I begun to have chills, fever, no energy and I couldn't get out of bed for the rest of the night. I was able to go to work, because I work from home. By the time that evening came, I was feeling better.
I had my vaccine on 04/05/2022. In the evening I did not feel well so I went to bed. I had chills, slight fever. I took Tylenol and I slept it off for nearly 2 days. Just getting up and using the bathroom and hydrate. I felt weak, fatigued, and it was my worst vaccine for sure. This lingered on an extra day, longer than the others.   I was exposed the first of May by my husband who tested positive for COVID on 5/8/2022. I had At-Home COVID tests, so when I knew I was exposed from him, I tested on 5/9 and it was negative. I tested on 5/11 and I was still negative when my symptoms began. I tested on 5/12 and I was still negative. 5/12/2022 I also had a vault test as a back up. I did take that test and had my son mail that out, but I do not have the results yet. I felt pretty bad at this point, so my husband made an appointment with his doctor on 5/13. I took another COVID test before this appointment and it came back positive. I knew I had to confirm with the doctor for the positive test, so I went to the clinic. From there, my daughter made a suggestion for me to go to an infusion center to get an antibody infusion. I went straight from clinic and to the infusion center. The lady at clinic prescribed the anti-viral Paxlovid and told me not to take it until I got the infusion. She suggested that I also use a nebulizer to help me keep my airways open. Prescribed a medication that was expensive and ended up using albuterol instead. Used the nebulizer for a few days to keep airways open. Also suggested Pepcid for the stomach part of the symptoms. Also another medication to help with breathing. Just took Tylenol for the aches and pains. I would consider my case to be very mild. No fever, just had a stuffy head, congestion, store throat, croaky like I had a cold, drainage and lost taste and smell. Heaviness in chest. Seemed like a severe bronchitis. My O2 never went below 90. Heart rate was elevated a little bit. Dropped a little bit one night, but honestly seemed like a mild case. My symptoms are completely gone now, other than just my taste.
They notice a foreign substance in that prefilled syringe and they wanted to let us know and it was not administered to any patient; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  The following information was reported: PRODUCT CONTAMINATION PHYSICAL (non-serious), outcome "unknown", described as "They notice a foreign substance in that prefilled syringe and they wanted to let us know and it was not administered to any patient".
Hands it started drying up; My skin when I washed my hand it started too turn red and felt like they were on fire; My skin when I washed my hand it started too turn red and felt like they were on fire; Body is irritated/ my hands is turning irritated; Feel itchy almost anywhere my face, neck. Arms, and legs upper back/ my legs get itchy/ itchy skin feeling; My face is irritated by the itchy skin feeling; This is a spontaneous report from a contactable Other HCP (reported for herself). A 37-years-old non pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration on 20Jan2021 at 03:00 as SINGLE DOSE for covid-19 immunization. Medical history included allergies to medications, food, and other products included catfish, fish oil pills. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and medications within 2 weeks of vaccination. It was reported that On 22Jan2021 at 10:00, patient had all the side effects plus a few more as hands it started drying up patient skin when she washed hand it started to turn red and felt like they were on fire and still today a week down the road patient still having trouble with hands and body is irritated by it. Patient feel itchy almost anywhere on face, neck. Arms, and legs upper back, still is bothersome with irritation to itch cause skin is drying up or something and hands are turning irritated the most when patient get them wet and legs get itchy after wash them. patient face was irritated by the itchy skin feeling. No treatment was received for the adverse events. On an unknown date, the events were recovered with sequelae. The vaccine was administered in nursing home/senior living facility. Prior to vaccination, was the patient has not diagnosed with COVID-19. Since the vaccination, the patient has been not tested for COVID-19.  No follow-up attempts were possible; information about lot/batch number cannot be obtained.
complains of sore throat, left ear ache, chills, painful knees, stomach ache, productive cough, and shortness of breath.
PATIENT 19 YEARS OF AGE WAS ADMINISTERED ENGERIX B 20MCG/ML INSTEAD OF 10MCG/ML
Redness, swelling, pain that went up arm and around to back. Still extremely red and swollen 4 days later.
approximately 3 months post 2nd vaccination, dropped his hemoglobin from 12.5 to 6, upon further workup he was diagnosed with a lymphoma, Waldenstorm's Macroglobulinemia; approximately 3 months post 2nd vaccination, dropped his hemoglobin from 12.5 to 6, upon further workup he was diagnosed with a lymphoma, Waldenstorm's Macroglobulinemia; approximately 3 months post 2nd vaccination, dropped his hemoglobin from 12.5 to 6, upon further workup he was diagnosed with a lymphoma, Waldenstorm's Macroglobulinemia; This is a spontaneous report from a contactable consumer (patient). A  71-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in the left arm on 24May2021 (Batch/Lot Number: ET6924) at an unspecified dose and  dose 2 via an unspecified route of administration in the left arm on 14Jun2021 (Batch/Lot Number: FC2396) as an unspecified dose for COVID-19 immunisation. Medical history included alpha Thal - HTN (hypertension) from an unknown date and unknown if ongoing , macular degeneration from an unknown date and unknown if ongoing, history of hepatitis B  from an unknown date reported as "50 years ago" and unknown if ongoing. Concomitant medication included candesartan (CANDESARTAN) taken for an unspecified indication, start and stop date were not reported; nebivolol (NEBIVOLOL) taken for an unspecified indication, start and stop date were not reported.  The patient's allergies included sulfa. The patient had received no other vaccines within four weeks. The patient was not diagnosed with COVID-19  prior to vaccination. Approximately 3 months post 2nd vaccination, the patient's hemoglobin dropped  from 12.5 to 6; upon further workup the patient was diagnosed with a lymphoma, Waldenstorm's macroglobulinemia on 28Oct2021 with outcomes of unknown.  The patient was hospitalized for 2 days.  Since the vaccination the patient has been tested for COVID-19; he was rt-pcr: negative on 17Nov2021 via  Nasal Swab.   Treatment for the events was reported as "no." The outcome of the events was reported as unknown.   This may be a duplicate if the reporter also submitted directly to his/her local agency.
Case number PHEH2016US032028, is an initial spontaneous report received from a medical assistant on 05, 2016. This report refers to a 46 years old female patient. Prior vaccination history included vaccination with influenza vaccine (unknown whether seasonal or pandemic, other manufacturer, batch number: not reported) at a dose of 0.5 ml intramuscularly into right arm on an unknown date with no side effects (well tolerated). Past medical history was not reported. Current condition included asthma. Concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (seasonal, batch number: not reported, Expiry date: Sep 2017) a t a dose of 0.5 ml subcutaneously into right arm on 01 Dec 2016 at 4:30 PM. It was reported that, the patient received FLUVIRIN as an injection in the back of the arm with a 1 inch 25 gauge needle, not in the deltoid muscle. The patient did not feel it was an intramuscular injection, reporter stated it was subcutaneous injection. No adverse event reported following this medication error (inappropriate route of vaccination and vaccine administered at inappropriate site). The Quality Assurance department confirmed that the initially reported batch number 1669901 and the follow up batch number Revie0018003 were not valid for FLUVIRIN. Follow up report received from a medical assistant on 06 Jan 2017: Updated reporter details (fax number), added patient demographics (height and weight), added prior vaccination history, current condition (asthma) and updated FLUVIRIN information (the dosage regimen anatomical location for FLUVIRIN and time of administration).
It was reported that a pt (3 of 3) received a Tripedia vaccination, date not specified. Reportedly, 24-48 hours, post vax, the pt developed a local reaction of swelling, redness and erythema at the injection site. Further information is requested. From additional correspondence received on 5/7/01, it was reported that the pt is unknown.
Information has been received from a nurse practitioner (N.P.) concerning a 93-year-old immunocompromised female who was vaccinated with a 0.65 ml dose of Zostavax. Concomitant therapy included an unspecified antibiotic. It was reported that the patient was just out of the hospital for pneumonia, received Zostavax. Subsequently, the patient died. The cause of death was unknown. No further information was available at the time of this report. No product quality complaint was involved. Additional information has been requested.  10/16/07 Reviewed ER medical records of 8/19/07 which reveal patient seen for UTI.  Exam revealed bilateral basilar rales & cool purple feet.  Tx w/IV antibiotics & IVF.  Foley catheter inserted.  D/C to nursing home to continue IV antibiotics x 5 more days. 4/1/08 Reviewed death certificate which states COD as urosepsis.
Flu-like symptoms (achiness in all joints, fever w/ chills, cough, and fatigue), migraine headache, elevated heart rate (115 avg. bpm resting), repeated inconclusive ecg readings.
Initial unsolicited report received from a healthcare professional on 23-Jan-2015. A 40 years old male patient, had received a dose of MENACTRA via intramuscular route in the right deltoid (batch number: U4798AA, expiry date not provided) and ADACEL via intramuscular route in the left deltoid (batch number: U4971AA, expiry date not provided) on 22-Jan-2015 at 08:30 a.m. There was no pre-existing physician diagnosed allergies, birth defects, medical conditions and no illness at the time of vaccination. The concomitant medications were not reported. On 22-Jan-2015, at about 09:00 p.m., the patient experienced chills, felt hot and his deltoid muscles were hurting. That morning the patient felt better. Chills had gone but the patient had headache. It was reported that the patient did not take any "ADVIL". Laboratory investigations were not reported. The patient had recovered from chills on an unknown date however he still had headache. The patient outcome was unknown. Documents held by sender: none. Follow up information received from a healthcare professional on 23 April 2015. It was reported that, patient had received a second dose of MENACTRA and ADACEL on 22-Jan-2015 at 08:30 a.m. Patient had no other prior vaccination within four weeks and laboratory investigations. On an unspecified date, patient had recovered. Documents held by sender: none. Addendum on 15 July 2015: Upon second medical examination of the case during internal review, a significant correction was performed on 15 July 2015 to change the reporter from non-healthcare professional to health care professional in the reporter screen and narrative, to change 'administered by' from unknown to blank, to correct lot numbers in narrative and product screen, to leave the medically confirmed field blank, to mention about the event 'headache' in narrative, to add onset time of events and to enter full name of the reporter in the reporter screen.
It was an increase in the amount of muscle spasms I was having in my body especially in my throat. My airway was closing up on me for no reason which was normal for me but was definitely increased after the vaccine. The amount of migraines I experienced had also increased. I had both pain and numbness on the left side of my body. I went to the ER for what they thought was a blood clot in my leg. Nothing was found despite symptoms pointing to blood clot. My neurologist, nor my doctor, have any reason as to why this is happening.
11/03/2021- I noticed bumps on my forehead. 11/04/2021 - I went to the doctor. He prescribed an Antiviral for shingles, it dissipated a lot. It was still annoying, but it did much better than it normally would. 11/18/2021- I still have pain from shingles and a little bit of bumps.
First dose: Sore arm: Caller reported that her arm was sore for 2 days after she received the first dose of the Covid-19 vaccine on 06Apr2021; First dose: Black spot on arm; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0151, Expiry date: unknown), via an unspecified route of administration, administered in right arm on 06Apr2021 (63-year-old at the time of vaccination), as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing High Blood pressure from 2002, Anxiety attack (she used to have anxiety attacks but hasn't for a while Investigation) and hypertension (she has a family history of high blood pressure, and she has a sister that is in remission from cancer). Concomitant medication includes unspecified blood pressure pill for the indication of high blood pressure from an unknown start date. On 06apr2021, after the first dose of vaccination, the patient experienced sore arm. It was reported that her arm was sore for 2 days after she received the first dose of the covid-19 vaccine and on an unspecified date in Apr2021, she experienced black spot-on arm. It was reported that patient arm was sore for 2 days after she received the first dose of the Covid-19 vaccine on 06Apr2021. Patient reported that she could feel the tension and soreness in her arm but within 2 days it had disappeared. First dose: Black spot-on arm: patient reported that within the first two days of receiving her first dose of the Covid-19 vaccine on 06Apr2021, a small black spot appeared on her arm. The black spot disappeared after about 5 days. Patient reported that she received the Covid-19 vaccine because she wants to be around her family. She has not really been around her family because she has an elderly mother at 93. There are a lot of people in her family, and she just wants to be safe. She has newborns and babies coming in her family and she just wants to be safe. Patient was queried for concomitant products twice. She was instructed to take vitamin D by her physician, but she has not started taking it yet. Patient reported later in call that she only takes a blood pressure pill. No details provided. On an unspecified date in Apr2021, the patient resolved from the events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021486009 similar report from same reporter
Information has been received from a medical assistant(also reported as office manager) referring to a 12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 25-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 2. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
Loud tinnitus in both ears approximately 12 hours after shot.; dizziness; vertigo; This is a spontaneous report from a contactable consumer, the patient. A 51-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 29Apr2021 at 09:15(at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA ALLERGY) for seasonal allergy from an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 21:00, the patient experienced loud tinnitus, dizziness and vertigo. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event loud tinnitus, dizziness and vertigo was not recovered at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
DIDN'T END UP WELL; This spontaneous report received from a consumer concerned multiple patients.  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 (dose number series 1). 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 didn't end up well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of didn't end up well was not reported. This report was non-serious.
Shingrix Vaccine at 4:50 P.M.; at 4:55 P.M. a headache shot up the back of my head and immediately after a wave of heat went through my body, lightheadedness overcame me and I thought I was going to pass out, tachycardia (114 BPM versus my normal 70), trembling. At 4:59 P.M. I alerted the nurse that I felt "weird." and described my symptoms. It was not an anaphylaxis but, I did feel like I had to take deep breaths in to catch my breath. I felt like I was going to have a heart attack any moment. I asked for an escort in case I passed out and had someone pick me up. My intentions were to go to the hospital parking lot in case my situation got worse. I didn't feel confident that they were equipped at the administration building. They told me that they have an epi pen but, I didn't want to start asking if they knew where the AED machines was. I opted to get a ride to a possible hospital instead. After 30 minutes, I felt like I was "out of the woods." I wasn't 100% but, better. It was extremely scary. I've never had a reaction like this to anything in my life and I'm not allergic to anything.
Initial report received from a healthcare professional on 18 September 2013. A female patient, whose age and date of birth were not reported, had received an intradermal first dose of FLUZONE ID (Batch number and anatomical side of vaccination was not reported) on 13 September 2013. The patient had no illness at the time of vaccination. The patient had previously received flu vaccine intramuscularly without side effects. Patient's pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. On 13 September 2013, after vaccination, the patient felt the shot like thousand tiny needles, pain and very hard softball size lump at vaccination site hard and hot to touch. Patient had pain to armpit. it was reported that the lump was of dime size by 17 September 2013. The pain in armpit also extended to ribcage. Laboratory investigations and corrective treatments were not reported. As of 18 September 2013, the patient had not recovered from the events.
1000 came back to the clinic from her department states just feels fuzzy/dizzy taken to cot VS 109/77 72 100RA denies any other issues witnessed far away gaze when talking with her . She states got back to department and just didn't feel right and had a bit to eat and drink and told coworker and they brought her back down to the clinic. She was monitored as denied any pain 0/10 or any other symptoms.  1010 112/60  70 100 RA denies any pain A&O times three able to focus no more distant feeling 10/20 114/78 72 100 RA denies any pain A& O times three denies any pain, nausea SOB, chest discomfort at this time 1030 116/76 75 100 RA denies any pain states she is not fuzzy or disoriented at this tiem feels much better but just feels tired. instructed to monitor herself and if any issues to go to ER. states she will comply.  1833 spoke with pt states went home slept and is feeling much better just felt fuzzy and disoriented for that hour after the vaccination.
Patient now has diabetes and heart condition.; Patient now has diabetes and heart condition.; This spontaneous report was received from customer and refers to a male patient before the age of 65. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, quantity: 1, for prophylaxis (lot #, expiry date, anatomical location, and route of administration were not provided).  On an unknown date, the patient experienced diabetes and heart condition. The reporter asked if the patient (he) could get another pneumonia vaccine. The causal relationship between the events diabetes and heart disease, unspecified pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, the event diabetes was determined to be medically significant.