chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CKD Stage 5; Anemia in chronic kidney disease; covid; This spontaneous case was reported by an other health care professional and describes the occurrence of END STAGE RENAL DISEASE (CKD Stage 5) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product EPOETIN ALFA EPBX (RETACRIT [EPOETIN ALFA EPBX]) for an unknown indication.    The patient's past medical history included Unconsciousness and Dyspnea (Severe). Concurrent medical conditions included Sulfonamide allergy (Sulfa (Sulfonamide Antibiotics): Dyspnea (Severe)) and Drug allergy (Codeine: Dyspnea (Severe) - unconsciousness).   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. and EPOETIN ALFA EPBX (RETACRIT [EPOETIN ALFA EPBX]) (unknown route) at an unspecified dose every two weeks. In 2022, the patient experienced COVID-19 (covid). On an unknown date, the patient experienced END STAGE RENAL DISEASE (CKD Stage 5) (seriousness criterion medically significant) and ANAEMIA (Anemia in chronic kidney disease). At the time of the report, END STAGE RENAL DISEASE (CKD Stage 5), ANAEMIA (Anemia in chronic kidney disease) and COVID-19 (covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Had covid 2022.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Primary diagnosis was reported as anemia in chronic kidney disease and secondary diagnosis was reported as CKD Stage 5.  It was reported as on an unknown date, the patient had Covid vaccine Moderna 2 doses. Had covid 2022.  No treatment medications reported. Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported relevant medical history, who experienced the serious (due to medically significant) unexpected event of end stage renal disease, which occurred on an unknown date after receiving mRNA-1273 Bivalent .222 (Moderna COVID-19 vaccine, bivalent (original and omicron BA.4/BA.5. Primary diagnosis was reported as anemia in chronic kidney disease and secondary diagnosis was reported as CKD Stage 5. NO further information was disclosed. EPOETIN ALFA EPBX was considered as a co-suspect drug. The benefit-risk relationship of mRNA-1273 Bivalent .222 (Moderna COVID-19 vaccine, bivalent (original and omicron BA.4/BA.5) is not affected by this report.
Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and expiration date not reported), intramuscular administered to left arm on 04Jan2021 14:00 for COVID-19 immunization. Vaccination Facility Type: Hospital. Medical history included migraine. Patient had medication for them, but has not had any migraines in a long time. The patient's concomitant medications were not reported. There were no other vaccines given the same day. Patient had no problems with vaccines in past. The patient had questions about the side effects of the Covid vaccine. On 04Jan2021 when she got the first dose, later that day (a few hours after the shot) the patient experienced flu like symptoms (body aches, headache, muscle aches, and light fever). Had the headache for about 4 days with the first dose. All this lasted about 4 days. They cleared up and she was fine. The patient wanted to know if anyone reported any of this or prolonged symptoms. Patient was unable to provide seriousness criteria when queried, only states that it was very frustrating, it's not life threatening, but she was at home versus being at work. No investigation assessment/relevant tests performed. The patient recovered from the events on an unspecified date in Jan2021. The reporter considered the events as related to the Covid vaccine.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
9/9 - Patient developed a penny sized bruise the evening of vaccination. It was described as sore and had shooting pain. 9/10 - bruise became rash like, warm, and symptoms persisted. Grew to the size of a half-dollar coin. 9/11 - at the time of reporting, the rash was rectangular in shape (approx 1"x2.5"), warm to the touch. Patient reports shooting pain of 4-5 and not able to sleep on the side of arm where shot was given. Patient denies pain or soreness at the site of Prevnar 13 injection (RA, deltoid). Some soreness was reported for LA deltoid from flu shot, patient has hx of soreness with flu shot).
Hives; palpitations; swelling lymphnodes; chills; vomiting; heart beating fast; Nausea; Swelling; Soreness around injection site; Redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), HEART RATE INCREASED (heart beating fast), URTICARIA (Hives), PALPITATIONS (palpitations) and VOMITING (vomiting) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives, Penicillin allergy since 1992, Allergy to antibiotic since 2014 and Environmental allergy (Acute hives or rashes all over the body) since 1988. Concomitant products included LORATADINE (CLARITIN HIVES RELIEF) for Hives.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PAIN (Soreness around injection site). On 06-Jan-2021, the patient experienced SWELLING (Swelling). On 16-Jan-2021, the patient experienced HEART RATE INCREASED (heart beating fast), VOMITING (vomiting) and NAUSEA (Nausea). On an unknown date, the patient experienced URTICARIA (Hives), PALPITATIONS (palpitations), LYMPHADENOPATHY (swelling lymphnodes) and CHILLS (chills). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) from 06-Jan-2021 to 15-Jan-2021 for Swelling, at a dose of 1 dosage form once a day; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) (oral) from 29-Jan-2021 to 30-Jan-2021 for Swelling, at a dose of daily and PARACETAMOL (TYLENOL) (oral) from 29-Jan-2021 to 30-Jan-2021 for Adverse event, at a dose of 4 doses within 24 h. On 03-Jan-2021, VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PAIN (Soreness around injection site) had resolved. On 15-Jan-2021, SWELLING (Swelling) had resolved. On 16-Jan-2021, HEART RATE INCREASED (heart beating fast), VOMITING (vomiting) and NAUSEA (Nausea) had resolved. At the time of the report, URTICARIA (Hives), PALPITATIONS (palpitations), LYMPHADENOPATHY (swelling lymphnodes) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 38.5 degree Celsius (High) 38.5. On 29-Jan-2021, Heart rate: 98 (High) 98. On 30-Jan-2021, Body temperature: 38.5 degree Celsius (High) 38.5. On 30-Jan-2021, Heart rate: 98 (High) 98.         This case was linked to MOD-2021-019963 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-Jun-2021: Some events were updated, Treatment information added.
Five days after receiving my first COVID vaccine I had a headache come on near my temple. I never get headaches and just thought it wasn't anything to be worried about. The headache remained the same and 4 days later I went to an urgent care. The nurse said it was probably a tension headache and gave me prescription Motrin. The headache never seemed to go away so I went to my primary care doctor's practice. She wasn't available so I saw another doctor. This doctor said it was probably some kind of virus and that it would go away in 3 weeks. I asked her about if this was a side effect of the vaccine and she said they don't know all the side effects. How awful! If you are going to tell people to get this vaccine, you need to be prepared for the side effects and not to brush people off. I followed up with my primary care doctor and she gave me an antibiotic because I felt so much inflammation in my face/head. The antibiotic and I switched doctors because she was also pretty unhelpful. My newest doctor has been so incredibly helpful! I'm currently on prednisone and it has eased some of the inflammation after 5 weeks of horrible headaches. I wish I would have never have gotten this vaccine. I know there are risks with everything, but this has been terrible and I wouldn't wish it on anyone.
Patient received vaccination on Friday 8/16/2013. Contacted clinic on Monday 8/19/2013 complaining of pain, redness, and swelling at injection site. Patient was prescribed cephalexin and advised to take OTC NSAID (not specified) and follow up with provider. Cephalexin 500 mg QID.
Patient came into the office with a complaint of right shoulder pain one day after having the Pneumovax vaccine . She was seen by one of our nurses and stated that her shoulder began to hurt about 2 hrs after she received a pneumonia vaccine in that arm and that it had become progressively worse and now she was having difficulty lifting her arm. Patient also stated that she was given a Shingrix vaccine in her left arm a short time after the pneumonia  and that shoulder was fine. She was seen and treated by one of our nurse practitioners.   Her recommended treatment was to  take acetaminophen or naproxen for the pain and ice for the swelling. . Her arm was placed in a sling to help relieve pressure.  The patient was referred for OT and PT and an MRI was ordered. Also a follow up office visit with her PCP was made for 3 days later. The patient went to OT/PT the next day and began working on ROM exercises. The patient was contacted by our compliance officer   3 days later for a follow up interview.  Patient stated that her arm is feeling  better and she was able to move and lift it again with minimal pain. She declined to have the MRI done and cancelled her follow up appointment with her PCP because her arm was better.
Next day after shot, had strong fever/aches/joint pain reaction. Several days later, developed petechiae across trunk and thighs. Went to Facility, saw Dr who prescribed bloodwork to test platelet levels. By the time of the test, platelets were within the normal range, so no treatment was undertaken. Lingering lightheadedness upon standing/headache for about another week.
Vaccine was drawn up 9-27-21 at 1710, exp time 2310. Vaccine was given 9-28-21 at 915a. Talked with Pfizer 9-28-21 at 945a, was advised if vaccine was stored in the refrigerator for less than 24 hours between 2-30 C vaccine did not need to be repeated
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with Human immunodeficiency virus (HIV). On approximately 23-AUG-2013 reported as two weeks ago the patient was vaccinated with VARIVAX (Merck) (dose, route, lot number and expiration date not provided). The pharmacist further reported that patient had a prescription for PEGINTRON at the pharmacy and would like to start the PEGINTRON at 06-AUG-2013. Pharmacist could not clarify as to when the patient was diagnosed with hepatitis C. The outcome of hepatitis C was unknown. The relatedness between vaccination with VARIVAX (Merck) and M-M-R II and hepatitis C was not reported. Additional information has been requested.
Information has been received from a physician concerning a 47 year old female patient with a history of Asthma and recurrent Sinusitis, who just recovered from Sinusitis, was vaccinated subcutaneously in the right upper extremity with a 0.5ml first dose of varicella virus vaccine live (Oka/Merck)(644031/1058M) on 04/06/2004.  Subsequently the patient's Sinusitis recurred.  Unspecified medical attention was sought.  It was noted that prior to vaccination the patient had a varicella titer drawn which was very low.  There was no product quality complaint involved.  Follow up information indicated that at the time of vaccination, the patient had a sinus infection that was almost resolved.  On 04/07/2004 she developed a runny nose, aching and chills which appear to be related to an upper respiratory infection (URI).  Subsequently the patient developed a cough.  The physician questioned if this was related to "VARIVAX" versus coincidence with the onset of URI.  On 04/16/2004 the patient recovered.  No further information is expected.
Within 15 minutes of getting  vaccine dizzy, lightheaded and nauseous, pins and needles tingling sensation down left side of body For the past week I've been incredibly nauseous and having leg pain and aches constantly.  Plus fatigue. Still feeling pins and needles sensation off and on
On Thursday May 13th, 2021, patient arrived  to receive his first Pfizer vaccination. Patient was vaccinated and sent to the observation area.  At 1342, the patient stated," I feel dizzy, like I might pass out," to EMT observer. EMT observer immediately assisted the patient to the gravity chair. The patient's vital signs were taken: BP 110/72, HR 84, RR 15, oxygen saturation at 96% . The patient was alert and oriented to person, place, time, and situation. The patient was given water and stated, " I feel so much better after sitting in this chair." No loss of consciousness or syncope occurred. The patient was given a bottle of water.  Co-lead, assessed the patient, who was alert and oriented to person, place, time, and situation, was in no apparent distress, and was speaking in full sentences. No pallor or diaphoresis was observed.  Vitals were taken at 1347: BP 108/70, HR 63, RR 14, oxygen saturation at 99%. The patient took off his mask to reduce anxiety. Denied any history of fainting. or having any known drug allergies. Vitals were retaken at 1352: BP 120/68, HR 63, RR 14 ,oxygen saturation at 98%. The patient was offered a granola bar but denied it, as he ate around 1230. Patient denied any shortness of breath, blurry vision, lightheadedness, dizziness, itching, nausea, or facial flushing. The patient stated, " I feel totally fine."  Vitals were retaken at 1357, BP 120/70, RR: 14, HR 63, and oxygen saturation at 98%. Notified patient to inform the vaccinator about his reaction when returning for his second Pfizer dose. Vital retaken at 1402, BP 125/ 68, RR 14, HR 63, 98% oxygen saturation. The patient felt comfortable to drive home and left the site at 1405. The patient left the site with an even and steady gait.
This spontaneous report was received from a certified medical assistant and refers to an unknown number of unspecified patients of unknown demographics. No information regarding any of the patients' medical history, concomitant medications and concurrent conditions was provided. On unknown dates in 2017, between 01-FEB-2017 and 04-MAY-2017, the patients were vaccinated with doses of improperly stored ROTATEQ oral liquid (lot number: M031553, expiration date: 19-MAR-2018 and lot number M038847, expiration date: 27-APR-2018, dose was not reported). The vaccine was stored in a temperature between 47 and 77 degrees Fahrenheit for 2256 hours. No previous temperature excursions were reported, the Digital Data Logger was not involved. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004568: US-009507513-1705USA004513: US-009507513-1705USA004567:
patient had to go to the emergency room because her jaw locked up after receiving first COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of JAW DISORDER (patient had to go to the emergency room because her jaw locked up after receiving first COVID-19 vaccine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Pulmonary arterial hypertension.    The patient's past medical history included Serotonin syndrome. Concurrent medical conditions included Pulmonary arterial hypertension since 29-Nov-2020. Concomitant products included MACITENTAN, TADALAFIL and WARFARIN SODIUM for an unknown indication.   On 19-Nov-2020, the patient started TREPROSTINIL SODIUM (Intravenous) .09 microgram/kilogram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JAW DISORDER (patient had to go to the emergency room because her jaw locked up after receiving first COVID-19 vaccine). At the time of the report, JAW DISORDER (patient had to go to the emergency room because her jaw locked up after receiving first COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Treprostinil sodium (IV) (TREPROSTINIL SODIUM) (Continued).
Redness over the left upper arm, pain and swelling that lasted 4 days (and counting). Though, swelling and redness are decreasing. Patient reported this same reaction when she receieved this same vaccine last year from a different facility.
Loss of appetite/experiencing the same symptoms; both had itching in both feet 1st week; This is a spontaneous report from a contactable consumer or other non-HCP (parent reported for daughter). A female patient of an unspecified age received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8737) via an unspecified route of administration in left arm on 01Apr2021 14:45 in left arm as dose 1, single for COVID-19 immunization. Vaccination facility type was reported as Pharmacy/drug store. Medical history included mental illness (reported as mentally ill). The concomitant medications were not reported. The patient had not taken other vaccines within 4 weeks. The patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. On an unspecified date in Apr2021, the patient experienced loss of appetite and had itching in both feet first week. Patient was mentally ill and was experiencing the same symptoms but decreasing for her. No nose bleed for daughter. The clinical outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Chills and headache. Started in the middle of the night after receiving vaccine and lasted the whole day. Arm sore and itching at site of injection.
Started 4 days after #2 she  has had incontinent fatigue and palpitations
Around 12 hours after the Moderna booster I woke up with a terrible headache. Mostly at the back of my head and neck. I took ibuprofen but it did nothing for the pain. A few hours later I developed a fever. It started at 101 and throughout the day went up to 104. Ibuprofen did not bring it down. I also experienced hot flashes and chills, congestion and body aches all on the right side of my body.  I couldn?t touch or lie on my right  arm the first night after the shot.  The intense and painful headache/migraine  lasted almost 24 hours.  The next morning around 7am the fever broke and headache subsided.
Lupus; Skin Rash; congestion in ears and head; congestion in ears and head; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249), via an unspecified route of administration, administered in right arm on 02Feb2021 12:00 at single dose for COVID-19 immunisation. The patient's medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of reporting. Prior to vaccination, the patient had no COVID and patient was not tested for COVID post vaccination. The vaccine facility type was hospital. On 05Feb2021 at 07:00 AM, the patient experienced skin rash, and congestion in ears and head. The patient was diagnosed with lupus on 25Feb2021 (also reported as 25Mar2021 - pending confirmation). Events resulted to Emergency Room visit and Physician Office visit. Therapeutic measures were taken as a result of the events and included steroid shots, antihistamines shots, and antibiotics. The outcome of the events was not recovered. Seriousness of the events was disability.
Information has been received from a registered nurse concerning an over 60 year old male who on approximately 15Mar04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On approximately 15Mar04, several hours after vaccination, the pt developed injection site pain, redness, warmth and swelling. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. A pt from the same source had a similar experience.
Idiopathic Thrombocytopenia Purpura platelet count 8,000. Following WinRho platelet count recovered to 234,000.  1/22/08 Reviewed pcp medical records which reveal patient experienced rash x 3 days when seen 12/31/07 w/o fever or other signs of illness.  Exam revealed petechia on extremities, trunk & back & multiple purple bruises on shins & left forehead.  Labs done revealed decreased plts.  Hospitalized 12/31/07-1/1/08 & received WinRo.  Plts increased from 8,000 to 58,000 & microscopic hematuria improved.  Consult by peds heme/onc while hospitalized.  Plts count repeated on visit 1/4 & were 234,000.  Having mild diarrhea & diaper rash.  Petechia & bruises were resolving.  Was to continue serial labs & heme/onc f/u. FINAL PCP DX: ITP, resolving; anemia secondary to WinRo. 1/22/08 Reviewed hospital medical records which reveal patient experienced rash, bruising, irritability & sleepiness x 3 days.  Transient diarrheal illness in pt & parents 1-2 wks & URI 1 mo prior to admit.  Both parents w/viral URI.  Admitted 12/31/07-1/1/08.  Responded well to WinRo & d/c to home w/heme  & lab f/u. FINAL DX: Immune thrombocytopenic purpura & benign hyperalkaline phosphotase (qcquired vx familial), microscopic hematuria, resolving.
She was observed after influenza injection for 15 minutes with no adverse SE noted.  Later that evening she states that her arm became red and pain progressed up to her neck and then she got a headache.  She states she did not go to her doctor.  She states pain was relieved by 1/2 Aleve.