chrisvoncsefalvay/vaers-outcomes huggingface dataset:
both arms are sore/flu shot in one arm and COVID in the other; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (both arms are sore/flu shot in one arm and COVID in the other) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    The patient's past medical history included Knee replacement (trying to rest from left knee replacement) on 23-Sep-2022.   On 06-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2022, the patient experienced PAIN IN EXTREMITY (both arms are sore/flu shot in one arm and COVID in the other). At the time of the report, PAIN IN EXTREMITY (both arms are sore/flu shot in one arm and COVID in the other) outcome was unknown.            No Concomitant medications were provided.  It was reported that patient had a booster, fifth one.  Patient was trying to get over the shot from yesterday 06 Oct 2022. Patient got the flu shot in one arm and the COVID shot in the other. Both arms were sore.  No treatment medications were provided.
Patient found unconscious. Presumed to be status epilepticus (known history of prior status epilepticus). Presently admitted to the PICU at hospital with continued loss of consciousness level.
05 02/2022  today i had sudden vertigo and blackout. felt like a train came though my head(. i previously had this happen not as severe with my first dose in february of 2021). I still feel dizzy and eyesight fuzzy. all 4 shots i also had typical side effects, fever, sore arm, headache, tired. This was a very bad vertigo spell that came out of nowhere.
Information has been received from a Registered Pharmacist concerning an 86 year old female with a history of being admitted to hospital for change in mental status and no drug reactions or allergies, who on approximately DEC-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23. There was no concomitant medication. On 28-DEC-2010, the patient's arm became swollen after receiving the PNEUMOVAX 23. Patient receive "supportive" treatment for the arm became swollen. No Lab diagnostic studies were performed. At the time of the report, patient was recovering from arm became swollen. Patient sought unspecified medical attention. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (feels pretty bad), headache, myalgia (muscle pain), fatigue and nausea in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 037A21B) for an unknown indication. The occurrence of additional events detailed below. No medical history provided. On Apr 1, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced feeling abnormal (feels pretty bad), headache, myalgia (muscle pain), fatigue, nausea, pyrexia (low-grade temperature) and injection site pain (left arm is sore). At the time of the report, feeling abnormal (feels pretty bad), headache, myalgia (muscle pain), fatigue, nausea, pyrexia (low-grade temperature) and injection site pain (left arm is sore) outcome: unknown. The patient was on blood thinner.
Patient received a flu shot on 9/17/13 of FLUVIRN. Pt called pharmacy the 1st week of Oct complaining of arm pain from shot. Pain is constant and doesn't resolve with prescription pain meds.
Swollen with redness left arm. 400 mm ind. Per Dr, advised to ice area and Tylenol prn
Member had an alleged allergic reaction to anthrax shot in October. His last shot was given in June. This was the conclusion of the members Primary Care Manager.
Information has been received from a physician and a medical assistant concerning a female who on an unspecified date was vaccinated with a dose of VARIVEX (Oka/Merck). Subcutaneously. Subsequently, on an unknown date, the patient experienced redness and extreme swelling at injection site after administration of VARIVEX (Oka/Merck). The swelling was so extreme, it expanded to part of patient's chest. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered from redness and extreme swelling at injection site. No additional information is available. Additional information is not expected as the physician requested not to be contacted.
Received influenza vaccination on 11/13/18 at my employer health clinic. Pain in left upper arm started on the evening of vaccination (11/13/18). Pain was dull and assumed it was from the injection and would subside over the next couple of days. However, the pain intensified over the next couple of weeks, then turned to extreme pain that radiated down arm. Pain was from shoulder to fingertips, with reduced strength in arm, wrist, hand and fingers.
Reported body aches "a few hours after the shot" with a 99.5F fever that night and 100.2F temperature the following morning with c/o nausea. Took Tylenol with relief and applied, cold compresses. Tolerating foods/fluids 24 hrs after injection. Symptoms lasted for about 36 after injection.
Narrative: Patient experience a red, swollen arm approximately 5 days after 2nd vaccination. He did not require treatment other than applying ice packs off on and on for a couple days.
She started feeling poorly the day after vaccination. She had flu symptoms with body aches, headaches and joint pain and thought I had the Covid-19. Called ambulance and they did a test but it was negative but did not go to the Hospital. I felt fine the next day,
tenderness in the armpit; tenderness in the side of my breast where lymph nodes are; lymph node reaction after 2 months post 2nd dose,swollen lymph nodes; the lymph nodes under her right arm have been tender & a tiny bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness in the armpit), BREAST TENDERNESS (tenderness in the side of my breast where lymph nodes are), LYMPHADENOPATHY (lymph node reaction after 2 months post 2nd dose,swollen lymph nodes) and LYMPH NODE PAIN (the lymph nodes under her right arm have been tender & a tiny bit swollen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 026D21A) for COVID-19 vaccination.     Family history included Cancer since an unknown date.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tenderness in the armpit), BREAST TENDERNESS (tenderness in the side of my breast where lymph nodes are), LYMPHADENOPATHY (lymph node reaction after 2 months post 2nd dose,swollen lymph nodes) and LYMPH NODE PAIN (the lymph nodes under her right arm have been tender & a tiny bit swollen). At the time of the report, TENDERNESS (tenderness in the armpit), BREAST TENDERNESS (tenderness in the side of my breast where lymph nodes are) and LYMPHADENOPATHY (lymph node reaction after 2 months post 2nd dose,swollen lymph nodes) had not resolved and LYMPH NODE PAIN (the lymph nodes under her right arm have been tender & a tiny bit swollen) outcome was unknown.            No concomitant product and treatment medications was reported. It was reported that patient had mammogram & a doctors appointment scheduled for next week.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow-up information contains additional event Lymph node pain, updated medical history and drug dosage information.; Sender's Comments: Case routed out of MR workflow as medical review is not required per new investigative process for non serious cases which are not AESI and LOE
Started to get a migraine with dizziness (atypical of when I usually get migraines) which then went Into mastitis, chronic dizziness and a second bout of mastisis, I?ve breastfed two other children and never had mastitis,. There have been many reports in my moms groups of women getting mastitis after receiving the vaccine. Currently still ill with fever body aches chills dizziness and breast tenderness
A pharmacist reports a pt received vaccine 7/4/2000, that same day she developed a fever and flu like symptoms which lasted more than 36 hours. The pt also developed a 15cm area of soreness at the injection site.
Does not have the lot#.  Redness, swelling, area is very warm.  This started this morning.  Feels tired, under the weather. Little dizziness.
Received vaccine @ facility so lot # etc unavailable to me.  Presented 3d later w/ arm swelling (severe) and itching x 2d.
Acute burning knee pain, never experienced prior to vaccine.  Pain was severe enough to awaken me when asleep and interrupt ADL's. Went to PCP after 2 weeks who prescribed Meloxicam with excellent results.
This spontaneous report as received from the registered nurse refers to multiple, unspecified patients of unknown age and unknown gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, multiple unspecified patients were administered improperly stored VAQTA (Lot # L028666 and expiry date: 04-NOV-2016, lot # L018499 expiry date: 25-FEB-2017, lot # L002717 and expiry date 02-JUN-2017) (dose, route, therapy type not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
1) Itchy rash on arms, shoulders, back and abdomen  ONGOING ON SHOULDERS, CHEST AND BACK steroidal topical treatment ameliorated it 2) Drenching night sweats PERSISTING, BUT NOT EVERY NIGHT 3) MS symptoms worsening PERSISTING particularly wobbly walking and lack of balance
Patient is now DECEASED (3.19.22).  Hospitalized 3.12.22 - 3.17.22.  COVID-19 positive (3.12.22).  Fully vaccinated PLUS booster.   Admission Date: 3/12/2022 Discharge Date: Mar 17, 2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia Pneumonia of both lower lobes due to infectious organism  Sepsis without acute organ dysfunction, due to unspecified organism (HCC) HOSPITAL COURSE: Patient is a 88 y.o. male who presented to the ED with shortness of breath. He was hospitalized at Hospital at the end of January with COVID pneumonia and again hospitalized at Hospital 3/2-3/5 for a fall and pneumonia. His admission CXR showed right lower lobe and ligula pneumonia. He was treated with a 5 day course of rocephin/azithro as well as PO prednisone for COPD exacerbation. At discharge he was sent to other facility for SAR and his lasix was held due to soft blood pressures. Over the last 3 days he had been feeling worse with increased cough and shortness of breath.  In the ED the patient had labs showing leukocytosis, elevated procalcitonin at 0.37, an elevated BNP at 8989. He was hypoxic on arrival and required supplemental oxygen at 2L. He had a CXR showing severe airspace disease in the right lung and left lower lobe concerning for pneumonia. The patient had blood cultures obtained and was started on vanco, cefepime and azithro due to his recent IV antibiotic treatment. He was admitted to the hospitalist team for admission and further management.  Broad spectrum antibiotics were continued.  Patient was evaluated by Medical nutrition and recommendations were followed.  PT/OT evaluated advised SNF.  SLP evaluated and recommended close supervision but did not advise any dietary adjustments.  Discussed with daughter regarding clinical picture and patient has expressed not wanting further treatment.  Daughter/MD advised transition patient to comfort care.  On board arrange for discharge back to Assisted Living and life circles to navigate hospice and outpatient equipment. Patient clinically improved and hemodynamically stable for discharge.  Patient and daughter voiced understanding was agreeable with plan of care discharge.  She also expressed the desire for him to have no further testing or returns to the ED or hospital.  We reviewed his home medications and discontinued any medications which did not directly result in symptom management.
Initial unsolicited report received from a Consumer (the patient) on 08 December 2014. A female patient, age not reported, had received an intramuscular dose of FLUZONE HD, (batch number, dose number and site of vaccination not reported) on 08 December 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. On 08 December 2014, same day after vaccination, the patient had headache. The pain level was a 5-6 on an scale from 1-10, 1 being lowest. The patient also experienced ringing in her ears which came and went. Laboratory tests were not performed and corrective treatments were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none. Follow-up information received from a Consumer on 27 January 2015: The patient was 68 years. The patient did not receive a flu shot since she was a child and never had an issue and never had the flu. Headache and ringing in the ears went away the next day, 09 December 2014. The patient did not take any medications.
29JUL 48hr p/vax pt devel redness, to bilat thighs, eyes & arms;trunk itching w/some redness;some swelling around eyes;upper lt thigh inj site red & swollen;31JUL exfoliation to arms & trunks;
Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Chills, Generalised muscle aches and Fever, at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not reported.
Metallic taste in mouth within 20 minutes of vaccine and persisting 5 + days at this point.
a few minutes after receiving vaccination, pt felt unsteady on feet and stated that he experienced pain throughout the body but was most extreme in legs and back. Pt did not have swelling of throat or any other anaphylactic symptoms.  emergency services were contacted, but did not take the patient away. pt was able to stand on his own and felt better after a short time.
w/in 6 hrs p/immun, pt exp a fever of 105.2; no other sx; fever continued for 2 days; there was no evidence of infect; pt is asymptomatic;
Patient received Tdap to (L) dt IM at 1106. Immediately after administering vaccine, pt stood up, walked a couple steps and fainted. Pt fell sideways and hit wall. Immediately RN was called and MD was notified legs were elevated. Transferred to a room via wheelchair for close monitoring on exam table. Regained consciousness within seconds. Discharged home at 11:30 am. Last BP 90/60. Parent was present the whole time.
Wednesday 9/28/11-dull pain #2 on scale 1-10. Left shoulder proximal to deltoid site of influenza injection given 9/20/11. 9/28/11 by 11:00 pm intensity increased to #10 on scale 1-10. Related to pain of rotator cuff as in Hx. Not sure if related to flu shot or participation in "Old Timers Baseball Game: 9/25/11. Improved by Friday 9/30/11 and resolved completely by 10/4/11.
suspected cellulitis- given cephalexin.   red, warm to touch, hard.  spots turned up on other side of thigh as well, changed diagnosis from cellulitis to adverse reaction.  bruised.
Case number PHEH2013US017048 is an initial spontaneous report from the physician received on 05 Aug 2013. This report refers to a 22-year-old male patient. He received first dose of RABAVERT on 15 Jul 2013. On 18 Jul 2013, he developed red itchy spots all over his legs and trunk and these events eventually went away (see case: PHEH2013US016817). On 22 Jul 2013, he received his second dose of RABAVERT (batch number: 524011C) via intramuscular route. On an unknown date, three days after second dose of RABAVERT he again developed red itchy spots. The event itching was so severe that he sought medical treatment at an urgent care clinic. It was reported that the spots were more intense after the second dose of RABAVERT. The outcome of the events reported as resolved at the time of reporting. The seriousness and causality of the events were not reported.
pt passed out immed p/being vaxed w/MMR vax; No further details were provided;
exceeded days to receive second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (exceeded days to receive second dose) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (exceeded days to receive second dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (exceeded days to receive second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided  No treatment medications provided
Td injection on 11/18/2004 as part of annual physical exam. Noted soreness in left upper arm, neck, and shoulder beginning 11/19. On 11/20 noted very tender "knots" on neck and left clavical. Returned to clinic on 11/22/2004. Provider notes 2-3 small supraclavicular nodes (0.5-1.5cm) very tender. Pt denies fever during period 11/18 to present.
10/22/02 Localized reaction - redness, swelling at injection site. Improved on 10/24/02.
Headache, Fever, Diarrhea & NauseaVomiting Narrative: Did not require medical attention. States 1/3/21 was the worse of it all. Today, 1/5/21, no longer having the side effects, however, taking Tylenol and temp is 99F and has slight headache.
Body aches; Fever 99.8F; Chills; Entire left arm muscle is in pain on movement; Choking in the throat; Facial Flush; Blurred vision; Dizziness; Confusion; I had no emotions; A spontaneous report was received from a pharmacist concerning a 48-years old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced choking, flushing, vision blurred, dizziness, confusional state, emotional disorder, body aches, pyrexia, chills and limb discomfort.  The patient's medical history included migraines and a hysterectomy. Products known to have been used by the patient, within two weeks prior to the event, included sumatriptan, naratriptan hydrochloride, and galconezumab.  On 02 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) in the left deltoid intramuscularly for prophylaxis of COVID-19 infection.   A pharmacist called stating she received the Moderna COVID-19 vaccine on 02 Jan 2021 at 9:45am in her left deltoid. Immediately after receiving the vaccine, she had facial flushing, blurred vision, dizziness, confusion and choking in the throat that lasted 20 minutes. After a few hours, she stated confusion would come and go, and she had no emotions. The next morning, the confusion was gone. On 03 Jan 2021, she reported having body aches and a fever of 99.8 degrees Fahrenheit. She reported chills, body aches, and a lot of pain in the left arm. If she tried to move her left arm, the entire muscle in the left arm hurt.  Treatment for the events included acetaminophen and an antihistamine.    Action taken with mRNA-1273 in response to the events was withdrawn.   The events, choking, flushing, vision blurred, were considered resolved on 02 Jan 2021. The events, confusional state, emotional disorder, and dizziness, were considered resolved on 03 Jan 2021. The events, body aches, pyrexia, chills, and limb discomfort, were not considered resolved.; Reporter's Comments: This case concerns a 48 year old female patient with medical history of migraines, who experienced a serious unexpected event of Choking, non-serious unexpected events of Flushing, Vision blurred, Dizziness, Confusional state, Emotional disorder, Pain, and Limb discomfort, and non-serious expected events of Pyrexia and Chills. The events of Choking, Flushing, Vision blurred, Dizziness, and Confusional state occurred immediately after administration of their first of two planned doses of mRNA-1273 (Lot number: 025L20A). The event of Emotional disorder occurred on the same day when the patient received mRNA-1273. The events of Pain, Pyrexia, Chills, and Limb discomfort occurred on the next day of mRNA-1273 administration. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Husband received his second dose at work.  The next morning he got up and turned on the shower and passed out.  I found him in the bathroom after he regained consciousness in a cold sweat, extremely pale, saying that he thought he was going to throw up.  He said it felt like food poisoning.  I got him back into bed with a cool wash cloth and he slept off and on the rest of the day.  He started feeling a bit better but struggled to comprehend simple questions and would just stare at me blankly as if he couldn't understand what I was saying.  Even though he slept most of the day he was falling asleep in his chair by about 8pm.  The paleness, waves of exhaustion, and inability to stay awake past 8:30/9pm has continued.