chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster; Vial caps and labels for Monovalent and Bivalent look too similar; Vial caps and labels for Monovalent and Bivalent look too similar; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar).    No concomitant medications were reported. Reporter was complaining that the vial caps and labels look too similar, and reporter was requesting that Moderna to do something about the vial similarities. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Live follow-up contains non-significant follow up -QE ID added.
Large inflammatory area 4-5 cm in diameter that resulted in decreased ability to raise left arm that appeared within 24 hrs of injection no s/s infection but area was very large an warm to touch.
About some months after receiving the vaccine, I was experiencing a lot of mucus in my nose and coughing up phlegm from my throat. I went where he conducted an oral and nasal examination; since I didn't have a fever, I was prescribed a nasal spray and MUCINEX to help reduce the sickness once I was diagnosed with a cold. Currently, I still have some residual mucus in my system that I'm blowing and coughing up every now and then.
Upon receiving two doses of SHINGRIX, experienced nighttime awakening, fever, chills, and sore arm.
Within 15 minutes of the vaccination, the patient reported scratchiness in her throat to an RN. I was notified and immediately went over to the patient. She did not have any chest tightness, chest itchiness, or swelling of the throat, mouth, tongue, or facial areas. No visible rashes. Patient then reported the scratchiness in the throat to me and seemed to be panicked. I recommended one dose of 25 mg diphenhydramine. Roughly 15 minutes after the dose, the patient told me the scratchiness went away. She was given a glass of water with the dose of Benadryl and had another full glass as well. She was continuously monitored throughout the process.
Mother stated her 14 mo is allergic to eggs and received the influenza vaccination today about 1630.  She does not think it was the H1N1 vaccine.  He has been sleeping on and off since then with no reaction noted.  Later in the call, the mother states he has redness to the top of his head.  Typical reaction to eggs is whole body redness (he has eczema that flares up) and itching.  Antihistamine dosing from pediatrician and epipen are available if needed.  Mother did give child a dose of benadryl as recomended by child's pediatrician, redness resolved but itching started,  hydrocorotisone cream was applied.  Mother refused any further followup,  Numerous attempts were made on various days and times for followup but calls were never returned.
This case is linked with case number 2012-07324 (mother case). Initial report received from healthcare professionals on 08 May 2013. A male patient, whose weight was 2.36 kg and height was 48.3 cm and was delivered on 16 February 2013 had exposed of ADACEL vaccine via transplacental (lot number unknown) on 11 June 2012. The patient's personal history, family history and concomitant medications were not reported. As per reporter, the patient had intrauterine growth retardation (IUGR). The patient laboratory tests and corrective treatments were not reported. At the time of this report, the outcome of event was not reported. Documents held by sender were none.
Heart pain; Joint pain is all over my body; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced ARTHRALGIA (Joint pain is all over my body). On an unknown date, the patient experienced ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant). At the time of the report, ANGINA PECTORIS (Heart pain) had not resolved and ARTHRALGIA (Joint pain is all over my body) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provider by the reporter.  Treatment information was not provided.   After vaccination on March, patient's had joint pain all over body on April and for heart pain patient went to doctor 2 weeks after first shot.  Company Comment: This case concerns a patient of unknown age and gender who experienced serious event angina pectoris and non-serious event of arthalgia after the first dose of the vaccine. Dechallenge is unknown and rechallge as not applicable. The benefit-risk relationship is not affected by this report   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender who experienced serious event angina pectoris and non-serious event of arthalgia after the first dose of the vaccine. Dechallenge is unknown and rechallge as not applicable. The benefit-risk relationship is not affected by this report
After about a week following my second shot, I began to feel pain and stiffness in my lower legs.  I saw a doctor on April 14 and he diagnosed my condition as arthritis (which I never had before)  He prescribed a ten day dose of Meloxicam.  I took the Meloxicam for about five days and stopped.  The pain and stiffness subsided for a week or so and then got worse over the next few weeks and spread to my shoulders and upper legs.  I left and came where I saw another doctor  He ordered a series of blood tests
Myalgia, Arthralgia, pain in Rt deltoid/shoulder with ROM>above shoulder, weakness . no sensory deficit. 12/31 arm better with IB.
patient reports feeling subjective fevers, sore throat, headaches, decreased appetite, and fatigue for at least 2-3 weeks after her first dose; this recurred with the second dose. A blood draw taken less than two weeks after her second dose was significant for leukopenia (WBC down to 3.0) and thrombocytopenia (Platelets to 154) whereas her CBC just 3 months prior had normal indices. Both her WBC and platelets are recovering however she continues to complain of fatigue and decreased appetite since her second dose on 4/23.
Flu-lik symptoms - Exhaustion, body aches, Pain at inj. site 1-2 wks This lasted about 3 days and gradually got better over the week. (Same reactions w/1st Shingrix vaccine, given at same location) My first Shingrix vaccine was given in Nov'19, but I don't know the date. I had all of the symptoms of the 2nd dose. I was planning to get the 2nd dose in March 2020, but then COVID 19...
Vaccine was administered subcutaneous instead of in right deltoid. Causing some swelling and bruising on the arm
Pt states, she awoke on 11/19/11 at 3 am with fever & felt every muscle aches - Did not take temp D/T no thermometer - could not get out of bed x 2 days D/T body aches & pain - whole body. States noticed a rash at 7 am on 11/19/11 on abdomen, back, 11/23/11 -> no body aches.
I received my third full dose of the Moderna vaccine on 9/3/2021. About 2 weeks later, I began having abdominal pains. The pain was in the mid- to upper right of my abdomen. The pain is almost constant and rarely abates, and there is a constant feeling of fullness. I went to the doctor on 9/20/2021; bloodwork was done and I was scheduled for more tests. The next time I went to the doctor, they tested my renal function, hepatic function, and autonomic nervous system. I also underwent a cardiovascular ultrasound. No discernible cause for my symptoms could be found. The only anomaly detected was elevated cholesterol, for which I was prescribed medication.
Arm was fiery red down entire arm to the elbow-later became a large hematoma. Treated with an antibiotic.
Nine days after receiving the vaccine, my left arm,  at the site of the injection, turned bright red , approximately 3 inches round and was painful, itchy and very hot to the touch. Today is 21 days after the injection, and although it is not painful, itchy or hot to the touch any more, it is still quite red.
Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,; Hot to touch; Blood pressure lowered (100/60).; Mouth felt like cotton; Had difficulty swallowing; Left side of my body; Very big Hiatal Hernia; Muscle pain; Very red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,), VACCINATION SITE WARMTH (Hot to touch), HYPOTENSION (Blood pressure lowered (100/60).), FEELING ABNORMAL (Mouth felt like cotton) and DYSPHAGIA (Had difficulty swallowing) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hiatal hernia. Concomitant products included METOPROLOL, LISINOPRIL, HYDROCHLOROTHIAZIDE, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), COLECALCIFEROL (D3), UBIDECARENONE (COQ 10) and ASCORBIC ACID (VIT C) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING ABNORMAL (Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,), VACCINATION SITE WARMTH (Hot to touch), HYPOTENSION (Blood pressure lowered (100/60).), FEELING ABNORMAL (Mouth felt like cotton), DYSPHAGIA (Had difficulty swallowing), PAIN (Left side of my body), HIATUS HERNIA (Very big Hiatal Hernia), MYALGIA (Muscle pain), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, FEELING ABNORMAL (Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,), FEELING ABNORMAL (Mouth felt like cotton) and DYSPHAGIA (Had difficulty swallowing) had resolved and VACCINATION SITE WARMTH (Hot to touch), HYPOTENSION (Blood pressure lowered (100/60).), PAIN (Left side of my body), HIATUS HERNIA (Very big Hiatal Hernia), MYALGIA (Muscle pain), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
COVID booster 5 days ago.   Felt achey later that night, associated with fever, diarrhea, had some black stool X 2.  Normal today.  Starting to eat today.  Hydration was definitely down, 10 oz daily.  Had some episodes of racing heart, never took her pulse.  Has resolved in the past 24 hours.  Does have known history of atrial fibrillation status post pacemaker placement for heart block.
sore to touch (day 1), swelling under arm upon waking (day2), burning under arm (day3),black and blue spot under arm, and yellow/red area under arm later in day (day 4).
I started to have tingling sensation to my left leg. I have history of DVT, hemochromatosis, hyperthyroidism but is all managed. The issue is that the tingling sensation I was experiencing was moving in my left leg, was painful but then it went away. I went to the emergency room 02-25-2021 that started with a blood clot and they placed me on Xarelto medication. My PCP encouraged me to go to the ER. they did an U/S of my left lower extremity which showed blood clot.  I am already on blood thinner medication and no one can explain  or give me an answer as to why I have a blood clot after my vaccine when i am on blood thinner medication.
Patient was fine and was able to answer all questions before the shot. After the shot was given He said he didn't feel well and passed out. His wife said this has happened to him before. He slumped over in the chair and became incontinent. he came to and then said he felt nauseous. he asked for the garbage can and threw up. I monitored his blood pressure that went to 160 over 100 and then came down to normal over the course of a few minutes. The patient stayed seated for about 30 minutes . After the blood pressure was good for 30 minutes  his wife said she was going to drive him home. I explained that they should always tell any immunizer of his previous reactions
Hot flashes, feeling hot, dizzy and nauseated, felt faint, very red painful knot - size of baseball and growing and spreading, and bruised. Most came one-two days after shot.
Chills; Shaking; Fever 100-101.3; Body aches; Weakness; Dizzy; Headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Feb2021 12:15 (66-year-old) (Lot Number: EL9261) as dose 2, single for COVID-19 immunization. Medical history included none. The patient did not have any known allergies. Concomitant medications included terbinafine; trazodone; vitamin D3 and cranberry syrup, all taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient was diagnosed with COVID-19 prior to vaccination. The patient experienced chills, shaking, fever 100-101.3, body aches, weakness, dizzy, headache on 07Feb2021 01:30. The patient received paracetamol (TYLENOL) for the event fever. The outcome of events was recovered. Since the vaccination, the patient has not been tested for the COVID-19.
I have pain in my left arm since 2nd shot.; This is a spontaneous report from a contactable consumer (patient).   A 76-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01Feb2021 10:45 (Batch/Lot Number: EL8982)  at the age of 76-year-old, as single dose for covid-19 immunisation.  Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number : EK9231) on 11Feb2021.  Medical history included   from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported.   The patient experienced pain in left arm since 2nd shot (pain in extremity) (non-serious) on 01Feb2021 11:00 with outcome of not recovered.  Therapeutic measures were taken as a result of the event pain in extremity.    No follow-up attempts are possible. No further information is expected.
Severe itching all over for over 2 months now. I have tried Avery home remedy and been to 3 doctors
2/4/23 I woke up that morning and was really lightheaded. It continued. After I got up and bathed, ate breakfast, and put on my Apple watch it began giving me alerts that my heart rate was low, below 45. The following day I called my doctor and showed her my apple watch information. She ordered a 48-hour halter monitor which I wore for a while. The light headedness lasted a few days. Then my heart was irregular, not consistent at all. This went on for about 2 weeks. It is slowly getting better. My doctor wanted me to go see a Cardiologist which I have not seen yet. The Cardiologist sent me a text and has me wearing a 30-day monitor for my heart.  I feel normal and not feeling bad right now.
RASH TO LEFT LEG AND ALSO SWELLING WAS MORE AND PATIENT COMPLAINED OF DISCOMFORT.  THIS IS A NEW PROBLEM. THE AFFECTED LOCATIONS INCLUDE THE LEFT UPPER LEG AND RIGHT UPPER LEG. THE PROBLEM IS MODERATE. THE RASH IS CHARACTERIZED BY REDNESS AND SWELLING.
Fever, nights sweats, weight loss, aches, pneumonia  7/16/09 ICD-9 Codes: 486 (pneumonia unspecified organism, 515 (postinflammatory pulmonary fibrosis)  7/16/09 ICD-9 Codes: 486 (pneumonia unspecified organism, 515 (postinflammatory pulmonary fibrosis) \ksk  8/28/09 Hospital records received DOS 3/12/09. Final Diagnosis: Eosinophilic Pneumonia. Patient presents with persistant pnuemonia, bronchitis. Tachycardia, crackles/rales, expiratory wheeze, inspiratory wheeze. Weight loss.
Continued pain in (L) deltoid muscle since vaccine was given on 09-21-2015. Tender upon palpation over injection site.
Immediately after administration patient fainted, she was caught and laid on her side. Patient LOC for 10 seconds, when she woke up she was disoriented, crying and scared. The doctor was immediately called to the room and the patient began to calm down. Vitals and exam were done, orange juice provided and the patient left the office after 15 minutes of monitoring.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Admitted for Covid-19 PNA and acute hypoxemic resp failure. Presented with hypoxia, congestion, cough, abdominal pain, nausea, vomiting. She was treated with dexamethasone, remdesivir, tocilizumab, oxygen support, and prone positioning. She improved gradually with treatment and was stable for discharge home on day 8. She required oxygen supplement 2L with exertion on discharge.
Grand seizure; Circulation of left side was dead; upper back and shoulders and arm aches; upper back and shoulders and arm aches; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Grand seizure) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epileptic seizure. Concomitant products included TIAGABINE HYDROCHLORIDE (GABITRIL) for Epileptic seizure.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced SEIZURE (Grand seizure) (seriousness criterion medically significant), ANGIOPATHY (Circulation of left side was dead), PAIN (strong body pain), BACK PAIN (upper back and shoulders and arm aches), PAIN IN EXTREMITY (upper back and shoulders and arm aches) and ARTHRALGIA (upper back and shoulders and arm aches). At the time of the report, SEIZURE (Grand seizure), ANGIOPATHY (Circulation of left side was dead), PAIN (strong body pain), BACK PAIN (upper back and shoulders and arm aches), PAIN IN EXTREMITY (upper back and shoulders and arm aches) and ARTHRALGIA (upper back and shoulders and arm aches) outcome was unknown.            Other concomitant medication included: cardatril.  Description: The patient experienced on 25 Mar2021, around 15 hours after vaccination grand seizure (medically significant), circulation of left side was dead. The patient also experienced on 25 Mar 2021, strong body pain, upper back and shoulders and arm aches.  Treatment information included  lorazepam  at home.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-073130 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient has a Hx of seizure
CHILLS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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 not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUL-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Information has been received from a pharmacist concerning a 62 year old male, with ampicillin allergy, sulfamethoxazole allergy, and simvastatin (manufacturer unknown) allergy, who on 1/13/06 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). ON 1/15/06 the patient was presented to the ER and diagnosed with cellulitis. The patient was treated with clindamycin manufacturer unknown and released. The patients present status was reported as unknown. The pharmacists is requesting a lot check. The patients experience was considered to be an other important medical event by the reporter (OMIC). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
I had a fever 100-101 for 3 days, shaking in the evening for 2 days, red and warm on the arm of injection for 6 days, fatigue for 5-6 days.
Painful left axillary lymphadenopathy roughly 6 hours after shot. Headache, fever, soreness, increased skin sensitivity and pain overnight. Shaking chills for several hours the next morning. Persistent low back pain 10/10 radiating to anterior thighs bilaterally from 6PM the day of and has not resolved as of the following afternoon.