chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. had swelling, redness, at site about 2 days later. Pt. was taking benadryl and was told by PCP to go to MD.
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL and GLIPIZIDE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient received the quad vaccine in the afternoon. Within a couple of hours, her chronic pain level had increased from a 6 (on 1-10 scale) to a 9.5. She ran a slight fever (99.5 to 101 F) for about one week. The increase in pain significantly restricted her movements. Both of her wrists and left knee were swollen at the joint for 2 days. We followed up at our clinic one week later (next Wednesday) and, on the advice of the physician assistant we saw, the emergency room on the same day. At the emergency room she received a 60 mg shot of toradol which did nothing to alleviate her pain, along with some advice that her pain wasn't real. Today, 12/04/2014 is one month later and patient is still at a 9 to 9.5 for pain level. She is becoming permanently disabled by the continued increase of her chronic pain.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # N019923 for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event.  The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1709USA003145: US-009507513-1709USA003453: US-009507513-1709USA003454.
A non-serious, spontaneous report of vaccination of 52-year-old was received from a consumer, involving a 52-year-old male patient subsequent to FLUMIST. The event was reported 14 days after the administration and the consumer indicated there were no symptoms or problems. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
she lost her eyesight after getting the Moderna shot; This spontaneous case was reported by a patient and describes the occurrence of BLINDNESS (she lost her eyesight after getting the Moderna shot) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    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, the patient experienced BLINDNESS (she lost her eyesight after getting the Moderna shot) (seriousness criteria disability and medically significant). At the time of the report, BLINDNESS (she lost her eyesight after getting the Moderna shot) outcome was unknown.        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 concomitant medications were reported.   It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    No treatment medications were reported.  Company comment: This spontaneous case concerns an adult female patient with no reported medical history, who experienced the unexpected serious (disability, medically significant) event of Blindness, unknown time after receiving a dose of COVID 19 vaccine with mRNA-1273.222 bivalent vaccine. It was reported that she lost her eyesight after getting the Moderna shot. No further information was available for medical review. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   Reporter did not allow further contact
pt recv vax & exp constant pain, arthralgia & stiffness in neck;it was unk whether the pt exp was related to hep b vax;
FEVER 101.6 FOR 5 DAYS FOLLOWING 1ST VACCINE, EXTREME FATIGUE, NAUSEA, ABDOMINAL PAIN  FEVER HAS NOT BEEN LESS THAN 99.2 SINCE INITIAL VACCINE PREVIOUS BODY TEMP CHRONICALLY/HISTORICALLY 97.1-97.5
pt recvd vax & devel extreme itching, running nose, red & flushed; this occured w/in 15 mins of vax; DPH & Epi given;
The pt experienced decreased appetite and slept allot. Mother gave Tylenol. The pt experienced "funny" breathing, irregular respiration for about 1/2 hour. The pt then developed hives.
This spontaneous report as received from a registered nurse refers to a 29 year old female patient who on 29-SEP-2012 at 12:25 pm, was vaccinated intramuscularly in the deltoid with the dose of LIQUID PEDVAXHIB (lot# H012570, dose and expiration date not reported). The patient received LIQUID PEDVAXHIB in error when she was supposed to get an unspecified Hepatitis B Vaccine. There was no adverse event. This is one of several reports received from the same source (other patients are captured under MARRS # 1211USA004476, 1302USA004703 and 1302USA004705). Additional information is not expected.
High heart rate (90- 100+) for several hours  approximately 10-11 hours after receiving vaccine. This happened after I went to bed and is not a normal heart rate when I am resting.  My heart rate finally went back to a normal rate for me  after 10:00 am the day after the injection.
Severe headache for 20 hrs. starting at 2am. Very weak and no apatite. Severe lower back pain for 30+ hrs. Slight fever for short period of time. (100.1) Sore arm at shot location.
Right arm swelling; redness spreading; itching; black and blue color; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right arm swelling), ERYTHEMA (redness spreading), PRURITUS (itching) and SKIN DISCOLOURATION (black and blue color) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PERIPHERAL SWELLING (Right arm swelling), ERYTHEMA (redness spreading), PRURITUS (itching) and SKIN DISCOLOURATION (black and blue color). On 08-Mar-2021, PERIPHERAL SWELLING (Right arm swelling), PRURITUS (itching) and SKIN DISCOLOURATION (black and blue color) had resolved. At the time of the report, ERYTHEMA (redness spreading) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Significant swelling, hot to touch, red at injection site showing following 5 days after injection. Significant achiness in R arm consistently since day of injection (2 weeks).
I also had a histamine response like I did on my 1st dose. I went to urgent care to listen to my lungs. I had an EKG that indicated something abnormal. They wanted to call an ambulance which I refused. At 3AM, I felt worse, so I drove to the ER. I had observations which nothing was indicated. I saw an infectious disease doctor. I had a horrible cough with lots of pressure in the center of my chest. I have produced more histamine than I use to. I am sensitive to chemicals including air pollution before the vaccine but now I am less sensitive. I also have brain fog and confusion.
Dtap given in LDMIM. 30 minutes after shot client upper arm had some swelling, heat to touch and reddened raised area L- 3inch W 3inch. Light rash down to elbow. Ice pack applied and BENADRYL taken.
Pt C/O severe L flank pain with nausea, dizziness 10 min after receiving vaccine.
pt exp suspected sz-passed out, eyes rolled back in head;given 02-assessed to be OK by MD;
BODY ACHES; SINUS HEADACHE; CHILLS; TIREDNESS; This spontaneous report received from a consumer concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and concurrent conditions included heart condition, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced sinus headache. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced tiredness. Treatment medications included: ibuprofen. On 12-MAR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sinus headache, and chills on 12-MAR-2021, and was recovering from tiredness. This report was non-serious.
questions on PENTACEL If only Dtap and IPV component given without HIB portion, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Agency inbound (reference number-00694792) and transmitted to Sanofi on 23-Jul-2021.  This case involves a six-month-old female patient who had questions on Pentacel if only DTaP and IPV [DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS, and POLIOMYELITIS VACCINE (INACTIVATED)] component given without HiB (HAEMOPHILUS TYPE B (HIB) VACCINE) portion, no adverse event (product preparation error) while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past vaccination(s) included PENTACEL with Dose 1: at 2 months and Dose :2 at 4 months.  The patient's past medical history, medical treatment(s), and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE on an unknown date for prophylactic vaccination.  On 23-Jul-2021, the patient received a dose 3 (0.5ml) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE without the HIB portion (lot number for Quadracel portion: U6940BA; expiry date: 21-May-2021) via intramuscular route in right vastus lateralis for prophylactic vaccination.  It was case of actual medication error due to product preparation error (latency: same day).  It was reported, "Caller has questions on PENTACEL If only Dtap and IPV component given without HIB portion, will the patient need Pentacel re-administered or only the HIB portion. AE (adverse event) symptoms or no AE - No reaction reported."  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On August 10, 2022, I learned I had a heart murmur that I did not have before. I did not have any symptoms prior to this. I have been very tired since the first vaccine but didn't have a health issue to report until after dose 4 when I learned of the heart murmur.
stomach was killing him; pee was cloudy; peeing blood; might have been blood in his diarrhea; calcium deposits in his kidney; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA HAEMORRHAGIC (might have been blood in his diarrhea) and NEPHROCALCINOSIS (calcium deposits in his kidney) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided.  Concomitant products included TRAMADOL, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN), ALPRAZOLAM (XANAX) and CEFALEXIN (CEPHALEXINE) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DIARRHOEA HAEMORRHAGIC (might have been blood in his diarrhea) (seriousness criterion medically significant), NEPHROCALCINOSIS (calcium deposits in his kidney) (seriousness criterion medically significant) and HAEMATURIA (peeing blood). On 24-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach was killing him) and URINE ABNORMALITY (pee was cloudy). At the time of the report, DIARRHOEA HAEMORRHAGIC (might have been blood in his diarrhea), NEPHROCALCINOSIS (calcium deposits in his kidney), ABDOMINAL DISCOMFORT (stomach was killing him), URINE ABNORMALITY (pee was cloudy) and HAEMATURIA (peeing blood) 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.   Concomitant medication use included muscle relaxant. Patient reported that he went to hospital and was peeing blood. He also believes there might have been blood in his diarrhea. His pee was a little cloudy, and there were drops of blood. Symptoms are ongoing and patient will be seeing his urologist. At the hospital, patient nurse said he was second one to report similar symptoms after taking the vaccine. Patient notes he hasn't been drinking water and was told that he has calcium deposits in his kidney.  Company Comment: This case concerns a 57-year-old male with serious unexpected events of diarrhea haemorrhagic and nephrocalcinosis, and nonserious unexpected abdominal discomfort, hematuria, and urine abnormality. Latency 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 57-year-old male with serious unexpected events of diarrhea haemorrhagic and nephrocalcinosis, and nonserious unexpected abdominal discomfort, hematuria, and urine abnormality. Latency 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Saturday April 10th at 5 pm: Back pain in the thoracic area, pain when breathing, breathing was short, pain when taking deep breaths. Monday 12th at 2 am: abdominal pain and bloating: pain similar to gastritis around the Cardia or diaphragm area. Pain in my intestines as I feel my digestion move, probably the large intestine. Pain in my back, in the lumbar area related to the abdominal pain.  All pain was manageable. I didn't go to the doctor.
Pt has erythematous papular rash at site of varicella vaccine administration to anterior right thigh. No vesicular lesions appreciated when pt presented to office 7/21/14 and was evaluated by physician.
Positive COVID test; body aches; low grade fever/felt feverish; A spontaneous report was received from a male, physician who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a positive COVID test, body aches, low grade fever/ felt feverish.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient received the vaccine and also had an antibody test and nasal swab the same day. On 04 Jan 2021, the patient had minor symptoms of body aches and low grade fever. He stated he felt feverish which was not normal for him. On 05 Jan 2021, his antibody test, IgG, was non-reactive and he tested positive for COVID.  Treatment included being quarantined when he tested positive.  Action taken with mRNA-1273 in response to the events was not reported.  The events, positive COVID test, body aches, low grade fever/felt feverish, was not resolved at the time of this report.; Sender's Comments: This case concerns a male of unknown age with a non serious unexpected events of SARS-CoV-2 test positive and pain along with expected pyrexia. Event onset 8 days after first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
ANTHRAX SHOT WITH REDNESS AND SWELLING.  HAD SHOT ON 2/21/08.  PT C/O ITCHING.
Day 16 -20 after vaccination developed chest discomfort, SOB, rapid heart rate. Saw pcp. Has EKG-normal. Diagnosed with injury from work. Not sure if blood work done. Pain lasted about 4 days then went away.
Pt C/O feeling dizzy, pt fainted, skin cold and clammy; pt regained consciousness and vital were within normal range; pt rested with a cold pack to her forehead.
SEVERE FOOT PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included no known allergies and does not have drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1008609, and  expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 04-APR-2021, the subject experienced severe foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe foot pain on 05-APR-2021. This report was non-serious.
Fatigue , Chills,  congestion, runny nose, diarrhea x3 days -DX ACUTE VIRAL SYNDROME
Mother called the clinic on 7/13/23 and stated that the child had swelling in his arm, all the way to his hand and it was numb.  Mother was instructed to take the child to the ER for evaluation.   Per written ER Report, mother voiced that patient had redness and itchiness at the site.   Impression from ER physician was that it was a local reaction to the injection site.
This spontaneous report has been received from a licensed practical nurse concerning to a 65 year old male patient. Current conditions, medical history and drug reactions/allergies were not provided. On 07-OCT-2013, the patient's father-in-law was vaccinated with ZOSTAVAX, 0.65ml, (lot # and route not reported). Concomitant medication was not reported. On approximately 11-OCT-2013 reported as 4-5 days after receiving ZOSTAVAX, the patient (son-in-law) developed a rash on his left hip diagnosed as shingles. At the time of the report, the outcome of shingles/a rash on his left hip and secondary transmission was unknown. Additional information has been requested.
Retinal necrosis; This spontaneous case was reported by a health care professional and describes the occurrence of NECROTISING RETINITIS (Retinal necrosis) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced NECROTISING RETINITIS (Retinal necrosis) (seriousness criterion medically significant). At the time of the report, NECROTISING RETINITIS (Retinal necrosis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Concomitant  medications  for the eyes but did not provide details and also received treatment medications for his symptoms.   Company comment: This spontaneous case concerns a 74-year-old male patient, with unknown medical history, who experienced the serious (medically significant) unexpected event of NECROSITING RETINITIS. The event occurred on an unknown date after the second dose. The rechallenge is not applicable since limited information about dosing and outcome of the event has been provided. There is limited information available for reviewing, but the event has been considered serious since it has had an impact on patient's vision and a query was sent to obtain further information. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-411495 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74-year-old male patient, with unknown medical history, who experienced the serious (medically significant) unexpected event of NECROSITING RETINITIS. The event occurred on an unknown date after the second dose. The rechallenge is not applicable since limited information about dosing and outcome of the event has been provided. There is limited information available for reviewing, but the event has been considered serious since it has had an impact on patient's vision and a query was sent to obtain further information. The benefit-risk relationship of mRNA-1273 is not affected by this report.
"pt recv vax 20DEC96 & 6JAN97 pt devel urticaria & pruritus;8JAN97 pt devel gen lesions consisting of 100 vesicular lesions on trunk & face;It was reported that 24hr, 7 days, & 2wk cult as well as initial DSA were all negative;"
Severe erythema at injection site with decrease ROM (LLE). (req'd treatment with ORAPRED x 5d.)
Large, hard, swollen lump.  3.5 inches diameter.  Hot to the touch.
Acute ischemic stroke vertigo, trouble walking, loss of balance & coordination, vomiting
This patient received his second vaccine on 2/24/2021 and subsequently developed fatigue, altered mental status, and fever of 101.6.  He was taken to the ED on 2/25/2021 by his son and needed supplemental oxygen at that time and had an increased respiratory rate.  He was fairly high functioning prior to his second vaccine and has been in and out of 2 hospitals and the rehab facility several times since 2/25 and has never fully recovered.  Palliative care has been discussed.  He has had extensive work ups.  I spoke to our covering physician prior to submitting this report and she agreed that I should submit it due to his huge decline and the timing of his vaccine.  Of note, this patient did have COVID in October of 2020.
Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently "a few days after" vaccination, she developed a headache and became lightheaded after drinking a glass of wine. There was no product quality complaint involved. No additional information is available