chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty Breathing; Wheezing; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), WHEEZING (Wheezing) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0368A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DYSPNOEA (Difficulty Breathing), WHEEZING (Wheezing) and FATIGUE (Fatigue). On 08-Mar-2021, DYSPNOEA (Difficulty Breathing) and WHEEZING (Wheezing) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included salbutamol.
NUMBNESS IN LEG; PAIN IN ARM; HANDS FREEZING COLD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hypothyroid, and concurrent conditions included seasonal 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced numbness in leg. On 14-APR-2021, the subject experienced pain in arm. On 14-APR-2021, the subject experienced hands freezing cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in leg, pain in arm, and hands freezing cold on APR-2021. This report was non-serious.
Information has been received from a health professional concerning a 17 month old male with no known medical history or allergies who on 05-JUN-2006 was vaccinated SC with a 0.5 mL Varivax (lot # 652664/1033R). Suspect vaccination administered on the same day included a 0.5 mL SC dose of MMR (lot # 653317/0211F). "Around" 09-JUN-2006 the patient developed a rash on the face and body. It was reported that the rash had gotten worse. At the time of the report the patient had not recovered. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. It was also mentioned that a rash occurred with other patients. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a RN concerning a 14 month old female pt who on 19Jul05 was vaccinated with varicella virus vaccine live (lot 646675/0710N), which was expired. The pt returned for lab work, six weeks later on 13Sep05 (also reported as 23Sep05), which indicated a non immune status/titer was negative, the pt did not seroconvert. The pt was re-vaccinated on 19Oct05 with varicella virus vaccine live. The reporter mentioned no adverse reactions were observed, there were no serious criteria and medical intervention was not needed. There was no product quality complaint reported. The pt sought unspecified medical attention. No additional information has been requested.
I went to the emergency room with severe chest pain and was diagnosed with COVID 19.  Received REGEN-COV infusion and was sent home after 9 hours in the emergency room.
1. Back Pain 2. Headaches t 3. Right jaw,  face, eye and right temporal pain 4. right eye lid feels weak , and tearing
severe quaking chills; severe pain in leg bone; severe pain in shin; severe pain in knees; severe pain in hip joint; A spontaneous report (United States) was received from a Consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe quaking chills, severe pain in leg bone, severe pain in shin, severe pain in knees, severe pain in hip joint.   The patient's medical history reported included Seasonal allergies and history of Lung cancer.  Concomitant medications reported were Protonix, Eliquis, Lasix, Aldactone for drug use for unknown indication.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the events severe quaking chills, severe pain in leg bone, severe pain in shin, severe pain in knees, severe pain in hip joint and also mentioned that the pain was similar to the pain she had during chemotherapy.  Treatment details included Tylenol, topical ointment and Tramadol  Action taken with mRNA-1273 in response to the events was not reported.   On 1 Feb 2021, the outcome of events include, severe quaking chills, severe pain in leg bone, severe pain in shin, severe pain in knees, severe pain in hip joint, the pain was similar to the pain she had during chemotherapy was not reported.
Sore arm after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm after vaccination). At the time of the report, VACCINATION SITE PAIN (Sore arm after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  No treatment medication was reported.  Patient experienced sore arm that lasted for a day, after a week patient's sore arm became more sore that she can barely raise the arm over her head.
Information has been received from a physician concerning a 17 year old female who on approximately 13-AUG-2007 was vaccinated intramuscularly with a first dose of Gardasil.  Concomitant suspect vaccination included Vaqta (dose not reported).  Concomitant vaccinations included DTaP and MENACTRA.  Subsequently, the patient fainted and as a result had whiplash and broke her front teeth.  It was reported that since the patient had received multiple vaccines, when the physician administered Gardasil she did so slowly and cautiously and the patient fainted when the physician withdrew the needle.  The patient had dental repair and went to physical therapy for the whiplash.  The patient was also treated with unspecified muscle relaxers.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a health professional concerning a 15 year old female with no medical history and no drug allergies, who on 08-AUG-2007 at 13:35 was vaccinated intramuscularly in the left deltoid with a first dose of GARDASIL vaccine (Lot# 655620/0171U). Concomitant suspect vaccination included a first dose of hepatitis A vaccine (inactive (Lot# 6580/0495U) administered intramuscularly in the right deltoid. Concomitant vaccination included a first dose of of diptheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot# AC528008) administered intramuscularly in the left deltoid and a first dose of MENACTRA vaccine (Lot# U2358AA) administered intramuscularly. There were no illnesses at the time of vaccinations. On 08-AUG-2007 the patient experienced vasovagal syncope, fainted, fell from examination table and as a result had a whiplash and broke her front teeth. It was reported that since the patient had received multiple vaccines, when the physician administered GARDASIL vaccine she did so slowly and cautiously and the patient fainted when the physician withrew the needle. The patient went to the emergency room. The patient had dental repair and went to physical therapy for the whiplash. The patient was also treated with unspecified muscle relaxers. No laboratory diagnostics were performed. At the time of the report. The patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Severe shoulder pain 4 hours post-injection, limited range of motion continuously after 10 days, swelling of shoulder joint
it was rpt from health care professional concerning a pt who was vax w/pneumococcal & devel a localized react described as cellulitis-like react;
mom states c/o child having persistent, inconsolable crying lasting @ least 3hr, occurring w/in 24hr of vax;
Pain in left shoulder near administration site.  Inability to move arm for days.  When I could finally move it, there was a lot of pain especially anytime I would cross my arm in front of my body and lift up or push down.  Driving w/ my left arm was difficult.  Sleeping on left side caused pain.  Dressing and undressing, especially removing a tight shirt, was excruciating.  Had x ray, MRI, and was sent for physical therapy.  Still recovering.  Feeling some improvement but still having problems.
cold; flu symptoms; arm soreness at the injection site; nausea; diarrhea/at least one loose stool daily; aches and pains; wicked headache that was a Migraine at first and now an intermittent headache; wicked headache that was a Migraine at first; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 56-year-old female patient received bnt162b2 (BNT162B2 Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 31Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 56-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After the vaccination on 31Aug2021, an hour after, the patient experienced a wicked headache that was a Migraine at first. On an unknown date, the patient had now an intermittent headache, cold and flu symptoms that subsided after a few days, arm soreness at the injection site that also subsided after a few days. The patient has also experienced nausea and diarrhea, at least one loose stool daily and aches and pains that was not improving. The patient asking as these were symptoms for the COVID-19 Virus and how long do it side effects. The outcome of events cold, flu symptoms, arm soreness at the injection site reported as recovered on Aug2021, for outcome for events diarrhea/at least one loose stool daily and aches and pains were reported as not recovered and for other events it was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
red blotchy knot at the injection site; red blotchy knot at the injection site; itchiness at the injection site; soreness and tenderness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of RASH MACULAR (red blotchy knot at the injection site), VACCINATION SITE PAIN (soreness and tenderness at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (red blotchy knot at the injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness and tenderness at the injection site). On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site). On 11-Jan-2021, the patient experienced RASH MACULAR (red blotchy knot at the injection site) and VACCINATION SITE ERYTHEMA (red blotchy knot at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 12.5 milligram. On 05-Jan-2021, VACCINATION SITE PAIN (soreness and tenderness at the injection site) had resolved. At the time of the report, RASH MACULAR (red blotchy knot at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (red blotchy knot at the injection site) had not resolved.        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.   Patient was treated with Tylenol and Benadryl 12.5 mg orally.; 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 with COVID-19, fully vaccinated and boosted. Instantly found 02/07/2022. Diarrhea for 1 week. CTA thorax rule out pulmonary embolism, but bronchial wall thickening with some ground-glass opacifications noted.
No additional AE reported; HCP reported PROQUAD was administered after a temperature excursion to patient; This spontaneous report has been received from a medical assistance, concerning a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, historical drugs, and concomitant therapies were not reported.  On an unknown date, a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA) vaccine (lot number U039957 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported and confirmed as 14-JUN-2023) suffered a temperature excursion of -4.5 Celsius degrees during a time frame of 3 hours 58 minutes. The vaccine had not suffered a previous temperature excursion.  On 02-JUN-2022, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA) (lot number U039957, expiration date 14-JUN-2023) (dose, route of administration, and anatomical location were not provided) once, as prophylaxis (Product storage error). The temperature excursion that had suffered the vaccine administered was first identified on 03-JUN-2022.  No additional adverse events were reported, no further information provided.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2206USA001552:
Swelling & redness at site of administration for 4-5 days after injection of vaccination. Today it has improved. He applied cold compress.
Patient was given entire vial of Covid-19 vaccine 2023-2024 6m-4yr formula, approximately 0.5ml. Failing to dilute the vial with sodium chloride and separate the vial into three doses. Pts mother was contacted 5 hours after injection and reports no Sx. Encouraged to seek medical attention if patient develops severe symptoms as described in the fact sheet.
sore throat; aches; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HER2-" (unspecified if ongoing); "Breast cancer survivor HR+" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN taken for breast cancer, human epidermal growth factor receptor negative. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; PAIN (non-serious), outcome "unknown", described as "aches"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Presented w/SOB, hypoxia. Admit for COVID PNA, AKI d/t COVID. Dx w/COVID a week prior. Hx of HTN. Tx w/abx, high flow O2, steroid, zinc, Vit C. DC'd to rehab on 4L NC.
Pt came in for second Monderna vaccine but wanted clearance first. 7/15/21 received first vaccine, within 6 hours pat. developed a rash from shoulder to shoulder and back of neck and upper back. Also developed extreme fatigue- Pt states 3 yrs ago stung by red hornet and had same rash, stung 1 year later by another red hornet reaction was much worse. She could not walk for 6 weeks due swelling in legs, she developed blisters form head to waist,
Swelling around the throat including tonsils & lymph nodes within 5 minutes of vaccine administration.
1 week after getting the vaccine, I developed a 1.75 inch, red, knot that is hot to touch. It is also tender and slightly throbbing. It is also tingly/tight  down to my hand.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: After the event occurred patient's mother stated that her daughter did not eat any thing prior to coming for the vaccine. She also stated that she was very nervous and had a panic attack prior to entering the pharmacy. At the time of vaccine administration she was a little apprehensive. EMS came after event and stated that patient was fine and alright to leave the pharmacy.
she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.; headache; heart rate has been dropping; blood pressure has been going crazy, really high, really low; very stressed out; blood pressure was low 94/62; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (blood pressure was low 94/62), PRE-EXISTING CONDITION IMPROVED (she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.), HEART RATE DECREASED (heart rate has been dropping), BLOOD PRESSURE ABNORMAL (blood pressure has been going crazy, really high, really low) and STRESS (very stressed out) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included BISACODYL (DULCOLAX [BISACODYL]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced HYPOTENSION (blood pressure was low 94/62). On 05-May-2021, the patient experienced HEART RATE DECREASED (heart rate has been dropping), BLOOD PRESSURE ABNORMAL (blood pressure has been going crazy, really high, really low) and STRESS (very stressed out). On an unknown date, the patient experienced PRE-EXISTING CONDITION IMPROVED (she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.) and HEADACHE (headache). At the time of the report, HYPOTENSION (blood pressure was low 94/62) had resolved, PRE-EXISTING CONDITION IMPROVED (she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.), HEART RATE DECREASED (heart rate has been dropping), BLOOD PRESSURE ABNORMAL (blood pressure has been going crazy, really high, really low) and STRESS (very stressed out) outcome was unknown and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 94/62 (Low) low.     The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown.       Treatment medications taken were Steroids   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up document was attached on 05-May-2021 in which treatment and concomitant drugs are added.
WITHIN 1 MINUTE OF VACCINATION AND INSTRUCTIONS, PT ASKED FOR AN EXTRA ALCOHOL PAD AND THEN STIFFENED WITH HEAD BACK AND WAS NONVERBAL.  PT HAD TONIC SEIZURE LASTING 15-30 SECONDS WITH NO RESPONSIVENESS.  CALLED FOR ASSISTANCE FROM STAFF.  NO INTERRRUPTION IN BREATHING.  UPON, RECOVERY, PT YAWNED AND WAS DROWSY.  REPEATEDLY CALLED PTS NAME.  FIRST RESPONSE RECOVERYING FROM DROWSINESS WAS THAT PT FELT DIZZY.  PUT PTS HEAD DOWN. PT WAS FULLY AND APPROPRIATEDLY RESPONSIVE.  NO PRIOR H/O SZ BUT UPON ASKING AGAIN, PT DID HAVE A H/O SYNCOPE W/ NEEDLES (DENIED THIS PRIOR TO VAX).  WHEN FEELING BETTER, PT WAS WHEELED INTO ANOTHER EXAM ROOM AND LAID ON A TABLE TO RECOVER.  REFUSED PARAMEDICS TO BE CALLED.  STRESSED TO PT THAT HE NEEDED URGENT FOLLOWUP W/ PMD.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On 6th April 2019, the patient received SHINGRIX. On 7th April 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness, upset stomach, shivering, headache, pain in arm, swelling and erythema. On 8th April 2019, the outcome of the influenza-like symptoms, tiredness, upset stomach, shivering and headache were recovered/resolved. On an unknown date, the outcome of the pain in arm, swelling and erythema were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, tiredness, upset stomach, shivering, headache, pain in arm, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms, arm soreness, tiredness, upset stomach, shivering, headache, swelling and redness. The arm pain, swelling and redness had not resolved. The patient consented to follow up.
Patient stated that she first started itching.  She began to wheeze and have difficulty breathing so she called a doctor on call service and they told her to go to ER immediately.
1 day post vax sl stiff-getting worse & becoming sore-joint pain, bad deep throbbing pain-(front area joint of shoulder) extreme pain;no ROM;can not lift arm-diff dressing-cannot bend elbow w/o pain;