chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a vaccine that wasn't diluted; received a vaccine that wasn't diluted; This is a spontaneous report from a contactable other health care professional (on behalf of Pharmacist) via a Pfizer sponsored program.   A 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EW0167; Expiration Date: Aug2021, NDC: 59267100001), via an unspecified route of administration, administered in Arm Left on 01Jun2021 (at the age of 58-years-old) as a single dose for covid-19 immunisation. Patient had no medical history and concomitant medications were not reported was not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EW0171, Expiration Date: Aug2021, NDC: 59267100001) via an unspecified route of administration, administered in Arm Left on 11May2021 at 0.3 ml as a single dose for covid-19 immunisation. On 01Jun2021, (reported as happened an hour ago) the patient received a vaccine that wasn't diluted. Reporter wanted to know the side effects that would happen to the customer who received the vaccine that wasn't diluted. The seriousness of the events was reported as medically significant. The outcome of the events was unknown.  Follow-up attempts needed. Additional information has been requested. ; Sender's Comments: Based on known drug safety profile there is reasonable possibility of causal association between the reported events and the suspect drug.
Information has been received from a registered nurse concerning a 9 year old female who on 27-JAN-1999 was vaccinated in the left thigh with a first dose of Varivax (lot # 626767/0668H). On 05-FEB-2007 the patient developed chickenpox. It was reported that the patient had less than 50 lesions with blisters on the chest, under her arms and on her legs. No further information was provided. Additional information has been requested.
1.5 hours after receiving vaccine patient broke out into hives all over body. Patient with raised, red wheels on arms, legs, back stomach, neck. No swelling of mouth, tongue, throat. No nausea/vomiting. No shortness of breath. Significant pruritus. Patient was started on BENADRYL 50mg scheduled q6 hours and given prednisone 20mg daily x5 days. Patient was contacted the next day on 8/7 and hives had resolved.
back and spine started hurting; back and spine started hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Auto Immune Disorder" (unspecified if ongoing), notes: verbatim:Auto Immune Disorder. The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), SPINAL PAIN (non-serious), outcome "unknown" and all described as "back and spine started hurting". Additional Information: Caller says that when she got the 1st shot, she had some reactions with it, her back and spine started hurting and some other things. Caller was very vague.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 100.4, chills, joint aches.  Most important, hip joint pain that developed while I was sleeping at the 2nd night after injection.  Hip pain continues into the 2nd day.
Vaccine was diluted with sterile water instead of the recommended normal saline.  No adverse effects.
Left upper arm was swollen in the area where the immunizations were given. It was red but not very painful. The child says it itches. Benadryl was prescribed.
This spontaneous report was received from a licensed practical nurse, referring to a 14 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 10-AUG-2015, patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Suffered a seizure a week after 2nd dose which was administered on May 16, 2021. 1st seizure began on May 25, 2021. Hit my head on wall and hit tongue and bled. 2nd seizure happened on June 23, 2021 and hit my head and bit tongue on same spot and bled. 3rd time seizure happened on August 22, 2021 and hit my tongue AGAIN on same spot.
Information has been received from a physician concerning his wife who is a nurse who "last year" in 2007 vaccinated herself with zoster vaccine live (Oka/Merck). Subsequently, in 2008 she came down with a case of shingles. The physician stated she had a rash , but no post herpetic neuralgia. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the physician indicated no adverse effects were experienced. Additional information is not expected. This is one of several reports from the same source.
Patient started with onset of swollen lips within 15 minutes after vaccination with significant swelling by 40 minutes after vaccinations.  Patient with puffy hands, face, periorbital swelling.  Patient appeared nervous, but also had taken benadryl and zyrtec prior to vaccination.  Patient kept repeating that he did "not feel well" and did not feel like himself.  That sensation lasted for 48 hours.  Patient still will puffiness of his lips and perioral area a week later.
just so much anxiety with the vaccine; bruising/bruising on her extremities, her upper thighs and arms; This is a spontaneous report from a contactable Nurse reported that. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Mar2021 13:30 (age at vaccination 36-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included constipation and food allergy from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT) 12.5 mg, daily within two weeks. Patient was not pregnant at the time of vaccination. The patient experienced bruising/bruising on her extremities, her upper thighs, and arms on an unspecified date Apr2021, just so much anxiety with the vaccine on an unspecified date. Ever since received the first vaccine dose, I have been bruising very easily anytime there is contact made to my body. Consumer was calling regarding the Pfizer COVID vaccine. She confirms she already filled and adverse reaction form online on Pfizer website. She is calling today because she is looking for advice. She has been bruising a ton since the vaccine and her legs have bruises all over them. She is just bruising super easily. She is just trying to figure out if this could be from the vaccine. She held off on her second dose. She just doesn't know what to do. There is just so much anxiety with the vaccine, but the bruising is new for her. Caller states he is calling on behalf of his daughter (as reported), the patient had her vaccine 3-4 weeks ago and about a week after she experienced bruising on her extremities, her upper thighs and arms and states their question is, should she get the second shot. Reporter clarifies that the bruising comes in waves, it got better and almost went away and then it came back again. Reporter stated the bruising started about a week after the vaccine, exact date unknown. The patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. AE bruising results in physician office visit. No other vaccine received prior to vaccination with in four weeks. No treatment was received for the adverse events.The patient underwent lab tests and procedures which included blood test and result was had blood work done that came back fine on an unspecified date. Outcome of the events bruising was not recovered, and anxiety was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtain. No further information was expected.
Systemic: reported existing cellulitis was exacerbated; symptoms lasted 0 days
Spent 2.5 days off work feeling like a moderate severity stomach flu. Lower GI cramping, which moved higher on day 2, hot and cold flashes, sweating, extreme fatigue, upper back muscle aches (severe). Diarrhea, total loss of appetite.
Weakness, vomitting, general ill feeling that was unexpected.  This happened at home after leaving the pharmacy some hours after the shot.   This was the booster and it hurt quite a bit.   With the first two doses  the shots were painless.
Reactive Lymphadenopathy in the left armpit (same side as vaccine side), as diagnosed by PCP. Tenderness and pain in the armpit starting on 6th day after 1st dose of vaccination. Symptoms still persists. PCP suggested a wait and watch for now and warm compress at the site.
Per patient, after getting the vaccine, the next morning she felt a burning sensation on her right arm that spread down from the injection stie.  She went to see the Dr. later that day and was prescribed Cephalexin 500mg with instructions to take 2 capsules by mouth 2 times daily for 10 days.
Nose bleed at work 12 days post vaccine, never had a nose bleed before in my life. Pain in left shoulder and right leg on day 11. Persistent headache for two days. Occasional light-headedness, blurred vision, slow cognitive abilities for 2 days since nose bleed.
Extreme Pain in lower back, headache, 102+ fever, weakness, swollen lymph nodes in neck, sore neck.
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 11-Mar-2022 at 12:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 12:56 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment information was provided.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day or within one month prior to any dose of Moderna COVID-19 Vaccine to the patient. Patient received the booster dose. Vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the expiry date of 04-Apr-2022.   This case was linked to MOD-2022-542869 (Patient Link).
2 days post vaccination, pt developed varicella lesions over whole body. No fevers, no superinfections noted. Unknown if prior exposure to Varicella.
Nausea/vomiting, fever, headache. Extremely sore arm. Dizzy. Blurred vision.   Motrin 800mg every 6 hours
Iritis, headache, eye pain, photosensitivity. Patient was given prednisone eye drops.
Idiopathic dermatitis starting 2 weeks after the vaccine, after a progression of cold-like symptoms.
Pt. reports 20 minutes post vaccine itching of (R) and (L) lower extremities. No other symptoms EMS notified of reaction. and pt. was to go to local hospital ER for evaluation.
Swelling, erythema and tenderness surrounding injection site. 16 x 15 cm right arm (seasonal flu), 5 x 6 cm left arm (H1N1)- responded slowly to Benadryl.
ACUTE PULMONARY EMBOLISM 8/13/2021 GASTRITIS ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 6/27/2021 GASTRITIS ACUTE DVT OF RIGHT POPLITEAL VEIN 6/28/2021 GASTRITIS ACUTE PULMONARY EMBOLISM 8/13/2021 ACUTE PULMONARY EMBOLISM ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 6/27/2021 ACUTE PULMONARY EMBOLISM ACUTE DVT OF RIGHT POPLITEAL VEIN 6/28/2021 ACUTE PULMONARY EMBOLISM
several pt recv vax & devel inj site rxn characterized by redness, swelling, warmth & tenderness;
Coughing, wheezing, difficulty breathing, neck glands swelling and sore, tongue felt as though it was thickening. Nebulizer treatment in ofc, albuterol and Medrol Rx's
Fever, Chills, Sweaty, Fatigue, Weak, Loss of appetite, Achy, Headache, and sore arm.  Stayed in bed for 2 days.
Child received vaccinations listed below, less than 30 minutes later child developed intense erythematous, pruritic rash covering all body severe now.  Also wheezing and paropysm of cough, treated with Decodron 8mg IM, Albuterol Neb 2.5mg and Benadryl with now complete resolution of symtpoms by 1 hour post treatment.
High fever of 102 F., extreme body aches, shortness of breath, cough, extreme fatigue, nausea, diarrhea, and loss of appetite. Fever lingered for over 1 week from vaccine date and shortness of breath and cough became increasingly worse and unable to eat and do normal activities. Went to PCP and had labs and chest X-ray confirmed pneumonia. Prescribed AMOXICILLIN-CLAV unable to work because of this.
worsening bilateral infraorbital edema; perioral edema; upper lip edema; mid-cheeks swelling and inflammation; malaise; fever; fatigue; myalgias; This literature-non-study case was reported in a literature article and describes the occurrence of ORBITAL OEDEMA (worsening bilateral infraorbital edema) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: Oral angiotensin-converting enzyme inhibitors for treatment of delayed inflammatory reaction to dermal hyaluroninc acid fillers following COVID-19 vaccination-a model for inhibition of angiotensin II-induced cutaneous inflammation. 2021:63-68     The patient's past medical history included Skin cosmetic procedure (she was injected with 1 mL of Voluma 1 in the bilateral tear troughs) in November 2019 and Lip cosmetic procedure (she was injected with 1 mL of Juvederm Ultra in the upper and lower part of the lips) in November 2019.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced ORBITAL OEDEMA (worsening bilateral infraorbital edema) (seriousness criterion medically significant) and CIRCUMORAL OEDEMA (perioral edema). December 2020, the patient experienced LIP OEDEMA (upper lip edema) and SWELLING FACE (mid-cheeks swelling and inflammation). December 2020, the patient experienced MALAISE (malaise), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (myalgias). At the time of the report, ORBITAL OEDEMA (worsening bilateral infraorbital edema), CIRCUMORAL OEDEMA (perioral edema), LIP OEDEMA (upper lip edema) and SWELLING FACE (mid-cheeks swelling and inflammation) had resolved and MALAISE (malaise), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (myalgias) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Body temperature: 38.8 (High) 38.8 degrees Celsius.     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.   Treatment for the events included Cetirizine 20mg and oral lisinopril 5mg QD. Historic use of corticosteroids was noted.  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.   Reporter did not allow further contact; 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.
Raised rash on chest.  Numerous red pimple like bumps.  Confined to chest area, not at site of injection.
lump in throat/numbness to tongue, redness to face, dry mouth, pressure under eyes, evaluated by EMS, symptoms improved, pt. refused transport.
RESIDENT RECEIVED THE VACCINE ON 1/20/2021, RESIDENT HAD BEEN MONITORED EVERY SHIFT AND HAS NOT EXHIBITED ANY SYMPTOMS. RESIDENT WAS OBSERVED TO BE UNRESPONSIVE WITH NO PRESENCE OF VITAL SIGNS ON 1/24/2021. RESIDENT WAS A FULL CODE, CPR INITIATED UNSUCESSFULLY. BASED ON REVIEW WITH PRIMARY CARE PHYSICIAN AND MEDICAL DIRECTOR, THE RESIDENT HAD NOT HAVE ANY OTHER EVENTS PRIOR TO RECEIVING THE COVID VACCINE 4 DAYS PRIOR TO EVENT.
16 year old patient who is under age of Emergency Use authorization was administered Moderna Covid-19 Vaccination (1st dose)
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was homeless and resident in facility. Ambulance was called on 3/30/21 because he was having difficulty breathing. His mother informed hospital he passed away that day but did not provide cause of death. Any comorbidities are unknown and not documented in chart.
got one flu shot several years ago, got sick as a dog; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 19-Oct-2020.  This case is linked to cases 2020SA295920, 2020SA295988, 2020SA295993, 2020SA296000, 2020SA296006, 2020SA296027 and 2020SA296037 (Cluster).  This case involves a male patient of unknown age who got one flu shot several years ago, got sick as a dog (illness), while he received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, 14 years ago, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that he got one flu shot several years ago, got sick as a dog.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.      The reporter assessed the causal relationship with suspect vaccine as related.
Around 11 pm on 2/12/2021 patient had sever body aches that required Motrin OTC , I woke at 5 am on 2/13/2021 and had sever body aches and chills, I went to the bathroom and woke up on the floor and had passed out.
No additional AE reported; Patient was administered improperly stored PROQUAD; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. . The patient's medical history, current conditions, drug reaction or allergies and concomitant medications were not reported.  On 02-AUG-2022, the patient was vaccinated with improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (recombinant human albumin (rHA) (lot number: U029148, which was determined to be valid, with an expiration date on 16-MAR-2023) (dose, route and anatomical location of administration were not reported) (product storage error). Administered dose underwent a temperature excursion of -5.70 degrees Celsius (C) for 1 hour and 10 minutes. It was reported that there was not any previous temperature excursion. No additional adverse event was provided.
hives minutes later; Breathing issues; Missed the recommended interval between doses/ she got the 1st Moderna covid-19 vaccine on January and didn't take the 2nd; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives minutes later), DYSPNOEA (Breathing issues), PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/ she got the 1st Moderna covid-19 vaccine on January and didn't take the 2nd) and RASH (Rash) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced URTICARIA (hives minutes later), DYSPNOEA (Breathing issues), PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/ she got the 1st Moderna covid-19 vaccine on January and didn't take the 2nd) and RASH (Rash). In January 2021, PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/ she got the 1st Moderna covid-19 vaccine on January and didn't take the 2nd) had resolved. At the time of the report, URTICARIA (hives minutes later), DYSPNOEA (Breathing issues) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.
Pt devel abnormal liver function tests following vax w/2nd dose of Hep B vax;
inflamed, red, hot to the touch, swollen and bruised area at sit of injection, continues through this day. 4 days later.  also suffered intense headache and fatigue, with body aches for 24 hours after the injection.