chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to a 3-year-old patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 16-MAR-2017, the patient was vaccinated with a dose of VARIVAX lot # M039318 (expiration date, dose, route of vaccination were not reported) for prophylaxis. Information regarding concomitant medication was not provided. No adverse effects were reported. There was no product quality complaint involved. It was also reported that the vaccines experienced temperatures from 6 F degrees to 14 F degrees for 22 days. There was no previous temperature excursion. The call was not because of a "data logger". This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014463: US-009507513-1705USA013513: US-009507513-1704USA000004: US-009507513-1705USA013527:
headache; After she got the vaccine, she was exposed to someone who had Covid; This is a spontaneous report via a Pfizer Sponsored Program, Pfizer First Connect from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the right arm 21Dec2020 at single dose for Covid prevention.  Medical history included blood pressure and can't see to read without her glasses.  Concomitant medication included amlodipine.  The patient stated, "she got the Covid vaccine on 21Dec2020 and had a headache for 1-2 days. After she got the vaccine, she was exposed to someone who had Covid, and wants to know if she can still get the second dose. She has had no symptoms after being exposed (Dec2020) but is about to be tested just in case she gets the virus. Her co-worker was positive and they were all in the breakroom without a mask. A couple other nurses are also concerned and don't know whether to get the second shot. They test at the hospital every Wednesday and wanted to know if she still can be tested before she gets the second shot. She had slight headaches on the 22nd, so she took some EXCEDRIN and it went away". The outcome of headache was recovered on 22Dec2020 and other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518688 same reporter/drug, similar event, different patient
Irritation with my tongue; My both inner ear are aching, happens when I swallow; Dry mouth; Swelling with my tongue on right side; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSITIS (Irritation with my tongue), EAR PAIN (My both inner ear are aching, happens when I swallow), DRY MOUTH (Dry mouth), SWOLLEN TONGUE (Swelling with my tongue on right side) and DYSPNOEA (Shortness of breath) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 043L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), ROSUVASTATIN CALCIUM (CRESTOR), FUROSEMIDE, FLUOCINONIDE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL], FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), DABIGATRAN ETEXILATE MESILATE (PRADAXA), LISINOPRIL, PROMETHAZINE, EZETIMIBE and GABAPENTIN 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 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced GLOSSITIS (Irritation with my tongue), EAR PAIN (My both inner ear are aching, happens when I swallow), DRY MOUTH (Dry mouth), SWOLLEN TONGUE (Swelling with my tongue on right side) and DYSPNOEA (Shortness of breath). At the time of the report, GLOSSITIS (Irritation with my tongue), EAR PAIN (My both inner ear are aching, happens when I swallow), DRY MOUTH (Dry mouth), SWOLLEN TONGUE (Swelling with my tongue on right side) and DYSPNOEA (Shortness of breath) had not resolved.            It was reported that patient discontinued medication lisinopril, promethazine, ezetimibe and gabapentin on advise by PCP which did not help much. Patient took allergy test on an unknown date which came back positive for many environmental allergies.  Treatment information was not provided.
Hives and treated with Benadryl started 5-26, resolved 6-1.
He of PCs allergy. No other medical problems.pt felt like her throat was itchy and short of breath. Color pink, pt able to talk in full sentences,sipping water.paramedics here to evaluate,behavioral health here to assist.
Severe pain at vaccination site from 9-22-15 through 9-25-15. Applied ice pack and took Extra Strength Acetaminophen. Moderate pain began 9-21-15. Pain varied back and forth between moderate and mild. Moderate pain June 2016. Pain for 9 months! Moderate pain in May 2016.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age and race/ethnicity received TRUMENBA, via an unspecified route of administration at 0.5 ml single on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date with outcome of unknown.
Pt. received a TYPHIM (typhoid) vaccine on 5/18/15. She developed hives on both arms and legs the next day, very itchy. The hives resolved in about 3 days on their own.
Patient presented to urgent care on 1/17/2021 after receiving second dose of Pfizer COVID-19 vaccine on 1/14/2021. Patient stated that she had a sore throat and was fatigued X 3 days. Patient endorsed body aches and nausea immediately after vaccination. Patient had expiratory wheezing in left upper lung and has a history of asthma. Patient endorsed increased inhaler use over the past few days. Patient was given outpatient rx for prednisone and viscous lidocaine.
This spontaneous report as received from a pharmacist refers to a 50 year old female patient. Currently patient was having unspecified pain. No historical medication was reported. On 14-SEP-2014, the patient was vaccinated with ZOSTAVAX lot # K000325 expiration date- 27-FEB-2015, (dose strength was unknown). Concomitantly patient was receiving unspecified narcotic pain relievers. Pharmacist reports that the patient who had ZOSTAVAX administered on 14-SEP-2014, returned to the pharmacy on 15-SEP-2014 with 1.5 by 2 inch red circle around the injection site that was warm, swollen and painful. The outcome of 1.5 by 2 inch red circle around the injection site that was warm, swollen and painful was unknown. Pharmacist recommended cold compresses and Ibuprofen to treat the symptoms. No rash was present. No further information was provided. Lab Diagnostics Studies Performed was reported as none. Sought Medical Attention was reported as Yes, pharmacy visit. No PQC involved. Additional information has been requested.
38-year-old man who is otherwise healthy received his Pfizer mRNA Covid vaccines on April 22 and May 13.  On May 22 he noted a nonitching rash on his left foot that then extended up his legs.  Rash is mostly on legs and a few papules on the arms.  He presented to  emergency department on May 27 for evaluation of a rash. labs stable (CBC you possibly indicating a thalassemia), PTT and ESR normal He was medicated with 125mg IV Solumedrol with mild improvement of rash and started in Prednisone 60mg daily for 4 days. 5/28/2021- presented to PCP office for f/u.  He is taking medications as directed rash has not improved but has not significantly worsened.  No other concerning symptoms.  Presentation monomorphic papules consistent with a viral exanthem likely secondary to the mRNA vaccine.   Advised to Continue prednisone 60 mg and follow-up with PCP on June 1
Evening of 9-10-07 (day of injections) pt mother states pt was running a slight temperature and lt upper became slightly swollen, red, very warm and painful. 9-12-07 pt here in clinic for PPD reading and advised her to apply cool packs to lt arm.
Information has been received from a physician and a registered nurse concerning a girl who on unspecified dates was vaccinated with her second doses of VARIVAX (Merck) (lot number not reported). On an unspecified date the patient broke out in hives around the injection site. No medical attention was sought. "After a few days", on an unspecified date, the patients recovered. This is one of several reports from the same source. Additional information is not expected.
Redness, swelling and tenderness at the injection site  Rash appeared at the injection site after 8 hours of administration.  Chills and  low grade fever
Flublok QIV given to patient 12 years old with no reported adverse event; Flublok QIV given by cutaneous route with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid non-serious case received via health professional.  This case involves a 12-year-old male patient who had INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] given by cutaneous route with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On unknown date in October 2022, the 12 years old patient received suspect FLUBLOK QIV VACCINE at (unknown: formulation, strength, dose) (lot: 4928107288) via cutaneous route in unknown administration site for annual flu vaccination (product administered to patient of inappropriate age and incorrect route of product administration) at same day latency. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both events.     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.
Moderna Booster to original J&J shot - may be coincidental but have had severe nausea and vomiting since 10/25 and also now have mild hives.
He had an immediate fever for 2-3 days with a rash starting at neck and working over entire body on 6th day after shot.  He was very irritable and showed signs of lost appitite through out the week.  Revisited the doctor 10 days after vaccination showing signs of redness in ears and a more developed rash over entire body.  Prescribed w/ Immoxicelin @ 6.25ml 2 twice a day. After 8 days a more prominant rash returned over entire body. Dr diagnosis of B19 (fifths desease) virus on 6/11 without blood test and told to stop medication. Patient had not previously been sick other than a small fever from previous vaccinations. Rash and irritablity still present 6/13/08.
Extreme fatigue, dizzy, foggy brain, disoriented, nausea, congestion, joints aching, extreme neck and shoulder pain on the left side . Feels like the Cortizone shot that I normally get for my joints stopped working once I got the J&J shot Shoulder doctor said the shoulder pain was caused from the shot being given to high in my arm
Hearing loss in ears; Severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times; severe vertigo; Walking sideways; Confusion; Double vision; Ear Fullness; Severe vomiting; Headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eosinophils esophagitis" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 03:45 PM), administration date: 14Sep2021, when the patient was 36-year-old, for Covid-19 Immunization. The following information was reported: CONFUSIONAL STATE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Confusion"; DIPLOPIA (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Double vision"; EAR DISCOMFORT (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Ear Fullness"; HEADACHE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Headaches"; DEAFNESS (disability, medically significant) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Hearing loss in ears"; TINNITUS (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times"; VOMITING (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Severe vomiting"; GAIT DISTURBANCE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Walking sideways"; VERTIGO (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "severe vertigo". The events "hearing loss in ears", "severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times", "severe vertigo", "walking sideways", "confusion", "double vision", "ear fullness", "severe vomiting" and "headaches" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Negative, notes: Covid test: Nasal swab. Therapeutic measures were taken as a result of deafness, tinnitus, vertigo, gait disturbance, confusional state, diplopia, ear discomfort, vomiting, headache. Clinical course: Multiple ENT visits, PCP visits, new med pres. Prior to vaccination, the patient was not diagnosed with covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
some of the side effects of the vaccine were very similar to the Rheumatoid Arthritis; Remicade lowers the effectiveness of the vaccine; Remicade lowers the effectiveness of the vaccine; She was tired; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [04Nov2021], this case now contains serious adverse reaction(s). Information processed together.   This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable female consumer. A elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; infliximab (REMICADE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to Sep2021, at UNK (every 6 weeks) for rheumatoid arthritis.  Medical history included ongoing rheumatoid arthritis which  I have Rheumatoid arthritis for 30 years now and I just this Remicade is really really worked well and I do not think it has worked this well since I took the vaccine back in February.The patient's concomitant medications were not reported. patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for  covid-19 immunization.The patient experienced some of the side effects of the vaccine were very similar to the rheumatoid arthritis, remicade lowers the effectiveness of the vaccine, she was tired on an unspecified date. Outcome of events was unknown. The clinical course was reported as follow: Caller received two doses of Pfizer BioNtech COVID-19 vaccine. She received the second dose on 05Feb2021. Caller is on Remicade infusion. She heard the use of Remicade can lower the immune response by 40 to 50 or 60%. Caller is interested to know if the effectiveness of Remicade can be diminished by taking the vaccine. Realized after the caller disconnected the line. Caller is a female who's almost 80 years old. She states she is concerned she felt Remicade did not work. She was tired and some of the side effects of the vaccine were very similar to the Rheumatoid Arthritis. Her last infusion was six weeks ago, and she felt the best. She never felt this way in months. She just feels like the booster dose is not ideal. She wishes she had done some studies because these drugs are very powerful and based on the ongoing studies she doesn't know if taking the booster dose can lower the effectiveness of her medication Remicade. She states Remicade can affect the liver and kidneys. The vaccine is presented like a flu shot and I heard of a possible 4th booster dose that's going to be out.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Shortly after I begin to feel a little sniffly, body aches and soreness.  I got tested for COVID which was neg and was prescribed a Z-Pack and after a few days I felt better.  I had a little fluid built up in the inner ear also.
On the morning of August 14, 2021, my daughter experienced injection site pain, tiredness and leg/thigh muscle pain.  Her leg pain caused her to stumble while walking.  That afternoon, her temperature spiked 101.6 at it's highest.  She was treated effectively with Tylenol and symptoms improved.  Today, her fever was 100.1 at it's highest and is no longer experiencing leg pain.
Large arathema of right upper arm Radiating from deltoid area to approximately halfway to elbow instructed to treat with benadryl & tylenol.
After vaccines given and pt out of treatment room she saw black spots, told her mom she was going to pass out and had controlled fall to ground. All VS WNL and quickly recovered.
Information has been received from a health professional concerning a 63 year old female patient who on Sept 22 2004 was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot # 647724/0946N). Subsequently in approximately Sept 2004, the patient developed cellulitis and was treated with levofloxacin (Levaquin). Unspecified medical attention was sought. The reporter would like an investigation into the lot number. The health care professional reported similar experiences for three other patients (WAES0410USA00566, WAES0410USA00567, WAES041USA00320). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Chills until  3:00 am on May 9th.  Fatigue from 9:00 am May 9th until i woke up the next morning.
Complained of severe headache, nausea and blurred vision, starting 2-2 1/2 hours after receiving vaccine. Headache continued for 3 days. She did call the local emergency room for instructions. She was told to alternate Tylenol and Ibuprofen every 4 hours and to come to the ER if sx continued. She fell asleep and did not go to the hospital.
Moderna vaccine used past the 12 hour window of use time once vial was punctured. Stored in fridge the entire time of use and cleaned between use with alcohol. Patient was contacted and no adverse reaction reported.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 3:21 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021 at 3:21 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that on an unknown date the facility had a temperature excursion for the Moderna COVID-19 vaccine and the excursion duration was 1 month. And also, the vaccine was stored in an ultra cold freezer at -82 degrees Fahrenheit. On 19-Nov-2021 the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. 70 vials were in the ultra cold freezer, 8 vials were in the refrigerator. The vaccine was never refrozen. Number of vials impacted were 78 and none of the vials were punctured and there were no previous temperature excursions.   This case was linked to MOD-2021-402935 (Patient Link).
Narrative:  74yo male patient died during inpatient hospice admission. Date and Time of Death: Oct 1,2021@19:05 Death was caused by: acute heart failure unresponsive to Additional comments: Dx with DVT 2 weeks ago. Then this admission, dx with endocarditis and septic shock plus multiple PE and new pancreatic tail mass with liver and local nodal metastasis. developed acute systolic HF - EF was 60% 9/27 and 20% 9/30. Additionally metabolic acidosis and was in need of HD but thought to be a poor candidate. Then patient's bp continued to decline despite increase in norepi and later addition of milrinone When more alert/clear earlier today, chose to be dnr with no lsts. Then worsened during day. HCS opted for hospice and was supported by patients living relatives - his two brothers and his step mother. when family was around bedside, pressors were stopped and comfort meds were given. Patient died peacefully. Pt had received covid vaccines on 2/3/21 & 3/5/21. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
LITTLE TIRED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little tired was not reported. This report was non-serious. This case, from the same reporter is linked to.
Child has developed and currently still has several swollen lymph nodes and severe eczema starting on September 16, 2019 as a result of his DTaP and rotavirus vaccination on September 13, 2019.