chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Pediatric patient received expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patient received expired dose) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient received expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patient received expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pediatric patient received expired dose).    No concomitant information was reported. The unbroken carton of 2.5ml vial was initially stored in freezer up until administration. The vial did not underwent any temperature excursions. No treatment information was provided.
Mom called office 10/16/2006 at 1347.  Child had broke out in head to toe hives about 1/2 hour after flu shot.  Gave BENADRYL and improved.
Information has been received from a nurse practitioner concerning an 8 year old pt who approx 7 years ago in approx 1997 was vaccinated with a dose of varicella virus vaccine live. On approx 16Apr04 the pt experienced a mild case of chicken pox. It was noted that the pt only had a few lesions and is recovering without treatment. No lab diagnostic studies were performed. Medical attention was sought. It was also reported that the event abated and that the pt was recovering with sequelae. No product quality complaint was involved. No additional information was provided. Additional information has been requested.
BURNING AND STINGING RASH WITH BLISTERS ON UPPER ABDOMEN. SPREAD OVER NEXT FEW DAYS WHEN I CONTACTED MY PHYSICIAN BY PHONE AND RECEIVED A PRESCRIPTION FOR A 7 DAY COURSE OF VALACYCLOVIR.
MUSCLE TIGHTNESS IN FOREARMS; FATIGUE; INVOLUNTARY TWITCHING IN CALVES AND IT MOVED TO THIGHS AND GOT WORSE AND TWITCHING OF THE EYELIDS; SINUSITIS; 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 immune suppressed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced involuntary twitching in calves and it moved to thighs and got worse and twitching of the eyelids. On 13-MAR-2021, the subject experienced sinusitis. On 24-MAR-2021, the subject experienced muscle tightness in forearms. On 24-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinusitis on 15-MAR-2021, had not recovered from involuntary twitching in calves and it moved to thighs and got worse and twitching of the eyelids, and fatigue, and the outcome of muscle tightness in forearms was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
I got the flu shot + Covid vaccine and now my fever is 101-102. That seems really high post vaccine. Is that normal?
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff). This case involves a 10 years old patient who received vaccine DAPTACEL. The patients past medical history, concomitant medication and family history were not provided. No other vaccines were given on 04-Oct-2018, the patient received a 0.5ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine lot number, expiry date not reported via intramuscular route in unknown administration site. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that a nurse at the practice injected a 10-year-old patient with DAPTACEL. Medical assistant stated that there were two vaccines boxes sitting side by side and the MA grabbed the wrong box and administered the vaccine from the wrong box. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender- none.
Lymph nodes in neck glands swelled causing it difficult to swallow. Joints have been achy for weeks.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ANXIETY-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient drank water as we talked to him. He started to look and feel better after a few minutes. He was able to hold a steady conversation throughout event. Within 5 minutes of being notified of event, patient was scrolling through his phone with no difficulty. We made patient wait for 20 additional minutes while monitoring him and patient stated \"I feel back to normal\" before leaving.
appetite not there; Cough worsened; can't sleep at night; she cannot even eat; Because of cough she can't rest; This is a spontaneous report received from a contactable other hcp (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration on 21Jan2021 (Age at the vaccination 52-year-old) as single dose for COVID-19 immunization. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EN6201) on 11Feb2021 as single dose for COVID-19 immunization. Medical history included sleeping problem. Concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced appetite not there, cough worsened, can't sleep at night, she cannot even eat and because of cough she can't rest. Caller states she got the Pfizer vaccine in January and she had been coughing ever since, it had been terribly worse. The doctor got her started on Tessalon Perles. Caller wanted to find out what she can do because she was so desperate because she can't sleep at night from coughing so much. Cough started a few months ago, in January, after the vaccine. It waked her up at night. She stated cough was almost disabling because she cannot even eat. It gets in the way of her eating. She cannot eat anything but sip coffee. She only had a small cup of coffee a day. When the caller was asked about details on the event, can't eat, caller states she does eat, but her appetite was not there. Caller clarified she was just started on Tessalon Perles to help with cough. Caller states the medication was not contributing to the cough. She started that it so it could help with the cough. Caller states she already had sleeping problem, but she was sleeping with her medication. Because of cough she can't rest or sleep. Therapeutic measures were taken as a result of cough worsened and can't sleep at night. The outcome of events was not recovered. The outcome of the events she cannot even eat and Because of cough she can't rest was unknown.  The event relatedness was reported as related for can't sleep at night and appetite not there.; Sender's Comments: Based on the information provided in the narrative, the causal association between the suspect drug and the events cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Severe dizziness, headache, but symptoms have not gone away. I feel horrible. Like I have a severe chest cold.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 21Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 05Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "ocular hypertension" (unspecified if ongoing); "chronic sinusitis" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL LUPIN, start date: 01Jul2021; BUPROPION HCL XL, start date: 01Jul2021; DIPHENHYDRAMINE HCL, start date: 01Jan2020; VITAMIN D 3; LUTEIN, start date: 01Jan2020; CETIRIZINE HYDROCHLORIDE, start date: 01Jan2020; ESOMEPRAZOLE MAGNESIUM, start date: 01Jan2020; CENTRUM WOMEN 50+, start date: 01Jan2020; BENZONATATE, start date: 27Jun2022; AZITHROMYCIN, start date: 07Jul2022; PREDNISONE, start date: 07Jul2022; FLAXSEED OIL [LINUM USITATISSIMUM OIL], start date: 01Apr2022; IBUPROFEN, start date: 22Jun2022. Past drug history included: Dextromethorphan, reaction(s): "known allergies: dextromethorphan", notes: known allergies: dextromethorphan; Guaifenesin, reaction(s): "known allergies: Guaifenesin", notes: known allergies: Guaifenesin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of suspected covid-19.  Clinical Course: Adverse event: Sore throat but not painful, more of a swollen throat, hard to swallow, cold feels worse then warm. Foods irritate it. Cough, difficulty breathing and shortness of breath. Fatigue. Felt better after taking Paxlovid but feels worse now. Adverse event start date was 04JUl2022. The patient was Not recovered, If treatment AE: Yes, AE Treatment: Antibiotics and steroids.
Patient was give vaccine that was past the "Do not use after" of 5/12/2022 at 11:00pm
Shot administered roughly 5:25 PM *Continued to keep arm/injection site moving and mobile throughout the night to prevent pain.* 7:00 PM- Noticed unusual itching, upon further inspection the injection site had broken out in a patch of hives (roughly pepperoni-sized) Hives disappeared roughly 45 minutes to 1 hour later. Site remained red, swollen and tender for the rest of the day 8:45 AM on 12/10/2022: Took band-aids off of both influenza shot (no adverse effects) and Moderna vaccine. Moderna vaccine band-aid was significantly bloodier than a standard vaccine bandage (1/3 of the cotton pad was covered in blood).  9:30 AM, current time of writing: Site remains swollen and warm to the touch. Arm remains painful to move, moreso than a standard vaccine injection.
RN TRIED TO VACCINATE AND PUNCTURED PT'S LEFT DELTOID AND PT PULLED AWAY. DOSE WAS NOT ADMINISTERED. BHS WAS CALLED AND PT WAS TAKEN TO PRIVACY AREA. FULL DOSE WAS ADMINISTERED TO RIGHT DELTOID WITHOUT COMPLICATIONS.
The patient was given a flulaval flu vaccine to earlier the client is month's old the requirement is 6 months
Developed ITP with platelets decreased 1,000/L. Presented with epistaxis, ecchymosis and petechiae of extremities and face 11 days after the vaccine. MMR given because of the travel to another country which was cancelled because of hospitalization. Had IV dexamethasone and IV immunoglobulin.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      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   This case was linked to MOD-2021-418964 (Patient Link).
Pain at the site of injection (left deltoid), tender/sensitive to the touch. Fever with chills. The person that submitted the event completed an outdated form which makes it unclear whether or not the result of the adverse event was a visit to the emergency room or a visit to the doctor's office.
received two doses of MMR II one year apart and when they tested him, he is not positive; This spontaneous report was received from a nurse referring to a 57-year-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On an unknown date, the patient was vaccinated with 2 doses measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dosage regimen, route of administration, lot number and expiration date were not reported) for prophylaxis, 1 year apart. When tested him, the patient remained negative (seroconversion test negative).      The outcome of seroconversion test negative was reported as not recovered. The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the events was not reported.
serious allergic reaction, fever, hives, itching of feet and hands, reddening of skin, swelling of eyes, face and ears, tiredness, weakness, dizziness, paleness, shortness of breath.
Extremely sore left arm started almost immediately, but it was not until 6 pm that chills, nausea and headache began and persist today, 4/28/21, as of 12:30 pm. I have taken Tylenol, Ibuprofen and am drinking a lot of water (and wearing a blanket at the office for the chills!)
Uncomfortable; very bad pain, hurt really bad; Very weak; Huge hard lump; Lymph node reaction; Pain at the injection site; Started getting swelling; chills; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Uncomfortable), PAIN (very bad pain, hurt really bad), ASTHENIA (Very weak), VACCINATION SITE INDURATION (Huge hard lump) and VACCINATION SITE LYMPHADENOPATHY (Lymph node reaction) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced DISCOMFORT (Uncomfortable), PAIN (very bad pain, hurt really bad), ASTHENIA (Very weak), VACCINATION SITE INDURATION (Huge hard lump), VACCINATION SITE LYMPHADENOPATHY (Lymph node reaction), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Started getting swelling) and CHILLS (chills). At the time of the report, DISCOMFORT (Uncomfortable), PAIN (very bad pain, hurt really bad), ASTHENIA (Very weak), VACCINATION SITE INDURATION (Huge hard lump), VACCINATION SITE LYMPHADENOPATHY (Lymph node reaction), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Started getting swelling) and CHILLS (chills) outcome was unknown.            No treatment information was provided.
Lightheaded. Fatigued. Out of breath with very light activity. Headache.
This spontaneous report was received from a pharmacist concerning his 58 year old wife with diabetes, hypertension, hypercholesterolemia and mycin allergies. The patient's medical history included thyroidectomy. On 05-OCT-2012 the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular and a dose of Influenza Virus Vaccine (manufacturer unknown) (route was not provided). No concomitant medications were reported. The pharmacist reported that on 06-OCT-2012, her wife experienced a light burning sensation in the upper part of her chest that would come and go. Last night, on 08-OCT-2012 she experienced a constant burning sensation in the upper part of her chest, described further as dull ache and found herself taking deep breaths, although not short of breath. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
about one week after my second Covid shot (first one was december 15th) I experienced severe fatigue.  Also had gastrointestinal symptoms of bloating, gas, diarrhea and cramps, frequent bowel movements, nausea and weakness.  Lost over 15 pounds.  Symptoms were severe for about a month and ended up in the ER for evaluation.  Work up did not show any other reason for these symptoms.  Now 5 months later I am still not back to normal.  Early satiety, tiredness, fatigue, memory issues and abnormal bowel movements.  Better but not normal pre vaccine.
I experienced nasal congestion the next morning, and redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; This is a spontaneous report from a contactable physician. A 30-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 23Dec2020 13:30 at a single dose for covid-19 vaccination. Vaccination was done in the hospital. There were no relevant medical history and no concomitant medications. The patient was not pregnant. The patient experienced nasal congestion the next morning, on 24Dec2020 07:00, and redness, induration and pain on the injection site. The induration and redness was around 1-1.5 inches diameter. The outcome of the events was recovering. There were no treatment involved for the events. This was assessed as non-serious.  Information on the lot/batch number has been requested.
Significant rash on LEFT forearm occurred on Saturday, April 3.  Rash continued for 10 hours.  No itching.  Note:  This is NOT the arm where I received the vaccine.
09/18/2001, 8:30 PM fever last night gave Tylenal, 09/19/2001, 12:00 noon reticad redness, swelling, warmth to RDT, No check out pain from child, 09/19/2001, 13:15 PM, temp 98.4, gave Benadryl 12.5 mg. By mouth and Tylenol 1 tsp by mouth per Dr. Cold compress applied.
Narrative: Moderna #2 2/8/21 Moderna #1 3/9/21 reported minor MI, CHF, resp failure, covid pneumonia, 94 years, multiple comorbidities home with hospice/comfort care
p/vax pt exp pain in both arms, felt tired & pale; treated w/tylenol; pt hosp next day due to viral illness;
This spontaneous report was received from a physician via company representative refers to a 12 year old female patient. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route were not reported). It was reported that the patient received her first dose of GARDASIL on an unspecified date, and one month after vaccination, the patient developed Bell's Palsy. Patient sought medical attention at emergency room. At the time of the report, patient's outcome was unknown. The relation between medication and event was unknown. Additional information has been requested.
Experiencing problems with memory, balance and feeling in right foot; Experiencing problems with feeling in right foot.; Experiencing problems with memory; On April 6 I suffered a stroke.  It was minor.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP6955), via unspecified route of administration in arm left on 27Mar2021 (at the age of 68-years-old) as dose 2, single and first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via unspecified route of administration in arm left on 06Mar2021 (at the age of 68-years-old) as dose 1, single both the doses for COVID-19 immunisation. The medical history of the patient included myacins and codeine allergy from an unknown date and unknown if ongoing. The concomitant medications of the patient included just vitamins. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested with covid-19 nasal swab and resulted negative on 06Apr2021. The patient reported on 06April I suffered a stroke. It was minor. Experiencing problems with memory at 16:30 and experiencing problems with memory, balance and feeling in right foot on an unspecified date. The patient visited Emergency room/department or urgent care. The patient was hospitalized for one day as a result of events. The patient underwent lab tests and procedures which included minor catscan (2); MRI; EKG; bubble test. Therapeutic measures were taken as a result of experiencing problems with memory and on april06 and suffered a stroke it was minor catscan (2); MRI; EKG; bubble test. The outcome of the events was reported as resolving.  Follow up attempts are possible. Further information is expected.