chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; administration of a booster dose of Moderna vaccine to a 5 year old patient; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of a booster dose of Moderna vaccine to a 5 year old patient) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     It was unknown if patient had any allergies or any medical history relating to mentioned adverse event and both Acute and chronic illnesses at the time of vaccination and ever had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: Pfizer vaccine (1st dose, Lot number: FK5127, Expiration date: 31-Jan-2021, Route Intramuscular) on 11-Nov-2021, Pfizer vaccine (2nd dose, Lot number: FK5127 and Expiration date: 31-Jan-2021) on 02-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 11-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of a booster dose of Moderna vaccine to a 5 year old patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of a booster dose of Moderna vaccine to a 5 year old patient) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of a booster dose of Moderna vaccine to a 5 year old patient).    It was unknown if other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. It was unknown if the patient was under any concomitant or regular medication. No treatment  medications were reported. It was unknown if there was any AE as a result of the misadministration.
he had a sore throat; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that  a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unknown date in Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient asked if its okay to take his 2nd shot today as he had a sore throat since a couple days ago in Apr2021. Patient had his 1st shot 3weeks ago in Mar2021. The outcome of the event was unknown   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
DECREASED COORDINATION; WEIGHT LOSS (LOST 90 POUNDS); NUMBNESS IN HANDS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced decreased coordination, weight loss (lost 90 pounds), and numbness in hands. Laboratory data (dates unspecified) included: Weight (NR: not provided) loss 90 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the decreased coordination, numbness in hands and weight loss (lost 90 pounds) was not reported. This report was non-serious.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB (strength, dose and frequency not reported) (route, lot# and expiration date not provided). It was reported that RECOMBIVAX HB was exposed to a supported temperature excursion on 06-OCT-2014 and had been administered to unspecified patients on unspecified dates since the excursion on 06-OCT-2014. No adverse effects had been observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received 2nd dose of Pfizer Vaccine. Patient reported to Vaccinator that she had experienced sudden onset of nausea and vomiting and chest tightness post 1st dose and was taken by EMS to Hospital after 1st dose. Per patient she was given clearance by her PCP to receive 2nd dose of Pfizer Vaccine. Within 5 minutes of receiving dose, patient with sudden nausea, sharp headache, and complaining of chest pain. EMS called, and patient transported to ER. Vital Signs Stable: 124/71, HR 80, 100% on Room Air upon transfer.
Headache every day, extreme fatigue, chills , rash on injection site, muscle pain, fever
I didn't have any reaction initially after receiving the vaccine. In the late afternoon I had sort of a headache feeling. I went home and felt very tired. I had some aching. The next day in the morning I had body aches especially in my legs. My neck started feeling weird. I took some Tylenol. I had no fever. My neck started hurting me. In January I went to go see my doctor. He said I have arthritis in my neck. It started to get really bed. I was supposed to be out of work for 6 weeks but I only was out for 4 weeks because of short staff. I seen an orthopedic doctor and they didn't think it was caused by the booster, but they also don't know for sure. My neck constantly aches and burns. There is currently a lump on my collar bone on the right side. It's not a soft lump but they don't know what it is. The doctor said if it doesn't go down by the ending of March 2022 then they are going to do a MRI. I was prescribed Methocarbamol and Diclofenac. I have a lot of muscle aches.
The patient has had no known side effects; Medical Assistant called to report that an expired dose of ROTATEQ that was administered to a patient on 7/28/2022. The patient has had no known side effects. ROTATEQ expired on 7/18/2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUL-2022 , the patient was vaccinated expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #T040207, expiration date: 18-JUL-2022, administered for prophylaxis (strength, dose, dose number and route of administration were not provided) (expired product administered).  The patient had no known side effects.
Caller states 17 patients received the doses after the light exposure, 13 of those being second doses.; Caller states 17 patients received the doses after the light exposure, 13 of those being second doses.; Problems are Hidradenitis and Folliculitis; Problems are Hidradenitis and Folliculitis; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 12 year-old female patient received bnt162b2 (BNT162B2, solution for injection) (Lot number: FA6780) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hidradenitis" (unspecified if ongoing); "Folliculitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT STORAGE ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) and all described as "Caller states 17 patients received the doses after the light exposure, 13 of those being second doses."; HIDRADENITIS (non-serious), FOLLICULITIS (non-serious) and all described as "Problems are Hidradenitis and Folliculitis".  Additional Information: Reporter is a nurse and they were told that the vaccines cant be exposed to light, However while in the freezer the lights were not turned off and the vaccines were exposed to light for 16 and 17 hours. Nurse wanted to know if the vaccines are still good to use. Nurse stated 17 patients received the doses after the light exposure, 13 of those being second doses. Nurse stated, It was for Covid. So, the vaccine was under the normal temperature, there was not a temperature excursion. The unit of the refrigerator unit, the light inside of unit was left on. So, the vaccine was exposed to that units of light for about 16 hour and a half so there was no temperature excursion. The temp were all within the limits. Nurse stated, Problems are Hidradenitis and Folliculitis.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021856936 same reporter/drug/AE, different patient
Experienced normal pain after first receiving the shot which was gone by day three. On day eight, a rash began to appear in the area right below the shot. It expanded and defined itself overnight. Mild itching  and some pain returning. Treatment of Advil and ice packs will be used.
Chest pain, itching, hive, TX Prednisone 10mg, Albuterol inhaler 2 Puffs.
Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Mild
developed shingles in his right upper extremity and face; profound loss of function in the shoulder/lost the ability to raise his right arm; This is a literature report.  A 80 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "right anatomic shoulder arthroplasty", start date: Sep2018 (not ongoing); "lymphoma" (ongoing); "postoperative chemotherapy" (unspecified if ongoing); "glenohumeral osteoarthritis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1 Unknown manufacture), for covid-19 vaccination. The following information was reported: HERPES ZOSTER (medically significant), outcome "recovered", described as "developed shingles in his right upper extremity and face"; HYPOKINESIA (medically significant), outcome "recovering", described as "profound loss of function in the shoulder/lost the ability to raise his right arm". The patient underwent the following laboratory tests and procedures: electromyogram: the results showed mild median, ulnar, and radial, notes: nerve neuropathy, while the axillary nerve showed normal function.was done 3 days prior to his clinic visit, within 6 weeks of the onset of his symptoms; magnetic resonance imaging: showed mild atrophy and fatty infiltration of the, notes: subscapularis and supraspinatus. The deltoid was difficult to assess due to signal artifact from the prosthesis; pathology test: diagnosed with lymphoma; physical examination: he had 90 to 100 degrees of active forward, notes: elevation and his pain was well controlled. in December 2018; active forward flexion was 0, notes: significant deltoid atrophy; passive forward flexion to 120 degree, notes: significant deltoid atrophy. Therapeutic measures were taken as a result of herpes zoster, hypokinesia.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202200159961 Same article/ drug and different patient/event
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 10-FEB-2014, at 09:45, the 23 year old female patient was vaccinated with the a dose of GARDASIL (lot # reported as H020845) into the right deltoid (dose, route not reported). The medication refrigerator was out of range in the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22: Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
As I stated before,  awoke from sleep 14 hours after injection feeling hot with severe aching bilateral kidney area and lumbar spine.  Lasted for 3-4 hours.  Simply drank glasses of water and rested until symptoms lifted.  (This has never happened before.)
This spontaneous report as received from a medical assistant, who refers to a 12 year old male patient. There was no information about patient medical history and drug allergies or drug reactions. ON 29-JUL-2013 the patient was vaccinated intramuscularly with a first dose of GARDASIL, 0.5 ml (lot # J003727, exp. date 11-JUN-2015). Concomitant medications were not reported. On 29-JUL-2013, 4 min after administration of GARDASIL the patient fainted. Ammonia was immediately used to wake the patient. The medical assistant reported that after the patient awoke, his ears, eyes and nose were checked and everything was okay. The patient was a little pale and was given candy and popsicle to eat. The patient sought medical attention, via physician's office. After 20 minutes, the patient's blood pressure and pulse were determined to be normal and the patient was allowed to leave the physicians office. None laboratory diagnostic studies were performed. The patient recovered from adverse event on 29-JUL-2013. It was reported that the therapy with GARDASIL was continued. The relatedness between therapy with GARDASIL and adverse event was not reported. Additional information has been requested.
Fever >102.4, congestion, sore arm, difficulty breathing, severe asthma, malaise, headache. Minor temp started around 10pm, woke up 3:30am with extreme cough and SOB, asthma, wheezing; fever rose throughout day greater than 102, continued shortness of breathe, coughing,  congestion, wheezing, sought treatment in Emergency Room
medial femoral condyle broken/thought hit knee on side of door; medial femoral condyle broken/thought hit knee on side of door; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4253215-00 (Abbvie).  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. Relevant medical history included: "Psoriatic arthritis moderate to severe chronic plaque psoriasis" (unspecified if ongoing); "orthoscopic surgery", start date: May2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TIBIA FRACTURE (medically significant), outcome "recovering", JOINT INJURY (medically significant) with onset 2021, outcome "unknown" and all described as "medial femoral condyle broken/thought hit knee on side of door". The action taken for adalimumab was unknown.   Clinical information: the patient experienced medial femoral condyle broken/thought hit knee on side of door. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect.  Causality for Humira (Adalimumab): The reporter's causality for the events of medial femoral condyle broken/thought hit knee on side of door and Knee injury was not provided. Since no determination has been received, the case is managed based on the company causality assessment.  AbbVie's opinion is that there is no reasonable possibility that the events of medial femoral condyle broken/thought hit knee on side of door unknown onset and medial femoral condyle broken/thought hit knee on side of door onset in 2021 are related to Humira(Adalimumab).  The reporter's assessment of the causal relationship of the events medial femoral condyle broken/thought hit knee on side of door and Knee injury with bnt162b2 was possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Tibial fracture, joint injury and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.
Two hours following the injection, the L side of the face became numb. The numbness spread down the L side of the body and now on 11/1/17, the entire L side of the body is numb. Saw doctor three times who prescribed anti-inflammatory medication.
Chills, Sweating profusely, no appetite, migraine on and off for 2 days, burning at injection site 30 minutes after receiving vaccination.
Initial misuse report received from a healthcare professional on 14 AUGUST 2013. On 05 AUGUST 2013 at patient was in advertently administered TENIVAC instead of ADACEL. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none
Arm is red and swollen the size of a baseball around the injection site. Advised her to take BENADRYL as directed.
Patient received adult dose of Pfizer on 1-29-2022 (0.3 mg) then received Pfizer Pediatric Dose on 2-19-2022.
Patient experienced chill for one night, little sore at the injection  site for one day , no fever, no fatigue.
Two weeks after receiving, vaccinee experienced symptoms associated with bronchitis, was treated with steroids and emergency inhaler SINGULAIR.
The right side of my face was swollen, they gave me heartburn medicine and Benadryl. I went to the ER the same day, 02/19/2021 and they gave my steroid injection. I was sent home after that. My face was swollen for about two days. I experienced no other symptoms.
Patient came into the clinic requesting the Pfizer Covid-19 vaccine. He stated that he received a Janssen Covid-19 vaccine 4/09/21 and was worried about the Delta variant. He stated that he and his PCP had discussed it and agreed that he should get the Pfizer Covid-19 vaccine. He received the vaccine 7/21/21
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L024124, expiration date 30-DEC-2016 and lot # L031600, expiration date 18-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was hospitalized on 12/21/21 for Covid-19 and died on 1/3/22
Headache/really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/really bad headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Medical history was not provided. .     On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, the patient experienced HEADACHE (Headache/really bad headache). At the time of the report, HEADACHE (Headache/really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up received on 28-Jun-2021 Email ID was added.
period on 09Dec and it started to go away around 14Dec and around the 16th I started bleeding again and on the 18th 19th 20Dec I bled a lot like another period; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received BNT162B2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 15:45 (Lot number: Fe3594) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 18Dec2021, outcome "recovered" (20Dec2021), described as "period on 09Dec and it started to go away around 14Dec and around the 16th I started bleeding again and on the 18th 19th 20Dec I bled a lot like another period". Therapeutic measures were not taken as a result of heavy menstrual bleeding. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.
I started with a headache then went to awful body aches and fever. I had chills all night and massive sweating. I had to change my shirt. This went on thru the next day 3/23
I started with palpitations lasting for approximately half an hour reaching 122. I took Motrin 800 mg after I got the vaccine by that evening about 11 o?clock I started getting chills and I started spiking fevers very uncomfortable muscle muscle aches bodyaches frontal headache fatigue x 2 days. I still have body aches and joint pain with a mild frontal headache
Tingling in mouth within 5 mins of injection; after 3 hours tingling in tongue, mouth, numbness on the left side of the mouth and of the left side of the face ; resolved after 7 hours on its own.