chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested positively for COVID-19 with symptoms Fever, chills, body/muscle aches, malaise; Patient tested positively for COVID-19 with symptoms Fever, chills, body/muscle aches, malaise; This is a spontaneous report from a contactable consumer. A 52-years-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 10Apr2021 08:00 (at the age of 52-years) (Batch/Lot number was not reported) as dose 2, single and dose 1 intramuscular, administered in Arm Right on 20Mar2021 08:00 (at the age of 52-years) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included High cholesterol, high blood pressure, pre-diabetes, allergies to fruit with skins, some nuts and some vegetables. Concomitant medication(s) included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient tested positive for covid-19 with symptoms on 09Sep2021 16:00, Fever, chills, body/muscle aches, malaise. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Sep2021 (Nasal Swab), sars-cov-2 test: negative on 10Sep2021 (Nasal Swab), sars-cov-2 test: positive on 10Sep2021 (Nasal Swab). Events results in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The events were assessed as non-serious by the reporter. Outcome of the event patient tested positively for COVID-19 with symptoms Fever, chills, body/muscle aches, malaise was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. They were filling out a temperature excursion assessment at that time. It was reported that no adverse reactions were reported by any patients. No treatment medications were reported.
mom brought pt in to have lt leg checked states has not been crying w/leg; only hard nodule where vax given; no redness or bruise on leg noted; nodule was size of fifty cent;
total body aches; 101.0 fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (total body aches) and PYREXIA (101.0 fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (total body aches) and PYREXIA (101.0 fever). At the time of the report, MYALGIA (total body aches) and PYREXIA (101.0 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.0 (High) 101.0 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 23-APR-2012. No other co-suspects were reported.  No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Initial misuse report received from a healthcare professional on 16 April 2014. A dose of YF was administered intramuscularly instead of subcutaneously (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Child could no longer stay awake all day, would nap and sleep in car, and after school sleep for 14 hours at a time.
Broke out with rash on trunk, arms, back, severe itching, whelp like quality.
Client reported that the same evening she had fatigue, fever, chills, and pressure headache that lasted 14 days.  Client was approved for 2nd dose.  Client had no reactions during her 30 minute observation.
The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hours of injection, could not touch my arm. The pain radiates from the shoulder to finger tips with sharp shooting, stabbing pains at times. A lot of pressure.  There is a burning feeling from my shoulder to finger tips. By the end of day on 01/18/2021, I had decreased range of motion in my arm, it is difficult  and very painful to try and extend my arm out to the side, which continues to today 01/29/2021..  My entire arm is still tender and sore, tricep, bicep, and shoulder.  It is difficult to sleep and work due to the pain.
Headache and feeling unwell the first 24 hours, followed by very high fever that lasted for 2 weeks.  Had to use Tylenol and Motrin together to keep the fever down, which never reached below 100.  Visited pediatrician 3 times during the two week period, having blood drawn twice and urine tested.  Nothing abnormal found.  At the pediatrician's office, her temp as so high they recommend we go to the ER.  Went to the ER and temp was 105.6 when she was admitted.  Had more blood drawn and urine tested.  Nothing abnormal found for any of the tests.  While in the ER she was given IV fluids before being sent home.  Was so tired that she couldn't keep her eyes open, sleeping for all but 3 hours during a 24 hour period.  This lasted for 3 days.  After 14 days, her fever finally broke, yet she had a hard time staying awake and was extremely weak for another 3 days.
swelling and redness started appx 2 hours after vaccine, swelling continued for 2 days spreading to neck and wrist, oral steroids were given to child
Redness, itching, swelling at injection site 8 days post vaccination.  Cold compresses, and watching.
Onset 4 days ago, following Tdap (R arm) and pnuemovax (L arm) injection. On R, ipsilateral side to Tdap injection, although Pt recalled this as pnuemovax side. Vaccine indicated 2/2 smoking status. Subjective fever. Arm hurt, body stiff, chills, no local redness or swelling at injection site. Improving. Was still able to go to work despite this problem. Took ibuprofen for swelling, which helped.
A report had been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST quadrivalent started on an unknown date. It was reported that there could have been consumers involved in receiving FLUMIST quadrivalent that was involved in a temperature excursion of 57.4 degrees Fahrenheit in the refrigerator for 203.83 cumulative hours. The outcome of the event of there could have been consumers involved in receiving the FLUMIST quadrivalent that was involved in a temperature excursion of 57.4 degrees Fahrenheit in the refrigerator for 203.83 cumulative hours is unknown. The report was considered to be non-serious.
TWITCHING IN BOTH LEGS AND BOTH ARMS NO PAIN LASTED AT LEAST 1 HOUR UNTIL FIRE RESCUE CAME AND STOPPED BEFORE REACHING HOSPITAL
accidentally administered the Fluzone high dose to a 64 year patient rather than 65 year old, no adverse event; accidentally administered the Fluzone high dose to a 64 year patient rather than 65 year old, no adverse event; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 64 years old male patient who was accidentally administered the INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], lot UJ253AB via intramuscular route in unknown administration site, on 19-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Reporter was not sure according to the chart if the patient had any other vaccines during the same visit.   This was a case of actual medication error due to product administered to patient of inappropriate age and overdose.  Caller said that the accidentally administered the Fluzone high dose to a 64 year patient rather than 65 year old. Caller said that he will be 65 years old next month.  At the time of report no adverse event was reported.  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.  Documents held by sender: none.
This case was reported by a nurse and described the occurrence of vomiting in a 42 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 28 October 2005 the subject received 1st dose of Fluarix in the right arm (lot AFLUA151BA). At an unspecified time following receipt of Fluarix, on 28 October 2005, the subject experienced vomiting and nausea. The subject "rested at home." The events were ongoing at the time of initial reporting, 28 October 2005. The nurse considered the events to possibly be related to vaccination with Fluarix.
Per clinic patient received J+J COVID vaccination on 4/8/2021 and then received Pfizer COIVD vaccination on 9/27/2021 as indicated on this report.
tightness in chest; Swelling of lips and cheeks; Swelling of lips and cheeks; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). This 39-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: not reported, Expiry date: Unknown) via an unspecified route of administration in Arm Left on an unspecified date (Age at vaccination 39 years) as dose 1, single for COVID-19 immunisation. Medical history included allergies to medications, food, or other products Penicillin and shellfish. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Concomitant medication(s) included metformin (METFORMIN) and pantoprazole (PANTOPRAZOLE). Patient was not pregnant at the time of vaccination. On 03Feb2021 08:00 PM, the patient experienced tightness in chest, swelling of lips and cheeks. Patient was received Benadryl as treatment for events. The clinical outcome of all events were recovered on an unspecified date in Feb2021.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
A non-serious spontaneous report of a patient received expired FLUMIST was received from a health professional concerning a four-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 02-Feb-2011. The patient received the expired FLUMIST on 15-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
hives breaking out again that is visible inside his left and right thighs, knee to groin, top of left foot; itchy; sore red; dry scaly; circular Patchy 1 diameter; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (hives breaking out again that is visible inside his left and right thighs, knee to groin, top of left foot), PRURITUS (itchy), ERYTHEMA (sore red), XEROSIS (dry scaly) and RASH (circular Patchy 1 diameter) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic dermatitis, Hypertension and Hypercholesterolaemia. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Anticoagulant therapy, EZETIMIBE and ATORVASTATIN CALCIUM (LIPITOR) for Cholesterosis, CARVEDILOL for Hypertension.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced URTICARIA (hives breaking out again that is visible inside his left and right thighs, knee to groin, top of left foot), PRURITUS (itchy), ERYTHEMA (sore red), XEROSIS (dry scaly) and RASH (circular Patchy 1 diameter). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 milligram. At the time of the report, URTICARIA (hives breaking out again that is visible inside his left and right thighs, knee to groin, top of left foot), PRURITUS (itchy), ERYTHEMA (sore red), XEROSIS (dry scaly) and RASH (circular Patchy 1 diameter) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Eosinophil count: high (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication also included Essential One vitamin.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Follow-up information received on 24-APR-2021, contains pictures of the event occurred. On 07-Jun-2021: Follow-up information received on 7-JUN-2021, contains pictures of the event occurred. On 12-Jun-2021: Follow up received on -June-2021and contains no significant information
Pain at injection site Arm, shoulder, neck pain  Headache Fatigue  Chills Nausea
Patient had his shots between 1:00pm and 1:30pm on Aug 7 2006. That evening around 7:00 he started to get a fever (101.7). By 7:30 his temp was 103.5 so I gave him infant tylenol and waited...his fever continued to climb, I contacted our  doctor and by the time I spoke to a doctor patient had a fever of 104.9 and was red all over his body as well as when he breathed it wounded like he was wheezing and he was breathing faster. The doctor told me to monitor him and he was fine as long as I felt ok watching him. His fever was at 105 for at least 48 hours as well as the reddness of his skin and breathing.
A serious spontaneous report of immunocompromised patient had been in contact with recipient of H1N1 LAIV presenting with shortness of breath, dehydration, coughing up blood, abdominal pain, influenza A with symptoms of fever of 103 F, nausea and vomiting has been received from a physician concerning a 51-year-old male, subsequent to H1N1 2009 vaccine, intranasal. The patient was reported as immunocompromised. No concomitant medications have been reported for this patient. The patient did not receive H1N1 vaccine. The patient was in contact with a recipient of H1N1 vaccine, intranasal, several days prior to development of symptoms. On an unknown date patient was admitted to ER, then on 02-Dec-2009, the patient was hospitalized for the symptoms of 103 F, abdominal pain, nausea, vomiting, shortness of breath and dehydration. Patient was tested positive for Influenza A on 03-Dec-2009. The patient was coughing up blood five days after hospital admission. A nasal wash on 03-Dec-2009 was antigen and culture negative; PCR test was positive for Influenza A. Diagnostic test on 07-Dec-2009, was antigen and culture positive and PCR test was positive for Influenza A. Influenza A subtype was pending state lab results. The outcome of the secondary transmission and for all the reported adverse events was unknown.
states that at 4:00pm on 1/21/2021 she started to have a headache and arm pain. took 50mmg of Tylenol and it helped relieve headache. At around 10:00 pm started to feel body aches and was unable to sleep. On 1/22/21 at 10:00 am started to feel a tingling sensation on lips, @10:30 am checked and her lips were very swollen and she started to feel numbness and tingling on left side of face. was seen by NP and was given 50mg of Benadryl IM and 6mg of dexamethasone IM, she was monitored for 2hrs and swelling slowly subsided. was prescribed cimetidine 400mg twice a day for 2 days and prednisone 20mg every day for 3 days. @12:00pm went to hospital and she was given Pepcid and was monitored for 3 hours and discharged home..
9/30/21: ED for AMS and hypoxic respiratory failure. Hx limited and mainly obtained from EMR review and ED physician. Pt was emergently intubated on arrival to the ED d/t saturating in the 60s. In the ED pt was found to have leukocytosis w/ PNA and was tx w/ Vanc and Cef. Patient has developed sustained hypotension at the time when she was in respiratory distress and getting intubated.  Currently patient is on norepinephrine.  Her urine output has been declining. Please note: Patient received J&J vaccine on 3/14/2021 Lot # 1805025
chills; Fever/fever 99.9; Malaise; Headache; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EL8952) (at the age of 72-years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included azilsartan kamedoxomil (EDARBI) and torsemide (MANUFACTURER UNKNOWN) both taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received BNT162B2 (COMIRNATY), dose 1, administered in Arm left (Batch/Lot number: EK9231) (at the age of 72-years-old) for covid-19 immunisation and experienced malaise, nausea, no appetite and throwing up bile. On 03Feb2021, the patient experienced chills, fever, malaise, headache. The events not resulted in emergency room/physician office. The outcome of events was unknown.
Patient developed a rash on her neck.  She described it as a shingles cluster.  By Monday, she said it had dried up and was no longer itching.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 27-JUL-2016, the patient was vaccinated with a dose of improperly stored human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route, lot number and expiration date were unknown), which was exposed to temperature excursion. On an unknown date in 2016, the patient experienced fatigue, which lasted for 2 days. The patient recovered from fatigue on an unspecified date in 2016. The causality between fatigue and HPV vaccine (manufacturer unknown) was not provided. This is one of several reports that received from the same source. Additional information has been requested.
Breakthrough case admission after 3 vaccines Pfizer 2/9/21 Lot# not given;  Pfizer 3/3/21 Lot# EN6202;  Moderna 12/7/21 Lot# 060H21B