chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested Positive for Covid-19; A spontaneous report was received from nurse a concerning a 48-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) was tested positive for Covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection.  On 25 Dec 2020, the patient reported positive for COVID-19. No information about the patient's symptoms was provided.   On 30 Dec 2020, the treatment information included, Bamlanivimab.  The nurse stated that since the patient received medication, they will wait 90 days and then proceed with the second dose of the Moderna vaccine.   Action taken with mRNA-1273 in response to the event was dose delayed.  The outcome for the event positive for Covid-19 was unknown.; Reporter's Comments: This case concerns a 48-years-old male patient, who experienced a non-serious unexpected event of SARS-CoV-2 test positive. The events occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included Bamalanivimab. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Additional information has been requested.
Hard lump , itching at site , redness larger as days go by, lot of pain, headaches , nausea, tiredensss , body aches
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date, on or before 07-FEB-2013 and on or before 25-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
First couple of days arm was sore, if I raised my arm. I felt sudden sharp pain. Haven't been able to raise arm without pain and even while sleeping moving arm causes pain that wakes me. Unable to rotate arm.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Hives below injection site-Mild
Tonic posturing 1-2 seconds following administration of Tdap vaccine, 1 minute following Influenza vaccine.  Tonic upper extremity posturing lasted approximately 20 seconds, with full resolution of symptoms.
Giant patch on head, getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Giant patch on head, getting bigger) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was reported by the physician.  Concomitant products included DICLOFENAC SODIUM for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SKIN DISORDER (Giant patch on head, getting bigger). At the time of the report, SKIN DISORDER (Giant patch on head, getting bigger) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication include Flexeril  Treatment medication was not provided
ost-vaccination after patient completed her grocery shopping and was heading out to her vehicle, became dizzy and light-headed. Patient called out for help, security remained with them while an associate came and got pharmacy personnel. Security contacted 911, EMTs arrived to scene and evaluated patient. Patient declined to be transported to the hospital. Patient's sister arrived, picked her up, and took her home.
Fainted after GARDASIL #1 within 5 min of admin - then moved from chair to bed without problems. Recovered within 20 min - no further problems reported.
I was very tired the second or third day, and I had shortness of breath. My eyesight started to get bad and I had extreme headaches.  I had so many different little reactions to the vaccine but these are the main ones that I spoke to my Dr. about. In general I just felt really bad. I also had weight gain during this time as well.
no additional AE; patient was inadvertently administered a dose of VAQTA on 10/28/2021 with a labeled expiry of 10/25/2021; This spontaneous report was received from a medical assistant and refers to a 37-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 28-OCT-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # T014589, expiration date 25-OCT-2021 for prophylaxis (exact dose, dose #, route and anatomical location were not provided).
During vaccine administration, the needle became separated from the syringe, and about half of the dose was lost. The dose was not repeated and the patient was counseled to return in 2-6 months for their 2nd dose of Shingrix
Patient was given a 0.25 ml Moderna booster today (4/4/22 )around 9am which had a refrigerator expiration date of 4/3/22 (yesterday). No adverse reaction reported by patient. The vaccine was pulled from the freezer on 3/3/22 with a manufacturer expiration date of 7/6/2022.
Pt recvd vax 11AUG93 & mom claims that  pt only recvd OPV; 4DEC pt hospitalized CSF pos for H. meningitis, blood culture neg; hearing test abnormal; f/u test scheduled; treated w/Ceftriaxone 2-3 days then switched to Ampicillin w/good resp
Rash on leg approximately 1/2 hour after receiving TD injection, 08/27/2001. By 09/04/2001, rash had spread to legs, arm, neck and face. Course of Allegra not helpful. Two courses of Prednisone and Atovax controlled symptoms but rash returned on 10/08/2001 after 1 week of stopping meds.
Got shingles for the first time in my life. All on the right side, the same side as the injection site.
pt states he noticed he had a rash on the left side of his chest and stomach.  He started getting a pounding headache with mild fever, body aches and chills.  His headache was getting worse and no medicine he took helped with the pain.  On 5/1/2021 he went to Urgent Care on  in.  He was diagnosed w/ Shingles.  He had blood work that was negative.  He was prescribed Valtrex and Ibuprofen and told to FU w/ PCP.  He had a tele visit w/ his PCP on 5/6/21.  He was prescribed more Valtrex and Ibuprofen and ordered more blood work.  He still has a rash and still feels weak but is getting better.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 09-MAY-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K003520 with expiration date of 20-NOV-2016; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt developed emesis intermittently for a 8-9 hour period. Recovered spontaneously.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. adeH21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication was not reported. The treatment medication was not reported.  On 16-Dec-2021, the Moderna vaccine pulled from freezer. On 26-Jan-2022, the staff brought to the attention that the vial was still in the fridge and expired, from which 5 doses had been given. On 31-Jan-2022, the Moderna responded of no re-vaccination and the patient had no adverse event. The dose of Moderna third vaccine was 0.5 with no units.
INCREDIBLE PAIN; PART OF HIS FACE WENT NUMB; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced incredible pain, and part of his face went numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incredible pain and part of his face went numb was not reported. This report was non-serious.
Following info given by mother: 11-17-05 c/o fever, vomiting & diarrhea, 11-18-05 no further fever, vomiting or diarrhea, 11-19-05 Left arm swollen with red blotches from deltoid to elbow, 11-21-05 symptoms have diminished slight itching called PMD office.  Not seen.
1st dose vaccine 2/21/21; developed weakness and went to ED via EMS on 2/26/21 and admitted to Hospital from ED DX: Acute respiratory failure with hypoxia ; Pleural effusion, left; Community acquired pneumonia of right lung, unspecified part of lung   currently admitted to hospital during time of this report.
Patient experienced pain for two days when moving legs, causing her to stop walking due to pain. Patient also experienced pain when legs were touched. Patient had a fever during those days.
This spontaneous report as received from a healthcare worker refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 14-JUN-2014, the patient was vaccinated with first dose of GARDASIL (0.5 ml) (lot number unspecified), intramuscularly. Concomitant medications were not reported. On 22-AUG-2014, the patient was vaccinated with second dose of GARDASIL (0.5 ml), intramuscularly. On 24-OCT-2014, the patient was vaccinated with third dose of GARDASIL (0.5 ml), intramuscularly which was much earlier than the recommended schedule. No adverse effect was reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. Additional information has been requested.
Mom called our clinic this am to report that patient had a 4 inch area of redness, swelling, hard lump with heat below injection site to right arm where the varicella injection was given.  We had pt come in to have area looked at.
I tested positive for COVID-19 on 7/6/22. I woke up with a severe sore throat, and body aches. Those were the only symptoms. I called my doctor that day after taking an at home test. I was prescribed PAXLOVID and I started taking it the next day.
Generalized body itching, puritus. Rash. Urticaria. Dermatographism. Lightheadedness. Vertigo. Chest palpitations. Flushing.  Ongoing for >6 weeks.
lost the use of legs; was able to walk a little bit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (lost the use of legs) and GAIT DISTURBANCE (was able to walk a little bit) 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (lost the use of legs) and GAIT DISTURBANCE (was able to walk a little bit). At the time of the report, MOBILITY DECREASED (lost the use of legs) and GAIT DISTURBANCE (was able to walk a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.
Patient received the vaccination on 12/30, later that evening and into the morning the patient had pain and redness at the injection site, patient took 2 Tylenol and noticed the effects went away 24 hours after receiving.  On 1/6 around 2 pm patient noticed redness and fever at injection site. Around 8 pm, pain at injection site started and patient notified the pharmacy. Patient was advised to take Motrin and use an ice pack on the injection site. Patient unable to take temperature at this time.
Initial and follow up information has been received from a 76 year old female with no known pre existing allergies, or medical conditions, who has been under stress due to her husband's death a few weeks prior to reporting. On 18-SEP-2007 the patient was vaccinated into the left deltoid with a first dose of Zostavax (Lot # 658083/0885U). Concomitant therapy included LEXAPRO which she takes for stress. The patient reported that two days after receiving Zostavax, on 20-SEP-2007, she developed a rash in the center of her chest. The patient reported it was not vesicular and not unilateral. The patient called the pharmacy where she picked up the vaccine. The rash resolved without incident. Medical attention was not sought. No labs were performed. There was no product quality complaint involved. At the time of reporting the patient had recovered. Additional information is not expected.
Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021); achy; feels like heart is beating too fast; slightly elevated temperature; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)), MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 014F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for Diabetes, APIXABAN (ELIQUIS) for an unknown indication.   On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)) had resolved and MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Body temperature: 100f (High) temperature is about 100F. On 04-Sep-2021, Heart rate: 97 beats per minute (High) Patient feels like his heart is beating a little bit too fast with 97 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient taken concomitant drug Blood pressure pill Treatment information was not provided
Information has been received from a physician concerning a 12 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL intramuscularly.  Concomitant therapy included MENACTRA and (unspecified) TDAP received on the same day.  The patient went to the emergency room twice.  The patient had weak muscles, fatigue and shortness of breath and difficulty breathing.  At the time of the report the patient was recovering from weak muscles, fatigue and shortness of breath and difficulty breathing.  Additional information has been requested.
This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority support received from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, both doses for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced prostate cancer on an unspecified date. The reporter would like to know when he would be able to get booster shot. As the therapeutic measure degarelix acetate (FIRMAGON) injection. The outcome was unknown for the reported events.  The information about lot/batch number gas been requested.
First shot received- arm got itchy, swollen at injection site, sore, and bad headache, symptoms went away approx. 7 days later. Symptoms returned 2days later- itchy, sore, swollen at injection site and bad headache.
7 days after vaccination pt had seizure (rolling of eyes upward, shaking / stiffening of the extremities, no fever. Pt. was brought to hospital where MRI and EEG were done. Result: Normal.
Flu short received 11/05/03  I have had shooting pains where administreded and head, left arm and under left arm
12//08/21, diagnosis Tachycardia  01/13/22, diagnosis full atrial figuration 02/09/22, Myocardial perfusion
Extreme joint pain in ankles, knees, and wrists.  Inability to walk. Treatment -- 20mg Prednisone Outcome -- reduced inflammation and pain.
Dizziness - like vertigo (room seems to be spinning) when I move to a prone position and put my head down.  Occurs during yoga practice and when I lie down in bed. Abates within minutes if I stay perfectly still.
Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 12:47 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  The patient did not have any adverse events and did not require any medical attention after receiving the dose.
Crying off & on irritable stopped breathing became cyanotic sym related to PHN by mom;
No adverse effects noted. Resident administered expired Moderna Vaccine  expiration 10/13/2021.
Rash under his eyes and on his feet/broke out in a rash under his eyes/ his feet; face feels like it's on fire; This is a spontaneous report received from a contactable consumer (patient's girl friend) reported that. A 38-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection) via an unspecified route of administration on Aug2021 (at the age of 38-year-old) (Batch/Lot number: Not provided) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. It was mentioned that consumer was calling on behalf of her boyfriend who received his first dose of the Pfizer COVID-19 vaccine last week and he developed rash under his eyes and on his feet, and his face feels like it's on fire on 08Aug2021. Caller was seeking information on treatment recommendations and if this was normal. Informed caller that company was unable to make treatment recommendations for individual patients and referred to HCP for medical advice. Informed caller that I can verify if this AE has been reported per Prescribing Information, but caller declined and stated that she will just call his doctor. The events was non-serious. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected; information about lot/batch number cannot be obtained.