chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021 at 2:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 2:20 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 44.10 and 44.19. Concomitant product was not provided. On 14-Feb-2021, excursion time was 09 AM,10 AM,11 AM, 2 PM and 3 PM temp was 32, 32, 32, 35, 35, total doses given for the day was 162, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vial was moved to clinic. Vaccine BUD date was 10-Mar-2021. Vial was stored on cooler 2, on 14-Feb-2021, excursion duration At 9 AM: 32, 10 AM: 32, 11 AM: 32, 12 AM: 39, 1PM : 37, 2 PM : 35, 3 PM: 35, 4 PM: 36. On 21-Mar-2021, excursion time was 09 AM,10 AM,11 AM, temp was 34, 32, 34, total doses given for the day was 94, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 16-Mar-2021, vial was moved to clinic on 21-Mar-2021. 10 vial was moved to clinic. Vaccine BUD date was 15-Apr-2021. Vial was stored on cooler 1, on 21-Mar-2021, Excursion duration At 9 AM: 34, 10 AM: 32, 11 AM: 34, 12 AM: 43, 1PM: 40, 2 PM: 40, 3 PM: 41, 4 PM: 41, 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medication was not reported.
Problem urination; Fever; Chills; Dry mouth; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), DYSURIA (Problem urination) and PYREXIA (Fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced DRY MOUTH (Dry mouth), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever) and CHILLS (Chills). On 09-Mar-2021, the patient experienced DYSURIA (Problem urination). At the time of the report, DRY MOUTH (Dry mouth) had not resolved and AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), DYSURIA (Problem urination), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Woke up about 2:30 AM with uncontrollability with bowels and urinary. Black ink like stoll. Chills and Sweating, Joint and Bone pain. Dizziness on arising, unsteady in Walking. Lasted for 2 days before subsiding. Still remain weak on 2//4/2021. Second shot due on 2/16/2021 Same Faculty.
10/13/99 nausea, lethargic, h/a, tired;T102;vomiting;3 episodes & red raised site 7-8inches long, 5-6 inches across oval shaped under arm & whole upper arm tend to touch w/heaviness & major discomfort;could not work for 2 days d/t rxn;
Patient received 1st dose Pfizer.  She missed her 2nd dose appointment and scheduled the vaccine for an event where we were only vaccinating with Moderna.  No adverse reaction reported at time of vaccine or after administration.
Patient stated on the phone she was nauseous right after the vaccine. On Saturday, the day after the vaccine, she states her top lip was tight and red. It was slightly evident Friday, but more apparent on Saturday as it bothered her more.
No reaction but gave a sterile diluent instead of the meningitis diluent with the vaccine.
Pt had injection 12/31.  Developed mild soreness and redness at injection site 1/1.  Resolved by 1/2.  Returned 1/8 with increase in size (6 cm in diameter), redness, firmness, and mild itchiness.  Improving by 1/13.
Crying for no apparent reason; Dead to the world; Felt nauseous; Tired; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (Crying for no apparent reason), FEELING ABNORMAL (Dead to the world), NAUSEA (Felt nauseous) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced CRYING (Crying for no apparent reason), FEELING ABNORMAL (Dead to the world), NAUSEA (Felt nauseous) and FATIGUE (Tired). In January 2021, CRYING (Crying for no apparent reason), FEELING ABNORMAL (Dead to the world), NAUSEA (Felt nauseous) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment:  Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up email was received and outcome was updated.
Monday morning as I got ready to work I felt nauseous, the nausea got worse and worse and I started violently vomiting, and it kept happening all day I could not hold anything on my stomach until Monday night around 7PM. Every so often I will have bouts of random nausea, but nothing debilitating or anything. I still feel them.
Received vaccine on 3/2/15 and was well and without complaints until on 3/5/15 had a high fever, chest congestion and tightness and loose cough. Took Nyquil. Had up to a 102 degree fever until it "broke" at 10:30 pm on 3/8/15. Spoke with Novartis, and CDC and health department and will delay further dose until well.
Pt received FLUAD when AFLURIA was indicated. Pt had no untoward effects. Pt was counseled about the error and will report any issues.
Patient complained of dizziness at conclusion of 15 min observation. Patient rested for an additional 15 minutes and verbalized dizziness resolved.
Patient experienced nausea, swollen arm that was also red itchy and painful. Some shortness of breath.
Rapid heart beat; Stomach cramps; Diarrhea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). At the time of the report, HEART RATE INCREASED (Rapid heart beat), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported. No treatment information was provided.
Low fever; Body aches; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6206, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 11Mar2021 10:30 (at the age of 58-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included arthritis and COVID-19 both from an unknown date. Concomitant medications included hydroxychloroquine and estradiol (ESTROGEN) both taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 12Mar2021, the patient experienced low fever and body aches. No treatment was received for the events. Since the vaccination the patient has been tested with COVID-19 using Nasal Swab: Results unknown. The outcome of the events was recovered.  No follow-up attempts are possible. No further information expected.
Severe diarrhea, dehydration, 1 week following 2 month immunizations: DTAP, HIB, PCV7, ROTATEQ. (+) intracerebral bleeding with stroke and seizures 2 hours to dehydration.  2/5/09 Received hospital medical records for 10/13-11/13/2008. FINAL DX: dural venous thrombi, stable; right lateral intraventricular hemorrhage w/cortical, basal ganglia & thalamic infarcts, improving; seizure disorder.  Dehydration, shock, DIC, pseudomonal tracheitis & HTN resolved. Records reveal patient experienced ICH, severe acidosis, respiratory failure, coagulopathy, hypothermia,  & severe dehydration & had been transferred from outlying ER intubated.  Vomiting, low grade fever x 4 days & episode of jerking x 1 day.  Neuro, neurosurg, ID, Heme, ophtho, consults done.  Anterior fontanelle enlarged.  Tx w/IV antibiotics, antivirals, antiseizure med, multiple blood product transfusions.  Improved gradually & d/c to home w/Ophtho, neuro, neurosurg clinic f/u & outpatient PT/OT/ST.
pt recvd vax;following day devel swollen red arm from the shoulder to elbow in injected arm;feverish,very tired & dragging & poor appetite;7nov94 felt better but rt arm still swollen from shoulder to elbow;had lump at inject site
Information has been received from a physician concerning a 16 year old female who in May 2008, complete her series of GARDASIL vaccine (yeast). In 2008, the patient experienced chest pain and she also had pressure in her head that caused blacking out. The patient had no problems when the series of GARDASIL vaccine (yeast) was completed. An MRI was performed (results not reported). At the time of this report, the patient was recovering. The patient sought medical attention. Additional information has been requested.
Low blood pressure low heart rate/pulse dizziness, sweating, pale color treated with O2 by paramedics
This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a adult female patient who received FLULAVAL QUADRIVALENT (batch number Y7X9Z, expiry date 30th April 2017). In September 2016, the patient received FLULAVAL QUADRIVALENT. In September 2016, 1 day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site warmth, injection site redness and injection site swelling. On an unknown date, the outcome of the injection site warmth, injection site redness and injection site swelling were recovered/resolved. The reporter considered the injection site warmth, injection site swelling to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced warm, raised and red areas around the injection site. The area was noted to be approximately 2 to 3 inches in diameter. In about 2 days all events were resolved without further medical attention. The health care professional stated that no other vaccines were administered on the same day. The reported lot number (Y7X92) for FLULAVAL QUADRIVALENT season did not exist and was updated to Y7X9Z, according to sales database. No further information was provided. This case was one of the 4 cases, reported by same reporter.
Severe hives all over various parts of my body for the past two nights. Significantly less during the day. Some help from antihistamines. Hoping they don't flare up again tonight.
REDNESS NEAR THE SITE OF INJECTION AND LITTLE REDNESS AROUND THE AREA OF REACTION.
After receiving the vaccine within 15 mins I had a metallic taste in my mouth. I exp fatigue and couldn't sleep  I went to ER HR 180/10, elevated HR/BP, muscle joint pain and tremendous back pain. After I followed up with my PCP still elevated BP 140/70  as a result I'm on blood pressure medication. I was advised to stay on this new medicine until I receive the second dose of the vaccine. Also was told to take Benadryl and Tylenol before taking 2nd Covid vaccine.
States he is not able to go to work due to pain and inability to lift arm.  Clarified with pt that he is able to physically move his arm but is not moving  it secondary to pain from his left shoulder to his elbow. c/o warmth, numbness  and induration within a 3-4 inch radius of the injection site .  Pain 8/10
erythematous papules on hands and elbows, erythematous patch on back of neck
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-JUN-2017, the patient was vaccinated with the improperly stored (15.8 degrees Fahrenheit for 3 hours) dose of PROQUAD (for prophylaxis, lot # M041083, expiration date 04-APR-2018, albumin status rHA; dose and route of administration were not reported) that was reconstituted with the correctly stored sterile diluent (lot # N003192, expiration date 05-JUL-2019 (also reported as 27-MAR-2018)). No previous temperature excursion and no adverse effects were reported. Data logger was involved. Additional information has been requested.
Sore left arm. After one month went to doctor. Limited arm movement. Diagnosed w/SIRVA and received a steroid shot in bursa. Physical therapy for next month. Still limited movement and pain. will be going to an orthopedic surgeon in April 2016.
had both shots and tested positive on 25Dec2021 & 26Dec2021; had both shots and tested positive on 25Dec2021 & 26Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2021, outcome "unknown" and all described as "had both shots and tested positive on 25Dec2021 & 26Dec2021". The event "had both shots and tested positive on 25dec2021 & 26dec2021" and "had both shots and tested positive on 25dec2021 & 26dec2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) positive; (26Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: patient had both shots and tested positive on 25Dec & 26Dec. The 28Dec patient went to the hospital and had the monoclonal antibodies infusion done. patient wanted to know how long must patient wait to have the booster shot , or can patient even get it done?  The lot number for bnt162b2 was not provided and will be requested during follow up.     .
The patient stated that he knows someone who's father had similar cardiac symptoms as him; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (The patient stated that he knows someone who's father had similar cardiac symptoms as him) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (The patient stated that he knows someone who's father had similar cardiac symptoms as him). At the time of the report, CARDIAC DISORDER (The patient stated that he knows someone who's father had similar cardiac symptoms as him) outcome was unknown.            No concomitant medications were reported.  The reported stated that, the patient had cardiac symptoms and had to have surgery. The patient also received the vaccine in the same county as of reporter.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-689920 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689920:Same reporter
Initial and follow-up information has been received from a nurse concerning her 6 year old male grandson with no pertinent medical history and no drug reactions/allergies, who on an unknown date was vaccinated with a first dose of VARIVAX (Merck) as an infant and on 16-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck). There was no concomitant medication. On 06-SEP-2008 the patient experienced chickenpox. The patient developed a couple of lesions on his skin and some in his mouth. He had less lesions than his brother (WAES # 0809USA02576). The child was treated with Ibuprofen and Tylenol. He was not seen by the physician because his mother is a nurse. The patient was able to return to school on 12-SEP-2008. There were no lab diagnostics studies performed. In further communication, the nurse reported that the patient did not see the physician and had a mild case with no adverse reactions, only fever and multiple sores in mouth and body (mostly buttocks and legs). This is one of two sibling reports from the same source. No further information is available.
Throwing up all the time after both doses; I got very sick for 2 weeks; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I got very sick for 2 weeks) and VOMITING (Throwing up all the time after both doses) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got very sick for 2 weeks) and VOMITING (Throwing up all the time after both doses). At the time of the report, ILLNESS (I got very sick for 2 weeks) had resolved and VOMITING (Throwing up all the time after both doses) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication was provided. This case contains information for the 33 out of 63 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report). This case was linked to MOD-2023-714826 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Information has been received from a pharmacist concerning an approximately 87 year old male who in June 2008 ("4 years ago"), was vaccinated with a ZOSTAVAX (Merck) (Lot#, dose and route not reported). In about 2011 ("about 1 year ago"), the patient experienced shingles. The patient sought medical attention by speaking to the physician. On an unknown date, the patient recovered from shingles. Additional information has been requested.
Pt reported 2 weeks of continuous yawning that resulted in a sore jaw. The symptoms self-resolved without treatment.
I just wanted to make you aware that one of your students has been very ill and in the hospital over this summer break.  If you didn't know, patient got deathly sick around the 23rd of June.  The local hospitals couldn't determine what was wrong with her, so she was sent to the hospital.  She came home last week.  The Doctors determined she had a rare allergic reaction to her recent Whooping Cough Booster Shot.  A 1 in 1 million chance of this side effect.  My understanding is...she can now stand to get to the bathroom, but is confined to wheelchair.  She is slowly improving, but has to be watched for a possible relapse for the next 12 weeks.7/24/08-records received for DOS 6/25-7/3/08-DC DX: ADEM(acute demyelinating Encephalomyelitis). Neurogenic bladder. Presented to ED with bilateral lower extremity weakness, started week prior with an episode of nausea and abdominal pain, evening prior to arrival legs felt sore. Dysesthesia of lateral aspects of thighs, low grade fever 99.7. During night attempted to walk and as a result fell, at that time temp 101.9. Sleepier, hypophonia. 1/25/2010 Follow-up: Activity is still being limited and is continuing with follow-up appointments (Sept 2009 and Feb 2010) for the weakness and tiredness with activity.
Doctor believes the booster shot caused ITP. Platelet count was at 6 Thousand/uL on 2021/11/16. Rebound to 119 Thousand/uL on 11/30/2021 after treatment with Prednisone and IVig.
1. Upon reception of the Jansen vaccine (0.5 mL, IM, left arm). Patient was mentally alert and conscious. Approximately 2-3 minutes later, patient felt faint. Reported blurriness, dizziness, and body weakness. Patient alert and responsive. 1 8 fl bottle of water administered before as well as 2 bottles after. 2 tablets of 500mg Acetaminophen also administered after the event.
Unable to eat/loss of appetite; Unable to eat/loss of appetite; tired; This is a spontaneous report from a sponsored program from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was unable to eat/loss of appetite and was tired on an unspecified date. There was no fever. The outcome of unable to eat/loss of appetite and tired was unknown.     The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Red circle developed around vaccine site- about two inches  Location ached and I took Tylenol.   Sensitivity continues but does not require Tylenol.