chrisvoncsefalvay/vaers-outcomes huggingface dataset:
foggy; Almost Past out; Nauseated; dizzy slightly; swelling of right arm; rapid heart beat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of right arm), HEART RATE INCREASED (rapid heart beat), DIZZINESS (dizzy slightly), NAUSEA (Nauseated) and FEELING ABNORMAL (foggy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling of right arm) and HEART RATE INCREASED (rapid heart beat). On 04-Apr-2021, the patient experienced DIZZINESS (dizzy slightly) and NAUSEA (Nauseated). On 05-Apr-2021, the patient experienced FEELING ABNORMAL (foggy) and PRESYNCOPE (Almost Past out). On 03-Apr-2021, PERIPHERAL SWELLING (swelling of right arm) and HEART RATE INCREASED (rapid heart beat) had resolved. On 04-Apr-2021, DIZZINESS (dizzy slightly) and NAUSEA (Nauseated) had resolved. On 05-Apr-2021, FEELING ABNORMAL (foggy) and PRESYNCOPE (Almost Past out) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional information 1
had fever w/n&v, red rash over entire body; seen by MD for rash & itching; welps;
"I looked like I had black eyes"; Neck and left facial swelling; Neck and left facial swelling; Nose felt plugged from facial swelling; Felt cold; Body aches; Fever of 102.9 degrees F; Pins and needles of left arm, top of hand and face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles of left arm, top of hand and face), EYE CONTUSION ("I looked like I had black eyes"), FEELING COLD (Felt cold), NASAL CONGESTION (Nose felt plugged from facial swelling) and SWELLING FACE (Neck and left facial swelling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PARAESTHESIA (Pins and needles of left arm, top of hand and face). On 16-Mar-2021, the patient experienced FEELING COLD (Felt cold), PAIN (Body aches) and PYREXIA (Fever of 102.9 degrees F). On 17-Mar-2021, the patient experienced NASAL CONGESTION (Nose felt plugged from facial swelling). On 19-Mar-2021, the patient experienced EYE CONTUSION ("I looked like I had black eyes"), SWELLING FACE (Neck and left facial swelling) and SWELLING (Neck and left facial swelling). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Ache, at an unspecified dose and frequency. On 16-Mar-2021, PARAESTHESIA (Pins and needles of left arm, top of hand and face) had resolved. On 18-Mar-2021, NASAL CONGESTION (Nose felt plugged from facial swelling) had resolved. On 20-Mar-2021, EYE CONTUSION ("I looked like I had black eyes"), FEELING COLD (Felt cold), SWELLING FACE (Neck and left facial swelling), SWELLING (Neck and left facial swelling), PAIN (Body aches) and PYREXIA (Fever of 102.9 degrees F) had resolved.        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 medications also included topical creams. Treatment details included Tylenol.
Inj given 3/17/03 about 11:50a, by 5pm 3/17/03 arm red swollen. 3/20/03 site about 50 cent size, started Cehalen, 3/21 tx'd with Rocephin.
EPILEPSY, UNSPECIFIED SLEEP APNEA OBSTRUCTIVE SLEEP APNEA CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Diarrhea; Colon spasms; Extreme headaches; Chills; Fever 104; 1st dose: 13Mar2023, 2nd dose: 03Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 03Jun2021 as dose 2, single (Lot number: EW0168), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "extreme pain" (unspecified if ongoing); "flam vax (headache)" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN oral taken for pain, headache. Vaccination history included: BNT162b2 (dose 1, single, time: 15:00, anatomical site of injection: left shoulder, batch/lot number: FL0182), administration date: 13Mar2021, for covid-19 immunisation, reaction(s): "diarrhea", "colon spasms", "extreme headaches", "fever 104 F", "chills". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Jun2021, outcome "unknown", described as "1st dose: 13Mar2023, 2nd dose: 03Jun2021"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "Colon spasms"; HEADACHE (non-serious), outcome "unknown", described as "Extreme headaches"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever 104". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300056924 Same reporter/patient/drug, different vaccine dose/event;US-PFIZER INC-202300085419 Same reporter/patient/drug, different vaccine dose/ event;
Pain in shoulders, hands, elbows, feet (bottoms) ("every joint in body").
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 4:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) 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 82.63  Concomitant products were not provided.  On 08-Jan-2021, the vaccine with batch number 041L20A was moved to fridge. On 11-Jan-2021, 9 vials were moved to the clinic. On the same day between 09 AM and 02 PM, vials underwent temperature excursion with temperature of 34 and 35 degrees Fahrenheit respectively. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 07-Feb-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.   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 brand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
14APR94 edema developed quickly in ankles, knees & hands; joints felt warm & stiff; advised to rest, elevate extremities, take Lodine 400 mg BID; 15APR94 swelling inc, knees very stiff; afebrile;
This spontaneous prospective pregnancy report was received from a nurse refers to an approximately 29 year old female patient. There was no information on pertinent medical history and drug reactions or allergies. On 12-SEP-2014, the patient was vaccinated with M-M-R II (reported as M-M-R II VACCINE VIAL (SDV, MDV OR ADDITIIVE (EA)), product lot # K002527, Expiry date: 18-FEB-2016, dose not reported, subcutaneously . After she received the M-M-R II vaccine she informed the physician that she was 16 weeks pregnant. The date of last menstrual period (LMP) was approximately 22-MAY-2014 (it was reported that the patient  was 16 weeks pregnant at the time of report on 12-SEP-2014). The expected date of delivery could be approximately around 26-FEB-2015. The exposure to M-M-R II was at 16 week(s) of pregnancy (third trimester). The pregnancy outcome was unknown. The fetal outcome was unknown. No known adverse effects was reported. There was no information on laboratory diagnostics studies performed. There was no intervention done to prevent the seriousness criteria. There was no product quality complaint involved. The outcome of the event was unknown (the patient present status reported as no known adverse effects). Additional information has been requested.
Information has been received from a registered nurse concerning a 44 year old male patient, with no drug reactions or allergies and no pertinent medical history, who on 08-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667912/0933Z, expire date 25-FEB-2012), 0.5 ml, intramuscularly. Concomitant therapy included CELEX, NORCO, SEROQUEL, vitamin D (unspecified), ADDERALL tablets, metformin, atenolol, WELLBUTRIN, amlodipine, TRUVADA, LEXIVA and RESTORIL. On 08-NOV-2010, after receiving PNEUMOVAX 23, the patient experienced a painful cellulitis like reaction. The patient developed fever, chills, convulsion, dizziness, vomiting, shaking and sweats. The patient went to an emergency room and was treated with levofloxin and discharged. On an unspecified date, a "ECHO cardiogram" was performed but the result was not provided. At the time of the report the patient had recovered. Upon internal review, convulsion was considered to be other important medical event. The nurse requested a lot check for this lot, due to adverse experiences. A lot check has been initiated. Additional information has been requested. This is one of two reports from the same source.
COVID; Covid; has a diagnosis of an underlying autoimmune disease who might have had an exacerbation post vaccination and post illness [actually had COVID as well]; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID"; COVID-19 (medically significant), outcome "unknown", described as "Covid"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "has a diagnosis of an underlying autoimmune disease who might have had an exacerbation post vaccination and post illness [actually had COVID as well]".  Clinical information: Patient had a diagnosis of an underlying autoimmune disease who might have had an exacerbation post vaccination and post illness [actually had COVID as well] at an indistinct time period.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the events covid19, drug ineffective, autoimmune disorder cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
expired dose was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva396a, expiry date 31st August 2021) for prophylaxis.   On 3rd September 2021, the patient received the 1st dose of Menveo. On 3rd September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided are as follows: The case was reported by Medical assistant. The patient received a expired dose of Menveo was expired on 31st August 2021, which led to expired vaccine used. The reporter consented to follow-up.
I felt extremely dizzy about 2 hours after my 2nd vaccination of Moderna so I tried to take it easy and stayed in bed most of the day and night .  The day after I did try to walk outside and suddenly became extremely dizzy while carrying an item and fell in my driveway without even having the ability to put my hands out front.    My face is now swollen, cut and bruised and I also have pain in my neck.I have pictures of my face after my fall and had to call out of work today Monday 4/26/2021 as a result.
My son had a fever, seizure and vomiting. We administered valtoco (diazepam nasal spray) for seizure.
Experienced arm pain after shot.  Continues today, with sharp intermitting pain radiating along arm.  Occasional art weakness.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 03-MAR-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Hemorrhagic stroke  NSTEMI (non-ST elevated myocardial infarction)
Client reports that 24 hours post-vaccine she experienced normal side effects plus sharp pains in her chest for 15 minutes and she fell asleep and it resolved on its own.  Client denies having any shortness of breath. Client did not follow up with primary care provider.
Information has been received from a registered pharmacist concerning a female patient who on an unspecified date was vaccinated with ZOSTAVAX (Merck) SQ.  On an unspecified date the patient called because she had a "skin discoloration" at the injection site.  The patient would only speak with the pharmacist who administered the vaccine who was not at the pharmacy at the time the patient called.  The patient was expected to call the pharmacy again the next day and speak with the administering pharmacist.  The patient had sought unspecified medical attention.  The outcome of the patient's "skin discoloration" at the injection site was not reported.  Additional information has been requested.
Recieved vaccine at 10:45. within 5 mins the injection site was itchy and the outer side of upper arm from the injection point to elbow felt cold. Itching went away within the next 15mins and the cold feeling took closer to 25mins to go away completely. I also experienced a dull achy headache that came on about 10mins after injection. The headache was at the base of my neck and traveled up to the top of my head- in a deep achy way that lasted all day. By the end of the day I was achy and stiff all over.  I took one ibuprofin at 9am and another at about 2pm. The next day I woke up extremely stiff and achy, possible low grade fever. Very fatigued, slept for 3 hours in the middle of the day. Next day felt back to normal. thank you.
A report was received from a healthcare professional on 12Nov02 concerning a 10 year old female vaccinee who experienced redness, swelling, purple discoloration and tenderness around the injection site within 1 day of receiving Fluvirin on 08Nov02. On 09Nov02 the vaccinee experienced redness, swelling, purple discoloration and tenderness within 1 day of receiving Fluvirin. Symptoms included redness, swelling, purple discoloration and tenderness of an 8cm area around the injection site. The symptoms were relieved by Benadryl topical cream and cold compress. On 11nov02 the vaccinee had not yet recovered. The vaccinees father indicated that the vaccinee received an influenza vaccine (brand unspecified) on the previous year and experienced a mild local reaction at the injection site. The reporter has assessed the relationship of the vaccine to the event as probable.
Herpes zoster; Information has been received regarding a case in litigation, referring to a currently 74 year old female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 13-FEB-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pte was treated by a physician due to herpes zoster. The pte claimed that the damages ad a result of vaccination with zoster vaccine live (ZOSTAVAX) were injury to themselves and economic losses. At the time of the report, the outcome of herpes zoster was unknown. The lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 26-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
7 days past immunization developed fever, malaise, night sweats, 4-5 days later developed rash erythematous maculo papular from head over trunk arms and legs.
For both first and second shot, I had severe acute cramps in my lower back, which began a minute after injection and gradually subsided over ten minutes.  For second shot, I had achiness in my lower back the day after injection and also got a low grade fever (101 degrees).
Tinnitus in both ears Instability - I have taken 2 hard falls since the vaccine and stumbled several time (particularly on the right side).  This is absoltuely ABNORMAL for me as I have nver struggled with instbility.  I am a runner, biker, water skier and stability is critical.  It has affected all three areas of my active hobbies.
Lower back; Put me down for 10 days; Muscle problem  sides and surface of lower rib cage; Loss of appetite(similar reaction like dose2)); Sore arm; Fatigue(similar reaction Like dose2); Right knee problem; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Lower back), ASTHENIA (Put me down for 10 days), MUSCULOSKELETAL CHEST PAIN (Muscle problem  sides and surface of lower rib cage), DECREASED APPETITE (Loss of appetite(similar reaction like dose2))) and VACCINATION SITE PAIN (Sore arm) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced BACK PAIN (Lower back), ASTHENIA (Put me down for 10 days), MUSCULOSKELETAL CHEST PAIN (Muscle problem  sides and surface of lower rib cage), DECREASED APPETITE (Loss of appetite(similar reaction like dose2))), VACCINATION SITE PAIN (Sore arm), FATIGUE (Fatigue(similar reaction Like dose2)) and ARTHRALGIA (Right knee problem). At the time of the report, BACK PAIN (Lower back), ASTHENIA (Put me down for 10 days), MUSCULOSKELETAL CHEST PAIN (Muscle problem  sides and surface of lower rib cage), DECREASED APPETITE (Loss of appetite(similar reaction like dose2))), VACCINATION SITE PAIN (Sore arm), FATIGUE (Fatigue(similar reaction Like dose2)) and ARTHRALGIA (Right knee problem) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications, Lab data details and Treatment information were not provided.  No Fever, Respiratory, head or stomach aches.   This case was linked to MOD-2021-293649 (Patient Link).
Client had one varicella vaccine at age 1 year and at age 12 dx'd with chickenpox.
8 hours after the shot, I developed a fever of 100 degrees Fahrenheit, chills, and body aches.  The next morning, the only symptom I had was a headache.  2 days after the shot I was fine.