chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delayed severe swelling with progression; initial itch; Localised Swelling; Localised Erythema; Localised Pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of SKIN REACTION (delayed severe swelling with progression), INJECTION SITE PRURITUS (initial itch), INJECTION SITE SWELLING (Localised Swelling), INJECTION SITE ERYTHEMA (Localised Erythema) and INJECTION SITE PAIN (Localised Pain) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (delayed severe swelling with progression), INJECTION SITE PRURITUS (initial itch), INJECTION SITE SWELLING (Localised Swelling), INJECTION SITE ERYTHEMA (Localised Erythema) and INJECTION SITE PAIN (Localised Pain). At the time of the report, SKIN REACTION (delayed severe swelling with progression), INJECTION SITE PRURITUS (initial itch), INJECTION SITE SWELLING (Localised Swelling), INJECTION SITE ERYTHEMA (Localised Erythema) and INJECTION SITE PAIN (Localised Pain) outcome was unknown.        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.   No concomitant medication were reported. No treatment information was reported.
Dizziness; Extreme tiredness; increased urination; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (Extreme tiredness) and POLYURIA (increased urination) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE, ROSUVASTATIN, POTASSIUM CHLORIDE (K-DUR), LOPERAMIDE HYDROCHLORIDE (IMODIUM), ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN B-COMPLEX VITAMIN C, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CALTRATE + D PLUS for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DIZZINESS (Dizziness), FATIGUE (Extreme tiredness) and POLYURIA (increased urination). At the time of the report, DIZZINESS (Dizziness), FATIGUE (Extreme tiredness) and POLYURIA (increased urination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.
No signs or symptoms reported; Administrator report a temperature excursion on ROTATEQ and the doses were administered.; This spontaneous report was received from a administrator referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 22-APR-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose for prophylaxis (strength and route of administration were not reported; lot # 1742458 had been verified to be a valid number; expiration 22-JAN-2022). It was reported the temperature excursion was at 49.0 degrees Fahrenheit (F) on 09-APR-2021 and 48.7 degree F on 23-APR-2021, for a time frame of 1 hour 15 minutes and 0 seconds (cumulative) excursions. It was reported that no had previous temperature excursion. It was reported that the call was not due to data logger. No signs or symptoms reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002894:
He developed 6 spots on his chest, back (one on the back of his neck). They later had tiny scabs on them. He also had a high fiver of about 102 for a couple of days.  Very fussy.
Second dose of moderna vaccine admin 3/24, rash noticed 3/25 in the morning and has been spreading since. Also has tender axillary lymph nodes to left side (vaccine arm).
Headache & Fever Narrative:  out of work 2 days, advised motrin 600 q 4-6 hours
AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:1/05/2021.pfizer Lot#EL3246 2nd dose:01/26/21.pfizerLot#EL9262 Diagnosed covid positive: 03/24/21 Exposure:Unknown Symptoms:Headache, rhinorrhea, insomnia
Arm hurts at the injection site; Glands are swelling; Whole body hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurts at the injection site), LYMPHADENOPATHY (Glands are swelling) and MYALGIA (Whole body hurts) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm hurts at the injection site), LYMPHADENOPATHY (Glands are swelling) and MYALGIA (Whole body hurts). The patient was treated with PREDNISONE on 15-Mar-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm hurts at the injection site), LYMPHADENOPATHY (Glands are swelling) and MYALGIA (Whole body hurts) outcome was unknown.
Patient was given the Covid19 vaccine as dose #2 in the series.  Should have received the COVID19.  Patient had no adverse reaction to the vaccine.
patient recieved the covid vaccine on the 02/02/2022 and the vaccine was given IM on the right arm.  Patient  reported the adverse effect on  03/03/22.   The   patient   says she started feeling pain on the left side of her body and the pain is not relieved as of the time  reporting the incident Patient says she has not being able to see her doctor as she could not get an appointment. The pharmacist has also  tried calling the doctor  immediately the patient reported  the incident but couldnt get through to the doctor.
On day six (8:00 pm) it became itchy and lightly swollen. On day seven (7:30 am) it became red and very swollen ( about the size of an orange) and still itchy. No fever.
Patient received vaccine on November 2, 2013. He stated that his arm is hurting and the muscle hasn't healed. It hurts in the morning and pain is not going away.
Sore arm the day of and several days after the vaccine. By day 3, just occasional soreness or soreness when pressure applied. By day 5, no noticeable soreness. On Day 8, noticed lump at injection site. Approx .5-1 cm. Mildly painful if pressure applied, got hot and a little itchy when discovered (and then messed with because I couldn?t leave it alone). About 15 -20 minutes after discovery, still warm to the touch and mildly itchy. Arm feels a little numb.
C/O nausea, vomiting, vertigo, fatigue, malaise, chills, low grade fever. Has follow up Friday 2/22/13 sees MD at hospital.
1 day of redness, swelling, tenderness and warmth at the site of injection.
The morning after receiving the vaccine I woke up with a headache. I drank lots of fluids and tested, but the headache seemed to get worse. It was throbbing with associated light-headedness and general fatigue. Maximum temperature after vaccine so far has been 98.8
received Pfizer 1st dose 2/2/21, unable to schedule 2nd with Pfizer, we provided 2nd dose with Moderna
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Mar2023 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (Jul2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Jul2023) Negative, notes: tested negative after the 5-day Paxlovid treatment. Therapeutic measures: Paxlovid was administered to the patient as a treatment from 08Jul2023 to 13Jul2023 as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300255011 same patient, different drug/event;
Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 2nd dose of Shingrix. In November 2021, less than 2 weeks after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's brother. The reporter stated that, his sister received 2nd dose of Shingrix and experienced 3 days of flu like symptoms. The reporter called to inquire on strategies for mitigating possible side effects for the second dose of Shingrix. The reporter consented to follow up.
Patient received a third dose of the vaccine.  Patient was asked whether it was the first or second dose to which they replied 2nd dose.  Upon attempting to enter into the LINKS database, it was discovered that this was in fact the patient's 3rd dose.
Information has been received from a registered nurse concerning a 13 year old patient who was believed to be vaccinated with MMR II and was believed to be autistic. Upon internal review, autism was determined to be other important medical event. Additional information has been requested.
Arm swelling; dizziness; pain swelling to same side of body; pain swelling to same side of body; fell as a result of symptoms; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 67-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 25Oct2023 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for immunisation. The patient's relevant medical history included: "Remission breast ca" (unspecified if ongoing), notes: Remission breast ca; "HTN" (unspecified if ongoing); "known allergies: Pcn" (unspecified if ongoing), notes: known allergies: Pcn. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 25Oct2023 at 18:00, outcome "recovered" (26Oct2023), described as "Arm swelling"; DIZZINESS (non-serious) with onset 25Oct2023 at 18:00, outcome "recovered" (26Oct2023); FALL (non-serious) with onset 25Oct2023 at 18:00, outcome "recovered" (26Oct2023), described as "fell as a result of symptoms"; PAIN (non-serious), SWELLING (non-serious) all with onset 25Oct2023 at 18:00, outcome "recovered" (26Oct2023) and all described as "pain swelling to same side of body". Therapeutic measures were not taken as a result of peripheral swelling, dizziness, pain, swelling, fall. Additional information: vaccine location Deltoid provided. There was no other vaccine on same date and in four weeks.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Achy, fatigue, headache, sniffles, nausea and diarrhea
Cold; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unknown route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patent called to inquire if she could get her second dose of vaccine today (as of 21Feb2021) because she had a cold from having no heat for days. The clinical outcome of cold was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a certified medical assistant concerning a 73 year old white female with allergies to sulfa and meperidine hydrochloride (Demerol) who on Sept 29 2004 at 11:30 am was vaccinated IM in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). There was no illness at the time of vaccination. Concomitant therapy included estrogens conjugated (Premarin), lisinopril (Zestril), alendronate sodium (Fosamax), fenofibrate (Tricor) and levothyroxine Na (Levoxyl). Subsequently, the patient developed a local site reaction of lightly raised area, painful, red, hot. The patient sought unspecified medical attention. No product quality complaint was involved. Follow up information indicated that on Sept 29 2004 at 4:00pm the patient developed swelling, pain, redness, and a fever in her arm. The outcome was reported as recovered. There were no relevant diagnostic test or laboratory data. There were no adverse events following prior vaccinations. It was also reported that 4 other female patients experienced these adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P) within the last 2 months (WAES0411USA02135, WAES0411USA02760, WAES0411USA02761, WAES0411USA02762). Additional information has been requested.
Breakthrough Case of COVID,  I started out with a scratchy throat, then it was a sore throat, coughing, head and chest congestion, very fatigue, and no appitite.
Tdap given in (L) arm and immediately after injection site started swelling and redness appeared around area.
Left ear pain: started after second dose of Moderna vaccine on 3/12. Patient describes the pain as a throbbing sensation that occurs in the upper earlobe.  It interferes with his sleep. Improves with heat, aspirin/ibuprofen/Tylenol. Aggravated by swallowing.Gradually this has improved over the weekend and until today.  He has not needed any ibuprofen over the past week.  He does endorse having other side effects associated with the second dose of the Moderna vaccine, including back pain and myalgias; these completely resolved within several days. Patient denies any associated headache.  He denies any jaw claudication symptoms.
PATIENT REPORTED PAIN IN ARM, WHICH SHE EXPECTED.  SHE SAID IN THE MIDDLE OF THE NIGHT SHE WOKE UP GASPING FOR BREATH ON 2 OCCASIONS.  SHE REPORTED IT TO HER PHYSICIAN WHO SAID SHE SHOULD TELL US TO REPORT.  SHE SAID SHE ONLY HAD SOB IN THE PAST IF IT'S EXTREMELY HOT IN HER BEDROOM.
At 1521, RRT was activated at the post-vaccination monitoring area for an 87 y/o F with c/o dizziness and fluttering in her chest area. She has a hx of Afib, currently taking Rx for it. Initial vitals: 78 HR, 96/62 BP, 95% on RA, 0/0 pain, 18 RR. Patients appears breathing even and unlabored, in no acute distress.  Head-to-toe assessment within normal limits. Throughout evaluation period, client?s symptoms improved. Client refused to get evaluated by ambulance personnel. Client was monitored for an additional 15 minutes after initial evaluation. At 1600, client left vaccination site AMA in no acute distress, breathing even and unlabored, experiencing no more symptoms. Symptoms resolved. Client left accompanied by her husband.
Varicella vaccine breakthrough. Diagnosed with varicella on 08/07/06. Rash started 8/05/06. Had 20 lesions on torso, face, arms and legs. No fever. Returned to office 8/12/06 and 8/11/06 with infected lesions. Treated with Keflex and Bactrim. Culture sent. Results pending.
Two days after receiving vaccine she presented to an emergency department with an episode of blurry vision and outward deviation of left eye that resolved within one hour. She went to Emergency Department for evaluation.
Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Ist done, single), for COVID-19 immunization.The following information was reported: THYROIDITIS ACUTE (medically significant), outcome "unknown", described as "Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results, notes: hyperthyroidsm & hypothyroidism was evaluated. Duration of duration of the hyperthyroid phase was also evaluated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported event and the suspect product BNT162B2 cannot be ruled out.  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.,Linked Report(s) : US-PFIZER INC-202200708586 Same article/ Event/drug and different patient
Injection site is warm; Injection site is red; Injection site is raised; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is raised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Jan-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 VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is raised). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is raised) outcome was unknown.        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 medication details were not reported by the reporter. Treatment details were not provided by the reporter.   Reporter did not allow further contact
After each dose their arm was sore, very hard and red, and hurt , for a couple of days.; After each dose their arm was sore, very hard and red, and hurt , for a couple of days; After each dose their arm was sore, very hard and red, and hurt , for a couple of days; After each dose their arm was sore, very hard and red, and hurt , for a couple of days.; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.), ERYTHEMA (After each dose their arm was sore, very hard and red, and hurt , for a couple of days), PAIN (After each dose their arm was sore, very hard and red, and hurt , for a couple of days) and VACCINATION SITE INDURATION (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.), ERYTHEMA (After each dose their arm was sore, very hard and red, and hurt , for a couple of days), PAIN (After each dose their arm was sore, very hard and red, and hurt , for a couple of days) and VACCINATION SITE INDURATION (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and BENZONATATE at a dose of 200 mg. At the time of the report, PAIN IN EXTREMITY (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.), ERYTHEMA (After each dose their arm was sore, very hard and red, and hurt , for a couple of days), PAIN (After each dose their arm was sore, very hard and red, and hurt , for a couple of days) and VACCINATION SITE INDURATION (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included nasal rinse with a neti pot.   This case was linked to MOD21-052130.
After my first dose my menstruation did not came for 56 days, also after that my body did not produce the sufficient progesterone for me to get pregnant.
they both knocked me off; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.  Additional deatils were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had shingles shot and it knocked off the patient for a day. The reporter stated that, it was well worth the actual shingles. For the tolerence of 2nd dose refer case US2022AMR028369 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR028369:same reporter