chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MOUTH TENDERNESS; RIGHT ARM SORENESS; FATIGUE; SKIN RASH; THIN FILM OF BLOOD ON HER NOSE "SINUSES"; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. Non-company suspect drugs included: palbociclib (form of admin unknown, oral, batch number was not reported) 125 mg, 1 time every 1 day, from 12-FEB-2021 for breast cancer. Concomitant medications included letrozole. On 12-FEB-2021, the subject experienced thin film of blood on her nose "sinuses". On 12-FEB-2021, the subject experienced skin rash. On MAR-2021, the subject experienced right arm soreness. On MAR-2021, the subject experienced fatigue. Laboratory data included: Blood test (NR: not provided) low white blood cell count. On an unspecified date, the subject experienced mouth tenderness. Treatment medications (dates unspecified) included: sodium chloride, and hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from skin rash, and right arm soreness, and fatigue on MAR-2021, was recovering from thin film of blood on her nose "sinuses", and the outcome of mouth tenderness was not reported. This report was non-serious.
Developed red rash about 6" in diameter that was very warm with a hard lump under the injection site.  Upper arm area was very itchy and progressed from the head to the waist area.  Face has been flush with .5 degree elevated temp.  Experiencing intermittent chills/feeling cold, muscle aches (all over), nausea, some diarrhea, fatigue and headaches.  Generally feels like flu-symptoms.  This has been happening from day after shot for next 5 days and may take an additional week (or more) to clear.
Fatigue, headache, joint pain, body aches, sleepiness - started approx 24 hours after vaccination and lasted approximately 14 hours
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Woke up on 11-14-07 with fluid filled blister on waist & belly.  Child seen 11-14-07, Dx with chicken pox.
pt exp severe h/a, bronchial cough & excessive post-nasal drip 2 hrs p/vax; 8PM began to exp myalgias & arthralgias, nausea-never vomited; woke 1AM eyes were crusted, feet, hands, face swollen; called ER because of swelling;
Fluvirin w/ Thimerosal (seasonal flu vaccine) given to OB pt. LMP = unknown. EDC = 11/24/2009. Pt does NOT have an OBGYN. Dr. at Medical Center is providing OB care for this pt. Pt NOT hospitalized after receiving seasonal and H1N1 vaccines. 11/23/09 OB medical records received. Normal IUP. Received vax 10/26/09. No complications reported. EDC: 11/24/09. 11/9/09 OB visit 37wks WNL. No PMH. 12/01/01 OB medical records received for DOS 11/09/09 additional pages. Normal IUP 37 week, 5days.
Low grade fever at onset, then 102-103 overnight. Also c/o intermittent fussiness.
Allergic reaction. Itchiness all over, rash in part of face and chest.  Feeling very groggy, felt lump in my throat, felt like I couldn't  breathe possible panic attack.
area where I got the shot going red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (area where I got the shot going red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (area where I got the shot going red). At the time of the report, VACCINATION SITE ERYTHEMA (area where I got the shot going red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information was not provided.
After vaccine, arm was sore a few hours later. A knot at site location can be felt under skin. Later during the week vaccine location became itchy. And then rash like appearance and knot still there on 4/8.
Patient states his throat started to close up and his lungs "filled with fluid" and he couldn't breath. He used an Epipen and recovered fully.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 07-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # N010495 with expiration date 31-MAR-2019 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
My heart started racing within 2-3 minutes from receiving the vaccine. This lasted about 3 hours. Within 10-15 minutes I felt light headed and then nauseous. Both of these symptoms lasted for several hours. Around 3 PM I felt pain in my liver area. This was intermittent throughout the evening. I rested on my bed for a couple of hours. About 3 PM the first symptoms ceased and only the right side/liver area or pancreas area remained, intermittently as I previously mentioned.
No adverse event; administered with Moderna COVID-19 Vaccine from vial with blue cap and purple border Booster doses only presentation instead of the Moderna Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered with Moderna COVID-19 Vaccine from vial with blue cap and purple border Booster doses only presentation instead of the Moderna Bivalent) and NO ADVERSE EVENT (No adverse event) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     Patient had no allergies. Patient had no history relating to both Acute and Chronic illnesses at the time of vaccination.    On 05-Nov-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (administered with Moderna COVID-19 Vaccine from vial with blue cap and purple border Booster doses only presentation instead of the Moderna Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administered with Moderna COVID-19 Vaccine from vial with blue cap and purple border Booster doses only presentation instead of the Moderna Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (administered with Moderna COVID-19 Vaccine from vial with blue cap and purple border Booster doses only presentation instead of the Moderna Bivalent).    It was unknown if patient was under any concomitant or regular medication. It was unknown whether patient ever had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient did not report any adverse events after getting the vaccine. It was unknown if any treatment was given to patient.
Pt received GARDASIL #1 on 3/1/11. On 3/2/11 awoke with nosebleed in am, felt "dizzy" for about 5 hours. Resolved. Felt fine on 3/3/11.
No additional AE reported; Nurse called and reported that a 12 month old consumer received VARIVAX on 3/16/2022 and MMR-II today, 4/6/2022; This spontaneous report was received from a registered nurse concerning a 14-month-old male patient. Information regarding the patient's current conditions, medical history and historical drug was not provided.   On 16-MAR-2020, patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX.)  On 06-APR-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliters subcutaneous route on the left thigh, lot number U006485 (rHA) expiration date 26-FEB-2023 administered as prophylaxis (Inappropriate schedule of product administration.)  No additional adverse events were reported.
Pain in injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in injection site left arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Fibromyalgia and Arthritis.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain in injection site left arm). At the time of the report, VACCINATION SITE PAIN (Pain in injection site left arm) outcome was unknown.            No concomitant products were reported.  No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-148240 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148240:
Rash and redness around site and down arm stopping at elbow with itching - started 3 days after injection, lasted approx 14 days.
Left arm in the area of the deltoid muscle had a large reddened area about 4 inches in diameter with uneven edges and was warm to the touch. Patient has been taking his regular dose of morphine and an anti-inflammatory whose name he could not remember. He said his arm was painful. He said he would contact his physician.
pt recv vax 15APR97 10AM & fine in AM, approx 12noon started w/sx;fever off & on, joint pain, appetite less;21,22,23APR97 sx got progressively worse t103.7, more joint pain in knee, ankle then hips;no appetite, listless, hardly able to walk
Swelling and redness left thigh started that night, spread the next day so pt came into the doctor's office. Skin only a light pink, so not concerned for infection, likely just the local immune response.
Immediately after vaccination, patient complained about pain in her arm. She then stated she was going to pass out and could not breathe. She felt like she was going to vomit. 911 was called and the EMT stated the patient might have had some vaso-vagal response, sometimes it makes the patient feel wonky per the Paramedic. Their vitals were within normal range.
My head is itching really bad; Really bad taste in mouth like chewed aspirin whole time on med; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Aug2021 (Lot number: Fc3184) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid long haulers" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline"; Paxil, reaction(s): "Known allergies: Paxil". The following information was reported: PRURITUS (non-serious) with onset 05Mar2022, outcome "not recovered", described as "My head is itching really bad"; DYSGEUSIA (non-serious) with onset 05Mar2022, outcome "not recovered", described as "Really bad taste in mouth like chewed aspirin whole time on med". It was unknown if therapeutic measures were taken as a result of pruritus, dysgeusia.  Additional information: Anti-viral details was noted as product for COVID-19 treatment; brand noted as Pfizer; treatment start date noted as 04Mar2022; treatment stop date noted as 08Mar2022; lot number noted as Ft5407 and indication noted as treatment of covid-19. It was reported that patient's head was itching really bad. Did not start until started that medicine (unspecified). Really bad taste in mouth like chewed aspirin whole time on med was also noted.  Follow-up attempts are completed. No further information is expected.
right arm was feeling weak, swollen and sore/right arm felt weak; right arm was feeling weak, swollen and sore/caller's right arm, where you normally put IVs in, feels really swollen and sore; right arm was feeling weak, swollen and sore/caller's right arm, where you normally put IVs in, feels really swollen and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 (Lot number: EW0173) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, lot : EW0173, location: left arm), administration date: 26Jul2001, when the patient was 26 years old, for Covid-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 16Aug2021, outcome "not recovered", described as "right arm was feeling weak, swollen and sore/right arm felt weak"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 16Aug2021, outcome "not recovered" and all described as "right arm was feeling weak, swollen and sore/caller's right arm, where you normally put IVs in, feels really swollen and sore".  Additional information: A 26-year old female consumer was calling about the Pfizer BioNTech Covid19 Vaccine. She had her 2nd dose of the vaccine yesterday 16Aug2021 on her left arm, and her right arm was feeling weak, swollen and sore. She wants to know if these are common side effects of the vaccine.The caller was calling about the Pfizer covid vaccine. The caller just got her second dose yesterday and had a question about a side effect. The caller got her second dose in her left arm yesterday. Last night the caller's right arm, where you normally put IVs in, feels really swollen and sore. The caller also noticed that her right arm felt weak.   Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Call was made by grandmother to HD at 12:50 PM. She states pt was non-responsive. HD nurse instructed to take child to ER. Child was reported to be responsive before arriving. He developed a rash on hands and arms and was instructed by ER MD to have no more vaccinations before age 4. No fever. Child was alert by 5 PM. Rash fading by next AM. Several follow up calls were made.
Child ran fever after getting immunized. Was hospitalized on 12/29/02. Had been on 3 different antibiotics from 12/18/02 to 12/29/02. Mother states possible viral meningitis. From Medical Center; 10/11/04 Discharge dx is febrile illness, tonsillitis with improvement with fluids, albuterol inhaler & IV antibiotics. To be followed w Dr in office.  Medical records include H&P states child had been treated for pharyngitis and otitis and continued w fever and was admitted.
Hives over legs, arms, and stomach area appeared 4 days post vaccine. No itching. Used topical steroid and benedril. No itching occurred. Continued through following week but much less.
vaccine given to 13 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old patient) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old patient) had resolved.        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.   Reporter did not allow further contact
Intermittent sharp, crappy abdominal pain, followed by loose stools.  Several hours later shaking chills, low grade fever (100).   Fatigue.  Symptoms resolved within 36 hours.
p/vax pt pupils were red, dilated & painful;pt recovered p/12hr;
Fever, dehydration, diarrhea. Follow up : Previoiusly reported symptoms have abated. Ne onset of cought 3-4 days ago. Seen today in office 12/21/2004.
Extreme pain in muscle of left arm. Could not move arm for 10  hours. Could not sleep because of pain. Took 5 low dose aspirin and two extra strength Tylenol. Pain lessened and could move arm in 12 hours.  Was then normally sore for three  days after .
Immense pain in left arm,  right around the jab area. Cannot move the left arm because it hurts so bad.
Mom - called our on call nurse. She stated patient c/o pain (L) arm where MENACTRA vaccine given with vein in the arm very prominent and blue parent was advised by the on call RN to apply ice, give acetaminophen q4h. Mom advised to call and schedule appt in peds office. Mom stated site looked much better next day and did not schedule f/u.
Fever starting around 10pm the day of the vaccine. Fatigue and fever lasting until around 10pm the next day. Symptoms subsided around 11pm.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 31-MAR-2017 the patient was vaccinated with expired dose of M-M-R II lot # L009212, expiration date 17-MAR-2017. No adverse effects reported. No further information provided. Additional information has been requested.
1 hour post injection: Site of injection is swollen, hot, red, itchy. 2 hours post injection: Spread into an itchy hot red rash on most of the left arm.