chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Patients medical history and current conditions were not provided. On an unknown date since 26-NOV-2014, the patients were vaccinated with an incorrect storage doses of ROTATEQ (lot #, expiration date and dose were not reported) route default as oral. No concomitant mediation was reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
2 hours after injection (Monday): fatigue, headache, sensitivity to light (migraine), sore arm, sore elbow (site of surgery three months prior), sore lower back muscles, some dizziness.  Mild nausea. 1 day after injection (Tuesday): Increased dizziness and nausea.  Fatigue about the same.  Headache treated with ibuprofen and acetaminophen, responded well. 2 and 3 days after injection (Wednesday and Thursday): No side effect symptoms. 4 days after injection (today, Friday): Diarrhea.
Dad describes past S2  post vaccination. Child place DL hand behind head and was twisted right and odd cry. Recovered and then had another few second episode. Taken to ED. nl exam.
drug ineffective; COVID-19; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4208727-00.  A 31 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2021 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single and intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "recovering", described as "drug ineffective"; COVID-19 (medically significant) with onset Dec2021, outcome "recovering", described as "COVID-19". The action taken for adalimumab was unknown. The reporter's causality for the event(s) of COVID with HUMIRA(ADALIMUMAB) was no reasonable possibility. Causality as per reporter for the event(s) of COVID with bnt162b2 was possible. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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
Patient's left arm, deltoid, was red, largely swollen and hot to touch. The reaction occurred 5 days after vaccine administration. Patient came to the office for an appointment on 10/24/17 and it was assessed by MD. MD prescribed patient Cephalexin to cover for cellulitis.
soreness.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPERSENSITIVITY (soreness.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE HYPERSENSITIVITY (soreness.). At the time of the report, INJECTION SITE HYPERSENSITIVITY (soreness.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Given PNEUMONIA 23 immunization, 8-5-14 started having fever of 101.9 in the evening of 8-6-14, Left arm sore with some redness, treated with TYLENOL.
When I caught COVID-19 I started with a raspy throat and a tight chest. I had a slight cough and a tight chest at the time that I first tested positive for COVID-19. On 7/3/2022 I started taking Lagevrio. I started feeling better. I never had a head cold but just a rattling in my chest. I felt worn down and my energy level is back up to normal. I got the antiviral on 7/3/2022. I'm still coughing a little but but not my badly.
Patient received varicella vaccine #1 in office on 3/21/12. He was seen in office on 5/23/14 and diagnosed with chicken pox.
Redness and burning along lower lip and gum line.; Rawness on inside of lower lip andalong lower gum line; Tingling lips; She looked up and told me this was an allergic response; Sore on right lower lip within first two hours. This has spread to multiple cold like sores on lower lip.; Burning along lower lip and gum line.; Burning along lower lip and gum line.; Redness and burning along lower lip and gum line.; This is a spontaneous report from a contactable healthcare professional. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Sep2021 at 10:30 as a single dose for COVID-19 immunisation. Medical history included epstein-barr and adverse reactions to stomach medicine as teenager and anesthesia in 2006. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Sep2021 at 12:00 the patient experienced sore on right lower lip within first two hour that had spread to multiple cold like sores on lower lip and a rawness on inside of lower lip and along lower gum line and the patient reported redness and burning along lower lip and gum line and burning and tingling. When she went to schedule next vaccine she asked pharmacist if she could wait until sores healed. She removed my mask and showed her mouth. She looked up and told the patient this was an allergic response and not to get second vaccine. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event sore on right lower lip within first two hour that had spread to multiple cold like sores on lower lip and a rawness on inside of lower lip and along lower gum line and the patient reported redness and burning along lower lip and gum line and burning and tingling and allergic response was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
started screaming inconsolably approx 10PM; LOC, inc temp 100-102 ax;
11/21/08, ADACEL given 3:45 pm. 11/23/08, 11:50 AM, pt. called, (L) axillary lymph node area red and very sore where injection given. Negative fever, positive erythema, warmth, tenderness.
This spontaneous report as received from a nurse refers to an 12 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 20-MAR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot #K004204, exp. date: 12-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
On 7/21/2022, I received my 2nd Moderna booster shot. On 8/8/2022, I started displaying COVID-19 symptoms: fever, chills, coughing, horrific headache and congestion. My highest fever on 8/12/2022 was 102.1ºF. On 8/11/2022, I tested positive for COVID-19 using an at-home antigen test. My doctor prescribed antiviral meds for me. As of today's date, 8/18/2022, I am still testing positive for COVID-19; and experiencing mild symptoms of congestion and coughing.
Escalating erythema, edema itchy 15.5 cm x 9.5 cm (R) anterior thigh.
Shot 1: Headache lasting several days; Shot 2: Headache lasting several days; Shot 3: Starting with 1 "pimple" on the day of the shot, there is a gradual developing folliculitis or rash on face and upper neck and hairline. This was treated as acne initially, because it took 2 weeks for me to realize my symptoms were from the shot. I suddenly  began getting very frequent migraines almost immediately after the shot and they are ongoing. I also had a petit mal seizure after 1 week. I haven't had a seizure in years; the timing is proof that it is related to the shot. I have increasingly swollen glands, after a week and a half I developed sores on my gums, chills, fatigue, and now after 2 weeks I am unable to tame this painful scabbing rash all over my face.
Initially a general ill feeling and then pain in the hip joint.; Initially a general ill feeling and then pain in the hip joint.; This is a spontaneous report from a contactable consumer. A 41-year-old female patient (NOT PREGNANT) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer) in Jan2021, via unknown route of administration at single dose (second dose); via unknown route of administration at single dose (first dose) in Jan2021 for unknown indication. Medical history and concomitant medications were unknown. There were unknown allergies. There was unknown if patient received other vaccine in four weeks and Other medications in two weeks. Patient experienced initially a general ill feeling and then pain in the hip joint in Jan2021. Patient did not receive any treatment. Patient did not have COVID prior vaccination and COVID tested was unknown post vaccination. The outcome of the events was recovered in Jan2021.  Information on the Lot/Batch Number has been requested.
A few hours after shot, patient complained of very sore arm.  2 days later he came back in stating after he got home and the whole next day he felt "like crap", entire body was aching and weak.  He took ibuprofen and felt better.  Today he says he feels better but his arm is still sore.
patient reported a couple weeks after 1st moderna vaccine (she was unsure of date, I guessed on the first page of the report because I had to put an exact date). she began to feel short of breath. eventually went to hospital where she was diagnosed with blood clots in both the legs and lungs. she said dr is saying it was due to the vaccine and told her not to get the second dose. she stayed 5 days in the hospital according to her. had surgery to place a filter for the clots and is now home on oxygen around the clock.
Pfizer-BioNTech Covid-19 Vaccine EUA one week After 2nd shot on Feb 16 I started experiencing numbness and pain in both legs, primarily in the thigh, in addition as of today I am experiencing slight tingling in both hands and some light pain in arms.
EXTREME chills and fever.  Alternated 4 or 5 cycles.  Woke up with having thrown off my blankets and had to get ice packs and open windows to cool down enough to sleep, a few hours later woke up SHIVERING like I never have before.  I thought I was convulsing until I realized I could control it with my breathing. I was shivering so hard that I bit my tongue several times.  I didn't have much energy so it took several minutes before I could grab blankets and even longer before I could close the window.  I was wrapped in several layers of blankets and was still shivering until I fell asleep.  I woke up again and my blankets were soaked in my sweat.  This cycle got more and more intense until the next day.  *I've been hospitalized with pneumonia and this felt 100 times worse. The next day, I had the worst diarrheic that I've ever had, sudden urge.. barely made it to toilet and INSTANTLY discharged what felt like a gallon of brown liquid (it was probably less but felt pretty nasty).
Patient reported itchy symptoms and burning to left side of arm 15 min post vaccination. Staff responded for evaluation. Patient observed and Staff called to scene for eval and treatment. While observing patient, itchiness and burning moved to right arms, legs and face. No angioedema or difficulty breathing. Patient drank a 16 oz. bottled water. Patient given 25mg Benadryl IM on left arm by Staff. Patient reported decrease in itchiness and burning.. Patient refused transport and signed AMA after calling her husband for a ride home. Patient left clinic with husband. RN called patient at 1830 and was unable to make contact. Patient husband was also contacted and he did not report patient condition. He referred RN to make contact with patient.
collapsed on the floor / laid on the floor; cold sweats but he was hot/cold and clammy; he was hot; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (collapsed on the floor / laid on the floor), COLD SWEAT (cold sweats but he was hot/cold and clammy), FEELING HOT (he was hot) and VACCINATION SITE PAIN (pain in the arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 038A21A and 013A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN and LISINOPRIL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (collapsed on the floor / laid on the floor), COLD SWEAT (cold sweats but he was hot/cold and clammy), FEELING HOT (he was hot) and VACCINATION SITE PAIN (pain in the arm). At the time of the report, LOSS OF CONSCIOUSNESS (collapsed on the floor / laid on the floor), COLD SWEAT (cold sweats but he was hot/cold and clammy), FEELING HOT (he was hot) and VACCINATION SITE PAIN (pain in the arm) outcome was unknown.       Treatment product was not provided by the reporter  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable.  This is a Spontaneous case concerning a 66-year-old, male patient with medical history of taking lisinopril and metformin as concomitant medication,  who experienced the unexpected non serious events of loss of consciousness. The event occurred approximately 1 day after the third dose of the Moderna COVID 19 vaccine..  The rechallenge is not applicable. The drugs metformin and lisinopril are co suspects for the event.   The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 66-year-old, male patient with medical history of taking lisinopril and metformin as concomitant medication,  who experienced the unexpected non serious events of loss of consciousness. The event occurred approximately 1 day after the third dose of the Moderna COVID 19 vaccine..  The rechallenge is not applicable. The drugs metformin and lisinopril are co suspects for the event.   The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
positive 1/7/22 sx migraine, temp, drainage, pfizer vaccine x 2 doses (no booster)
Slurring of speech developed on 1/17, eventually led to what was diagnosed as bulbar predominant ALS.  Eventual cause of death was widespread thrombus/emboli of arterial and venous system.  She also developed wide fluctuations in her blood pressure.
Headache, Sedation, Myalgia, Arthralgia, Fever, chills and fatigue. pain and swelling at the injection site. Narrative:  Other Relevant History:
Patient's arm was red and swollen near the injection site. She said it was very painful and was itching. She did visit her doctor but she did not treat. She asked her to come to the pharmacy and show us so we could report it. It looked like a normal reaction to the shot. I told her she could use a moist compress to ease the pain and itching. She will follow up with us if she continues to have problems.
A non-serious spontaneous report of tested positive for influenza has been received from a health professional concerning a four-year-old female patient, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither medical history nor concomitant medication was reported for this patient. On 18-Jan-2011, the patient received FLUMIST. On 26-Jan-2011, the patient tested positive for influenza using the rapid diagnostic test. The outcome of the event tested positive for influenza was unknown.
I tested positive on February 2, 2023. Body aches, low grade fever and cough and general fatigue.
My symptoms started on March 27, 2023. I felt poor. I had congestion, cough, and diarrhea. I tested myself for COVID-19 on March 28, 2023. The result was positive. I went to Urgent Care. They prescribed Paxlovid, a cough suppressant, and nasal spray. I felt horrible for two more days. I was tired. I was also coughing and had more diarrhea. By the end of the fourth day, I was feeling better. I still have a little bit of a cough and a little bit of congestion periodically.
Around the Injection site is red and a little puffy as well as hot.  Currently feeling very fatigued and tired.
This case was reported by a pharmacist and described the occurrence of redness of eyes in a 37-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject had no relevant medical history.  There were no concurrent medications.  The subject received influenza virus vaccine in previous years with no subsequent adverse events and also had no adverse events following receipt of any prior immunizations.  On 2 November 2007 at 9:45 a.m., the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On 2 November 2007 at 11:45 a.m., 2 hours after vaccination with Flulaval, the subject stopped back by the pharmacy because she was experiencing problems following her vaccination, including redness of eyes, cough, chest tightness and white exudate in eyes.  The subject did say that the symptoms have not been getting worse.  At the time of reporting the events were unresolved.  The pharmacist considered the events were probably related to vaccination with Flulaval.  Follow-up was received on 27 November 2007 from the reporting pharmacist.  The onset of the adverse events was 2 November 2007, one hour after the receipt of Flulaval.  The events resolved on 04 November 2007.
Post vax the patient broke out with hives on his arms, chest and back. The patient was treated with epinephrine.
Pt recv vax on 8/31/98; on 9/1/98 pt exp increased redness, swelling, and itching of 2 x 2.5 circular area of papuals bumpy to touch on left leg, non tender to touch. Pt pupils very large.
Itching all over the body, about to vomit. Patient went to see a doctor. She got prednisone for treatment on 8/28/14.
Urinary Tract Infection.  I have to use antibiotics for treatment.  I had no changes in my daily life, other than vaccine, to potentially trigger UTI.
The patient reported that his arm was tender in May2021. The patient was wondering if this was normal and asked was it normal for the pain in his arm to last this long. The patient also asked whether it was a problem if he was on blood thinners. The outcome of the event was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021530614 same reporter/drug, different patient/event
high fever, morbilliform rash, irritability, & koplik spots 10 days p/MMR:dramatic rash;
temperature of 100.4; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature of 100.4) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (temperature of 100.4). At the time of the report, PYREXIA (temperature of 100.4) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100.4 (High) temperature of 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
(PER PTS MOTHER) APPRX 10 HOURS AFTER INJECTION, PATIENT WOKE UP WITH PAIN AND HARD KNOT POSTERIOR LEFT ARM.  THE NEXT AM, AREA WAS SWOLLEN, WARM AND RED (APPX 2 1/2 INCH OVAL SHAPE) PATENT COMPLAINED OF NAUSEA, HEADACHE AND SLIGHT WHEEZING.  WHEEZE RESOLVED WITH BENADRYL.
Arm where Tdap and varicella vaccines administered reported to have a reddened, hard, warm, soft-ball sized lump at site of Tdap injection.  Also reported that child "felt feverish."
Small pruritic rash on L thigh and pruritic poorly circumscribed rash covering the anterior and lateral aspects of R thigh with a small area of nontender induration.
high grade fever; headache; This spontaneous case was reported by an other caregiver and describes the occurrence of PYREXIA (high grade fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PYREXIA (high grade fever) and HEADACHE (headache). At the time of the report, PYREXIA (high grade fever) and HEADACHE (headache) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Red spot which is size of half a dollar and painful and sore to touch; Red spot which is size of half a dollar and painful and sore to touch; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red spot which is size of half a dollar and painful and sore to touch) and INJECTION SITE PAIN (Red spot which is size of half a dollar and painful and sore to touch) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Red spot which is size of half a dollar and painful and sore to touch). On an unknown date, the patient experienced INJECTION SITE PAIN (Red spot which is size of half a dollar and painful and sore to touch). At the time of the report, INJECTION SITE ERYTHEMA (Red spot which is size of half a dollar and painful and sore to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.