chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VERY SLEEPY; NO APPETITE; TROUBLE BREATHING THAT COULD BE DUE TO ALLERGIES; FELT THE NEEDLE GO IN AND FELT LEFT ARM WAS SORE AFTER; FELT TIRED/ FATIGUED; NAUSEA; FELT FEVERISH AT THE TIME BUT NO ACTUAL TEMPERATURE WAS RECORDED; This spontaneous report received from a consumer concerned a 70 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies. The patient experienced no adverse event when treated with covid-19 vaccine ad26. cov2. s (manufacturer unspecified) (series 1) for prophylactic vaccination on MAR-2021.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1822811, expiry: unknown) dose was not reported, 01 total administered on left arm on 28-OCT-2021 for prophylactic vaccination (series 2). No concomitant medications were reported.  On 28-OCT-2021, the patient experienced the needle go in and felt her left arm was sore, within few hours she felt tired, fatigued and was very sleepy, felt nausea and had no appetite. She had trouble breathing but as per the reporter that could be due to her allergies as well. She felt feverish at the time but no actual temperature was recorded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt the needle go in and felt left arm was sore after, very sleepy, felt tired/ fatigued, nausea, no appetite, trouble breathing that could be due to allergies, and felt feverish at the time but no actual temperature was recorded. This report was non-serious.
developed Bell's Palsy  placed on one week of steroids.  Left side  of face as of today 90% improved Am an RN  and thought  I should make you aware.
From initial information received on 05Jan05 from a RN regarding an adverse event occurring it was reported that a 21 yr old male pt received his first dose of JE VAX, lot number EJN213A, administered SC in the left arm and a second dose of TD, lot number U1341AA, administered IM in the right deltoid on 23Dec04. Several hours later, the pt developed several cold sores on his mouth and several canker sores in his mouth. The pt stated that he was afebrile and denied itching, rash, hives, or any other symptoms. The pt recovered from the events.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 72 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "bee stings" (unspecified if ongoing); "Known allergies: fragrances" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. Past drug history included: Septra, reaction(s): "Allergy". Vaccination history included: BNT162b2 (DOSE 2, SINGLE, lot number=EN6205,, lot unknown=False,, vaccine location=Left arm), administration date: 01Mar2021, when the patient was 71-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, prev dose lot number=EW0188,, prev dose lot unknown=False, prev dose vaccine location=Left arm), administration date: 12Oct2021, when the patient was 72-year-old, for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 24May2022, outcome "recovering", described as "elevate blood pressure"; BLOOD GLUCOSE FLUCTUATION (non-serious) with onset 24May2022, outcome "recovering", described as "fluctuations in blood sugar"; HEADACHE (non-serious) with onset 24May2022, outcome "recovering", described as "severe headache for 10days". The events "severe headache for 10days", "elevate blood pressure" and "fluctuations in blood sugar" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood pressure increased. Additional information: If other vaccine in four weeks: No. Other medications in two weeks: 25 mg Losartan bid. Ae treatment: increased strength of bp medication. If covid prior vaccination: No. If covid tested post vaccination: no.
Weakness; Mouth become dry; Low grade temperature 101f to102f; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DRY MOUTH (Mouth become dry), PYREXIA (Low grade temperature 101f to102f) and FATIGUE (Fatigue) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included IRON for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced ASTHENIA (Weakness), DRY MOUTH (Mouth become dry), PYREXIA (Low grade temperature 101f to102f) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), DRY MOUTH (Mouth become dry), PYREXIA (Low grade temperature 101f to102f) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Body temperature: 101 f-102 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Blood pressure medicine and  Iron infusion.; Sender's Comments: Based on the current available information and the temporal association between the product sue and the start date of the events a causal relationship cannot be excluded.
I only had a slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Lot number: EP7533) at the age of 48 years as dose 2, single and administered in arm left, administration date Apr2021 (Lot number: ER8736) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Car accident in year 2008 that caused concussion and titanium pin in left shoulder near injection site.", start date: 2008 (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "titanium pin in left shoulder near injection site" (unspecified if ongoing), notes: due to a car accident about 10 years ago. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I only had a slight fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient only had a slight fever as a response and no serious side effects or mental diminution.  Follow-up (22Feb2022): Follow-up attempts are completed. No further information is expected.
Obtained seasonal flu shot at Pharmacy located at the store location at approx. 4PM on Friday, October 16, 2020. Injected in left upper shoulder. At approx. 7:30pm the same evening, I began having problems breathing and my neck and chest were blotchy red with what looked like hives, but not itchy just hot to the touch. My throat tightened, and my voice became very raspy, and my lips began to tingle but were not swollen. I began coughing to clear my throat, and drinking cold water, but the odd feeling continued to progress. I took my temperature at approx 8:15pm on the same evening and did not have any noticeable change, but my heart rate was increasing. By 8:30pm I called an urgent care facility to obtain their advice, as my primary physician's office was closed. The admin nurse listened as I recounted my situation of getting a flu shot earlier in the afternoon. She suggested I immediately go to the Emergency Room and if I had a Benadryl tablet, to take that immediately before leaving for the ER. I did take one 25mg Benadryl. I arrived at the ER approx 8:50pm, and was immediately triaged. I was admitted by 9:15pm, after having an IV line placed in my left arm. The attending nurse placed EKG leads on my chest to monitor my heart rate and pulse oxygen rate. By approx. 10:34pm the decision was made to give me (all via IV): diphenhydramine, famotidine, and methylprednisolone sodium succinate. The ER doctor on duty, visited with me at approx 11:15pm, at which time I was improving and the most alarming of the symptoms were regressing. I was discharged at approx. 11:45pm and was given a prescription of Prednisone (pill form) to take over the next 5 days to ensure the anaphylaxis symptoms stayed in check. As of Saturday,  October 17th, I was feeling much better and back to normal.
Client received varicella vaccine approx 14 days ago. Father brought client in this am stated she woke up with this reaction. Client appears to have one single lesion on left thigh with pustular center and redness around approximate the size of a half dollar. Advised father to take child to private MD and have checked. He said he would.
Dizziness,lightheadedness.; Muscle stiffness; Tiredness; tenderness in Left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 66-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 24Mar2021 at 11:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 27Feb2021 at 13:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included as colonoscopy preparations and daily supplements (unspecified) (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 (day 1), the patient experienced only tenderness in left arm. Then on 25Mar2021 (day 2), the patient experienced muscle stiffness, tiredness and began to feel dizzy and on 26Mar2021 (day 3), the patient experienced dizziness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The clinical outcome of the event tenderness, muscle stiffness, tiredness and dizziness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Routine follow up phone call to mom-states had strange higher pitched cry for 2 hrs following vaccine and on and off for next week. Gave child Tylenol and seemed better. Child not seen by MD, but MD office was called-told to come in if no change or worse. Child very irritable, noticeably pale and very jumpy according to mom. Mom has nx of food/medicine intolerances. Older 1/2 sibling had some swallowing and fever with previous shots. Refer to MD for future vaccines.
Patient developed 3 itchy red patches about 3-4 inches across on her arm adjacent to the injection site.  They have become more itchy and red over the last 2 days.  Patient hasn't taken anything yet, but I instructed her to take benadryl tablets to help with the itching and to monitor the areas to make sure they do not become larger.
Rebound of Covid after testing negative for 3 days after last dose of Paxlovid, tested positive again 21Apr; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: other medical istory Allergies; "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: 01Mar2022; CLARITIN ALLERGIC, start date: 01Mar2022. The following information was reported: COVID-19 (non-serious) with onset 21Apr2022, outcome "not recovered", described as "Rebound of Covid after testing negative for 3 days after last dose of Paxlovid, tested positive again 21Apr". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are possible. No further information is expected.
injection site redness; injection site swelling; injection site heat; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 10-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA151A, expiry date 31st July 2020) for prophylaxis.   On 14th August 2019, the patient received Menveo. On 16th August 2019, 2 days after receiving Menveo, the patient experienced injection site erythema, injection site swelling and injection site warmth. The patient was treated with benadryl (nos) (Benadryl) and ibuprofen. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Menveo.  Additional details were provided as follows: The patient had redness, swelling and heat at the injection site 2days post vaccination. At the time of reporting the patient told to continue Benadryl and Ibuprofen. The reporter did not agree to follow up.
This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, exact dose and route of administration were not reported) or PREVNAR (lot #, expiration date, exact dose and route of administration were not reported). The patient was a poor historian and could not provide which vaccine he was administered with in the past. On an unknown date, the patient was seeing a rheumatologist for an unknown reason and he became immunocompromised. It was unknown if he became immunocompromised prior to or after possibly getting the vaccine. It was unknown if any relevant tests were done. The pharmacist reported that on an unknown date, the patient was requesting the PNEUMOVAX 23 but the pharmacist did not give it to him since he did not known if he received it previously. The outcome of immunocompromised was unknown. At the time of report, it was also unknown if the patient would receive the PNEUMOVAX 23. The relatedness between the event and both suspect therapies was not reported. Additional information has been requested.
PATIENT RECEIVED AN EXPIRED DOSE OF THE PFIZER BOOSTER. NO ADVERSE EVENTS REPORTED, PATIENT HAS OPTION TO GET REVACCINATED.
Vaccine was administered at 9:30 AM 5/5/21 Aching muscles started 5:30 PM Fever and chills started 8:00 PM Severe nausea started 6:00 AM 5/6/21. Fever and chills continued.  I was unable to keep down even water. I tried to stay hydrated, but vomiting continues throughout the day. Nausea stopped 8:00 PM 5/6/21. Fever and chills greatly reduced. symptoms reduced to mild muscle aches 6:00 AM 5/7/21 symptoms gone 6:00 AM 5/8/2021
Patient received a pediatric Moderna dose during booster appointment. Patient was schedule to receive a pfizer 5-11 year old booster. nurse inadvertently grab the Moderna dose scanned it and bypass message pop up. after administering realized she had a moderna dose not a pfizer dose incident disclosed to parent and  notified.
2nd dose h/a, fever, malaise, nausea, vomiting-10 times;
didn't feel good; The pain at times took her breath away; terrible pains around to the left side of her back at elbow level; terrible pains in her left side/doubled up in pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel good), PAIN (terrible pains in her left side/doubled up in pain), DYSPNOEA (The pain at times took her breath away) and BACK PAIN (terrible pains around to the left side of her back at elbow level) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included Sickness (January/February of 2019, & it lasted 10 to 15 days.) in 2019.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-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 FEELING ABNORMAL (didn't feel good), PAIN (terrible pains in her left side/doubled up in pain), DYSPNOEA (The pain at times took her breath away) and BACK PAIN (terrible pains around to the left side of her back at elbow level). At the time of the report, FEELING ABNORMAL (didn't feel good), PAIN (terrible pains in her left side/doubled up in pain), DYSPNOEA (The pain at times took her breath away) and BACK PAIN (terrible pains around to the left side of her back at elbow level) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to the hospital because she was doubled up in pain. It took about 2 to 3 weeks to go away. They never found a cause. No concomitant medication were provided. No treatment information were given.
13 December 2021 - massive hives, dermatographic uticarria (awful). Tinnitus for a month starting on same date - but as of seven days ago (last week of April) - MASSIVE AND UNRELENTING TINNITUS. I cannot concentrate, i have migranes, and the ringing is incessant.
Patient reported complaints of chest "irritation", cough, runny nose and headache within few hours of receipt of flu shot.
pt recvd vax & exp urticaria approx 30 mins following DT/HBOC immun; pt recovered; pt given DT skin test-prick neg;
Friday 04/07/2006, Mom states felt warm and gave Advil.  Saturday, 04/08/2006, no fever but left leg child was keeping straight, no noted redness or swelling.  Was seen at doctor on Monday, 04/10/2006, but Mother upset and was unable to examine baby well.
Case previously recorded as MA2009-6259. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
my daughter received the vaccine on Wednesday the 19th, on Thursday afternoon my child started with fever, She had a high fever at night , she could not breathe well and at six o'clock in the morning on Friday I realized that she  had her glands inflamed and  it looked like two lemons and she had sweated all night, she had a fever all Friday and Saturday. On Sunday she woke up with red spots on her back, chest and face
a week later she tested with COVID positive; This is a spontaneous report from a Pfizer sponsored program. This consumer (patient) reported that a female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route on 03Apr2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. One week later on 09Apr2021, she was tested with COVID positive, she currently was in quarantine. The patient's second dose was scheduled on 24Apr2021 and also she would be out of quarantine on that day. She wanted to know if she could get the vaccine or she needs to see doctor first. She was trying to see if she needed to rescheduled the second shot or go ahead and take it. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 20-AUG-2018, the patient was vaccinated with improperly stored dose of PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449.
Pain at injection site immediately. Redness, minor swelling. By midnight of day of injection had high fever, extreme fatigue, extreme body aches, and headache. These symptoms lasted 48 hours, and the fever went away but the fatigue, and body aches and mild headache remained. The symptoms increased and chest pressure, SOB, neck pain and tightness started. I finally decided to make appt with primary MD and could only get in on April 21. Saw her and she ordered labs and testing and noted the symptoms were abnormal for me. Labs drawn on 4/23 in am and in afternoon I was called to go to the ER due to my symptoms and elevated D-Dimer for potential clots or cardiac issue. ER visit was additional labs and Chest CT which was negative. They doubled my newly prescribed BP med and sent me home.  On 4/30 symptoms exacerbated and I woke up at 2 am with elevated BP 188/116 and heart rate 112. with increased chest tightness, SOB and headache. I again went to the ER more testing done, all negative.  I also was noted to have a temp of 101.3 F on admission. No cause for fever could be found, labs all normal. Discharged on doubled BP medication. Now taking 50mg Losartan twice daily.  I continue to have elevated BP, extreme fatigue, body aches, SOB on any exertion, Chest tightness, neck/ throat pain, mild headache, random fever that pops up and funny flushing/ chill sensations which have been present since vaccination.  Also noted is occasional muscle cramping.
pt recvd vax; pt devel nausea, hot flashes & body aches w/ 1st dose; pt exp'd nausea, vomiting, hot flashes, itching at injection site & sweating w/ 2nd dose;
Pt requested vaccine while admitted to the hospital.  Pt stated he had not received a Covid-19 vaccine. It was later found that patient had received 2 doses of Covid-19 vaccine in January and February  of 2021. No adverse effects noted. Pt was monitored from date and time of vaccine until discharge on 03/22/2021.