chrisvoncsefalvay/vaers-outcomes huggingface dataset:
each time had gotten sick; had felt the palpitations; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (each time had gotten sick) and PALPITATIONS (had felt the palpitations) in a 37-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (each time had gotten sick) and PALPITATIONS (had felt the palpitations). At the time of the report, ILLNESS (each time had gotten sick) and PALPITATIONS (had felt the palpitations) outcome was unknown.            No concomitant medication was reported.  Patient had taken Moderna shots before and each time had gotten sick and had felt the palpitations.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-749030 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749030:Same patient, different dose
Tick bite; Diagnosed with Lyme disease post Tick bites; This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE (Diagnosed with Lyme disease post Tick bites) and ARTHROPOD BITE (Tick bite) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced LYME DISEASE (Diagnosed with Lyme disease post Tick bites) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHROPOD BITE (Tick bite) (seriousness criterion medically significant). The patient was treated with DOXYCYCLINE for Lyme disease, at an unspecified dose and frequency and TINIDAZOLE for Lyme disease, at an unspecified dose and frequency. At the time of the report, LYME DISEASE (Diagnosed with Lyme disease post Tick bites) and ARTHROPOD BITE (Tick bite) outcome was unknown.            Concomitant medications were not reported.  It was reported that she was diagnosed by Lyme disease in Apr-2021 post tick bites and She was on lyme disease treatment with Doxycycline and Tinidazole. She stated that the package insert for tinidazole warns not to take any vaccination. She has been off tinidazole for two weeks because she would like to get the booster Moderna shot.  Company comment: This case concerns a 79 year old female with no reported medical history , who experienced Serious ( medically significant ) unexpected events of Lyme disease and Arthropod  Bite  which occurred approximately 1 month after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) , The patient was treated with Doxycline and Tinidazole and the outcome of the events was unknown. The re-challenge for this case is not applicable since the event outcome is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report; Sender's Comments: This case concerns a 79 year old female with no reported medical history , who experienced Serious ( medically significant ) unexpected events of Lyme disease and Arthropod  Bite  which occurred approximately 1 month after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) , The patient was treated with Doxycline and Tinidazole and the outcome of the events was unknown. The re-challenge for this case is not applicable since the event outcome is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report
mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) dose via an unspecified route on 19Feb2021 at single dose (at the age of 67 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) dose via an unspecified route on 29Jan2021 at single dose (at the age of 67 years) for covid-19 immunisation and had no adverse event. The patient experienced mild fatigue on an unknown date in Feb2021. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Given history of anaphylaxis to flu vaccine in 2011, patient underwent skin testing to flu vaccine as recommended by the Practice Parameters, detailed below: 1. Skin prick test with 1:10 -no reaction at 15 minutes. 2. Skin prick test with full strength - no reaction at 15 minutes. 3. Intradermal with 1:100 dilution - Patient tested positive (12mm wheal/48mm flare) with associated flushing and pruritis of ears and face, throat clearing, and coughing. Epinephrine and Claritin were administered for anaphylaxis and symptoms resolved. She was monitored for 1 hour after and discharged from clinic in good health.
Patient stated before vaccination she has a history of becoming faint with blood draws in past. Nursing there when medic vaccinated. Patient stated two min after she started to become faint. Patient lost consciousness Two assist to floor. Patient did not hit or injure any body parts. Patient breathing unlabored even. B/p 100/60 R 16 o2 98%. After 1 min patient arouse. Ice to back. Patient assisted to sitting position. Patient able to drink juice and cookie. Monitored 30 min. Declined EMS assist to hospital. After 30 min patient states she is feeling better and not dizzy. No slurring of speech able to swallow and gait steady.
Sore arm; Muscle was swollen; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Muscle was swollen) and VACCINATION SITE RASH (Rash) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Muscle was swollen) and VACCINATION SITE RASH (Rash). The patient was treated with Physical therapy for Pain in extremity. On 02-Mar-2021, VACCINATION SITE SWELLING (Muscle was swollen) and VACCINATION SITE RASH (Rash) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient had been doing physical therapy and daily exercises for sore arm but it has not helped.  No relevant concomitant medications were reported.   Treatment information was not provided.   Reporter did not allow further contact
Patient began with abdominal pain and diarrhea on 8/6/22. Presented to the ED at another hospital on 8/8/22 and tested positive for COVID. Patient then came to this hospital on 8/9 with the same complaints. Patient is hospitalized and cause of GI issues are being investigated.
I stayed for 30 mins sitting after infection. I left and was driving and started feeling disoriented, dizzy, shaking and throbbing headache. I pulled into my school with 5 mins and started taking a rubbing alcohol/saline taste in my mouth and smelling it. I was dizzy, feeling ?floaty? out of body,  chills, extremely tired, unable to stand, high blood pressure and loss of color to face and hands. This  all happened within 35 minutes to one hour after removing the actual injection. I was being monitored. I was unable to drive and had to be picked up.  Within 6 hours after injection, the dizziness subsided and the body shaking.  9 hours after the injection I still have throbbing headache, extreme exhaustion, weakness in standing and alcohol taste in mouth.  Rheumatologist was contacted and left message for her.
Sharp, burning nerve pain when walking on bottom of left foot at base of 3rd/4th toes; Intermittent pain continues; no treatment.
From telephone contact received on 10/28/02, it was reported that a 53 year old adult female was vaccinated with Fluzone, lot # U0913AA, on 10/21/02. By 10/24/02, she complained of being tired with a low grade fever of 37.4C, sore throat, and sinus congestion. On 10/26/02, she developed a peppery roseolla-like rash that did not itch as she does with fever. Patient called to report, but was not seen. It was not reported whether the patient recovered.
7 days after the Moderna shot, I developed a large knot at the injection site. It is slightly itchy and red. The next day (10/22), I also have a swollen lymph node, about the size of a pea on the left side of my neck. The underarm area is also tender.
Other side effects I am noticing the day after the second dose are joint and muscle pain; Other side effects I am noticing the day after the second dose are joint and muscle pain; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ew0179), via an unspecified route of administration on 17Jun2021 (at the age of 30-year-old) as dose 2, single for covid-19 immunisation. Medical history included known allergies to sulpha drugs. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (at the age of 30-year-old) as dose 1, single for covid-19 immunisation and had bad breakout of acne on her forehead, nose, and chin. Her cycle was currently over a week late. Patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient reported that side effects she was noticing the day after the second dose (18Jun2021) were joint and muscle pain. Patient did not receive treatment for adverse events. Patient did not have covid prior vaccination and covid was not tested post vaccination. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
He got a superficial blood clot in left arm ?He's got the shot May 21 and I noticed he had two hard knots on left arm and there was probably about a half inch between them and as hard as a rock on that following Monday may 24,2021 , he said it was sore some more when you touched it we was told to keep an ion it make sure it didn't get any worse, turn red, swell, feel hot to the touch, and then to put a warm compresses on it ??
Patient had scratchy throat prior to vaccine administration.  31 minutes after vaccine, patient c/o feeling hot all over, difficulty breathing, increasing scratchy throat, coughing.  Had expiratory wheezing with cough only.  O2 sat 100%, HR 108, BP 123/83, RR 20-28.
Medication Error. LVN gave vaccine too early. 1s does given 9/29/19. 2nd dose given 10/10/19. Patient monitired closely(q30 min) x 24 hours. No adverse side effects noted or reported.
Patient stated she went and received 2nd dose Moderna at 0920. She stayed for 30 minutes and they let her leave, as she was getting into car with the kids, she felt her face flush and hot, she saw hives on her face, neck and arms. Did not go back in but called us at 1700 to report the symptoms. She stated her symptoms resolved completely after about 2 hours by around 11am
stated both arms & thighs were sore & exp back & neck stiffness;rt arm was red & swollen;
The patient was punctured in her left deltoid with a flu dose. When I started to inject the contents of the vial I noticed that there was considerable amount of vaccine leaking in the area between the needle and vial. I immediately stopped pressing the plunger and  withdrew the needle. It is unknown how much of the flu dose the patient received from the event, but there was about half the total volume left in the syringe and a considerable amount had leaked. (My guess was that the patient got 20% or less of the dose). I decided to prepare another syringe and give the patient the full dose. This was done on the same arm separated from the initial puncture. This dose was given without complication. The patient was acting normal at this time.  1-2 minutes after completion of her shot the patient lost consciousness and fainted. She was standing at the time, but was caught prior to her falling and she did not have any further injuries due to the fall. She regained consciousness within about 15 seconds, and reported that her ears were ringing. She did not show any signs of anaphylaxis or other allergic reaction. I gave her soda after she said that she had little to eat so far today. Her mom called paramedics and when they arrived they checked vitals and reported that everything was in normal ranges. She and her mother declined being taken to the hospital. During this time the patient reported to feeling better and was able to stand up and walk out of the store without assistance. According to her mother she had not had a fainting episode after receiving a vaccine before. I called later that afternoon to follow up, but had to leave a voice message.
Pt states experiencing debilitating joint pain since moderna vaccination. Also described "leaving body" type feeling involving paralysis below the waste lasting 1-10 seconds. Pt does state he has also reviewed this with physician.
After patient received FLUVIRIN vaccine she became very red and claimed she was overheating. She was red in the face and neck. The pt. did not have any hives. She did have slight shortness of breath, but she said it was because of her asthma and because she was overheating. She asked to be cooled down and we did so with a fan from our store as well as manual fanning. She rested for several minutes with a fan until she was cooled and comfortable. The patient was escorted from the store after this.
My friend mentioned that she had a fever after her Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (My friend mentioned that she had a fever after her Moderna booster) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (My friend mentioned that she had a fever after her Moderna booster). At the time of the report, PYREXIA (My friend mentioned that she had a fever after her Moderna booster) outcome was unknown.     No concomitant medications were reported. No treatment information was provided.
abdominal pain followed by diarrhea x10 then vomiting x1, plus low grade fever. Symptoms lasted 12 hours.
I have blurred vision that started the morning after my vaccine.  I also experienced flu like symptoms, but those went away after ~48hrs.  The blurred vision still persists.
febrile seizure-admit-tx w/APAP & cefotaxine;EEG checked; resolved;vax given by pvt MD and no further data w lot#, brand, etc in our records
This was an administration error.  Patient received a dose from a refrigerated vial that was punctured more than 12 hours ago.
"1AUG97 fever 102;red, raised spots-gen on face body & extremities-also have mild diarrhea & cutting 1st molars;1st had fever on 30JUL97 also cutting teeth;4AUG97 no fever today inc in rash;6AUG97 rash receding did not reach vesicular stage
My reaction was to the Pneumococcal Polysaccharide Vaccine. I experienced extreme soreness around injection site that spread up my shoulder and under my arm pit and down my arm about 4 inches below the injection site. Felt like my arm had been set on fire. Slight inflamation of the skin around the injection site. The skin was feverish and whenever I bent over the arm would sting and throb from the gravity. I had body aches all day long on November 04, 2009 and a low grade fever of or around 100 Degrees. By Thursday morning 8:00AM my body aches had subsided as well as my fever and the pain in my arm reduced. I still had mild soreness when touched on my arm for a week after the vaccination.
My symptoms were muscle aches and pains,  headache and nausea.  it started about 10 hours after the injection and lasted about 36 hours.  Thereafter I was just very tired for 24 hours.  I took an Advil  about 10 hours (around noon) after the headache set in, which lessened the headache.
I woke up with a cough productive of clear mucous and sinus drainage which was the same fatigue and I had a worsening of an existing condition of numbness and tingling around my mouth and cheeks. I took a COVID-19 test which was positive and I had minor aches and pain I had a fever which was a high of one hundred and one degrees.
Muscle spasms/muscle spasm in her back; Pain; This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number: AG8353, expiry: Jun2021, NDC number: 0005-1971-02) in the left deltoid at 18:00 to prevent pneumonia and influenza vaccine (FLUZONE, Manufacturer: Sanofi, Lot: UJ249AA, Expiry: 30Apr2020, NDC: 49281-0405-65) in the right deltoid for immunization; both via unspecified route of administration on 30Sep2019 at a single dose at the pharmacy. Medical history included ongoing diabetes. There were no concomitant medications. The patient previously received influenza vaccine (FLUZONE) for immunization in 2018. On 01Oct2019, the patient experienced muscle spasms/muscle spasm in her back and pain. When asked about the location of the pain, the reporter stated it was in general and unbearable. Events caused hospitalization on unspecified date. Outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of muscle spasms/muscle spasm in her back and pain cannot be excluded, considering the plausible temporal association.  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.
FEELING LESS DEPRESSED; SWELLING; TIRED; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 72.7 kilograms, and height was not reported. The patient's concurrent conditions included depression, and primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZM021B0101 expiry: 30/NOV/2023) 10 mg, every 1 day, frequency, and therapy dates were not reported for swelling, and tired. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included tadalafil, and treprostinil sodium. On an unspecified date, the subject experienced feeling less depressed, swelling, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The patient recovered from swelling, and the outcome of feeling less depressed and tired was not reported. This report was non-serious.
No additional AEs were reported; 9 month old patient received GARDASIL 9; This spontaneous report was received from a medical assistant and refers to a 9-month-old female patient.No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.    On 08-DEC-2021, the patient of inappropriate age was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dosage form , lot # T030749 with expiration date on 16-MAR-2023 (route of administration was not reported) for prophylaxis. No adverse event was reported.
Pt recvd 3 doses of Engerix-B & was a nonresponder;
Per pt's report: after receiving the vaccine, the vaccination site started to get sore, red, and warm to the touch. The soreness and warmth increased into next day and persisted, and she came in to pharmacy to consult with us what OTC remedies can/should be taken to help control pain. Pt reported warmth and redness just locally (area about the size of her palm around injection site and lower) and pain "from shoulder to elbow".
Narrative: A 51-year-old male Veteran received the 1st dose of the Moderna COVID-19 vaccine on 4/14/21. Shortly after administration patient complained of  feeling nauseated, with facial tingling and lip numbness/itching. No shortness of  breath, tongue or facial swelling, or throat tightness. Patient was evaluated by on- site physician. Vital signs were stable, and no visible swelling noted on exam. An Epi-pen 0.3mg was administered, and EMS was called. Patient was transported to  a nearby non- VA- ED for further evaluation/care. Documentation of care received  in the ED noted that patient was observed for 1 hour and then discharged to home.  He was given a methylprednisolone dose-pak. Patient has history of anaphylaxis.  from bee stings, but no allergies to medications. A primary care provider spoke with him by phone on 4/20/21. He noted an increase in joint pain (hip, lower back,  and knees) with onset on 4/17/21, but complete resolution of facial numbness and  tingling.
didn't feel good; left arm pain that occurred with certain movements; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel good) and VACCINATION SITE PAIN (left arm pain that occurred with certain movements) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced FEELING ABNORMAL (didn't feel good) and VACCINATION SITE PAIN (left arm pain that occurred with certain movements). At the time of the report, FEELING ABNORMAL (didn't feel good) outcome was unknown and VACCINATION SITE PAIN (left arm pain that occurred with certain movements) had not resolved.            No concomitant medications were reported. No treatment medications were reported for dose 2.   This case was linked to MOD-2021-436255, MOD-2021-436405 (Patient Link).
pt became pale, diaphoretic, hypotensive;placed on floor gave epi & DPH;BP 104/70, 122/70 improved sent to ER;
Not feeling "right" 7/20 eve. Fatigued, sore, headache, pale 7/21- sent home from work. Debilitating headache  and leg pain 7/21 and 7/22 (missed work 7/22) returned to work 7/23 some mild headache very sore legs