chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Duracef, reaction(s): "Known allergies: duracef medication". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid Treatment start date: 23Dec2022 until 27Dec2022. On 01Jan2023 i started feeling bad again after making what I thought was a full recovery - i was previously symptom free and I had gotten a negative COVID result on 30Dec2022  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Fever, chills, body aches, vomiting, diarrhea, heart palpitations, extreme fatigue, loss of appetite, dizziness, extreme joint pain, and difficulty walking. Missed work.
The adverse event is I developed gastritis. Initially developed GI symptoms that lasted 3-4 days and loss of appetite/ nausea that still persists to today. About 2 weeks after the shot, I started getting severe stomach pains, went to the ER, and was diagnosed with gastritis due to ruling out differential diagnoses with imaging. I have struggled with gastritis symptoms off and on ever since the shot. I have never had issues with gastritis in my life.
Patient received monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) 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 (Patient received monovalent vaccine given as booster). No concomitant medication was reported.    It was reported that reporter found out that they could not gave the Moderna as a booster starting 31-Aug-2022, but administered monovalent doses as boosters. She was told that booster that they received did not cover omicron, so the patients would need to be revaccinated with the bivalent later.  No treatment information was reported.
Client was not 65 years of age and was given the Fluzone HD for65 years or older
There was no reaction on 04-01-2021 when the shot was administered. At 1:00am on 04-02-2021, I awoke to fever, sweating, racing heart rate, headache, and severe body ache. The racing heart, fever, and sweating lasted until 6:00am. The headache and body aches lasted until 04-05-2021. On 04-03-2021, I also experienced an allergic reaction around 8:00pm. My face, neck, and throat were red and itchy and my upper lip began to swell. I took three doses of Benadryl and the allergy symptoms went away.
There is also a very small raised blemish near the site of the injection; soreness in my left shoulder muscle; soreness in my left shoulder muscle; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient).  A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: not reported), via an unspecified route of administration on left arm on 04Mar2021 as dose 1, single for Covid 19 immunization. Medical history and concomitant medications were not reported. After first shot of covid vaccine, the patient was noticed with soreness in his left shoulder muscle. The area of soreness from the first shot was still there. It was mild and more noticeable when he extends his arm to its limits. There was also a very small, raised blemish near the site of the injection. The patient received both covid shots. The patient received second shot on 25Mar2021. There was no soreness from the second shot. Outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 40, and 48 hours, with the lowest recorded temperature of 34, and 33 degrees Fahrenheit (1.11, and 0.55 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
THIS CHILD RECEIVED 0.25 ML OF FLU VACCINE INSTEAD OF 0.5 ML OF FLU VACCINE FOR THE FIRST DOSE OF A TWO DOSE SERIES.
I went to bed 2h after the vaccine, but woke up at ~6h after to find that the injected arm was mostly limp at the shoulder--I could only move it a bit before encountering muscle weakness and pain. I went back to sleep on and off until getting up at 17h after, at which point I could move the injected arm forward but not backward/outward. At 18h after, I took 1 capsule of Ibuprofen. By 22h after, I had regained full muscle range, with still some pain when moving it backward/outward.
Patient here for 2nd dose of pfizer and informed staff of a reaction he had to his first dose which included tingling throughout the body and lasted for 2 days ("comes and goes") then resolved. Pt did not notify staff of tingling at the time of the 1st dose. Patient also reported today that he had again experienced the tingling with the 2nd dose. Patient was monitored for another 30 minutes after the tingling had resolved and was provided education on adverse/allergic reactions and when to seek care prior to leaving the vaccination site.
generalized fussiness; crying/insomnia/anorexia starting 10 hrs post vax (18 month DTP/OPV) & resolving about 24 hrs post onset of fussiness;
Pt c/o SOB. Asked pt to remove mask to take some deep breaths. Called Dr. @ 1047; pt  stated she had a Humira shot 2-3 wks ago and is feeling  SOB after 1st shot. . Pt encouraged to wait add 15 minutes. pt should get clearance from primary MD take 25mg Benadryl before 2nd shot
tingling from my elbow down to my hand; left arm (injection site arm) began itching; left arm (injection site arm) had little hives; lymph nodes on left elbow were the size of a golf ball, lymph nodes on right arm were slightly swollen / lymph nodes right above the elbow on both arms are swollen & about half the size of a golf ball; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling from my elbow down to my hand), VACCINATION SITE PRURITUS (left arm (injection site arm) began itching), VACCINATION SITE URTICARIA (left arm (injection site arm) had little hives) and LYMPHADENOPATHY (lymph nodes on left elbow were the size of a golf ball, lymph nodes on right arm were slightly swollen / lymph nodes right above the elbow on both arms are swollen & about half the size of a golf ball) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    Concurrent medical conditions included Heart murmur (From past 20 years) and Drug allergy (Trazodone).   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and INFLUENZA VACCINE (FLU) (unknown route) at an unspecified dose. On 29-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (left arm (injection site arm) began itching), VACCINATION SITE URTICARIA (left arm (injection site arm) had little hives) and LYMPHADENOPATHY (lymph nodes on left elbow were the size of a golf ball, lymph nodes on right arm were slightly swollen / lymph nodes right above the elbow on both arms are swollen & about half the size of a golf ball). On 08-Apr-2022, the patient experienced PARAESTHESIA (tingling from my elbow down to my hand). At the time of the report, PARAESTHESIA (tingling from my elbow down to my hand), VACCINATION SITE PRURITUS (left arm (injection site arm) began itching), VACCINATION SITE URTICARIA (left arm (injection site arm) had little hives) and LYMPHADENOPATHY (lymph nodes on left elbow were the size of a golf ball, lymph nodes on right arm were slightly swollen / lymph nodes right above the elbow on both arms are swollen & about half the size of a golf ball) had not resolved.            No concomitant medication was reported.  On 25-Oct-2021, the patient got the flu shot in my right arm. On 29-Oct-2021, on left arm (injection site arm) began itching and had little hives. The lymph nodes on left elbow were the size of a golf ball. The lymph nodes on right arm were slightly swollen.  08-Apr-2022, the lymph nodes right above the elbow on both arms are swollen and about half the size of a golf ball. The patient also had tingling from my elbow down to my hand, on occasion. The swelling on both arms sometimes gets a little more enlarged than others. No treatment medication was reported.  It was reported that the swelling was related to the shot (Flu shot).   This case was linked to MOD-2022-535832 (Patient Link).
I almost fainted the night after my shot. I had vaped cannabis prior at around 1:00am, and probably re-dosed at around 3:00AM, before falling asleep at around 4:30AM. I had a harder than normal time falling asleep that night, and I didn't sleep very well. At around 6:00AM I woke up and walked to the bathroom, feeling pain in my anal region. As I started to sweat profusely, I recognized that I was likely about to faint, so I pre-emptively lied down on the floor of the bathroom until I felt well enough to stand up. I don't remember exactly how long I was on the floor but most likely a few minutes. I then had a bowel movement, still feeling pain in my anal region but to a lesser degree, and then drank some water and went back to sleep at around 6:30AM.
Client reports feeling a lump in her throat after vaccination. Fire Rescue at scene to evaluate client.  Client reports symptom subsided.  Vitals all wnl.  Per Fire Rescue, no further eval. needed.  Client released at 10:32am.
This is a spontaneous report obtained from a contactable nurse. A patient of an unspecified age, gender, race and ethnicity received, on 17Aug2017, PREVENAR 13 intramuscularly, at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. Nurse stated that the injection site was normal except for the front and back part of the patient's arm. On an unspecified date, in Aug2017, the front and back part of the patient's arm was red and had fluid filled pustules. They wanted to know if the patient can receive the PNEUMOVAX 23 subsequently, since she is allergic to the PREVNAR 13. Clinical outcome of the events was unknown at time of this report.
ED to Hosp-Admission  to Current  10/10/2021 - present (4 days) Hospital  COVID-19 Principal problem   Plan     Chief Complaint Patient presents with ? Shortness of Breath     1. COVID 19 2. Acute hypoxemic respiratory failure 3. CKD stage 3   Plan:   Start decadron 6mg IV daily x 10 days   Start 5 day course of IV Remdisivir   Procalcitonin is normal -> no antibiotics indicated.    Check a full set of inflammatory markers including ferritin CRP LDH lactate   Gentle hydration for a short period of time for the sake of the kidneys -> but careful to aim for a more conservative fluid management approach given the COVID.    Spoke to ED physician personally and agree with admission.     History of Present Illness     Patient is an 80 y.o. female.       I personally interviewed patient, reviewed chart, and reviewed emergency room resident history and agree with it in its following entirety unless otherwise noted below.  "Patient is a 80 y.o. woman with a history of dementia, HTN, HLD, CKD stage III, hyperparathyroidism, GERD, who reports the emergency department with shortness of breath.  Patient coming from SNF via EMS, is reportedly COVID-19 positive.  This morning was found to be complaining of worsened shortness of breath, found to have room air saturations in the 70 percentile.  Placed on 1 L nasal cannula with improvement to 95%, sent to ED for evaluation and care. Patient currently reports shortness of breath, nonproductive cough. Denies any chest pain, nausea/vomiting, diarrhea, myalgias, headache.    Has received 1 dose of the Pfizer vaccine.   80 y.o. woman with a history of dementia, HTN, HLD, CKD stage III, hyperparathyroidism, GERD, who reports the ED via EMS from SNF with shortness of breath and hypoxia in the setting of COVID19 infection.  HPI as per below.  Afebrile, tachypneic in the mid 20s with an SPO2 95% on 3 L nasal cannula, hemodynamically stable.  Physical exam shows well-appearing elderly woman in NAD, heart regular no M/R/G, lungs with faint crackles in all lung fields, abdomen soft and ND/NT, mucous membranes are moist, no significant lower extremity edema.  Differential diagnosis includes likely worsening COVID-19 infection, possible superimposed bacterial pneumonia, lower concern for PE or ACS given lack of chest pain or other significant symptoms.  Will obtain CBC, CMP, lactate, Covid inflammatory markers, RVP, EKG, CXR.  Will give 6 mg Decadron IV for hypoxia in the setting of COVID-19.  Anticipate hospitalization given degree of hypoxia and new supplemental O2 requirement.   Per POLST, patient is FULL CODE."   On my bedside evaluation she is resting on 3 L nasal cannula and is relatively comfortable appearing but she is a very poor historian.  Does not note any pain or edema in her legs.  No belly or chest pain.  She does feel like she is getting enough air at this time
I have noticed significant decrease in libido and inability to maintain an erection; I have noticed significant decrease in libido and inability to maintain an erection; I experienced swelling and pains in my testicles the day after each dose; I experienced swelling and pains in my testicles the day after each dose; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732), via an unspecified route of administration, administered in left arm on 24Mar2021 15:00 (33-year-old at time of vaccination) as single dose for COVID-19 immunisation. Medical history included PTSD. The patient had no known allergies. Concomitant medications included finasteride (FINASTERIDE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported he experienced swelling and pains in his testicles the day after each dose (from 25Mar2021 after dose 1). Since then, he has noticed significant decrease in libido and inability to maintain an erection. Event onset date was also reported as 22Mar2021 08:00 (pending clarification). The events were assessed as non-serious. The adverse events did not result in doctor or other healthcare professional office/clinic visit, or emergency room/department or urgent care, or prolonged hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Clinic No therapeutic measures were taken as a result of the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Fever started the night after I got the vaccine and continued for 2 days. My body ached and I was nauseous the whole next day as well. I took some acetaminophen and the symptoms were less severe, but did not go away until time was done
5x5.5 cm induration distal to left deltoid vaccine site 48 hours following vaccine. Pruritis. No systemic sx
Information has been received from a 61 yr old female physician with reactive airway disease who about 7 years ago and on 01Nov04 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (lot649914/0578P). Subsequently, after 24 hrs her arm became red, swollen and hot. She also felt exhausted and was febrile. Unspecified medical attention was sought. No product quality complaint involved. The pt was considered to be recovering. The pt took tramadol hydrochloride (Ultram) to help sleep after vaccination. It was also reported that her husband had a similar reaction after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES0411USA00917). Additional information has been requested.
I have pain in my left upper arm in the area where I received both shots.  It feels like a sharp, pain when I move my arm in certain directions and lasts a few minutes.  More like a shredded muscle than an on-going muscle pain.  It doesn't hurt unless I reach the wrong direction.  I am not aware of anything I have done to injure the arm and it is in the exact area of the injections.  It started at some point after the second injection.  I am wondering if anyone else has suffered the same reaction and hoping it won't get worse or be lasting.
Several hours after vaccine, sinus passages closed to approximately 1/3-1/6 of normal opening.  Sinuses opened slightly with normal treatments (sinus medication, saline spray, etc.).  After one week, sinuses have opened to approximately 1/2 of normal opening.
After vaccine administration, pt had a vasovagal episode. For 4-6 hrs afterwards, had visual limitations of visual fields & dizziness.
Information has been received from a health professional concerning a 20 year old white female with sinusitis and no known drug allergies, who on 04-JAN-2008 was vaccinated IM in the left deltoid (previously mentioned as in the right arm) with GARDASIL (lot#658219/0755U). Concomitant therapy included MOTRIN, DURAPHEN FORTE and ZITHROMAX. In January 2008, the patient experienced red itchy hands. Two days after the vaccination the patient developed red itchy hands. She stated that when the patient applies lotion to her hands they burn and "feel like they are on fire". Follow up information indicated that the patient experienced dry red hands on 05-JAN-2008 (left worse than right) looked like eczema. A steroid cream was given for hands. The patient's outcome was unknown. No product quality complaint was involved.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: heat at injections site, pt took temp at 3 or 4 degrees hotter than the skin adjacent to it. the welt on the arm after three days from initial symptoms. per pt, injections site looks more red than before and maybe continuing to spread. mild itch comes and goes. redness and heat continues to fluctuate. possible intensification of heat in the area due to sun exposure.
Started with a headache on 02-26.  By that night, I was itching all over my body.  No rash, though.  By 02-27, headache was severe and ears were ringing.  Later that night, I was dizzy, had severe chills, was nauseated, was fatigued, and my joints and muscles ached so bad I could barely move. On 02-28, the symptoms started to subside, and by today (03-01), I'm just back to a regular headache.  Hopefully, that will be gone by tomorrow.
Intense shivers, headache, upset stomach, vomited many times all night, muscle pain, couldn't take medicine.
Vial had been removed from deep freezer and placed into cooler longer than prescribe timeline outlined by Pfizer. Administered into patient (employee) prior to issue being identified. Pfizer states unlikely to have harmful effect, however cannot guarantee effectiveness. ID physicians recommend offering 3rd dose ~3-4 weeks, which will be done.
shortness of breath; pain in my body like I was having the flu; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and INFLUENZA LIKE ILLNESS (pain in my body like I was having the flu) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Cholesterol.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) and INFLUENZA LIKE ILLNESS (pain in my body like I was having the flu). At the time of the report, DYSPNOEA (shortness of breath) and INFLUENZA LIKE ILLNESS (pain in my body like I was having the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure medications and cholesterol medications.  Treatment includes tylenol