chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient walked up to the counter, said he was feeling dizzy, eyes were starting to roll back, He fell forward, when he came to we got him a seat, then his eyes started rolling back and he started having what appeared to be a seizure, I went and grabbed a EpiPen, gave him the shot and he responded right away.  He didn't know what happened. We called ems and they took over after about 5 minutes.
Received vaccines 6/12/08, that evening left upper arm became red, hot and swollen at site of IPV. No fever or other systemic sx. Max size 10x8 cm. Area resolved spontaneously by 6/18/08
My right arm was red and sore at the injection site; My right arm was red and sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (My right arm was red and sore at the injection site) and VACCINATION SITE PAIN (My right arm was red and sore at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur (from past 20 years) and Drug allergy (Trazodone).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (My right arm was red and sore at the injection site) and VACCINATION SITE PAIN (My right arm was red and sore at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (My right arm was red and sore at the injection site) and VACCINATION SITE PAIN (My right arm was red and sore at the injection site) had resolved.            No concomitant medication was provided. No treatment medication was provided.  The patient had not experienced any side effects with first dose of Moderna COVID-19 vaccine.  The patient had denied COVID positive test or diagnosis. AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized) for the adverse events. Symptoms were reported to improved.   This case was linked to MOD-2022-535852 (Patient Link).
Patient received MENACTRA in clinic in left arm. Patient went pharmacy after office visit and received another dose of MENACTRA in left arm. Patient had left arm pain/loss of grip.
He presented to the ED on 8/11/2021 for palpitations and upper abdominal pain. He was noted to be in SVT and received medication which converted him back to a normal sinus rhythm. CT scan was negative for PE. Remained in sinus rhythm and was able to be discharged back home with follow-up to see PCP.
Acute onset extreme lower left abdomen pain, but also entire abdomen, lasting for several hours, painful to the touch; Bloating; gas; Feels like I have a full bladder, but urinating does not relieve the pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 09:15 (Lot number: EP7533) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "endometriosis resulting in hysterectomy" (unspecified if ongoing); "bladder & bowel issues" (unspecified if ongoing); "bladder & bowel issues" (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA; BYSTOLIC; LINZESS; DULCOLAXO; GAS X. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer BioNTech, lot number=en6205, administration time=10:30 AM, vaccine location=Left arm, DOSE 1, SINGLE), administration date: 08Mar2021, when the patient was 50 years old, for COVID-19 immunization.  The following information was reported: ABDOMINAL PAIN (non-serious), outcome "not recovered", described as "Acute onset extreme lower left abdomen pain, but also entire abdomen, lasting for several hours, painful to the touch"; ABDOMINAL DISTENSION (non-serious), outcome "not recovered", described as "Bloating"; FLATULENCE (non-serious), outcome "not recovered", described as "gas"; BLADDER DISORDER (non-serious), outcome "not recovered", described as "Feels like I have a full bladder, but urinating does not relieve the pressure". The events "acute onset extreme lower left abdomen pain, but also entire abdomen, lasting for several hours, painful to the touch", "bloating", "gas" and "feels like i have a full bladder, but urinating does not relieve the pressure" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abdominal pain, abdominal distension, flatulence, bladder disorder.  Additional information: It was reported that the patient had already have bladder and gastrointestinal issues that she take medication for, but with both doses, this extreme and onset of pain was after the vaccination shot. The pain was severe and lasts several hours. It was reported that, the patient had no covid prior vaccination. The patient was not tested covid post vaccination. The patient received no other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021349025 same reporter/patient, different events/doses
Within a week of the vaccine dose, had extreme itchiness, headaches, aches and pains, typical vaccine symptoms. Had a video call with Dr. regarding the reaction, was prescribed Benadryl and Benadryl spray, relieved symptoms.
feels sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included patient was steroid dependence. The patient's concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunization. Per caller she was steroid dependent. When she feels sick, she was supposed to increase her steroid dose. Caller asked if she increased her steroid dose would it decrease the effectiveness of the Pfizer Covid 19 Vaccine? Caller stated "I'm sure it's just from the vaccine and I'm not sick". Outcome of the event was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies, concomitant medications were not reported. On 12-SEP-2002, the patient was vaccinated with the first dose of VAQTA, and then on 18-AUG-2003 the patient received the second dose (strength, dose, frequency, route and lot number were not reported). Additionally, the patient received extra 4 doses on 13-FEB-2007, on 01-FEB-2008, on 12-JUN-2012 and on 09-DEC-2013. No adverse effects were reported and no product quality complaint was reported. Additional information has been requested.
This is a spontaneous report received from a contactable consumer. A 70-year-old patient of an unspecified gender received PREVNAR 13, single dose for prevention of pneumonia and influenza vaccine at unknown dose for immunization both via an unspecified route of administration on an unspecified date. Medical history included 'high blood' from an unknown date and unknown if ongoing. There were no reported concomitant medications. On an unspecified date, the patient reported swelling and tightening in arm where they give the shot, described by the patient like tightening your neck. The patient did not mind as a Flu shot was administered in that evening and was eased with an icepack. The next morning, the patient reported that it was still hurting, aching and the patient had pain, red hot, swelling and cannot event raise the arm. The patient stated that redness was not at the injection suite but was previously at the top of where the vaccine was given and was going down to the elbow described as "big redness". The outcome of the events 'cannot even raise the arm' and 'tightening in arm where they give the shot' was recovered: patient reported can raise the arm and no more tightness; all other events were unknown.
Information has been received from a nurse, who was the patient's grandmother, concerning her 14 year old granddaughter who in November 2007, was vaccinated in the outer thigh with a first dose of GARDASIL. Sometime in November 2007, the patient developed swelling, redness and warmth that lasted for about a week. She was reported to have improved (date not specified). No further information is available.
Rash, hives, intense itching, redness, pain at injection site (R arm, pain traveling down R arm.
This spontaneous report as received from a registered nurse refers to a 4 year old male patient. On 12-MAR-2013 the patient was vaccinated with PROQUAD (lot number H015792, expiry date 24-FEB-2014) dose 2, 0.5 ml, subcutaneous. The first dose of the vaccination was on 13-SEP-2010. No adverse events were reported for that dose. On 17-MAR-2013 the patient experienced broke out with rash and pain. The patient was seen in a clinic and was prescribed oral steroid, only one dose given. The patient was also seen in physician's office shortly after and was tested for varicella with PCR testing (identified Varicella zoster, unsure of wild type or vaccine strain). The patient was prescribed with oral and topical valcyclovir (manufacturer unspecified), and MOTRIN (manufacturer unspecified) for relief of pain which was effective. The outcome of broke out with rash and pain was reported as recovering/resolving. Additional information has been requested.
Headache; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient developed "a not feeling well", followed by nausea, 102 fever, and vomiting. Still present at the time of writing this, 2 1/2 days later.
Systemic: Fever-Mild, Systemic: Lymph Node Swelling-Medium
Sore arm - 4 days after injection; Sore shoulder - 4 days after injection; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 11:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included diabetes. The patient did not had any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 19Apr2021, the patient had sore arm and shoulder 4 days after injection. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events sore arm  and shoulder  were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
idiopathic transverse myelitis; This is a literature report. This is a literature report based on a Health Authority database analysis.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 24Jan2021, outcome "recovering", described as "idiopathic transverse myelitis". Adverse event summary was reported as inability to walk. Bowel and urinary dysfunction. Left side numb from toes to breast and right side numb from toes to groin. Left leg weakness. Some recovery of sensation but ongoing bowel and urinary issues. Treated five days high dose steroids. Recovering. Diagnosed as idiopathic transverse myelitis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and close temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event Myelitis transverse. 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.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug/event and different patient;
Extensive papular confluent exanthum w/fever starting 9 days post vax;
1-28-13 rec'd Hep A vaccine. 1-29-13 woke up with chest congestion. 1-30-13 diarrhea. 1-31-13 crying, fever 101.4 gave TYLENOL q 4 hours. 2-1-13 fever broke. 2-2-13 hives (gave BENADRYL). 2-4-13 hives gone.
Information has been received from a pharmacist as reported by a physician concerning a patient with no reported medical history who "last year" in 2006 was vaccinated with pneumococcal 23v polysaccharide vaccine. The patient developed erythema and pain at injection site. The patient sought medical attention by having an exam in the office. No further details are available. Additional information has bee requested.
This spontaneous report as received from a pharmacist via company representative to two patients of unspecified demographics. Patients medical history was unspecified. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, frequency, lot number and expiry date were unspecified). Concomitant therapy was unspecified. On an unknown date (after receipt of ZOSTAVAX at a later, unspecified date), the patients developed herpes zoster. The representative reported that the pharmacist could not remember who the patients were at the time of this report. It was reported that VZV not offered to the pharmacist because these occurrences of herpes zoster occurred an unspecified period of time ago. No product quality complaint was involved. The outcome of event herpes zoster was reported as fully recovered (also reported as patients present status as unspecified). The reporters causality assessment for the event of herpes zoster with the therapy of ZOSTAVAX was not reported. No further information was available. Additional information has been requested.
Patient presented with erythema, pain redness and rash on the area where the vaccine was administered. She has been on panadol so doesn't  know if she has been on fever. Medical evaluation was recommended as soon as possible.
10 days after second Moderna boaster, itchy hives appear on neck, ear, back, arm, legs, buttocks. Similar to Dermatographia, but not raised skin. Took Zyrtec and helped all day, when worn out a night, used cortizone cream.
Developed shaking, shivering with pain around 1am after receiving flu shot at 6 pm night before. Symptoms lasted about 3 hours. Pain was headache.
This spontaneous report was received from a registered nurse, concerning a 19 year-old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA 25/0.5 (units not provided) (dose, frequency and route were not reported) lot # M036458 with expiration date of 02-MAR-2018, for prophylaxis.  No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
With 48 hours of vaccine administration had severe reaction to vaccine, fever of 104+, dizziness, headache, muscle aches, cough, and chest congestion. Unable to attend work on Friday 12/15/2006 which was the next day scheduled to work.
1 day post vax, pt developed nausea, vomiting, fever, headache, extreme local soreness/swelling. Resolved in 2 days.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. The first time occurred on 03/09/2021 for severe sepsis, tachypnea. The second time occurred on 3/22/2021 for Acute cystitis without hematuria.
difficulty breathing; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and DYSPNOEA (difficulty breathing) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (headache) and DYSPNOEA (difficulty breathing). At the time of the report, HEADACHE (headache) and DYSPNOEA (difficulty breathing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No adverse event occurred. Recipient had received an initial dose of Janssen, a Janssen booster, and then a second Janssen booster--which is not approved by the CDC.
extreme fatigue after first dose but it gradually improved; 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 FATIGUE (extreme fatigue after first dose but it gradually improved) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extreme fatigue after first dose but it gradually improved). At the time of the report, FATIGUE (extreme fatigue after first dose but it gradually improved) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants included. No Treatment mentioned.   This case was linked to MOD-2021-200705 (Patient Link).
This is a 31 year old who received her 6th anthrax vaccination on 08/05/2004. She states that she developed a large, red, warm swollen area approximately 15 cm, encompassing the majority of the circumference of her left arm, after receipt of this vaccination. She reports having developed a similar reaction following her 5th anthrax vaccination. In addition, she states that she has developed intermittent pain down the ulnar nerve pathway between her elbow and wrist of her left arm. She denies any numbness or tingling in the arm, or hand involvement.
For 36 hours patient had a warm arm, headache, chills, extreme head and neck pain. She took EXCEDRIN every 5 to 6 hours to treat. But didn't do much for her.
she has had health issues from the booster vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "cancer", start date: 2012 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer by- unknown, dose number - unknown, Primary immunization complete), for COVID-19 immunization.  The following information was reported: GENERAL SYMPTOM (non-serious), outcome "unknown", described as "she has had health issues from the booster vaccine".  Additional information: It was reported that, caller states she had the Pfizer COVID 19 Vaccine "shot" and her booster was in Oct. She states she has had health issues from the booster vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Puffy eyes, erythema multiforme (no mucosal involvement, no trouble breathing).  Treated with epinephrine in the ER several times, oral Prednisone, Benadryl, dexamethasone.  Symptoms occurred 6 days after vaccine and the rash lasted about 4 days then resolved.
Two days after injection: dizziness & nausea (vertigo). Persists to current time (2.5 days later).
Syncopal episode. Patient started feeling nauseous a minute or two after vaccination. She turned red and then passed out while sitting.  She was unconscious for maybe 10 seconds then started coming around. While unconscious her arms went very stiff and jerked twice. When she was awake she was very pale and sweaty.  She complained of blurry vision, nausea, and tingling heavy arms. We gave her some cold water and a cold compress for her head an had her lie down for a few minutes until she felt better. The whole episode lasted about 20 minutes.  She was instructed to follow-up with her PCP.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored oral ROTATEQ (lot#, dose# and dose unspecified) via oral route. No adverse symptoms reported. No product quality complaint was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Administered Pneumonia vaccine in L deltoid.  Upper left arm red, swollen and painful.
Very dry eyes - developed watery eyes of a puss like fluid that made eyes stick - enlarged throat.  Heaviness in chest with congestion.  Face swelling and puffiness with red eyes by morning.  Still have puffy face and red eyes.