chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-OCT-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Pt instructed to wait 15mins. During that time started getting warm all over - furry taste in mouth, headache. 9/21/09 p/c to f/u. Pt stats she is feeling fine.
Facility where I received vaccine but seen at Community Hospital for side effects. 1 hr. after: sore left arm shot site, fatigue, chills/no fever, sore muscles, blurry vision. 3 days after: face swelling/numbness 4 days after :  left shoulder numb/sore 5 days: part of  right hand numb.  Vision blur, right hand and face numbness still on day 10 - has not yet resolved.
Had strong flu-like symptoms for 36 hrs after receiving the vaccine which included a 101 degree fever, bad muscle aches, and headache.  Felt worse than when I actually had Covid-19.
(1) macular lesions with scornt surrounding erythema-very pruritic on neck, face, shoulders, hands, abd, pelvic, torso, back. (2) also-6 cm x 4 cm raised red, hot, hard indurance at site of vaccine
extreme pain in right arm, swelling and heat at injection site/ redness, body feels like pins and needles, stomach pain, nausea.
arm pain; when needle came out of arm felt coldness or fluid running down my arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (when needle came out of arm felt coldness or fluid running down my arm) and PAIN IN EXTREMITY (arm pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING COLD (when needle came out of arm felt coldness or fluid running down my arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, FEELING COLD (when needle came out of arm felt coldness or fluid running down my arm) had not resolved and PAIN IN EXTREMITY (arm pain) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.    This case was linked to MOD21-033798 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Follow up received included No new Information.; Reporter's Comments: This case concerns a 72-year-old female who experienced nonserious unexpected events of ARM PAIN and FEELING COLD described as "coldness or fluid running down her arm". The ARM PAIN occurred with first dose mRNA-1273 and FEELING COLD occurred the same day as second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Following my vaccines, I have been formally diagnosed with peripheral ulcerative keratitis (February 2021)  and a small parotid cyst (June 2021.)  Blood test from March 3, 2021 showed a positive  ANA panel. Vectra blood test from April 22, 2021 scored in the moderate range for inflammation. Other bloodwork has been unremarkable, aside from a drop in vitamin d from the March bloodwork to bloodwork in May.
Tingling in (L) hand, (L) arm, & (L) side of face. Has some numbness as well.
swelling on the right arm where he got the injection; Migraine/he is experiencing pain specifically a migraine headache; This is a spontaneous report from a contactable pharmacist. A 47-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, strength: 0.5 ml, lot number: AG8353, expiration date: Jun2021), intramuscularly into right arm on an unspecified date at 0.5 ml, single for prevention. Medical history included diabetes, high blood pressure, and obese from an unknown date and unknown if ongoing. Concomitant medication included insulin human, insulin human injection, isophane (HUMULIN) 75 to 80 units twice a day for diabetes, insulin lispro (HUMALOG) 75 to 80 units twice a day for diabetes. The patient was given the vaccine a couple days ago and he was experienced swelling on the right arm where he got the injection in Jan2020 and he was experiencing pain specifically a migraine headache in Jan2020. With the patient's right arm swelling, at first time it was small and then in the last couple of days it was growing then the symptoms started a couple days ago. Both events were reported as serious per medically significant. The outcome of the events was not resolved.; Sender's Comments: Based on the information currently provided, the vaccination with PREVNAR 13 in triggering the onset of vaccination site swelling and migraine headache cannot be fully excluded.  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.
NauseaVomiting Itchy Throat/Hyperventilating Narrative:
reported the patient fell while ice skating with her "arms out-stretched; tender to touch but is not warm to touch; 1 inch by 1 inch seroma at the injection site; Medical Assistant reported the patient developed a walnut size swelling at the injection site.; soreness at the injection site for a few days / tender to touch but is not warm to touch; lump/mass/spot; This spontaneous report was received from a medical assistant and the physician, referring to a female patient of unknown age. Her concomitant medications included terbinafine hydrochloride (LAMISIL). The patient did not have any pertinent medical history, drug reactions or allergies.  On 01-AUG-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly in the lateral deltoid (exact dose dose and anatomical location were unknown) (lot # R017624 has been verified to be a valid lot number, expiration date 17-MAR-2021) to finish the dosing schedule. On an unknown date in August 2019, the patient fell with her arms out-stretched while ice skating. On an unknown date in August 2019, after the fall, the patient noted swelling at the injection site (also reported as walnut size swelling at the injection site). The patient sought medical attention and was seen by the physician, however she did not receive any treatment and had no lab diagnostics or studies performed. The physician informed that the patient developed 1 inch by 1 inch seroma at the injection site. According to the reporter the area was tender to touch, but it was not warm to touch and it seemed to be getting smaller. It was reported, that on an unspecified date, the patient would have an ultrasound performed.  The outcome of the events soreness at the injection site, area tender to touch and fall was unknown. The outcome of the other events was recovering. The causality assessment was not provided.  Follow up information has been received form the reporting physician on 04-SEP-2019, regarding the patient.  According to the physician, on 30-AUG-2019, the patient was doing fine and the spot went down.  On 04-SEP-2019, the physician contacted the patient and the mass was completely gone.
Inflammation erythema at injection site. 4 1/2 x 2 cm after injection. Noted red welts next day. Seen 11/14/05 diagnose with erythema
patinet was given Covid 19 vaccine first dosage. Minutes after she started to experience a tingling sensation on her face, arm and feet. Patient was brought to the infirmary where she laid down . Virtals signs were taken  BP 119/86. HR 100, RR 20 Sat 100% RA.  MD at the bedside. Zyrtec 10 mg PO given to patient. We will continue to monitor patient.
Fatigue. Pain in the arm. Itching. Localized swelling. Localized redness and rash.
Heart rate increase Blood Pressure increase  Chills Fever Headache Body Ache Tight Chest  Lethargy Weakness
body cramps/spasms for 3 days . Cramping muscles were, arms, fingers, back, abdomen, thighs, calves, etc.
Beginning 8/5/02, developed fever and pain upper left arm. As time progressed, pain became intense left shoulder, aslo left elbow, wrist and hand, accompanied by swelling. Pain not relieved with 2-3 800mg Ibuprofen at a time. Movement causes intense pain. She applied sling to immobilize arm. Took Darucet at bedtime 8/8/02 so she could sleep and fever broke thorugh night. Did not take temp. Rash left deltoid 8/10/02. 8/13/02 still swollen, improved but limited mobility. 8/13/02 improved.
Consistent fever- high throughout Thursday night, only broke with Tylenol. Fever free beginning Saturday at 12:00 pm without medication.
extremely ill/horribly ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Having covid three times" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "extremely ill/horribly ill". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "extremely ill/horribly ill". Additional information: Having covid three times was a better reaction than she had to having the covid vaccine times two and one booster. The patient stated the covid vaccine made her extremely ill and she was having long-term covid effects. The covid vaccine times two and the booster times one made her horribly ill.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300175426 same patient, drug and event with different dose;US-PFIZER INC-202300340351 same patient, drug and event with different dose;
Information has been received from a registered nurse concerning a 18 year old female patient with no medical history and no drug allergies  who, on 30-Nov-2007 at 13:40 was vaccinated IM in the left deltoid with a 0.5 mL third dose of GARDASIL (Lot # 658490/0820U). There were no illnesses at the time of the vacination. On 30-Nov-2007, 20 minutes post vaccination at 14:05 the patient felt dizzy while standing at the check out window and immediatley fainted and hit her head against the hallway wall. The patient was bleeding profusely from a head laceration. First aid was performed and the patient was sent to the emergency room via emergency medical service "EMS." The patient recovered on an unspecified date.No further information was provided. Outcome was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008.
arm pain; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and VACCINATION SITE SWELLING (swelling at injection site) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, PAIN IN EXTREMITY (arm pain) had resolved and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included ibuprofen.   Reporter did not allow further contact
lost hearing of the right ear; ear infection; sinus infection; couple of hours later she started hearing like a buzzing sound, hollow sound; she couldn't hear very well; This is a spontaneous report from a contactable consumer. This consumer reported for a 51-year-old female patient (Reporter's sister-in-law) that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL3247;solution for injection), dose 1 via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Patient's age was 52 years old at the time of vaccination with weight 76.644 kg, height; 154.94 cm. Patient's medical history included diabetes. Patient's concomitant medications included Metformin at 1000 mg for diabetes, Lisinopril at 10 mg for blood pressure, Insulin at 100 units, Atorvastatin at 40 mg (therapy dates unspecified). Reporter stated, "This is regarding my sister-in-law, it's in regards to, I had called few weeks ago and they had told me to call back I need to know who do I speak to as I need to send some paper work. She had a reaction to the Covid injection and I have all the paper work here. They told me that we needed to send also that they are going to try and see how she can get compensated back because she had to go to the hospital, she had to go to the  clinic twice, she had to see specialist and things like that." Reporter stated, "On 29Jan2021 (Later corrected), she got it done at work and couple of hours later she started hearing like a buzzing sound, she end up she couldn't hear very well and then the next day she (word incomprehensible) out of her right ear. It's been like the longest time. Pfizer EL3247." Treatment: Reporter stated, "Well she went to the clinic twice although she had, one doctor said she had sinus infection the other doctor said she had ear infection. So, she went to a specialist ENT and he said she had none of those infections. He did put her on Prednisone because she lost hearing of the right ear so, he gave her 10 mg of Prednisone, gave 6 tablets 5, 4, 3 like that." She did not take the 2nd vaccine. She had loss of hearing, a buzzing sound, hollow sound, still has loss of hearing in right ear. Reporter was provided with the number of Pfizer Medical Information as # and was requested to select option 3, timings as 8 am to 8 pm Monday to Sunday as per (EST). Investigation assessment; no. The outcome of events was not recovered for lost hearing of the right ear and for other events were unknown.
ISSUES PARTLY BECAUSE OF THE VACCINE; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported.  On an unspecified date, the patient experienced issues partly because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of issues partly because of the vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211009810.
Patient called 3/3 stating she received her second dose of the pfizer covid vaccine about 1 week ago and had a reaction. She states that her arm is better, but thought she should call and report. She states that the day after receiving her vaccine her arm developed a hard lump about the size of a quarter that felt like a hive. She reports that it was itchy and hot to the touch. It then increased to 50 cent size and got as large as a golf ball.
Information has been received concerning a pt who on 12/09/97 was vaccinated with her first dose of varicella vaccine. On 06/12/00 the pt developed classic varicella with teardrop lesion, erythematous base and differing stages of healing. Follow up information received on 08/23/00 indicated the pt recovered.
Diarrhea; Chills; Headache; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle ache). At the time of the report, DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle ache) outcome was unknown.            No concomitant medications were provided. No treatment medications were taken by the patient.
Injection site red, hard to the touch the size of a large he marble, itchy, and tender.  7 days after first dose
Slurred speech at 3am on 20Jan2021. Emergency room doctor diagnosed TIA at 7am.  Discharged but symptoms returned at 10am. HCP transferred me to hospital for possible Stroke. I was admitted to the hospital on 1/20/2021 at 2pm. MRI indicated that I had a stroke.
This spontaneous report as received from a other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # K009506, L023936 and K012457 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA002370: US-009507513-1708USA002371: US-009507513-1708USA002372: US-009507513-1708USA002373: US-009507513-1708USA002369.
MULTIPLE MOUTH ULCERS; This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-JAN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. Age at time of vaccination 44 years old. No concomitant medications were reported. On an unspecified date, the patient experienced multiple mouth ulcers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient had not recovered from multiple mouth ulcers. This report was non-serious.
This spontaneous report was received from a physician refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses (temperature excursion: 49.94 F, time frame: 15 minutes, unspecified date in October 2015) of ROTATEQ with lot/batch # K011562, expiry date 08-APR-2017 and lot/batch # J010265, expiry date 05-MAY-2017 (dose, dose number, vaccination site and route of administration not provided). There was no previous temperature excursion. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the several reports from same reporter link. Additional information has been requested.
11pm I began to feel dizzy.  Throughout the night started with chills, fever, sweating,  headache,  sore muscles,  back ache,  swollen left arm.
burning hives on back of neck...was not sure if resulted from vaccination but did not notice the rash before.
Pt recvd vax 18NOV92 & 24 to 36 hrs following inject pt exp general achy flu-like sx but no joint pain or fever; THis resolved p/36 hrs; No further details were provided;
The day after the vaccine, experienced extreme pain in my right shoulder which severely limited my range of motion. I had a torn rotator cuff before which this exacerbated. I went to the doctor on 4/15 and was given pain medication but it has resolved.
Parent reports he noticed redness and swelling on the patient's right thigh upon awakening on 12/12/2009. Upon evaluation the doctor observed an approximately 2cm induration with 3-4cm erythema and swelling of right thigh.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 18-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N017698, expiration date: 09-JUN-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.