chrisvoncsefalvay/vaers-outcomes huggingface dataset:
aches and pains; chills; tiredness; under arm swelling/swelling under her arm like the size of an orange/saw on the papers that swollen lymph nodes were a side effect; dull ache under her arm; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021, NDC number was unknown), via an unspecified route of administration, administered in left arm on 14Feb2021 at 13:00 hours as dose 2, single (at the age of 47-years-old) for COVID-19 immunisation. Medical history included diabetes from 2011 to an unknown date, high blood pressure (caused by birth control taken at age 24, unable to provide the name, NDC, Lot or Expiry) from an unknown date and unknown if ongoing and thyroid cancer (has half of a thyroid) from 2011 to an unknown date. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262; Expiration Date: 31May2021), via an unspecified route of administration, administered in left arm on 24Jan2021 as dose 1, single (at the age of 47-years-old) for COVID-19 immunisation. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect. Patient received no additional vaccines administered on same date of the Pfizer suspect. Patient stated that she takes a lot of daily medications/concomitant medications but declines to provide details. On 15Feb2021, patient experienced aches and pains, chills and tiredness, under her arm was huge, it was like the size of an orange. Patient saw on the papers that swollen lymph nodes were a side effect. Patient had a dull ache under her arm which caused her to look at her arm. It had not gotten any smaller. Patient saw her doctor yesterday (15Feb2021) for a blood pressure check. The doctor checked her blood pressure on the same arm, and it was not swollen. Patient does not know if that may have something to do with it. Patient feels well rested today (16Feb2021). Patient asked what she should do, was there any treatment recommendations and how long will it last. Patient had no emergency room and physician office visit for the events. No relevant tests were performed for the events. The outcome of chills was recovered on 15Feb2021, tiredness and aches and pains was recovered on 16Feb2021, unknown for under arm swelling/swelling under her arm like the size of an orange/saw on the papers that swollen lymph nodes were a side effect and dull ache under her arm.   Follow-up attempts completed. No further information expected.
Information has been received from a registered nurse concerning a patient who was vaccinated SC with a 0.5ml first dose of varicella virus vaccine live.  Subsequently, 10 days after being vaccinated, the patient developed a rash.  It was noted that the patient received a letter from the old doctor's office where the vaccine was administered stating that the patient may have received "subpotent vaccine".  Unspecified medical attention was sought.  No laboratory diagnostic studies were performed.  Subsequently, the patient recovered from the rash.  There was no product quality compliant.  No further information is expected.
Pfizer 2nd dose- LOT: ER8732- itching, hives face and arms- No SOB- able to swallow ok- took benadryl prior to coming and took second benadryl at 1030 (pts own)- came inside for monitoring instead of waiting in the car- bloos pressure 160/90- has asthma also took AM inhaler- states does not normally need rescue inhaler and did not bring to vaccine appointment- continue to monitor at 11am pt felt improved- itching and cough improved. No facial redness. No difficulty breathing or swallowing- pt wanted to go home and left clinic.
idiopathic urticaria; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adolescent male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, 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: IDIOPATHIC URTICARIA (non-serious), outcome "unknown".  Additional information: Teen had idiopathic urticaria. Patient had a COVID vaccine a few months prior. Not sure if related. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
INJECTION SITE PAIN IT WAS LIKE A MUSCLE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included active chemo therapy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) once a total dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced injection site pain it was like a muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain it was like a muscle pain. This report was non-serious.
Technician gave patient his first covid pfizer shot. Patient went back to prescription waiting area and technician observed that he was laying flat on the floor for a few minutes. At this time, technician notified pharmacist. The pharmacist quickly ran to patient to make sure that he was alright. Patient was advised to sit on the chair and given cold water to drink. We also gave him saltines as well as orange juice. We observed the patient for more than 30 minutes in the pharmacy waiting area. At this time, the patient informed us that he felt well and left on his own accord. We advised patient to contact his primary care physician and let them know what happened. Pharmacist will follow up by calling patient prior to closing pharmacy.
Weakness/headache 1 day (24hrs after injection). Temp: 98.2. Medication: Vicodin. Shortness of breath, wheezing, cough 1 week after injection. Medication: NyQuil. Asthma, bronchitis diagnosed on 3/3/02. 17 emergency room visits since injection. The ER record and discharge summary received on 1/6/04 confirms diagnosis of acute dyspnea, asthma and bronchitis. Other diagnoses were acute cephalgia and generalized weakness.
Chest heaviness; like someone was stepping on her chest/feel like someone is on her chest; hard to breath; headache; had chills; Feel lousy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel lousy), PAIN IN EXTREMITY (Sore arm), CHEST DISCOMFORT (Chest heaviness), CHEST DISCOMFORT (like someone was stepping on her chest/feel like someone is on her chest) and DYSPNOEA (hard to breath) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Overweight and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MALAISE (Feel lousy), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and CHILLS (had chills). On 30-Apr-2021, the patient experienced CHEST DISCOMFORT (Chest heaviness), CHEST DISCOMFORT (like someone was stepping on her chest/feel like someone is on her chest) and DYSPNOEA (hard to breath). At the time of the report, MALAISE (Feel lousy), PAIN IN EXTREMITY (Sore arm), CHEST DISCOMFORT (Chest heaviness), CHEST DISCOMFORT (like someone was stepping on her chest/feel like someone is on her chest), DYSPNOEA (hard to breath), HEADACHE (headache) and CHILLS (had chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Full blood count: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was not provided.
Fever, Chills, Extreme fatigue, Joint/Muscle pain, felt like I could not move, headache, foggy feeling all up until about 6:45 pm the next day
swelling of the left armpit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling of the left armpit) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWELLING (swelling of the left armpit). At the time of the report, SWELLING (swelling of the left armpit) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Patient came back to the pharmacy the next day after receiving the shots, She preceived adverse reactions from the immunization.
p/vax pt w/pain in rt upper arm & deltoid insertion 3-4" distal to immun site;local heat advised;referred to orthopedic MD;rt shoulder pain questionable r/t flu vax;lab work pending;
Pain in muscle, loss of control of muscles, difficulty breathing, excessive swelling , headache, nausea
Case number PHEH2015US020303, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 24 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) 0.5 ml intramuscularly on 07 Oct 2015. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that was stored out of temperature range at 47 Fahrenheit before administration. No adverse event was reported following the medication error.
Vaccine administered Wednesday 8/18/21. Patient reports he was fine on Wednesday. Thursday, he started to notice his right eye was dry but was tearing in order to rewet the eye. He was also experiencing coryza in his right nostril. Friday, he reported experiencing some pain towards the back of his head behind his ears and near his neck. On Saturday, he reported a little HA throughout the day, and still with coryza and tearing/dryness in the right eye. By Saturday PM, he was still feeling ill with HA. He went to a facility and was tested for COVID; resulted negative and was diagnosed with allergies and was told to take antihistamines. He went home, did not take any meds. Sunday, he still had a HA and coryza. He called out of work for Monday. Upon awakening and drinking some orange juice, he spilled some orange juice on himself. His wife asked him if he was ok, to which he replied yes. His wife then alerted him that he was possibly having a stroke, and that his face was drooping on the right side. He and his wife rushed to ED where he was diagnosed with Bell?s Palsy and was told that it was likely due to his recent vaccination. He was referred to neurology who then ordered an MRi and physical therapy. He was told that his droop will probably resolve in 30-60 days depending on therapy but that it is likely temporary.
Patient starting feeling flushed ~10 mins after vaccine. Her BP remained in the 160's/90's and HR 80-90. She felt better after drinking some water.
Myocarditis: The patient presented to the emergency department with pleuritic, positional, non-radiating, non-exertional, chest pain and an elevated blood pressure reading at home. Labs were notable for elevated ESR, CRP, as well as elevated troponins which increased and then trended back down (0.076 -- > 0.109 -- > 0.105 -- > 0.088). EKG was negative for acute ischemic changes. The patient was admitted to the hospital. TTE was notable for LVEF 61% with normal RV function without significant valvular disease and no pericardial effusion. Cardiac MRI was notable for myocardial edema and inflammation with findings overall consistent with acute myocarditis without pericarditis. Patient was initially treated with prednisone 40 mg daily. Cardiology was consulted who recommended stopping the increased prednisone. Etiology of myocarditis remained unclear; given onset after second Pfizer mRNA vaccine, it was considered whether it might be a reaction to the vaccine. The patient was recommended to avoid NSAIDS, extensive exercise, and alcohol, follow-up with outpatient Cardiology.   The patient has now been seen in follow up - his chest pain has resolved, blood pressure normalized, and repeat cardiac MRI shows stable to improved myocarditis (6/3/21 cardiac MRI read: "1.  Overall, compared to prior CMR from 4/12/21, the findings are similar. The pattern and extent of LGE is unchanged. 2.  Normal left ventricular size and function. Moderate concentric hypertrophy, with the thickest segment measuring 18mm at the mid inferoseptum. Diffuse midmyocardial LGE  with mildly elevated myocardial T2 suggestive of mild inflammation. The differential for these findings include 1) resolving myocarditis in the setting of a preexisting nonischemic cardiomyopathy, most likely underlying hypertrophic cardiomyopathy, 2) amyloidosis given the diffuse pattern of delayed enhancement and moderate hypertrophy (although the pattern of LGE and lack of atrial enlargement is unusual), and 3) resolving myocarditis in the context of underlying hypertensive cardiomyopathy.  3.  Normal right ventricular size and function.")
pt had a sz while walking home from school;curled into fetal position, non responsive;became combative in amb;postictal;h/a w/nausea;
Patient had reaction to DTAP.  Diffuse Erythema mild to moderate.  Induration diffusely, mild to moderate, increased warmth, diffusely.  Minimally tender, no pint of fluotuance, prurulence, or localized.  Nydus 15cm x 9cm area upper later right buttocks and toward right hip.  Doctor prescribed Pediapred, tapering dose.  Mom reported on 09/15, reaction was resolved.
pt came in with redness, swelling, warm to touch injection site and extreme soreness.. recommended cold compress and nsaid along with benadryl and to come back tomorrow
pt describes pain and inflammation post 2nd and final dose of Shingrix IM administration per pt, resulting in needing surgery/PT, decreased range of motion.
Took pt to doctor on 10/14/02 for check up and to get scripts for services for school. While there they said he needed a TD shot. They gave it to him. The next day the school called and said he was pacing back and forth saying the same phrase over and over -they had never seen before-the next day after this he was raging by the weekend we at home had notice he was flapping and by Sunday he had developed a what I think is a vocal tic, and yesterday the 23rd he has developed insomnia. These things tend to happen late at night or when he may be under stress but hav never happened before.
Sore throat, fatigue, heart inflammation, diarrhea, vomiting and dehydration along with blisters forming in my hands.
EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme fatigue was not reported. This report was non-serious.
had a side effect of a rash; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. Medical history included allergic to Nickel and allergic to Gold. The patient's concomitant medications were not reported. The patient previously took Bactrim and experienced drug allergy. On an unspecified date, after the vaccination she had a side effect of a rash. Caller asking if this was because she is allergic to bactrim, nickel and gold. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nurse gave an expired vaccine to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E525, expiry date 21st June 2022) for prophylaxis.   On 28th June 2022, the patient received Boostrix. On 28th June 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: On 28th June 2022, a nurse gave a Boostrix vaccine to adult patient. The reporter consented to follow up via email. Additional Supportive Information: The patient was administered an expired dose of Boostrix vaccine, which led to expired vaccine used.
Information has been received from a pharmacist concerning an approximately 77 year old female patient with sulfur allergy, who, in approximately October 2008 (4 years ago), was vaccinated with a dose of PNEUMOVAX23 ("pneumonia vaccine", dose route and lot # not reported). It was reported that in approximately October 2008, after the vaccination, the patient had an anaphylactic reaction. The pharmacist stated the client's throat closed after getting the pneumonia vaccine. The patient then went to a hospital (unspecified if hospitalized) and was treated with BENADRYL. The patient then (4 years ago, in 2008) got hives from BENADRYL. The patient recovered from anaphylaxis and hives on an unspecified date. The reporter felt that anaphylactic reaction was related to the vaccination with PNEUMOVAX23. Anaphylactic reaction and hives were considered immediately life-threatening by the reporting pharmacist. Additional information is not expected.
Shooting pain up her arm, neck and head; Shooting pain up her arm, neck and head; Her eye area was still very itchy, both inside her eye and around it; Sometimes her forehead and head with itch; Shooting pain up her arm, neck and head; Fever of 100.8; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Shooting pain up her arm, neck and head), NECK PAIN (Shooting pain up her arm, neck and head), EYE PRURITUS (Her eye area was still very itchy, both inside her eye and around it), PRURITUS (Sometimes her forehead and head with itch) and HEADACHE (Shooting pain up her arm, neck and head) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021 at 2:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever of 100.8). On an unknown date, the patient experienced PAIN IN EXTREMITY (Shooting pain up her arm, neck and head), NECK PAIN (Shooting pain up her arm, neck and head), EYE PRURITUS (Her eye area was still very itchy, both inside her eye and around it), PRURITUS (Sometimes her forehead and head with itch) and HEADACHE (Shooting pain up her arm, neck and head). At the time of the report, PAIN IN EXTREMITY (Shooting pain up her arm, neck and head), NECK PAIN (Shooting pain up her arm, neck and head), EYE PRURITUS (Her eye area was still very itchy, both inside her eye and around it), PRURITUS (Sometimes her forehead and head with itch), HEADACHE (Shooting pain up her arm, neck and head) and PYREXIA (Fever of 100.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Body temperature: 100.8 (High) A fever of 100.8 was reported.. On 26-May-2021, Heart rate: 110 (High) A rapid heart beat of 110 beats/min was reported..         No concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD-2021-250985 (Patient Link).
Started feeling tinnitus, lightheadedness, blue lips, blurry vision, fainting. All occurred in less than 5 minutes. Gained consciousness in less than a minute. Blood pressure and oxygenation were monitored after fainting spell. Blood pressure remained low for about an hour after incident.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Nauseous, sight where shot was given is swollen several times the normal size, feels as if it is going to burst open from the skin being stretched so much, severe pain in the sight, it is now 11/2/2010, and the swelling and pain is getting worse.
Information has been received from a physician concerning an adult female pt, who was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine. The physician reported the pt developed an inflamed injection site reaction, and swelling to the elbow. The adverse event resolved within 48-72 hours and no treatment was necessary. No other information is available. There was no product quality complaint reported. The pt recovered from the adverse events, inflamed injection site reaction and swelling to the elbow. Unspecified medical attention was sought. Additional information has been requested. The reporter also mentioned another pt who had a similar experience following vaccination with the pneumococcal 23v polysaccharide vaccine (WAES # 0312USA00001).