chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency, and route of administration were unspecified) for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown). no adverse effects were reported. The lot number for the vaccines were as follows: M033910 (expiration date: 17-OCT-2017), N014942 (expiration date was unspecified) and lot# reported as M105925 (expiration date was unspecified). It was reported that there were multiple unspecified excursions since February 2016, and that it was found because of a digital data logger. No product quality complaint was involved.  Lot# M105925 was verified to be an invalid lot number for ZOSTAVAX.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age, race & ethinicity. 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) (1 Total) 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. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and the patient was fully vaccinated along with his wife and both got covid (suspected covid-19 infection), and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was associated with Product Quality Complaint-90000190997. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210859063.; Sender's Comments: V0: 20210852596-Covid-19 vaccine ad26.cov2.-Suspected Clinical Vaccine Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. 20210852596-Covid-19 vaccine ad26.cov2.s-Suspected Covid 19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
About 1 1/2 hours after the vaccine, I began to have bad waves of nausea. In three hours I was vomiting. Took Zofran for that.  Sore arm, swelling, chills, bad body aches, low grade fever? Next day, dizzy and nauseated (little bit vomiting).  Third day, I am feeling fine. Would do it again!!! Don't want the virus!
This case meets criteria for vaccine breakthrough review. Tested positive at care facility, early November, unknown exact date as of this report.  SxS SOB, malaise, body aches, headaches, chest pain, vomiting.
patient was supposed to get the Pfizer COVID-19 vaccine Adult dose booster but she was given the Pediatric COVID-19 vaccine by mistake
Face gets red and hot on right side every night. I had ankle surgery in March and it's still healing but now my joint has become very stiff and it hurts to walk.; Face gets red and hot on right side every night. I had ankle surgery in March and its still healing but now my joint has become very stiff and it hurts to walk.; Face gets red and hot on right side every night. I had ankle surgery in March and its still healing but now my joint has become very stiff and it hurts to walk.; Face gets red and hot on right side every night. I had ankle surgery in March and its still healing but now my joint has become very stiff and it hurts to walk.; This is a spontaneous report from a contactable healthcare professional, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 12:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included joint surgery (right ankle surgery), attention deficit-hyperactivity disorder (ADHD) and anxiety. The patient did not have any known allergies to food, medications or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), gabapentin (MANUFACTURER UNKNOWN), vitamin b nos (B-COMPLEX) and multivitamin (MANUFACTURER UNKNOWN); all for unknown indication and start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 21:00, the patient experienced face got red and hot on right side every night. She had ankle surgery in March and it was still healing but then her joint had become very stiff and it hurts to walk. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the events face got red, hot on right side, joint had become very stiff and hurts to walk were not recovered at the time of this report.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Patient developed fluid overload in her heart and lungs that evening, as well as severe range blood pressures. Was diagnosed with preeclampsia with severe features
Employee (patient) was sitting talking and then stated her arm felt numb/heavy, donor lifted arm in lap.  Employee proceeded to stand up and held on to exam table and stated she felt dizzy.  She then laid on her right side and had moments of confusion and then moments of clarity.  She also had a twitch, when additional staff was called in, employee was alert and stated could she go home.  Then employee was having trouble sitting up. BP was 140/88 and pulse 94.  Employee then laid back down and had slow speech and would occasionally stare off.  Employee then called a family member to come pick her up from work, she was also smiling/laughing intermittently. She also stated she had only had coffee today.  She also said she had only approx. 4 hours of sleep. BP was checked again and it was  142/84 pulse 90.  Employee at times seemed dazed/confused or had delayed reaction. Employee laid back down and was talking normal for approx. 5-10 mins and then she began staring off again.  Family member arrived and she left approx. 0940 am.
Swelling; redness; heat; itchiness; Anxiety; sporadic sharp pulsating pain; This case was reported by a other health professional via sales rep and described the occurrence of anxiety in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2022, the patient received the 1st dose of Shingrix. On 31st March 2022, 4 hrs after receiving Shingrix, the patient experienced anxiety and pain. In April 2022, the patient experienced swelling, erythema, feeling of warmth and pruritus. On an unknown date, the outcome of the anxiety, pain, swelling, erythema, feeling of warmth and pruritus were unknown.   It was unknown if the reporter considered the anxiety, pain, swelling, erythema, feeling of warmth and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's Comment: The reporter was office manager. The patient experienced anxiety 4 hours after vaccine administration, sporadic sharp pulsating pain over the course of a day.  The patient had swelling, redness, heat and itchiness reported 4 days after vaccination.
Dizziness immediately following injection. Sat to rest then ate after returning home. Severity of dizziness improved but still felt dizzy during the day. Also felt sore in all/ injection site soreness
LIPS SWELLED UP AFTER 35 MIN , NEXT MORNING  HEADACHE , BODY ACE AND ARM  VERY SORE , LIPS STILL SWOLLEN BUT NOT AS MUCH
Vx given subcutaneous instead of intramuscular; Sleepy; Redness at injection site; Swelling at injection site; Heat at injection site; This case was reported by a physician via call center representative and described the occurrence of sleepiness in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 18th October 2021, the patient received Menveo (subcutaneous). In October 2021, less than a week after receiving Menveo, the patient experienced sleepiness, injection site erythema, injection site swelling and injection site warmth. On 18th October 2021, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the sleepiness was recovered/resolved and the outcome of the injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the sleepiness, injection site erythema, injection site swelling and injection site warmth to be related to Menveo.  Additional details were provided as follows: The patient received dose of Menveo vaccine in the right arm. The reporter stated that, the medical assistant in the office inadvertently gave Menveo vaccine to the patient subcutaneously instead of intramuscular, which led to intramuscular formulation administered by other route.
Warmth came over my body.  Red blotches on both arms, intense itching all over my body. Slight headache.
Groggy/sleepy; mild cognitive impairment; mild unsteady gait; light headed; malaise; tired; This is a spontaneous report from a contactable other health professional (patient). A 55-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EJ1685), intramuscularly on 22Dec2020 06:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Rheumatoid arthritis, hypothyroid and remission of DM2, known allergies: Penicillin. Concomitant medication included arginine hydrochloride, ascorbic acid, calcium, calcium pantothenate, cyanocobalamin, ferrous fumarate, folic acid, magnesium, methionine, nicotinic acid, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, triticum aestivum, zinc (MULTI VITAMIN), methotrexate, thyroid, sertraline. The patient previously took tramadol and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. The patient experienced Groggy, mild cognitive impairment, mild unsteady gait, light headed, malaise, tired, sleepy on 22Dec2020 11:00 AM. No treatment was received for all events. The patient underwent lab tests and procedures which included covid test: negative on 21Dec2020 (Nasal Swab). The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
87y.o. year old female with a PMH of  HTN, HLD, and hypothyroidism presented on 8//4/2022 with chills, cough, SOB. Patient's X-ray on admission was concerning for PNA. She was treated with rocephin and zithromax. She tested negative twice for COVID on admission. The patient underwent left thoracic  decortication, VATS on 8/16/2022 for parapneumonic effusion. Chest tube was removed on 8/25/2022.  The patient tested positive for COVID-19 on 8/29/2022. CT values revealed: E-value 39.6 and N2 42.6. WBC 12.5. The patient is afebrile. SpO2 94%. Repeat chest x-ray was ordered.
04/05/2022 I started feeling nervous, anxious and was worrying. I was very irritable. I lost all motivation and became depressed. I was having trouble sleeping. I spoke with my doctor, and they gave me an appointment with a therapist which I began seeing. I started taking medicine in June. I feel a little bit better, but feel I need my medication increased. I am sleeping a little better now.
Initial and follow up information has been received from a physician and a 78 yr old retired white male with medically controlled hypertension who on 29Oct04 at approx 1300 was vaccinated IM in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot649914/0578P). Concomitant medication included amlodipine besylate (Norvasc) and hydrochlorothiazide (+) losartan potassium for hypertension. There was no illness at the time of vaccination. AT the time of vaccination the pt developed a slight burning sensation which was unremarkable. At approx 1600 the pt developed a very painful feeling at the site of vaccination and when he massaged the area he noticed that his arm was swollen from his shoulder to the elbow and was itchy. The pain and swelling persisted for many days. The pt reported that it was now more than 2 months since his immunization and he still felt an abnormal tightness at the injection site. Sometimes it was accompanied by an intense flash of pain down his arm to a point below his elbow; as if it is following a nerve track. The pt wondered whether the injection accidentally hit a nerve. Unspecified medical attention was sought. The pt took tramadol hydrochloride (Ultram) to help sleep after vaccination. The pt noted that he had at least two previous vaccinations of pneumococcal 23v polysaccharide vaccine (one about 7 yrs ago) without any remarkable response. He also noted that only tetanus immunizations have ever produced a short term local cramping response. No product quality complaint was involved. It was also reported that the pt's wife was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an AE (WAES0411USA00725). Additional information has been requested.
Patient currently inpatient at (8) days starting from 11/18/2021. Patient is a 90 y.o. female who presents today with shortness of breath.  History is limited from the patient, however patient's son provides additional history as possible.  Patient's son states that she was hospitalized a couple weeks ago for suspected urinary tract infection.  He states following hospitalization she had significant weakness and she was discharged to assisted living for ongoing care.  While at assisted living the patient was noted to have significant respiratory distress and fevers, for which reason the patient was sent to the ER for further evaluation.  Patient was noted to be COVID positive.  She reports being vaccinated.  Patient is somewhat immunocompromised with her CLL.  On presentation, the patient was requiring high-flow nasal cannula to maintain appropriate saturations.  Patient does report that she uses 2-3 L of oxygen at night while sleeping, however she is unsure of any specific associated pulmonary diagnosis.  Anticipated care plan was discussed with the patient and her son.  Both report should patient's respiratory status worsen intubation is not desired.  Questions have been answered to patient and son satisfaction.  ASSESSMENT/PLAN: Acute on chronic respiratory failure with hypoxia  Assessment & Plan Patient reports baseline oxygen needs of 2-3 L at night Patient was requiring high-flow nasal cannula on admission secondary to pneumonia   Continue weaning oxygen as tolerated otherwise treatment as outlined under pneumonia   * Pneumonia Assessment & Plan Patient with noted positive COVID test in the emergency department (11/18/2012) Unclear whether pneumonia is bacterial in nature or related to COVID-19.   Will continue to cover with IV Rocephin and azithromycin for potential bacterial pneumonia Additionally will start patient on 6 mg of Decadron for possible COVID pneumonia Routine monitoring of vitals Will monitor blood culture results Patient's home Eliquis should be adequate anticoagulation for patient's positive COVID status   Type 2 diabetes mellitus, without long-term current use of insulin  Assessment & Plan Very low-dose mealtime and corrective scale coverage while admitted Will continue trending patient's bedside glucose for further titration   CLL (chronic lymphocytic leukemia)  Assessment & Plan Likely cause of patient's noted leukocytosis Will continue monitoring complete blood count throughout admission   Atrial fibrillation  Assessment & Plan Continue Eliquis for anticoagulation and metoprolol for rate control   Atrophic kidney Assessment & Plan Patient's son reports a history of an atrophic kidney he states his chronically infected.  He notes patient recently underwent a 10 day antibiotic course.  UA in kidney function reviewed.  No further indication of ongoing urinary infection is noted and patient has appropriate kidney function
Currently undergoing IV antibiotics, VICODIN for "cellulitis" L arm post pneumonia vaccine.
Left arm that received injection continued to feel weak off and on over the next 2 weeks.  Would not describe it as painful, but more like a dead arm and very weak. In the early morning of April 25, it was painful. It has remained sore and weak all day. The pain is not by the injection site, but in the bicep.
Case number PHEH2016US023459, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 29-year-old patient of an unknown gender. Medical history was not reported. Concomitant medication was not  reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
Pt received covid vaccine # 2 on 6/1/21 at 10:15 am and an hour later (11:15 am) developed itch and swelling in both eyes with sob. Pt also reported face feeling  warm to touch. Eyes were sensitive to light and felt pressure around eyes.  Patient was unable to keep her eyes open. No temp noted. Pt took Claritin at 2:00 pm with no relief, felt symptoms became worse. Pt reported having side effects from first vaccine  on 6/1/21.  She states she had lethargy, low-grade fever and body aches.  Pt was advised to go to Urgent Care for evaluation. Pt went to Urgent Care and left without being seen, she has not followed up with primary care provider.
Headache which was constant all day; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 09:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown if the patient had allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  On 11Apr2021, the patient experienced headache since 4 days which was constant all day. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient had tested for COVID post vaccination. The clinical outcome of the event headache was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
INJECTED INFLUENZA FLUBLOCK VACCINE TO THE PATIENT UNDER 18 YEARS OLD.  PATIENT IS FELLING FINE RIGHT NOW .
Mom called 9/24/18 reported R thigh with red, pin point rash at injection site and swollen area size of baseball denies hot to touch, no itch, doesn't seem to bother him. Symptoms occurred more than 48h after vaccines given. Did not sound like typical reaction. Appt was scheduled 9/25. Exam 9/25 petechial rash, sl. raised (R) ant thigh. Researching by Dr. showed this was not allergic reaction but due to crying vigorously, fighting shot; study reported "discolored leg syndrome). Pt developed slightly tender raised area right ant thigh where HAV given 24h after injection; purple reddish, raised; now fading and flattened out; no other SXs. No hemophilia or bleeding do in family; no excessive bruising or bleeding with teething. No recent viral illness.
Chest pain; 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 CHEST PAIN (Chest pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
Information has been received from a registered nurse concerning a teenage female who on unspecified date was vaccinated with a dose GARDASIL. After receiving GARDASIL, the patient was lightheaded. The outcome of the patient was not reported. This one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a physician assistant refers to 21 unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On multiple unspecified dates, 21 patients were vaccinated with improperly stored GARDASIL 9 lot # M004508, expiry date:03-OCT-2017 (dosing details were not reported. It was reported that the vaccines were exposed to the temperature of 34.7 F during a time frame of 2 hours. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe body ache, headache, fatigue, and weakness. Severe pain at the injection site, unable to my move arm. Fever 103.2 F., nausea, vomiting, and heart palpitation.