chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Fever of 102 F and may have went higher; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever of 102 F and may have went higher) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M24A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 25-Feb-2021, the patient experienced PYREXIA (Fever of 102 F and may have went higher). On 26-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 26-Feb-2021, PYREXIA (Fever of 102 F and may have went higher) had resolved. At the time of the report, HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 102 (High) fever of 102 F..         Concomitant medications were not reported  Treatment using  wet cloth and  ice water was reported   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received contains non-significant information
Eleven days  post vax, the patient developed a mild case of chickenpox. Several days post-onset, the patient recovered. In the beginning of August 2000, the patient developed a severe rash "that started off looking like chickenpox; however, it then developed into welts all over his entire body and face. The rash cleared up after 1 week. The patient was treated with Prelone and Benadryl. The rash reappeared and the patient was seen by a physician who thought the patient may have experienced a reaction to the varicella virus vaccine. No further information is available.
Pain in right armpit moving into her back, High fevers of  102 F , treated her with fever reducers.
This spontaneous report as received from a licensed practical nurse refers to a 13 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 14-SEP-2015, the patient was vaccinated with a dose of GARDASIL 9 lot # L007560 (dose, route of administration and expiration date were not reported) that had experienced temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Having pain at the injection site; Being warm to the touch; He developed a "bump" or a lymph node under his armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 31 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Jan2022 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Von Willebrand Syndrome" (unspecified if ongoing); "Platelet Aggregation" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Having pain at the injection site"; VACCINATION SITE WARMTH (non-serious) with onset 2022, outcome "unknown", described as "Being warm to the touch"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "He developed a "bump" or a lymph node under his armpit".  Additional information :He received gray cap booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Not feel very good; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient described that the vaccine made him "not feel very good" on an unspecified date. He did not sound overly concerned. No treatment received for the event. The outcome of the event was recovered. The event was considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown if the patient has been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
trouble breathing, blurred vision for about 40 seconds.  arm still itching a week later.  arm itch might be caused by band-aid
headache within 5 minutes, dryness of throat/claimed itch of tongue 5-10 minutes post vaccination, to which patient was given a chair to sit, a glass of water and 25mg of liquid diphenhydramine and observed for appx additional 15-20 minutes. Patient then claimed to be feeling better and she and her mother left pharmacy.
Patient with severe back spasm, shortness of breath and shaking. Patient monitored in office for 45 minutes and symptoms subsided without intervention. Vital signs stable and within normal limits
I received my first dose on 12/22/2020. On 01/12/2021 I received my second dose and was tested positive for COVID on 01/18/2021.
Swelling, hardness, itchiness, redness, soreness around injection site.  Within roughly an hour of the 2nd dose of the vaccine my arm felt slightly tender, but not in the muscle, just surface. A small red bump developed about 7 hours after receiving the vaccine. By the next morning (Saturday 5/8) it had spread to about 3 inches in diameter and was red and itchy. 29 hours post injection diameter was roughly the same but the lump protruded more and was harder, bright red, extremely tender to the touch, and itchy. It felt as if the skin might tear. The next morning  (Sunday 5/9) the redness and soreness dulled but were still present, and all other symptoms remained the same the remainder of the day. Monday morning, 5/10, diameter has increased to roughly 4 inches but the bump does not protrude as much as it used to and the redness has dulled substantially. It still remains itchy and hard, though the tenderness has slightly subsided.
Internal pain at the injection site, especially at night when in bed.   When using the arm during the daytime, the pain will subside.  Treating with, icyhot, hot compresses at night, six Advil/Tylenol through the day, and one gabapentin 100mg before bed.  This treatment works if I can get the pills in me before the pain starts and will stay working for about 5 hours, then the pain starts again.
Soreness in arm that lasted around 6 days after vaccination. Fever the night after vaccination. 3 days after vaccination, a red rash appeared around the vaccination site as well as along the side of my chest. I had a lot of pain in my armpit as well. The pain and rash went away for 3 days, and then returned with a red swollen area on my left arm at the vaccination site.
Vomiting 4 times without other symptoms. Occurred 5-6 hours after vaccine given
Injection Site Pain Tiredness Headache Muscle Pain Chills Joint Pain Nausea Feeling Unwell Swollen Lymph Nodes Decreased Appetite  Fatigue
stroke after taking the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke after taking the vaccine". Clinical Course: The reporter mentioned that her daughter got Covid but got over it. She said that her daughter doesn't want to be vaccinated because they don't trust the vaccine since she heard that her neighbour had a stroke after taking the vaccine. However, their company is requiring them to be vaccinated. The reporter wants to know the ingredients of the vaccine so they would know what to tell their allergist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After my 2nd shot my menstral cycle was very irregular. I have continued to bleed or spot for over 20 days
pt recv vax 5MAR96 & dx w/varicella in office on 25JUN98 by MD;
I can not walk right anymore/ I can walk, but it is very difficult; I can not even climb in car or anything, it is really bad; It is just persisting, I can not push because I fall if I do; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stroke" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Anatomical site of injection: Left arm), administration date: 28Mar2021, when the patient was 53 years old, for COVID-19 immunization.  The following information was reported: GAIT DISTURBANCE (non-serious) with onset 16Apr2021, outcome "not recovered", described as "I can not walk right anymore/ I can walk, but it is very difficult"; FEELING ABNORMAL (non-serious) with onset 16Apr2021, outcome "not recovered", described as "I can not even climb in car or anything, it is really bad"; FEAR OF FALLING (non-serious) with onset 16Apr2021, outcome "not recovered", described as "It is just persisting, I can not push because I fall if I do". Therapeutic measures were not taken as a result of gait disturbance, feeling abnormal, fear of falling.  Additional information: Patient got the first vaccine in March, got the second Vaccine in April. Now was due, this month to get that, the booster, but was afraid to get it. Because after patient got second shot in April, can not walk right anymore and can walk, but it was very difficult. When asked about medical history, patient reported had a stroke before, but do not take any medication anymore. When asked if still experiencing, patient replied can walk but can not even climb in car or anything, it was really bad. It was just persisting, patient can not push because patient fall if did anything. The patient just do not walk very much.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
a dose of PENTACEL was administered without reconstituting with the Hib portion of the vaccine with no AE; Initial information received on 26-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 month old female patient who administered dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without reconstituting with the hib portion of the vaccine (Product preparation issue).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 21-Jan-2021, the patient received a 05mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ336AAA, Expiry date: 05-Jul-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (Product preparation issue) [latency: at the same time of vaccination].  It was reported that, caller reporting two patients were administered the vaccine but unsure of which patient was administered only the DTap-IPV portion of the vaccine. Caller with asked on when to re-vaccinate both patients.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt was taken home p/immun turned purple started screaming & was trembling;was taken to ER immed;had temp of 104 was given shot unk ER evaluated & released;
injection site reaction /huge side efects; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 61 or 62 years. The patient had huge side effects after vaccine. The patient reported that one in 100K reactions which he guessed was ok but in this case were both at the same time and same place of injection and one day apart. The patient's perception was that the whole lot had something wrong. The reporter just want to report the incident and make sure no one else was hurt. The reporter gave permission to follow up. This case had been linked to the case US2019AMR147386, reported by same reporter.
SHE FELT A BIT DIZZY AND WEAK, SHE ATE AND WENT TO SCHOOL, BUT WORSENED AND WENT TO THE NURSE TO LIE DOWN.  SHE   STABLIZED BUT CONTINUES TO FEEL THAT WAY.  YESTERDAY, SHE HAD  HER MENACTRA BOOSTER. HER LEFT ARM IS SLIGHTLY SORE. LOW B/P AND HEART RATE.
Was given Pfizer instead of Moderna.  Had Moderna for 1st covid vaccination.
Slight local reaction. Erythemia with asuilary ademopathy. Nausea with vomiting 24 hours. Home from school 2 days. Achiness. Seen in clinic by provider second day.
STARTED WITH FEW RED AREAS ON BODY. I SAW THE PATIENT ON 06/14/10 AND SHE HAD HIVES ALL OVER HER BODY. MOM STATED THE RASH STARTED THAT DAY AFTER SHE RECEIVED HER VACCINES. NO NEW FOODS WERE INTRODUCED AND NO NEW PRODUCTS USED ON THE CHILD.
Approx. time of flu shot 2:10 PM, then approx. 2:25 PM vomiting, red and hot facial cheeks, tingling in (R) arm and felt throat closing or tight. EPI given at 2:31 PM 911 was called. Client taken to hospital at 2:45 PM approx. Still with nausea on 10/15/10.
pt recv vax 2MAY97 & 5MAY97 pt had trouble breathing;pt was cranky, was not eating well, coughed & was fatigued;8MAY97 pt devel temp of 102.4;9MAY97 pt devel OM;pt presented t MD office & was treated w/Proventil, Motrin, Cefzil;
Patient received a pneumonia shot at her physician's office. Patient-then got her flu vaccination at the pharmacy. Then approx. 15 minutes after her flu shot, pt experienced mild dizziness, sweating and labored breathing. Pharmacy staff called 911 while RPh assessed patient and took blood pressure while ambulance was en route. Patient was taken to the hospital by the paramedics.
I was feeling tired, scratchy throat, runny nose, diarrhea. I took a home COVID-19 test, it came back negative, I went to a walk-in clinic on March 24, 2023. The asked me to do a stool sample but I no longer had diarrhea, so I was not able to do it,
Presents for CP, SOB. Admit for atypical CP & URI with COVID 19. Not hypoxic, tachypneic, or tachycardic. CXR unremarkable. Tx: steroids, zinc, abx. DC home
Patient had delayed immunization schedule and immunisation was being updated on 11-19-07 at around 2 PM. Patient got DTaP, IPV, MMR, and Hep A. While he was to step out of waiting room, he collapsed with eyes rolling backwards but no abnormal body movements. Patient was responding sluggishly but appropriately. Vital signs were normal.
anaphylaxis, severe face swelling, throat closing, arm swelling, headaches, ongoing dizziness, equilibreum issues,  aches, stomach issues, rash on face, neck, torso and both legs, nausea ongoing, tingling sensations.  8 benadryl in first 30 min.   kept me there for one hour - almost two weeks out and still not fully resolved (very dizzy, severe headaches, some swelling remains)
This spontaneous report as received from a billing manager refers to a child patient of unknown age or gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA (exact dose, dose number, route of administration was not reported; lot # N020689 with the expiration date of 22-OCT-2018 (also reported as 22-OCT-2017)) for prophylaxis. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (exact dose, dose number, route of administration was not reported; lot # N017686 with the expiration date of 02-FEB-2020) for prophylaxis. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II (exact dose, dose number, route of administration was not reported; lot # N009172 with the expiration date of 20-MAR-2019) for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the vaccine was properly stored. On unknown dates, the patient was vaccinated with an unknown number of unspecified vaccines, reported as "multiple vaccines" and "everything else in the fridge". No adverse effects were reported. The administered doses of vaccines underwent multiple temperature excursions. Digital Data Logger was involved to capture the temperature excursions. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA000902.
headache; very sore arm. She said my arm is hurting a little bit; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE PAIN (very sore arm. She said my arm is hurting a little bit) and MYALGIA (Arm pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 030M20ALot# 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (very sore arm. She said my arm is hurting a little bit) and MYALGIA (Arm pain). At the time of the report, HEADACHE (headache) had resolved and VACCINATION SITE PAIN (very sore arm. She said my arm is hurting a little bit) and MYALGIA (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment used for Pain is Tylenol
reactive acute genital ulceration triggered by the SARS-CoV-2 vaccine; This is a literature report.  A 12-year-old otherwise-healthy female patient presented with painful vulvar ulcerations that had been present for approximately 5 days. Review of systems was positive for dysuria and hematuria. She was initially evaluated by her pediatrician and empirically treated with oral nitrofurantoin, fluconazole, and phenazopyridine for suspected urinary tract infection. She was then referred to pediatric dermatology for further evaluation and treatment due to lack of improvement. She was otherwise healthy and was not taking any other medications, denied any history of sexual activity, and had no previous history of oral ulcers, inflammatory bowel disease, or autoimmune disease. The family reported that the patient had received her second dose of the Pfizer-BioNTech SARS-CoV-2 vaccine approximately 48 hours before symptom onset. The day following vaccination, she also developed subjective fevers, fatigue, and malaise lasting 24 hours. On physical examination, there were approximately 2 _ 2-cm well-circumscribed, shallow ulcers with yellowish sloughing and purulent exudate on opposing surfaces of the bilateral labia minorae. Significant labial edema was present. Her oral mucosae were clear. Laboratory findings were notable for normal complete blood count and comprehensive metabolic panel and negative urine culture. Urinalysis demonstrated large leukocyte esterase, 20-29 white blood cells per high-power field, and moderate mucus. Lesional herpes simplex virus (HSV)-1 and HSV-2 polymerase chain reaction (PCR), Trichomonas/Gardnerella/Candida DNA probe, EBV antibody panel, respiratory viral panel, and SARS-CoV-2 PCR were negative. These clinical and laboratory findings were supportive of the diagnosis of reactive acute genital ulceration triggered by the SARS-CoV-2 vaccine. The patient was given topical clobetasol 0.05% ointment twice daily, lidocaine 2% jelly every 4-6 hours as needed, oral acetaminophen and ibuprofen as needed, and sitz baths with improvement of her symptoms. Ulcers healed over the course of 2 weeks.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  the reported event Genital ulceration cannot be completely excluded based on temporal association and known drug safety profile 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-202200948342 Same article/drug/event and different patient (Patient 2);
R09.02 HYPOXIA 3/6/2021 BENIGN NEOPLASM, LEFT CHOROID
This spontaneous report as received on 18-JUN-2015 from a consumer refers to a 62 year old male patient with hypertension, hepatitis c, heart disease, "COD" (coronary artery disease) and iodine allergy. On 11-JUN-2015 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included TOPRAL, OMEPRAZOLE, RANITIDINE HYDROCHLORIDE and HYDROCODONE and VALIUM. The patient stated he has had redness at the injection site of a quarter that started the day after getting the vaccine. No further information was provided. The outcome of redness at the injection site is unknown. Additional information has been requested.
Per client "redness throughout thigh and up onto hip" blotches around body" "15-20 min after vaccine given," client returned to clinic. Visualized injection sight. Slight pinkness noted around site. No swelling or heat noted. No "blotches" noted on surrounding skin. Sight reported was (R) thigh.
Developed clot in lower leg (shin), 60 mg Lovenox at ER, 81 mg aspirin daily, cephalexin 500 mg three times a day for 10 days, smz/tmp 800mg/160mg twice daily for 3 days