chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster; I might have cancer; the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy); extreme coldness; freezing to my extremities/My hands are like ice; elevated lymphocytes; short of breath; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 Immunization, reaction(s): "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)", "I might have cancer"; Bnt162b2 (DOSE 1), for COVID-19 Immunization, reaction(s): "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)", "I might have cancer". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "I might have cancer"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)"; FEELING COLD (non-serious), outcome "unknown", described as "extreme coldness"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "freezing to my extremities/My hands are like ice"; LYMPHOCYTE COUNT INCREASED (non-serious), outcome "unknown", described as "elevated lymphocytes"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath".The patient had extreme coldness, and freezing to her extremities, this has never happened before, until now when she took the booster. Her hands are like ice, if touch someone they jump back. She had to raise the temperature up in her house. She also want to report something that has happened to me every time she took the shot, and she tired of the Doctors not believing her when she tells them. The radiologist was telling, she might have cancer. She kept telling him that the nodules that form in her breast, only happens after she took the vaccine, and then it goes away, she wants to report this so that Pfizer can document, and people know that this is happening, and I am not the only one. Her doctor told me that she has elevated lymphocytes, which could mean that her immune system is very active. She was feeling short of breath, so much so, that she has to rest when she climb stairs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports ongoing, intermittent pain since first Shingrix dose, which was not present prior to vaccination.
Tell call today, Patient c/o left arm bump, itchiness evening after shot was administered, then spread to right arm and now on lower legs, described a 5" mosquito type bites. Left arm has healed up.
Lightheadedness, dizziness,  tongue tingling and numbness, general weakness initial high blood pressure 200
This my second dose. Within five minutes I experienced lightheadedness and balance difficulties. These abated after twenty minutes. The injection site arm was very sore and grew even more sore throughout the evening and I had a slight headache about 7:00 PM, a rare occurrence for me -- I often only have one or two per year. The headache disappeared within about an hour after manifesting. By about 10:00 PM I was beginning to feel a general achiness all over, mostly manifested in my joints.  By the time that I awoke on Thursday, 03/25/2021, I was aching quite badly all over. By 5:00 PM on that date I felt as if I had chills and a fever but a check with a digital thermometer showed that my temperature was 96.4F.  By evening I was aching  even more severely and in pain - mostly in my joints and hands -- took to my couch and covered up where I dozed in and out. I took a generic acetaminophen around  7:00 PM.  When I got up from my couch around 10:30 PM on the 25th, the aching had abated quite drastically and by midnight the worst was over. My temperature registered 98.0F at 10:30 PM.  When I arose from bed around 11:00 AM on Friday the 26th, both my hands were still aching and paining badly but most of the other aches in my joints had dissipated. By 6:00 PM on the 26th  the severe pain in my hands had decreased to my customary levels of pain from arthritis.
When I woke up 8 days later and left arm swollen at site with red bumps that were raised and itchy. Chest had red flat circles. Raised red bumps under bra line. Nausea.
at 6:00 pm. i started with light headedness and eyes blurred. by 830pm,started get cold and hot sweats together. i felt like my bones were going to break especially in toes. i was afraid to stand up, also it felt like my breathing was effected if i laid down, id cough and than get a sharp headache pain, so around 1230am, with still freezing and sweating started with sharp pains in left lower stomach and top left chest stabbing pains, felt like i have to vomit and go to the bathroom. ended up just vial vomit .this lasted until 0700am took a hour nap woke up sweating was drenched, continuing day on with left side stomach and chest pains and back shoulder pain. with nervousness. on 4-13-21 woke up to diarrhea and shaking still
Multiple days of bad headache; fatigue; "foggy brain"; muscle aches; muscle aches and weakness; diarrhea; potential menstrual period change; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0176) via an unspecified route of administration in the right arm on 20May2021 at 19:30 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications in two weeks of vaccine. The patient had no known allergies. 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 vaccination. On 20May2021, the patient experienced multiple days of bad headache, fatigue, foggy brain, muscle aches and weakness, diarrhea and potential menstrual period change. No therapeutic measures were taken as a result of the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events multiple days of bad headache, fatigue, foggy brain, muscle aches and weakness, diarrhea, and potential menstrual period change were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
3" X 2 1/2" pine, erythematous, non-tender, diffuse swelling over mid 1/2 anterior/lateral thigh. No fluctuation, induration or bruises. No blistering or papules. Normal gait with no limp.
Received DTap, Hib 1-10-06. Fever that night of 103.7. Next AM-vomiting. 1-12-06 had seizure of 10 second duration. 1-12-06 PM temp returned to normal, vomiting stopped.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 09-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Initially pain at site followed with swelling and Headache. Next day, 2/17, additional swelling, induration, warm to touch along with nausea/vomiting and fever, dizziness and headache. 2/18: Same symptoms with Chest Pain now and call to 911 and brought to Hospital where she was worked up for Pulmonary embolus with CT Scan of chest and CT Angio of heart. Heart showed no disease.  CT chest Pulmonary showed Pulmonary Embolus. Treated with Lovenox and Coumadin and now placed on long term coumadin therapy. Back to work 3/11/10.
1.Local reaction with local edema and erythmia, warmth 2/2/2021 2. Rash behind ears, abdomen, back. hives vs roseola- 2/9/2021 3. Bruising of BLE, buttocks, back, BUE with petechial L upper trunk 2/23/2021, Thrombocytopenia @ 14,000
Dizziness. No other symptoms. EMS arrived onsite. Patient refused transport. Dizziness improved while in observation.    BP 140/80, O2 sats 100%
Pt received immunizations on Monday 3-24-08; woke up 6:30 am, Tuesday (3-25) with 101 deg fever. Rash started Wednesday (3-26) evening, worse today (3-27). Rash on hands, feet, face. No respiratory problems. Vital signs today (3-27) Temp 97.5 tympanic. No wheezing, no SOB Rash urticarial.
Large local reaction to left upper arm, below injection site. Patient reports that she began feeling pain and noticed redness and swelling starting the day after her influenza injection was given on Friday, October 19th. Area increased in size gradually from Saturday to Monday. Treatment included Rx triamcinolone 0.1% ointment BID and OTC ZYRTEC or BENADRYL, cool compresses.
I am updating report # 608369.  Historically my blood pressures had been normal until receiving covid vaccine. Apart from ringing in my ears now I also have high blood pressure.
Information has been received from a 68 year old female consumer who in 2006 (exact date not reported) was vaccinated (site and route not reported ) with pneumococcal 23v polysaccharide vaccine (lot# not reported). Concomitant therapy included influenza virus vaccine (unspecified) given in the opposite arm. In 2006 (exact date not reported), post vaccination, the patient's whole arm swelled and got red. No lab diagnostic test were performed. The patient did receive unspecified medical attention and recovered. No additional information is expected.
Later during the day of the vaccination and the following 2nd through 4th day, I experienced common symptoms such as injection site pain, joint pain, fatigue and itchiness. On the 5th day, the palms of my hands became very itchy and turned red and splotchy although I refrained from scratching. My arms felt itchy as well. Late that night (4/30), I broke out in full body hives. By morning, when I woke up, I felt itchy, but the hives had resolved. I continued to feel occasional itchiness and joint pain for several more days. On 6/3/21, I completed blood tests for my 6-month check with my oncologist/hematologist. My AST level, typically/historically in the 20's, was elevated at 112. A 6/22/21 abdominal ultrasound showed signs of fatty liver infiltration. This was a new development, and I do not fit the typical physical/lifestyle profile of someone at risk for liver disease. A 2nd round of blood tests ordered by my primary care physician were completed on 8/13/21, and my AST had dropped to 36. I am now waiting for an appointment with a GI specialist as recommended by my primary care physician. My oncologist/hematologist and his nurse had both mentioned seeing an unusual number of patients with sudden elevation of liver enzymes which caused me to wonder if there is any connection with the vaccine?
Information has been received from a registered nurse concerning a 77 year old female patient with no known allergies and no pertinent medical history, who on 27-SEP-2007 was vaccinated with ZOSTAVAX (Lot not provided). There was no concomitant medication. The patient developed (on an unspecified date) painful shingles around face, scalp and forehead. She also experienced shooting pain, chills and fever. She was prescribed VALTREX for the treatment. As of 26-JAN-2009 the patient hadn't recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.   Follow up information has been received from a registered nurse and a completed questionnaire, concerning a 78 year old female patient with a history of chickenpox in 1938, who on 27-SEP-2007 was vaccinated with 0.5 mL the first dose of ZOSTAVAX (Merck) (Lot 658084/0888U) subcutaneously in the left arm at 2:15 pm.  It was reported the patient had no illness at time of vaccination.  The reporter stated a failure in the ZOSTAVAX (Merck) vaccine.  On 26-Jan-2009, the patient developed shingles.  The patient had a maximum of body temperature of 91.8 degrees F, with a pain degree of 5 (0 lest to 10 most), she also had trouble with vision and went to see the ophthalmologist.  The nurse reported the patient had had no recent exposure to chicken pox or herpes zoster.  A direct fluorescent antibody test was not done and no specimen was collected for PCR.  On an unspecified date the patient recovered.  Additional information is not expected.
From initial information received on 03APR2003 from an office manager regarding an adverse even occurring in the US, it was reported that a 52 year old female pt received TD ADS ADULT, given in the left lateral thigh,with an expiration date of April 2004, at 4:30PM on 24MAR2003. Three hours later, the pt developed a fever of 100 degrees, chills and severe cellulits. It measured 9.5x10.5cm for the outer area, the center was 25mmx40mm, was pink and hot in the outer area and red and hot in the center. Pt also experienced limping. The pt was seen by a physician in a doctor's office and given 500mg of Duricef, 5 mg of Percocent for pain and 750 mg of Relafen. The pt was requested to get bed rest for four days. The pt was seen again on 31MAR2003, by the physician, and had improvement, but the center was till very pronounced, tender and raised 25mmx45mm. The pt has a pre-existing condition of Mitral Valve prolapse, depression and constipation. Reportedly, the pt has not fully recovered form these events. The reporter of this case is the same reporter for case 2003-00498.
3 month old female patient received Quadracel instead of Pentacel, no AE; 3 month old female patient received Quadracel instead of Pentacel, no AE; Initial information received on 24-Jul-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a three month old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered) (Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) ; HIB VACCINE CONJ (TET TOX) (ACT-HIB); and HEPATITIS B VACCINE (HEPATITIS B VACCIN) which were given on 24-Jul-2020 for Prophylactic vaccination.  On 24-Jul-2020, the patient received a first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5635AA and expiry date: 18-Jun-2021) once instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  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.
Flushing-2 hours; Vomiting-3 hours; Weakness-3 hours;
Irregular menstruation following vaccine.; Bleeding more frequently than usual - every 12 to 14 days; This is a spontaneous report from a contactable consumer. This 41-Year-old non pregnant female consumer (patient) reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 31Mar2021 at 10:00AM (at the age of 41 years old) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included fluticasone propionate (FLOVENT) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), started on unknown dates and for unknown indications. No relevant past drug history. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 10Mar2021 at 10:00AM (at the age of 40 years old) as dose 1, single for covid-19 immunization. Prior to 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 4 weeks prior to the COVID vaccine. On 30Apr2021, she had irregular menstruation following vaccine. Bleeding more frequently than usual: every 12 to 14 days. Patient visited doctor or other healthcare professional office/clinic. No hospitalization prolongation or treatment received for the events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
No adverse event; Reported that they inadvertently administered 51 doses of the monovalent vaccines; 1st dose on 02-Sep-2021 and 2nd dose on 23-Sep-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 02-Sep-2021 and 2nd dose on 23-Sep-2021) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, FF8839 and EW0186) for COVID-19 prophylaxis.     It was unknown if the patient was ever been diagnosed with or tested positive for COVID-19. Acute illnesses at the time of vaccination and up to one month before was unknown. Chronic or long-standing health conditions were unknown. Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and all at the time of adverse event was unknown.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 02-Sep-2021 and 2nd dose on 23-Sep-2021). On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 02-Sep-2021 and 2nd dose on 23-Sep-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 02-Sep-2021 and 2nd dose on 23-Sep-2021).    No concomitant product reported by reporter.  No treatment medication was reported.  Dose/ volume for 3rd booster dose was reported as 0.25.   This case was linked to MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow-up received: Suspect route of administration, site of administration was updated, and additional event was added. Sender's Comments:  MODERNATX, INC.-MOD-2023-704260: Master case
Hositalized for Stroke on May 5, 2021. Patient dismissed from hospital May 12, 2021. Under continuing treatment to reduce blood clots.
pain in the right side of body including hip; Urine was cloudy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in the right side of body including hip) and URINE ABNORMALITY (Urine was cloudy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Kidney stone. Concomitant products included OMEPRAZOLE, OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (pain in the right side of body including hip) and URINE ABNORMALITY (Urine was cloudy). The patient was treated with ACETAMINOPHEN on 25-Mar-2021 at a dose of 1 dosage form and NITROFURANTOIN for Kidney stones, at a dose of 100 milligram. At the time of the report, PAIN (pain in the right side of body including hip) and URINE ABNORMALITY (Urine was cloudy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Red, swollen at injection site. Hot to touch for 12 hours. Used ice pack.
my arm swelled and was red and I broke out in hives; my arm swelled and was red and I broke out in hives; my arm swelled and was red and I broke out in hives; This spontaneous report has been received from a female patient of unknown age via Pfizer. Pertinent medical history and concomitant medication were not reported. She was allergic to a lot of antibiotics.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (formulation, strength, dose, route, lot#, and expiration date were not reported).  On an unknown date, the patient experienced a reaction to the varicella vaccine where her arm swelled and was red, she broke out in hives. She was not sure if the hives were all over the body or just the arm. The outcome of the events was not reported.  The events were considered to be related to the vaccine by the reporter because she learned that there was neomycin in the varicella vaccine, and she was allergic to a lot of antibiotics.