chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist on 20-JAN-2015 referring to a 64 year old female patient. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K009770, expiration date 09-OCT-2015), 0.65 ml, subcutaneous for vaccination. Concomitant therapies included escitalopram oxalate(LEXAPRO), alprazolam(XANAX) and acetaminophen, hydrocodone bitartrate(VICODIN). On 23-OCT-2014 the patient began to experience swelling at the injection site and was assessed by an unspecified physician. The unspecified physician prescribed unspecified antibiotics to decrease swelling. On an unspecified date after starting the antibiotics, the patient began to experience nausea and right upper quadrant abdominal pain. Unspecified labs studies were completed on an unspecified date, after starting antibiotic therapy, which had shown that the patient's liver enzymes were elevated. Other unspecified diagnostic studies have been completed on unspecified dates. The outcome of the adverse events was reported as not recovered. Follow-up information was received on 11-FEB-2019 from a lawyer regarding a female patient who had received the ZOSTAVAX)  The complaint alleges that the female patient , sustained injuries as a result of a ZOSTAVAX vaccine administered on 21-OCT-2014 at a pharmacy. In recent responses to supplemental discovery, the patient claimed that the ZOSTAVAX vaccine itself may have been defective. On or about 21-OCT-2014, the female patient visited the drugstore to get a shingles vaccination. At the drugstore, an employee administered the vaccination to the patient, but administered it negligently (not further specified), causing the patient serious injuries from which she still suffers almost 2 years later. The drugstore company's negligence injured the patient in and about her body and extremities, and suffered physical handicap and impairment, disfigurement, mental anguish, inconvenience, loss of capacity for the enjoyment of life, aggravation of a previously existing condition (not further specified), and her working ability was impaired; the injuries are either permanent or continuing in nature and the patient will suffer the losses and impairment in the future. Interrogatory: State whether the patient is contending that the shingles vaccination administrated on 21-OCT-2014 was itself unreasonably dangerous and/or defective. The patient response to Interrogatory was Presently, the patient does not know whether the actual substance that was injected was defective, but discovery is ongoing. The events of Injured in and about her body and extremities, swelling at the injection site, liver enzymes were elevated, right upper quadrant abdominal pain, and nausea were considered to be disabling. Additional information has been requested.
Developed productive cough ,with clear sputum, sore throat. afebrile. Unknown if related to vaccine
I was immunized with the 2nd dose of the Pfizer COVID-19 vaccines on May 4th, 2021, and on May 5th started experiencing left shoulder pain radiating to the arm, and upon breathing in pain would intensify. On the night of May 5th pain started to increase and decided to report to the hospital. On May 6th I was admitted to the hospital to further identify what was causing the shoulder pain, deferent test were performed with normal result but upon performing CT Scan, it was identify that I had blood clots on the left lung (pulmonary embolism). Upon several questions asked by the health care team, the doctors at the Hospital stated that the main cause of the blood cloths was the 2nd dose of the Pfizer COVID-19 vaccine due to my healthy status and being the only thing that I had completed different in the days prior to the hospitalization. Due to this I was prescribed a 3 month anti coagulant treatment for the embolism.
Information has been received from a health professional concerning a patient who in 1998 was vaccinated with a first dose of varicella virus vaccine live. Subsequently, the patient sought unspecified medical attention and it was noted that she "failed to seroconvert". Additional information has been requested.
Initial reaction was fever, swelled lips, urticarial, with injection site redness and soreness.
has a full blown Covid-19 infection. It has been 6 months past after getting her second shot of the vaccine on 07Jan2021; has a full blown Covid-19 infection. It has been 6 months past after getting her second shot of the vaccine on 07Jan2021; This is a spontaneous report from a contactable physician (Patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on 07Jan2021 as Dose 2,Single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. On an unknown date, (also reported as: It has been 6 months past after getting her second shot of the vaccine), she had experienced full blown COVID-19 Infection. She mentioned that she had reported this to CDC and asked her to report to Pfizer. It was her first time to report. She wanted to know about the possible waning immunity of the vaccine after 6 months. She had read this online if there was more information about this. It was reported that provided information from attached document Antibody Persistence and Duration of Immunity, "Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of Landmark COVID-19 Vaccine Study. Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) is effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose." and Table 1: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup. The outcome of the event was Unknown.   Information about Lot/Batch number were requested.; Sender's Comments: The events of drug ineffective and covid-19 are assessed as possibly related to the suspect BNT162B2 based on information provided.
Pain at injection site (moderate) - acetaminophen every 6hr Headaches (mild) Chills (mild)
A non-serious spontaneous report of administration to 22 month old, nose picking, mild croup and cough have been received from a physician concerning a 22-month-old female, subsequent to H1N1, Intranasal. The patient's past medical history includes diaper rash and lactose intolerance. No concomitant medications have been reported for this patient. On 14-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On the same day after vaccine administration, the patient experienced nose picking. On 03-Nov-2009, the patient was seen for mild croup and was prescribed dextromethorphan and guaifenesin. On 19-Nov-2009, the patient was examined for cough at night time but no wheeze was noted and the patient was prescribed albuterol and PHENERGAN. On 20-Nov-2009, mild croup was resolved and on 25-Nov-2009, night time cough also resolved and the patient was doing well at the time of reporting. The outcome for the event of administration to 22 month old, nose picking, mild croup and cough was resolved. Additional information was received on 24-Nov-2009 and incorporated into the narrative: medical history and concomitant medications, patient's demographics, adverse event terms and treatment. Additional information was received on 03-Dec-2009 and incorporated into the narrative: about the outcome of the reported adverse events.
Tachycardia, Night Sweats, Persistent Cough, Fatigue, Brain Fog
Received 4 yr shots and flu vaccine on 10/15/15. The next day, developed redness and swelling of both thighs and they were warm to the touch. No fever. Taken to ED on 10/17 due to continue redness and swelling. Worse in right thigh. ED placed on KEFLEX x 10 days. F/U visit in PCP office on 10/28 - Per exam pt had 3 cm bruise on later aspect rt thigh; no redness swelling or fever.
I have experienced significant dull in taste from the bivalent booster. I can mostly taste  salt, sugar, and spices, those these items are dulled as well. For example, I can taste a hint of strong spices, but I can feel my throat burning more than I can taste the spices. I had Covid in January. My taste was dulled in a similar way. My taste eventually returned after the virus, but it could also come and go. When it seemed to "fully" return it wasn't 100 percent and was slightly dulled. I also haven't been able to taste chocolate since I had Covid in January. However, since about 3-4 days after I had my booster, my taste has been extremely dulled.   From the previous Covid vaccines I have experienced typical reactions to them. I get a headache every time about the same time period after administration of the vaccine. I also experience nausea, chills, and fatigue. I haven't had a fever with the vaccines, but my temperature is usually higher than normal. I experience some difficulty sleeping. My chronic health issues also flare-up after each vaccine, particularly Postural Orthostatic Tachycardia Syndrome (POTS) symptoms and Narcolepsy symptoms. I have an increase in presyncope, cataplexy, and sleep attacks to the point where I am temporarily bed ridden.  However, this is the first time I have experienced loss of taste with a Covid vaccine. Since it isn't listed as a common experience, I wanted to report my experience. My taste is still dulled and shows no signs of returning at this point. Please note that I did take several fda approved at home rapid tests. All were negative for Covid. Please also note that my son tested positive for RSV and Rhinovirus on October 24th. I tested again for Covid during this period, just to be sure. Still negative.
First time tested positive; First time tested positive; Sore throat; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: Er2613), in left arm, on 09Apr2021 at 10:00 as dose 2, single (Lot number: Ew0153), in left arm and on 30Nov2021 at 10:00 as dose 3 (booster), single (Lot number: Fj8762) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METFORMIN HYDROCHLORIDE; CALCIUM; VITAMIN B COMPLEX; CRANBERRY [ASCORBIC ACID;VACCINIUM MACROCARPON]. Past drug history included: Reglan, reaction(s): "Known allergies: Reglan"; Compazine, reaction(s): "Known allergies: Compazine".  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "First time tested positive"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore throat"; FATIGUE (non-serious) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: First time tested positive; (2022) Negative, notes: 5 days later tested negative; (27Apr2022) Positive, notes: Tested positive for Covid a second time. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient took other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. First time tested positive Sore throat, fatigue. Mild symptoms. 5 days later tested negative. The patient received treatment for the adverse event with Paxlovid. 4 days later started with stuffy nose, sneezing, and mild cough. On day 5 after completing Paxlovid, tested positive for Covid a second time. The symptoms are much worse this time. Date of start of reaction/event: 27Apr2022. Date of end of reaction/event: 02May2022. No Hospitalization Prolonged. AE resulted in none of the above.
Rec'd injections/vaccines (Tdap & INFLUENZA) on 9/30/2011 & on 10/20/11 came in c/o 2 1/2 wk hx of bilat hand pain & stiffness. By Oct 28 had developed fatigue & numbness in arms & legs, EMG was ordered. Ultimately diagnosed with Transverse Myelitis.
Severe lymphadenopathy.  Lymph nodes on the left side across upper chest, clavicle, and left arm, and left arm pit were swollen and painful.
She had a former patient complain of chronic cough after receiving Prevnar; This is a spontaneous report from a contactable consumer via Pfizer sales representative.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) () via an unspecified route of administration on an unspecified date at single dose for immunisation.   The patient medical history and concomitant medications were not reported.  The patient experienced she had a former patient complain of chronic cough after receiving PREVNAR 13on an unspecified date. The outcome of the event was unknown.  Information on the batch number has been requested.
This is a spontaneous report received from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 29Jan2021 11:45 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, and allergies to medications, food, or other products (unspecified). The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jan2021 12:15, the first 8 hours, the patient experienced nausea, dizziness, and slight headache. The patient did not receive any treatment for the events. The clinical outcome of nausea, dizziness, and slight headache was recovered on 29Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
pt recvd vax; w/in 20mn pt tongue & throat became swollen;pt exp tight feeling in chest & difficulty breathing; also hot flashes & a metallic taste;MD felt BP norm but pt said BP usually much lower;
Patient was given the bivalent formula by mistake. She should have received the original formula since she was getting her 2nd injection in the series. Her initial injection was given  11/18/22.
Minutes after receiving the shot on Monday, 3/22/2021 at approximately 11:15am, I (F/37yo) felt a very small, but acute tightness/pressure in my upper right chest area. I didn't initially report it as it was not one of the listed reactions I had read about in the information given to me -- I assumed I was very anxious, maybe breathing nervously, and that it would go away. The next day I felt very fatigued, light-headed, had extreme muscle and joint pain throughout my body, slight nausea, and the injection site (my left arm) was very sore. I took Tylenol and slept.  I felt weak and "off" the whole day. The acute chest pain I felt after the shot had now become less "acute" and turned into a wider and duller general pressure. The next day, Tuesday, I also began feeling intermittent flashes of hot or cold-like patches in my head, which I also consider a part of a general inflammation my body might be having. It is now Thursday, 3/25/2021 and the chest pressure has increased even more, having now spread from the upper right side to include the center of my chest. My headache is still lingering, I still don't feel like my normal self and feel "off" somehow, and the chest pressure is worrying me because I don't know what's going on internally. I reported the chest pain to my doctor and was told that my exact reactions don't make any sense in relation to the known adverse reactions to the Moderna COVID vaccine. I was advised to report this here and to also go to an urgent care clinic or emergency room if my symptoms worsen.
Nickel-sized raised red area that itched and caused pain on left knee area, similar on right side of forehead but did not itch until a later date. He claims it felt similar, but less severe, than a previous case of shingles.
Rash all over the body 1 week after receiving the booster; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH (Rash all over the body 1 week after receiving the booster) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, LOSARTAN for Hypertension.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced RASH (Rash all over the body 1 week after receiving the booster). At the time of the report, RASH (Rash all over the body 1 week after receiving the booster) had resolved.            Symptoms: It was reported that the patient had experienced rash all over her body and wanted to know information about fillers, she spoked to her dermatologist and it was told to her that they had seen cases like this after Moderna vaccination. Patient had experienced similar rash in the past with other medicine, she had done patch test prior and one of the ingredient was the concern for her rash. It was reported that the rash was no longer there.  Concomitant medication includes: Thyroid Pill No treatment medications were reported
Got the 2nd vaccine at day 14 instead of 21.  No known side effects
A report has been received from a physician concerning a female patient (her daughter). Medical history, concurrent diseases and concomitant medication of the patient were not reported. On 06-Sep-2012, FLUMIST was administered to the patient as a single dose in one nostril. The action taken with FLUMIST was unknown. The outcome of the event of full dose administered in one nostril was unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 03-Oct-2012: vaccination date added. Corrected report 06-Dec-2012: Coding of event 'full dose administered in one nostril' changed from intentional drug misuse to drug administration error, narrative updated. Corrected report on 18-Apr-2014: reporter's details updated, full narrative added.
Large knot under skin where the shot was given, and red circle approximately 1 inch around the area where the shot was given
Sore arm (left); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (left)) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm (left)). At the time of the report, PAIN IN EXTREMITY (Sore arm (left)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-297408.
Vaccine not properly injected - Immediate discomfort with increasing pain and loss of range of motion in (L) arm/shoulder over next few days which had persisted with some resolution.
big red itchy hive appeared near the injection site.; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8727) via an unspecified route of administration in the right arm on 20Mar2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had allergies to shellfish, mushrooms, cats and seasonal allergies. Concomitant medication included daily vitamins (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. On 20Mar2021, it was reported as "within few minutes after receiving my first dose, a big red itchy hive appeared near the injection site. Should I get the second dose?". The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measure was taken as a result of the event. The clinical outcome of the event big red itchy hive was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
RHEUMATOID ARTHRITIS FLARE UP HERE AND THERE (HAND AND WRIST); COVID-19; This spontaneous report received from a patient via other manufacturer (Company) concerned a 60 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose, 1 total start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Concomitant medications included methotrexate, prednisone, hydrochloxine and patient took shingles vaccine.  On an unspecified date, the patient experienced rheumatoid arthritis flare up here and there (hand and wrist). On JUN-2022, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from rheumatoid arthritis flare up here and there (hand and wrist), and covid-19 on 2022. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220832304-Covid-19 vaccine ad26.cov2.s- rheumatoid arthritis flare up here and there (hand and wrist). The event(s) has an unknown/unclear 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
(Tdap vaccination) Headache, sore throat, fever, tiredness the following day and still as of 09/26/2010 red soreness at back of throat with pussy zits near tonsils. Patient must cancel endoscopy scheduled for 10.01/2010 due to soreness and difficulty swallowing.
Fever 101.5, headache, chills, 1 1/2  day
Client stopped by pharmacy to get flu/pneumonia vaccines. After she was vaccinated, she was fine. She left the pharmacy and in about 10-15 minutes she came in complaining about her , trouble breathing. I called 911 immediately, she was still conscious till help arrived. Paramedics came and took her away.
Temp of 103.1 afternoon of shots. Treatment was to give TYLENOL/MOTRIN and watch for any other symptoms.
Right deltoid very swollen-free ROM  of arms over tricep. Red, hot, very swollen Gave Motrin and Tylenol
Slightly swollen, warm/hot to touch, red rash around injection site 8 days after injection . Noted on 1/26/2021
pt recv vax 4NOV98 awake 6NOV98 w/hives over entire body;took DPH w/some relief;