chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states they tested positive for Covid19 on 11Dec2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller states they tested positive for Covid19 on 11Dec2022) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 32M20A and 0114214) for COVID-19 prophylaxis.     Concurrent medical conditions included Food allergy (Apple allergy).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2022, the patient experienced COVID-19 (Caller states they tested positive for Covid19 on 11Dec2022). At the time of the report, COVID-19 (Caller states they tested positive for Covid19 on 11Dec2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2022, SARS-CoV-2 test: Positive. On 21-Dec-2022, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient was tested positive for Covid-19 on 11-Dec2022, after 10 days they tested negative and she would like to know if she can now receive the Moderna Covid 19 Bivalent vaccine. She heard from a friend that it could reactivate the virus and she wanted to know what was the recommendation. When she tested positive she had fever and cold like symptoms, but her biggest fear was to have respiratory complications. As treatment she took antivirals but does not remember the name.
Dyspnea and Chest pain, Pulmonary Emboli, Apixaban, admitted to hospital for further workup
Pain in muscle at site of vaccination for 2 days; Converted to swollen lymph nodes; Lethargy for 2 days; Pain in muscle at site of vaccination for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jun2021 08:00 (Lot number: EW0713) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SYNTHROID; LISINOPRIL; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION SITE PAIN (non-serious), MYALGIA (non-serious) all with onset 04Jun2021 11:00, outcome "recovered" (06Jun2021) and all described as "Pain in muscle at site of vaccination for 2 days"; LYMPHADENOPATHY (non-serious) with onset 04Jun2021 11:00, outcome "recovering", described as "Converted to swollen lymph nodes"; LETHARGY (non-serious) with onset 04Jun2021 11:00, outcome "recovered" (06Jun2021), described as "Lethargy for 2 days". Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy, lethargy, myalgia.  Additional information: The patient did not receive any other vaccine in four weeks. Other medications in two weeks included Metformin, Synthroid, Lisinopril, Aspirin. The patient was neither diagnosed with Covid prior vaccination, nor been tested with Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
soreness at injection site; Left arm pain for a week; developed body aches which lasted for 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021417529 (Pfizer).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 11:45 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]; IBUPROFEN. Vaccination history included: Bnt162b2 ({product=COVID, 19, brand=Pfizer, lot_unknown=False,, administration_date=19/03/2021,, administration_time=10:45 AM,, vaccine_location=Left arm,, dose_number=1}]), administration date: 19Mar2021. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "recovered", described as "soreness at injection site"; PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "recovered", described as "Left arm pain for a week"; PAIN (non-serious) with onset 09Apr2021, outcome "recovered", described as "developed body aches which lasted for 24 hours". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, pain.  Additional information: No treatment received, no covid prior to vaccination, no covid tested post vaccination, no vaccines received within 4 prior to the covid vaccine, no allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a doctor of pharmacy concerning a pt who about 5 years ago was vaccinated with varicella virus vaccine live. It was reported that a recent titer did not show seroconversion. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
pt said she felt nausea/heart rate racing/dizzy she had szlasted less than a minute 911 activated she did not go with them-they checked her out and said she was going to be fine.
Allergic reaction; Itchy; Tingly tongue, gums, and lips; Tingly tongue, gums, and lips; Tingly tongue, gums, and lips; Swollen arm; Sore and upset all over; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that Caller states that she already received her first dose of the Pfizer BioNtech COVID-19 vaccine. She states that she experienced itchy, tingly tongue, gums, and lips 20 minutes after receiving the first dose and it lasted for 2-3 days. She is asking if she can receive the first dose after having an allergic reaction to the 2nd dose. Caller mentioned that she took some antihistamines and that it what was given to her but the side effects are still there and it did not stop it, and stayed that way for 2-3 days. She is asking if we have data on how many people has had this particular reaction before. She states that she had done some allergy testing before, years ago, but she had no problem with any other vaccine. She clarified the problem that was not completely normal as she started having itchy, tingly stuff with her tongue, gums, and lips. She was informed this was not a typical reaction. It started 20 minutes after the injection. She had to stay there a while and was given Benadryl. After the Benadryl it did not get any better, but it did not get any worse. She had this reaction go on for two days. This was not typical. The outcome of the events was unknown on an unspecified date. Therapeutic measures were taken as a result of allergic reaction (hypersensitivity), itchy (pruritus), tingly tongue, gums, and lips (paraesthesia oral), tingly tongue, gums, and lips (paraesthesia oral), tingly tongue, gums, and lips (paraesthesia oral) , swollen arm (peripheral swelling), sore and upset all over (pain). Follow-up attempts are needed; information about lot/batch number has been requested. Follow-up (16Jul2021): 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.
Patient had an allergic reaction. Onsite EMS was called vitals BP 148/62  98% O2 HR 70. Patient Refused evaluation or care. Released against medical advise.
Woke up sometime around 18 Hrs post vaccination (2nd Dose). Extreme chills, dehydration, and skin tempreture (Internal showed normal at 97.9)
11/9/2021 pt tested positive for COVID at Urgent Care; came to Hospital on 11/15/21 for SOB; treated with remdesivir, Baricitinib, dexamethasone with no improvement; found to be positive for AIDS on 12/4/21; intubated; 12/9/21 transferred to Medical Center for ECMO evaluation; severe ARDS with opportunistic infections; pt required heavy sedation; grim prognosis; refractory shock; pt's condition continued to deteriorate and he passed away in the hospital; death certificate and med records sent
6 hours after shot, pt experienced chills, joint/muscle pain, fever, headache, rash appeared at site of injection four days after injection. Rash was red, bumpy, and itchy. No treatment was needed.
Patient states site of injection swelled within hours of receiving vaccine. Large bruise at site 4-5 inches round. No blistering or peeling. Bruise now yellow and purple in color.
The patient's arm is very sore and swollen over one week past injection. The injection site is hard and there is a rash on the arm. The rash is around the injection site about the size of patient's palm.
Influenza vaccination given during school-based flu clinic. Client states that she went to the school nurse approximately 2 hours after she received her influenza vaccine complaining with hives and itching. School nurse gave her Benadryl and symptoms improved.
This person should have received adult Td instead of DTaP. Age at time of vaccination was 8 years. No adverse reaction occurred.
#1 dose 12/18/02 arm (entire) burned for two days. #2 dose 1/8/03 same as above. #3 dose 1/22/03 arm burned for two days. A couple of days post the shot-developed overall body rash-burning all over and itchy. Rx'd with steroid, Tagamet, and Atarax. 3/3/03 still has rash.
Thrombosis leg; Allergy to vaccine; This spontaneous report received from a patient concerned an adult female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: unknown) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in left leg (thrombosis leg) and allergy to vaccination shot with humira (adalimumab)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported for event blood clot in left leg (thrombosis leg) and not applicable for event allergy to vaccination shot. The patient recovered from allergy to vaccine, and had not recovered from thrombosis leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211105084-covid-19 vaccine ad26.cov2.s-thrombosis leg. 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).
2 hours after office visit and MCV she had chest tightness and difficulty breathing. She was treated for wheezing in the ED with Albuterol x 1. She also reported vomiting and diarrhea x 1 about 4 hours after. Some dizziness; No syncope. Had 2 doses of BENADRYL. Has had headaches on and off too. Sore throat began 4 hours after immun.
Right arm sore; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  An adult female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm right, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Right arm sore". Additional Information: The patient received the first dose on Feb2021, 02:00PM. The patient did not receive any other vaccine in four weeks. The patient has not been diagnosed with COVID prior vaccination and has not been tested for COVID post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021362101 same patient, vaccine different dose, different AE.
COVID-19; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. 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, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for rheumatoid arthritis. No concomitant medications were reported. On JAN-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 covid-19. This report was non-serious.
Information has been received from a nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with a dose of improperly stored (Merck) VARIVAX (strength, lot# and route not provided) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to a patient of currently 60 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L027322, expiry date unspecified (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX was involved in temperature incident. This is one of several reports from the same reporter. Additional information has been requested.
Chills; Felt hot on outside; Pain at injection site; Feels like can't think straight; Tenderness at injection site; Swelling at injection site; A spontaneous report () was received from a consumer concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, felt hot on outside, felt cold on outside, pain at injection site, tenderness at injection site, swelling at injection site, feels like can't think straight.  The patient's medical history was not provided. Concomitant medications reported were Shot of vitamin d 12 for drug use for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010a21a) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) chills, felt hot on outside, felt cold on outside, pain at injection site, tenderness at injection site, swelling at injection site, feels like can't think straight.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), chills, felt hot on outside, felt cold on outside, pain at injection site, tenderness at injection site, swelling at injection site, feels like can't think straight was unknown.
Extreme heart burn, menstrual cycle, body aches, sweating, soreness at the injection site
Child fainted on the chair 30 minutes after receiving IPV,MMR,Varicella,Flu and Mantoux testing.Episode lasted for 1-2 minutes. As per father child was scared of needles. Child was observed in the clinic half hour.Follow up call on 4/22 child was doing well,active and playing complaining of just soreness from the injection site.
Went to primary care physician. Described as flu/pneumonia-like symptoms and antibiotic was given (amoxicillin then Levaquin) and an injection (unknown name).
Since the middle of July I started getting dizzy, headache, back ache. my  hands are shaking, vertigo, and unable to maintain balance.  And general body aches.
03/18/2021 Woke up with hearing loss, fullness and loud tinnitus in left ear; fullness and increased level of tinnitus in right ear. Had small amount of ear wax removed from left ear with no improvement. Erratic blood pressure and pulse rate. Doctor started me on Amlodipine which I have now discontinued as BP has returned to normal. Fullness and high level of tinnitus continues in both ears with some intermittent improvement.
Post vax, the pt experienced severe epigastric pain, sharp constant pelvic pain bilaterally, vague viral type reaction, loose bowel movements, weakness, and myalgias. He was treated with Prevacid.
Approximately 1 hour after injection face turned numb . Then left side of body went numb . Than burning fever , over the next 8 hours I had spasms,  sight became poor in left eye . Headache and profuse sweating . Burning fever for 2 days . On 08/12/21  had to go to doctor with chest pain . Blood pressure was extremely elevated . Shortness of breath . Diagnosed with pneumonia.  Left long infected . Previous symptoms lasted about 5 days .
Case number PHEH2015US020110, is an initial spontaneous report received from a consumer (patient) on 07 Oct 2015. This report refers to a 60 years old female patient. Historical condition and concomitant medication were not provided. Her vaccination history included administration of influenza vaccine (manufacturer and batch number: not reported) with no problems. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 05 Oct 2015. Later that evening the patient experienced pain in left foot arch; redness in foot, ankles and hands; swelling of ankles, hands and knuckles. Further the patient experienced low grade fever. The patient got his uric acid levels tested at physician's office and those levels did not indicate gout. Final outcome of the events were unknown. The seriousness and causality of the events were not reported.
Glands swollen; pain; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media  This case involves a patient (age and gender unspecified) who had glands swollen (lymphadenopathy) and Pain, when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was glands swollen (lymphadenopathy) and pain (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Body ache, severe sore throat, headache and tightness next to my brain behind my ears sneezing!
Patient received the 65 and older flu vaccine at the local pharmacy administered by the pharmacist paid for by our insurance. She received the shot about 1:30 p.m. on 9-24-13 Tues. and felt okay until the next day (Wed) about 6:45 a.m. when she started vomiting and continued to vomit about 25 times until about 4:00 p.m. and I took her to an urgent care. No temperature. We had to wait about 2 hrs. to be seen and they gave her a bag to vomit in. About 6 p.m. the doctor gave patient a ZOFRAN ODT 4mg tablet which she vomited up. The nurse tried to administer an I.V. but could not find a vein because of dehydration and the doctor didn't try. The doctor gave her another ZOFRAN tablet which stayed down this time and stopped the vomiting and she was released at 7:45 p.m. Patient felt better by the morning of 9-29-13 (Sat.) but became very constipated over the weekend so on Mon. 9-30-13 I bought some DUCOLAX suppositories which helped. It took about 6 days to recover. No more flu shots for us. The flu shot cost our insurance about $31.00 which was the cheapest part of the process.
Left upper out arm has large raised welt-like erythematous area with pinpoint center, large 5 inch welt, treatment: CLARITIN or BENADRYL, along with applying ice or heat as tolerated, and follow up by 9/17/18 if symptoms are still present or sooner if symptoms worsen.
Information has been received from a pharmacist concerning a male baby who was born from a 23 year old female with penicillin allergy and obesity with a history of 1 pregnancy and 1 full term live birth with no birth defects or infant complications in previous pregnancies and a history of postpartum depression after first pregnancy, who on 04-DEC-2008 was vaccinated into the left deltoid with first dose of GARDASIL (dose and route not provided) (lot number 661044/0548X). Concomitant therapy included prenatal vitamins (unspecified) for supplement. It was reported that the patient's mother gave birth to a normal male infant with no congenital anomalies, weighing 9 pounds and 13.9 ounces (length 22 inches; head circumference 36.3cm) on 17-JUL-2009, at 40 5/7 weeks from LMP. The baby experience fetal macrosomia and reduced fetal movement but was a normal newborn. Medications the mother used during pregnancy included cyclobenzaprine (started on 04-FEB-2009) for the treatment of muscle spasm/shoulder strain, metronidazole (From 09-MAR-2009 to 16-MAR-2009, dose 500mg BID) for the treatment of bacterial vaginosis and sulfamethoxazole (+) trimethoprim (from 05-JUN-2009 to 09-JUN-2009, dose 800/160mg BID) for presumed UTI, culture negative. Follow up information was received from a pharmacist. It was reported that the intended vaccine for the mother was influenza virus vaccine (unspecified). The patient's mother delivered a live born infant on 17-JUL-2009 without problems. It was noted that the patient's mother received prenatal vitamins, sulfamethoxazole (+) trimethoprim, cyclobenzaprine and metronidazole during her pregnancy. The mother's experience during pregnancy is reported in WAES 0812USA02810. No further information is available.