chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SKIN RASHES THAT BRUISED UP; BIG DARK RED CIRCLES SPOTS ALL OVER BODY (ITCHY, PAINFUL AND BURNING SPOTS ON HANDS, LEGS, ARMS AND PRIVATE PARTS AND THE SPOTS APPEAR FLAT (NOT RAISED)/RED SPOTS ON HANDS AND FINGERS/SKIN RASH; SWELLING AROUND EYES; ITCHY, PAINFUL, AND BURNING DARK PURPLE SPOTS UNDER THE SKIN ALL OVER THE BODY; This spontaneous report received from a consumer via a company representative concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no prior medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 21-OCT-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-JUN-2021, the patient experienced swelling around eyes. On 20-JUN-2021, the patient experienced itchy, painful, and burning dark purple spots under the skin all over the body. On 20-JUN-2021, the patient experienced big dark red circles spots all over body (itchy, painful and burning spots on hands, legs, arms and private parts and the spots appear flat (not raised) /red spots on hands and fingers/skin rash. On an unspecified date, the patient experienced skin rashes that bruised up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling around eyes, big dark red circles spots all over body (itchy, painful and burning spots on hands, legs, arms and private parts and the spots appear flat (not raised)/red spots on hands and fingers/skin rash, and itchy, painful, and burning dark purple spots under the skin all over the body, and the outcome of skin rashes that bruised up was not reported. This report was non-serious.
Information has been received from a nurse practitioner concerning an 18-20 year old female who on an unspecified date was vaccinated with her first dose of Gardasil (lot number, route and site not reported). On an unspecified date the patient was vaccinated with her second dose of Gardasil (lot number, route and site not reported). The nurse practitioner reported that the patient experienced seizures the day after receiving the second dose of Gardasil. The patient's outcome was not reported. No further information was provided. Upon internal review seizures were considered to be an other important medical event. Additional information has been requested.
immediate tingling in injected arm which went after 10 minutes photophobia and blurred near vision 30 mins after vacc 8 hours after vacc: severe headache, chills, joint pain over whole body, extreme fatigue, sinus congestion. these lasted over 24 hour period.
I had severe swelling under my left armpit and it was very painful. I was given antibiotic.
Warm, red rashes', swelling at shot site and down arm.  Swollen and painful
Moderna COVID-19 Vaccine EUA 1/5/2021- injection site soreness (8/10), stiff muscle in arm and warmth to site. Unable to lift arm fully due to pain/stiffness 1/6/2021- continued as above 1/7/2021- very mild tenderness to injection site only if touched.
severe migraines; This is a spontaneous report from a non-contactable consumer (patient).  A 31-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 31 years old, via an unspecified route of administration in left arm on 29Apr2021 at 12:00 at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient had no known allergies. Other medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in four weeks or any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 31 years old, via an unspecified route of administration in left arm on 08Apr2021 at 12:00 at single dose for COVID-19 immunisation. The patient started getting severe migraines after second dose on 29Apr2021 at 16:00. Migraines continue even after 5 months since last shot. Event resulted in none of the above. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Painful and difficult urinating, similar to UTI. Burning sensation amplified after urinating. Prescribed in Urgent Care antibiotics on 07/18/2021 did not help. Prescribed on 07/21/2021 Fluconazole treated the infection, felt the relief after 1 day.
A few days later experienced pain in my lower back and strange pains in my head. Those subsided and I started feeling a pain in my upper back on the right side. By the beginning of October(7th) I started with very strong chest pains and went to the cardiologist. Everything was normal. On October 11th my husband took me to the ER with the same chest pains.  All normal.  By October 13 I developed the shingles rash and extreme pain.
patient ever had the flu, whwn got a flu shot; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves patient (unknown demography) who had the flu (influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication (s) 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 and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious who had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for the event influenza.  There will be no information on the batch number for this case.
This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 16-SEP-2014 the patient was vaccinated with PEDVAXHIB, (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 79 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was received Paxlovid as treatment. Treatment start date: 22Jan2023, Treatment stop date: 27Jan2023.
Felt light-headed /nauseous/raised hand/EMT/paramedic/nurse responded /pt. placed on stretchers. Decreased Blood pressure, Increase Heart rate within 10 minutes, Increase Blood Pressure, taking water, responsive, wife called. Blood sugar 76 per finger stick. Wife picking patient up.  4:20 BP=84/57        HR=100 Now 4:27 BP=114/81     HR=98 Vital signs at 4:40  BP=128/87   HR=97          Recorded by  Paramedic
Two days later 01/18/2021 to 02/01/2021  increase in my glucose levels   range from 125 to 283
Headache, intestinal ache, aching in neck, shoulders, back, elbows wrists, hands, hips, knees, feet
pt recv vax 12AUG97 & on 14AUG97 pt presented to MD w/ 10.5cm x 7cm induration & redness @ the inj site & exp a h/a;pt also reported that was burning & itching inside entire body;19AUg97 pt recovered;
headache; body ache; Stomach ache; felt like fever, was hot; little soreness in upper arm; ill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Sep2023, outcome "unknown", described as "Stomach ache"; PAIN (non-serious) with onset Sep2023, outcome "unknown", described as "body ache"; FEELING HOT (non-serious) with onset Sep2023, outcome "unknown", described as "felt like fever, was hot"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown"; ILLNESS (non-serious) with onset Sep2023, outcome "unknown", described as "ill"; PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "unknown", described as "little soreness in upper arm". Additional information: The patient's wife (reporter) stated that this time, there was not only soreness but, overnight, got very ill, had headache, body aches, stomach aches, thinks she had fever. Was too sick to get up and check temperature. Eventually, it subsided, just surprised her a lot. Reporter and husband were in 2 different places, both had same reaction. Both had vaccines at same place.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312069 same reporter/vaccine/event, different patient;US-PFIZER INC-202300312076 different patient/vaccine, different dose and event;US-PFIZER INC-202300024576 different patient/vaccine, different dose and event;
Severe Stomach pain; 3 in red hard spot where my injection was given; Injection site hard; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site induration. On 28th October 2019, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain, injection site erythema and injection site induration were unknown.   It was unknown if the reporter considered the stomach pain, injection site erythema and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient experienced about a 3 in red hard spot where injection was given. The patient also experienced severe stomach pain. The patient was concerned about stomach pains and asked whether it is normal.
Initial case received from a consumer, who is also the patient, on 13 August 2010.  The patient also reported similar events in his wife; that information is captured in case number 2010-04382.  A 46-year-old male patient received an intramuscular left deltoid injection of MENACTRA (lot number not reported) on 11 August 2010 for travel purposes.  The patient denied relevant medical history or illness at time of vaccination, and had no known allergies.  One day post-vaccination, on 12 August 2010, the patient complained of a fever, headache, and fatigue.  He also noted redness, swelling, and warmth at the injection site, and complained that his arm was sore.  He was seen by a physician on 14 August 2010 and treated with steroids and antibiotics.  The patient noted that he had missed 3 days of work.  As of 15 August 2010, he reported feeling "better", although his arm was still sore.  Follow-up information was received 31 August 2010 from a health care professional who provided lot numbers for which identified the events experienced by this patient and his wife (captured in case 2010-04382) are in the context of a cluster.  The MENACTRA lot number was U3434AA.  Outcome remained not recovered.  Documents held by sender: none.
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 12 year old female patient with no pertinent medical history or drug reactions/allergies who on 07-MAR-2011 was vaccinated with a dose of GARDASIL (lot # 662299/1099Y, exp unspecified). There was no concomitant medication. Subsequently the patient found out she was pregnant on 01-APR-2011. She took blood work, results not was reported. There was no adverse reaction reported. There was no treatment given. The patient did not seek medical attention. Follow-up information has been received from a healthcare worker. It was reported that the patient chose to have an elective abortion on 11-JUN-2011. It was reported that her LMP was 02-MAR-2011. It was reported that she had a fetal ultrasound on 15-APR-2011 that revealed cardiac activity with a gestational age of 6/2 to 7 weeks. No fetal anomalies were noted in the ultrasound report. Upon internal review, elective abortion was determined to be an other important medical event. Additional information is not expected.
Arm, red, swollen, and warm to touch at site of immunization. Augmentin 600 ES 1 teaspoon BID x 7days.
Breezed through #1 and #2. Had those 03/28/2001, and 04/28/2001. Took the booster on 11/25/2021. Put me in bed for 2 days wondering if my husband got the license number of the bus that hit me.  On the second night it felt like a fever that broke. My endocrinologist ran my T-SHIRT and a cbc . My cbc was all over the place. Had steroids,n-plate, ridican, bone marrow biopsy (2), immune globular, pet scan..full body, vide a and much more. Having transfusion of platelets just about every week, and whole blood about once a month.
Lost my taste and smell/ there are thousands of us; Lost my taste and smell/ there are thousands of us; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Lost my taste and smell/ there are thousands of us".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300055322 same suspect drug and AE/different patient;
Reports that after his Td shot on Sept 22 the site of the injection still numb and with a knot that bothers him to raise his arm. He also report breaking down in a rash. He reports that he has taken Tetanus shots before and had never cause him any problems. He said that the rash has subsided and gone but his Rt deltoid area is sore. Denies any fever or chills.
Noted Left arm painful the morning following the vaccination with erythema and welting (firmness extending laterally) and onset of Temp > 102 that evening. Erythema and welting continued to spread and fever continued, peaking at day 3 before gradually receding. He also missed one day of work due to feeling so poorly, but says he felt fine by day 4. Client did not seek medical assistance.
2/23 vaccination Within 12 hours, I started shaking, spiked fever, HR increase, SOB, out of body experience, scary experience. Called 911 transported to ER. Monitored cardiac unit for 24 hours, HA. Two months of HAs. I went home and I don't recall exact how everything transpired.  I do remember they wanted follow up with PCP.  I developed blood clots in R arm, platelets were high since getting vaccinated.  *originally diagnosed with colitis but now diagnosed with Chrohns disease.  1/16 I did have a personal injury in a parking lot that exacerbated the issues, I was vaccinated after.  *In transition with new doctors now and have not really discussed the potential of this being caused by vaccine, focused more on pain management.  **before this vaccine, I was relatively healthy before, no issues.
Initial misuse report received on 09-Dec-2013 from a health care professional. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient received underdose of PENTACEL. As of 09-Dec-2013 patient did not have any adverse events. List of documents held by sender: none.
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Developed a rash on chest, back, and legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (Developed a rash on chest, back, and legs). At the time of the report, ERYTHEMA (Developed a rash on chest, back, and legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Pregnant at the time of vaccination?: Yes; Body chills; Headache; Fatigue; This is a spontaneous report received from a contactable consumer or other non hcp. This consumer reported information for both mother and fetus/baby. This is a maternal report. A pregnant patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 13Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. The patient experienced body chills, headache and fatigue on Apr2021, pregnant at the time of vaccination?: yes on 13Apr2021. The mother reported she became pregnant while taking bnt162b2. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Has developed sterile granulomas at injection sites, multiple times after receiving 2 sets vaccines 8/6/06 and 9/7/07.
09/21/2012  SEVERE VOMITING, CHILLS, SWEATS. PHARMACIST RECOMMENDED GATOR ADE OR PEDIALYTE.
pt recv vax & 5hrs later devel a fever 104-105 & an inj site rxn,characterized by local induration & an inability to bear weight on lt thigh;tx IV ATB for suspected cellulitis;addtl info recv 13FEB96 resulted in reclass rpt as serious
customer works at a physician office and the doctor called to let  us know that the customer received a booster dose of the moderna and has a warm red patch at the site of injection.
5 hrs p/vax pt suffered an allergic asthamatic reaction accompanied by wheezing; pt wheezed for 1 wk p/the vax; pt would have died if someone else had not been in the room;
pt recvd flu vax @ 1030AM waited for 15 mins w/no adverse react; 4PM the same afternoon pt c/o throat tightening & muscle tenderness on rt side of neck under chin; difficult swallowing & throat sore but not red; muscle achiness, tiredness;
Generalized itching after receiving the second dose; Losing sleep because of the itching; Severe itching - mostly on her arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Losing sleep because of the itching), PRURITUS (Severe itching - mostly on her arms and legs) and PRURITUS (Generalized itching after receiving the second dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015B20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Drug allergy (Sulfamethoxazole). Concomitant products included AZELASTINE, BUDESONIDE, LATANOPROST, ALBUTEROL [SALBUTAMOL], MESALAMINE, FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), BUSPIRONE, MELOXICAM (MELOXICAN), ENALAPRIL and DICLOFENAC (VOLTAREN [DICLOFENAC]) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2012,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Severe itching - mostly on her arms and legs). On 17-Mar-2021, the patient experienced INSOMNIA (Losing sleep because of the itching). On an unknown date, the patient experienced PRURITUS (Generalized itching after receiving the second dose). At the time of the report, INSOMNIA (Losing sleep because of the itching), PRURITUS (Severe itching - mostly on her arms and legs) and PRURITUS (Generalized itching after receiving the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment: Antihistamine Drugs   This case was linked to MOD-2021-072689 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Events, product information updated On 11-May-2021:
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 07-OCT-2013, the patient was vaccinated with VARIVAX (lot # J003223 expiration date: 15-MAR-2015) (dose, indication and route were not reported). From 19-SEP-2013 to 17-OCT-2013, the VARIVAX may had gone through an unsupported temperature excursion. No adverse effects reported. The outcome of an unsupported temperature excursion was unknown. Additional information has been requested.
11/11/21: screening COVID-19 PCR negative 11/14/21: Pfizer COVID-19 vaccine administered.  That evening felt tired 11/15/21: Awoke with chest pain.  Evaluated at Urgent Care, EKG, CXR normal 11/16/21: Worsening chest pain, SOB, cough.  Afebrile. COVID-19 PCR+  That evening presented to ED at a local health care facility. Hypoxic, tachycardic.  Troponin-I  0.89.  EKG normal.  Echo normal.  ESR, CRP normal.  Admitted to ICU. Received Redemsivir.  Recieved ibuprofen.  Cardiology consulted.  Serial EKGs normal.  Serial troponins decreased to 0.47, 0.2.  Weaned off O2, discharged to home on ibuprofen. Length of hospitalization: <24 hours.   11/17/21: well appearing, no chest pain, no tachycardia, no hypoxia, no SOB.