chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning an 8 year old male pt who on 07Dec1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approx 08Apr04, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
This is follow-up to report(s) previously submitted on 5/24/2008. Information has been received from a 68 year old registered nurse with an unspecified thyroid disorder, mitral valve prolapse, haemangioma of liver, acute fibromyalgia, nodules and scar tissue on the lungs from bouts of pneumonia, DEMEROL and VICODIN drug allergies, unspecified environmental allergies and a history of pertussis, who on 17-JUN-2008 was vaccinated subcutaneously in the deltoid with 0.65 ml of ZOSTAVAX (Merck). Concomitant therapy included LIPITOR, amitriptyline hydrochloride, lorazepam, AMBIEN and diltiazem HCL. The nurse reported that she developed a swollen arm a day after receiving ZOSTAVAX (Merck) on 18-JUN-2008. The nurse stated the swelling resolved without treatment in about one week; however, the nurse stated there appears now to be "a small mole" that developed at the injection site. Follow up information was received from the physician on 03-DEC-2010 indicated that there was no actual adverse event. The patient did not seek treatment for the symptoms, and did not seek for medical attention. At the time of reporting the patient is recovering from the AE. There was no product quality complaint. Additional information has been requested.
Fever, Nausea, Vomiting, Weakness, Muscle Aches, Increased Heart Rate, Shortness of Breath
Pain in left arm; Runny nose; Continuous cough; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown], via an unspecified route of administration, in left arm on 11Mar2021 at 10:00 AM (at the age of 67-year-old) as single dose for COVID-19 immunisation. Concomitant medications and past drug/medical history were unknown at the time of reporting. 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 COVID-19 vaccine. On 12Mar2021, the patient experienced Continuous cough, Pain in left arm, Runny nose. The patient did not receive any treatment for the events. The clinical outcomes of the events continuous cough, Pain in left arm, Runny nose were not recovered/ not resolved at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.
headache; increased thirst; This is a spontaneous report from a non-contactable consumer (patient). An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, it was unknown if the patient has been diagnosed with COVID-19 and post vaccination, it was unknown if the patient has been tested for COVID-19. On an unspecified date, the patient experienced headache and increased thirst. It was reported that it persist for one day. It was unknown if the patient received therapeutic measures. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dizzy, shaky, abd pain 5min p/vax;VS nl: ok p/leaving the clinic;
pt recv vax; large 140 mm x 135 mm red, swollen, warm area to lt deltoid w/in 48 hr p/ vax; no systemic sx; referred to MD to get tx; pain & itching; tx w/ cream & atbs
Janssen COVID-19 Vaccine EUA: three days after vaccination patient brought to emergency department (ED) via ambulance for sudden onset right upper quadrant pain. Admitted, administered pain medications, underwent procedures/testing, symptoms and labs improved, and patient discharged to home medically stable.
After the third dose my daughter got very pale, sweaty, aand dizzy.  The nurse and I layed her back on the exam table.  She became unresponsive for 10-20 seconds and stayed laying down for about 10 minutes after that until she was no longer dizzy.  My daughter started having heart palpitations after this and still has them today.  Starting in February 2009, they are accompanied by chest pains.  4/8/09  PCP records received from 7/15/08 to 2/10/09. Seen for 14 yr WCC on 7/15/08 with c/o heavy periods.  ROS (+) for headaches QOD.  PE WNL with acne. Started on Concerta of ADD and OCs to regulate periods.  Seen again 9/9/08 and 9/12/08 with c/o racing heart and irregular heartbeats associated with some anxiety.  PE WNL.  HR 95-105.  Assess:  Palpitations and/or tachycardia while on Concerta.  Nausea from OCPs. Referred to cardiology for Holter. Returned 2/10/09 for c/o chest pain with skipped beats and feeling like the heart is beating hard.  4-6 episodes in last 2 weeks. Assessment:  Likely precordial catch syndrome.  Palpitations. Holter to be scheduled.  4/29/09 Received Cardiology medical records of  10/7/08-3/5/2009. FINAL DX: Palpitations Records reveal patient experienced palpitations w/chest pain & dizziness.  Concerta had been d/c approx 1 mo prior to initial eval & palpitations had improved; however, patient needed to restart meds to maintain academic performance.  When seen 3/5/09 palpitations had recurred while on Concerta esp when exercising. No further records available.
Two days post vax, the pt's physician noted scattered erythemous papules with no fluid. The pt was treated with calamine lotion and Benadryl. On 8/11/00, the pt was again seen in the physician's office. The pt had a temperature of 98.3 which increased to 103. It was also reported that the pt complained of his mouth hurting.
Patient is a CNA that received vaccine at her work site clinic on the afternoon of 2/15/21. Pt expressed that not that much later at around 5pm she started experiencing cramping. Symptoms continued to worsen with hot flashes and vaginal bleeding for 10 days. Pt visited her PCP on 4/26/21 after continued symptoms and was prescribed Provera 10mg daily for 10 days. Pt states this helped with her symptoms and pt states she was fully recovered by 5/09/21.
Persistent proximal muscle ache. Sleep disturbance, fatigue, pervasive uterine temporarily, Ibuprofen, Tylenol, Destinez Lt3
On 08/22/2018 - Tdap given at time of PE. She started developing soreness in site and numbness in fingers. Has seen a little bit of improvement. Still tender to touch and move arm.
Seizure generalized tonic clonic with post ictal headache, confusion. No fever.
Client has a previous history of severe allergic reactions and carries an epi pen. At 1148 am, she reported her vision was changing and her voice was changing. She could feel her throat closing. 0.3ml of epinephrine given in the left deltoid at 1150 am. Within 2 minutes, her voice returned and she felt relief of the throat closing symptoms. Vital signs improved over 30 minutes. Took 50 mg of benadryl orally. She left the vaccine clinic with her epi pen in her purse with instructions to call her provider. We had a retired physician and two registered nurses at the clinic during this time.
Pfizer Dose 1 5/18/21 (EW0168) Pfizer Dose 2 8/18/21 (lot NA) Pfizer Dose 3 9/16/21 (lot NA) COVID Positive 2/6/22  2/5/22: The patient is a 73-year-old female who came to the emergency room with worsening shortness of breath.  The patient tested positive for COVID-19 infection 10 days ago after she had fatigue, generalized body aches and weakness. She has received all 3 doses of COVID-19 vaccination.  She is not normally on oxygen.  She is experiencing shortness of breath, headache, fatigue, nausea in the last 3 days for which she decided to come to the emergency room.  She has been isolating herself and taking precautions in the last 2 years not get any infection because of her immunosuppressive status because of methotrexate.  She has chronic psoriatic arthritis and multiple shoulder surgeries for dislocations.  She denies any cough, chest pain or weight gain.  She had remote history congestive heart failure but does not remember being on diuretics.  She never been a tobacco smoker and denies any history of COPD, denies any history of thromboembolism, seizure disorder malignancy.  In the ED blood work showed hyperglycemia, elevated anion gap, metabolic acidosis.  CT of the chest is unremarkable for any acute abnormality.  No PE  2/10/22: Patient is 73-year-old female came into the ED with worsening shortness of breath tested positive for COVID-19 10 days prior to admission reportedly had weakness shortness of breath as noted.  Was started on COVID-19 treatment protocol Rocephin/azithromycin, dexamethasone, Lasix inhaler/DuoNebs.  Was placed on supplemental oxygen wean down to between 2-3 L remains steady.  Has been able to ambulate some without acute symptoms.  Has some congestion mild coarse sounds noted, will finish empiric course of antibiotics on dispo doxycycline for 7 days, vitamin-C, vitamin-D, zinc, Mucinex, Tessalon.  Will need to mobilize.  Holding antihypertensives were held will continue metoprolol lisinopril, will need to be re-evaluated later this week on reinitiate Ng blood pressure medications.  Is getting Lasix initially IV will continue additional 3 days p.o. and potentially patient can switch over to hold hydrochlorothiazide subsequently.  Is maintained on Lantus and sliding scale during admission home regimen on dispo will need close monitoring.  Will be discharged on oxygen likely will need time to wean completely.  Isolation, COVID-19 precautions provided.  And will need to see PCP within 7 days for re-evaluation of blood pressure and to discuss re-initiation of medications, BMP to be done within 3 days to check on hypokalemia and ensure it is improving.
The patient is an exchange student. Arrived to the school with no vaccine records. Vaccines were ordered on a catch up schedule. Patient presented to clinic with signed consent forms. Patient was given vaccines. Patient then pulled out a vaccine history sheet which showed they had already been immunized previously. The patient had no side effects.
This spontaneous report as received from other health professional refers to a 9 month old male patient. On 03-DEC-2013, patient received expired dose of COMVAX with lot number (lot# H014513 and expiry date 29-OCT-2013), (strength, frequency unknown) 0.5 ml, intramuscularly and no adverse effect was reported. The outcome of received expired dose of COMVAX was unknown. No further information was provided. Additional information has been requested.
Four days after vaccines, he developed abnormal movements. He was evaluated in the ED and by PCP over the next three days, and was eventually seen by neurology. initial EEG was concerning for infantile spasms, so he was hospitalized. He was treated with Keppra and then high dose steroids. Repeat EEG was normal, and on outside read of initial EEG, the diagnosis of infantile spasms was questioned. It is now thought that he has benign shudders.
lymph nodes in armpit pain; armpit pain; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on 19Apr2021 (Batch/Lot number: not reported) as second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration on unspecified date (Batch/Lot Number: not reported) as single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced lymph nodes in armpit pain. Patient reported that today (at the time of reporting, 17Jul2021 patient was still with lymph nodes in the armpit. Patient visited the doctor, and the patient underwent the blood test which came back clear. Patient mentioned that it was a lot of time already and it was not going away. The outcome of events was not recovered.  Information on lot/batch number has been requested.
I experienced after taking a shower a rash, was red, blotchy down my torso and down to both of my legs which lasted a couple of hours. I talked to my HCP gave me a metrodose pack was also put on an anti histamine medication. I take quick warm showers. I called my oncologist who is recommending  to see an allergist specialist and have an appointment next Tuesday.  On 12-9-2020 had a swap to her nose.  Yesterday after taking a hot shower, I still continue with rash on my body.
Patient returned to pharmacy on 03/21/19. Patient had small bruise at injection site as well as warm, red skin surrounding injection site. Patient described their arm as being sore.  Presumed injection site reaction. Confirmed with primary care provider to have patient take BENADRYL as well as to draw a circle around the inflamed area. I drew the circle and counseled patient on taking BENADRYL appropriately. Patient returned to pharmacy on 3/22/19 as a follow-up. Injection site was not as inflamed and was not warm to the touch anymore. Patient stated the BENADRYL helped (visibly improved).
Disabled and very close to dying; Initial information was received on 05-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media. This case involves a patient (demographics unknown) who was disabled and very close to dying (disability), when received INFLUENZA VACCINE.  Past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination (had them for probably 30 years prior).  Medical history, medical treatment(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 disabled and very close to dying (disability) (unknown latency) following the administration of INFLUENZA VACCINE.  This event was assessed as medically significant and was leading to disability.  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.  The information on lot number was requested for this case.; Sender's Comments: This case concerns a patient (demographics unknown) who had disability after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Past vaccination(s) included INFLUENZA VACCINE for probably 30 years prior. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 01/14/2021 and 02/03/2021. The individual tested positive for COVID-19 on 08/31/2021 at the nursing home at which they were a resident. I see no evidence of hospitalization in our system. The nursing home may have additional details regarding this case. The individual died on 09/07/2021.
After receiving the vaccine the following day my throat was sore and I had an infected submandibular gland that was secreting pus. It was very inflamed. I took a course of antibiotics Augmentin for 10 days from an ENT. As of today on 11/6 my arm is still sore and has mild swelling from the injection site. My infection has cleared up but arm is still sore.
slight soreness at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received BNT162B2 (Pfizer BioNTech Covid 19 Vaccine) (Lot/batch no: EL 3247) dose number 1, via unspecified route of administration on right arm as a single dose for COVID-19 vaccination (at the age of 51-year-old). Medical history and concomitant medications were not reported. The patient has allergy to penicillin. The patient neither received any other vaccines within 4 weeks prior to the COVID-19 vaccination nor received any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 15:00, the patient experienced slight soreness at injection site. No therapeutic measures were taken for the event. The outcome of the event was not recovered at the time of this report. On 16Mar2021, the patient received BNT162B2 (Pfizer BioNTech Covid 19 Vaccine) (Lot/batch no: EL 3247) dose number 2, via unspecified route of administration on right arm as a single dose for COVID-19 vaccination (at the age of 51-year-old). No follow-up attempts are needed. No further information is expected.
This medically confirmed health authority report (initial receipt 03-DEC-2014) concerns a female patient. The patient had medical history of hives from Penicillin. Her concomitant medication included levonorgestrel. On an unspecified date, the patient received influenza report (manufacturer and batch number not reported). On an unspecified date, the patient developed flu-like symptoms. The outcome was not reported. Linked case: 2014047332 (same patient).
Achy Neck; Stiff neck; Headache; Shoulders sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Achy Neck), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache) and ARTHRALGIA (Shoulders sore) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 00B21A) for COVID-19 vaccination.     No medical history was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced NECK PAIN (Achy Neck), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache) and ARTHRALGIA (Shoulders sore). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form. On 31-Mar-2021, NECK PAIN (Achy Neck), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache) and ARTHRALGIA (Shoulders sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant includes high blood pressure medication.  Action taken with mRNA-1273 with the events was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up received on 28-jun-2021 which is updated with the information of Concomitant medication and expiry dates for the 1st and 2nd doses.
Within 24 hours: I woke up with chills, extreme dizziness. One to two weeks: Muscle aches in arms and legs (Body felt as it were on fire).
This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arms continued to be tender.  Pharmaceutical product complaint was also identified.  It was unknown if the subjects had previously received influenza injections.  Also any previous reactions following vaccinations was also unknown.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The reporter noted that this occurred in six patients.
Left arm muscular soreness  Headaches  Nausea  Dizziness  Fatigue
Two minutes after getting the vaccine patient experienced itching  on palms of hands.  A few minutes later L arm itching and red rash noticed.  BP  100/60  HR  72  Pulseox 98%  RR 20.    Monitored for increased symptoms.  Benedarly 50 mg given po .  10 minutes later itching subsided and rash decreased.  Monitored for 20 extra minutes with no other symptoms.  Patient called husband to pick up as she walked here.  Advised to seek medical advise if she experiences any other or increasing symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 12:15 as dose 1, single (Lot number: EL9263), in right arm, on 17Feb2021 at 12:30 as dose 2, single (Lot number: EL9267), in right arm and on 25Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FF2588) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Heart" (unspecified if ongoing), notes: Heart. Concomitant medication(s) included: PLAVIX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jun2022 at 08:00, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.The patient previously received a COVID-19 Vaccine. AE resulted in none of the above. other medication in 2weeks product included Diabetes cholesterol Plavix antidepressants. Treatment started on 06Jun2022 and stopped on 09Jun2022.
Subcutaneous cellulitis, erythema, edematous around injected area, no fever. Tx w/ warm pads and Clindamycin.
Heart racing, most of the day shortly after the flu shot was received. Resulting in feeling like I had been running a race all day. Heart beating hard and fast. Even laid down for a few hours in the early evening thinking it would help. Symptoms seemed to clear upon waking next morning.
Fever to 104 F and whole upper arm inflamed and swollen - ~ 20-24hrs.