chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient got Varicella 6 months after the patient got the VARIVAX; This spontaneous report was received from a consumer referring to a currently 19 years old patient (gender unspecified). The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.   On 02-APR-2020, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, strength and route not provided; Lot No. S019584 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date not reported, but upon internal validation established as 25-JUN-2021) for prophylaxis.   The patient got varicella 6 months after the vaccination on an unspecified date in October 2020. Whether the patient had sought medical attention, lab diagnostics/studies were performed or treatment was given was not reported. After that, no more information was provided on case. The outcome of the event was unknown.   The causality between the event and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Patient did not report any adverse events. Received his second dose of MODERNA COVID vaccination to complete his series.
Pt vaccinated with DTP one of three children received immunization in the buttocks area & following day, mother called to report swelling at injection site w/redness & pain.
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 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTICS; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: indication=Treatment of COVID-19; (22Nov2022) Positive, notes: Tested positive 22Nov; (28Nov2022) Negative, notes: Tested negative 28Nov; (30Nov2022) Positive, notes: Tested negative 30Nov. Therapeutic measures were taken as a result of drug ineffective, covid-19. Product COVID 19 Treatment brand was Paxlovid with treatment start date-22Nov2022 and treatment stop date-27Nov2022. Tested positive 22Nov. Took full Paxlovid course as directed. Tested negative 28Nov. Tested positive 30Nov.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician and from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. The reporters stated that the patient received GARDASIL outside the recommended vaccination schedule: the patient was vaccinated with the first dose of GARDASIL injection (lot# J015378, expiry date 09-APR-2016, 0.5 ml intramuscularly) on 20-APR-2015; with the second dose of GARDASIL injection (lot# K006960, 0.5 ml intramuscularly; expiry date was not reported) on 29-MAY-2015; and with the third dose of GARDASIL injection (lot# K006960, 0.5 ml intramuscularly; expiry date was not reported) on 29-JUN-2015. There were no concomitant therapies reported. No adverse effects were reported. There were no product quality complaint involved. Additional information has been requested.
Could only bend over and walk. After laying down and then getting up, could not even move. After a 30-minute massage, the patient is now able to move, but is still experiencing symptoms. Addendum to initial note from 3/26/21 at 15:02  Patient took four Advil's. Patient inquired if the steroids she takes could interact with the vaccine. Advised patient that there is not an interaction between the vaccine and her steroids. Patient inquired if she should stop taking her steroids. Advised that she should not discontinue her steroids without getting approval from her doctor or without oversight by her doctor. Time of call: 10:07 3/27/21  Spoke with the patient, who stated that they are 99% back to themselves now. They are able to walk now and can sit in a chair, but that there is still some pain. Per the patient, yesterday, their side was burning and they could not hold their urine. Patient reported that the day when the symptoms started (yesterday), the morning of she went to the gym and did hip presses. Patient reported that she has never had backaches before. Patient did report that she asked her doctor if she can stop her steroids, and per the patient, the doctor advised the patient that she can go off steroids for a week.  Patient inquired if side effects to the vaccine can show up 48 hours of receiving the vaccine, as well as that she was wondering how much protection/efficacy is provided by one vaccination/one round of the Moderna COVID-19 vaccine.  Advised patient that it is a possibility that the side effects to/of the vaccine did not/may not show up until 48 hours after receiving the vaccine. Advised the patient that per the CDC, the efficacy of only one round/one dose of the Moderna vaccine has not been evaluated/studied. Advised patient that she should receive the second dose of the Moderna COVID-19 vaccine, if she is able/willing to, to ensure that she is protected.
SINUS HEADACHE; DRY MOUTH; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced sinus headache. On 10-APR-2021, the subject experienced dry mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus headache, and dry mouth. This report was non-serious.
Migraine with severe photosensitivity, nausea, dizziness, visual aura. Aching pain on both sides of head. Severe throbbing/stabbing pain on left side.
Patient received 2 Moderna Bi-valent shots instead of 1 moderna and 1 flushot.
Severe vertigo; This is a spontaneous report from a contactable other hcp (patient herself). A 60-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FA7485), via an unspecified route of administration, administered in left deltoid on 13Aug2021 (age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history included hypotension and depression. The patient's concomitant medications were not reported. The patient was administered the vaccine in a pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and scopolamine aminoxide and experienced drug hypersensitivity. On 16Sep2021, the patient experienced severe vertigo lasting over 1 and 1/2 weeks. The adverse event resulted in emergency room visit. The patient received Meclizine as treatment for the adverse event. The patient was not diagnosed with covid-19 prior to vaccination nor was tested since the vaccination. The outcome of the event was not recovered. The device date was 28Sep2021.  Follow-up attempts are completed. No further information is expected.
sore arm; fever; chills; diarrhea; nausea; muscle aches; feeling weak; tired; dizzy; unable to stand; This is a spontaneous report from a contactable consumer (patient) reported that:   A 39-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Er8731), via an unspecified route of administration, administered in Arm Right on 14Apr2021 11:00AM (At the age of 39 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously  received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Er8727), via an unspecified route of administration, administered in Arm Right on 24Mar2021 (At the age of 39 years) as DOSE 1, SINGLE for covid-19 immunisation and later experienced light headed and sore arm. Patient was not pregnant at the time of vaccination. Medical history included anemia from an unknown date and unknown if ongoing. The patient took other medications in two weeks like, Iron supplement, birth control. Patient was allergies to doxycycline. The patient experienced sore arm, fever (24Hours), chills, diarrhea, nausea, muscle aches, feeling weak, tired, dizzy, unable to stand on 14Apr2021 18:00. Yes, drug Ibuprofen was received in response to adverse event as treatment. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On15Apr2021 18:00, the event fever was recovered. At the time of reporting, the outcome of the events sore arm, chills, diarrhea, nausea, muscle aches, feeling weak, tired, dizzy, unable to stand were recovering.  No follow-up attempts are possible. No further information is expected.
ABOUT 10 MIN AFTER VACCINATION, PT FELT WARM WITH SOME SOB AND TINGLING IN HER BODY + RINGING IN HER EARS. HUSBAND WENT TO GET HELP AND PT FELL OUT OF HER CHAIR WITH LOSS OF CONSIOUSNESS. PT RECOVERED IMMEDIATELY WITHOUT CONFUSION,. VITALS BP: 102/71 HR: 81. PMH STROKE 2008 WITH RESIDUAL L WEAKNESS. MEDS: ASPIRIN, ZYRTEC, FLONATE. NO PREVIOUS VACCINE REACTIONS OR ANAPHYLAXIS. EMS CALLED TO TRANSPORT TO ER.  VASOVAGAL LIKELY.
Information has been received from a health professional concerning a 36 month old female who in approximately April 2004 (also reported as 03-APR-2003), was vaccinated subcutaneously with a 0.5 ml dose of Varivax (lot # 647259/1137N). On 24-APR-2006 the patient developed a chicken pox rash which was mostly on her abdomen and left palm. Patient was also noted to have an external ear infection with fever at the same time. Subsequently, the patient recovered from chicken pox. There was no product quality complaint involved. Additional information has been requested.
10-3-07 Mother stated child was very fussy after vaccines 7/23/07.
Dizzy/passed out/nauseated called 911 - patient went to ER for observation.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On 01-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L037921 and expiration date of 31-MAY-2017(strength and dose were not reported). No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
10/23/2021  I started having heart palpitations The heart palpitations lasted on and off, sporadically, for about 3 or more weeks.  In the beginning of January, I had an echocardiogram done, they found a pericardial effusion. It was large and it continued to grow. On 3/16/2022, I had a pericardiocentesis. After that procedure, the fluid returned and is continuing to build. All the common causes for this have been ruled out. I am also now under the care of a rheumatologist and Infectious Diseases Specialist to try and figure out what is causing this and if it could be related to my booster.  In January 2021, I had a CT of chest and heart, and it was normal. This was before my vaccine.
Client was administered wrong vaccine on 11/22/21 and this was previously reported in e-report #724747. Client was informed and was  to be scheduled for second dose at 28 days post first dose vaccine. Client and parent presented to previous scheduled follow-up scheduled at 21 days for age appropriate Pfizer dose. Client received correct dose and correct vaccine, but at the wrong interval. Parent informed of error and per CDC guidance was recommended to schedule an additional dose in 21 days from last dose (Pfizer 5-11).  Parent confirms client has not had any adverse effects from vaccine
The client has hx of anaphylaxis and was being monitored for 30 min post 2nd dose of the Moderna Covid-19. The client received the vaccine at 11:59 am via documented route. At 12:15 pm the client began looking up at the ceiling unable to move out of that position and stating he was having neck soreness, dizziness and a headache. Assessment revealed muscle tightness in the neck and shoulder area. Client denied chest pain, SOB, itching or swelling in the facial or throat area. The client was escorted by his  .  Stated he has a hx of schizophrenia and recently had his medication changed. He also stated he was in the ED the day before and was treated for dystonia related from the medication changes. This information was not given during the screening process by either the or client. The options were discussed with the client and he was transported to the ED by EMS at 12:30 pm. At the time of transfer, the client denied neck soreness and had increased ROM but continued to c/o dizziness and headache.
Pt reports she went to pharmacy to have a shingles vaccine on Monday 1/25 after work.  Since Tuesday has felt terrible- arm is painful and sore to touch (no redness or swelling however). Headache, nausea, very fatigued and just wants to sleep.  No vomiting or fever however.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Day of vaccine symptoms nausea, vomiting, coughing up flem. Clear.  Day 7 neuropathy in Bilateral lower extremities, migrain, severe pain in left leg. Day 10 unable to walk and bear weight on left leg for 24 hours unable to get out of bed. Continue severe pain in Bilateral hip, knees, left wrist. Joint pain inflammation. Coughing up flem chronic cough.
Lot of swelling at my injection site and my glands under my arms; Lot of swelling at my injection site and my glands under my arms; This is a spontaneous report from a contactable consumer (patient). The 49-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL1284), unknown on an unknown date in Dec2020 at single dose for COVID-19 immunisation. Medical history included Allergy and asthma. Patient also took take allergy medicine and have to use an asthma inhaler. It was reported " I got the Pfizer COVID Vaccine and I had a lot of swelling at my injection site and my glands under my arms". When talking about treatment, Consumer stated, "I did ice, I did heat, I did allergy cream (Unspecified Medication), I didn't go to the doctor where they follow up with you and check on you, the swelling got up to like 6 inches." The outcome of the events was unknown.  No follow-up attempts are needed.
This spontaneous report concerning a female patient of unknown age, was received from the patient herself. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 26-DEC-2017, the patient was vaccinated with ZOSTAVAX (dosage, route, lot number and expiration date were not reported) for prophylaxis. On 27-DEC-2017, the patient had scheduled a mammogram. At the reporting time, the outcome of mammogram was unknown. The causal assessment between the event and the suspect therapy with ZOSTAVAX was not provided.
Syncope within 48 hr of vaccination and persisting lightheadedness, palpitations, then hypertensive urgency
FEVER; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and nausea was not reported. This report was non-serious.
Patient had a syncopal attack after administration of the HPV vaccine. She was unresponsive and was immediately placed in the supine position with legs raised and cold towels were placed on the head. She was aroused and was crying. She did not have a headache and did not vomit. She was observed for 15 minutes more and then was able to walk out of the office and was feeling alright.
This study case was received from the investigator MILVAX in the above mentioned trail on 02 May 2011. A 22-year-old male subject received on 17 September 2010 the following vaccinations: an injection of a ACAM2000 (lot number not reported), Anthrax vaccine (manufacturer and lot number not reported), Influenza vaccine (manufacturer and lot number not reported) and TYPHOID VI (lot not reported). The subject had no medical history. On 28 September 2010 the subject had an abnormal troponin I of 0.25. His electrocardiogram (ECG) results were not available. On 28 September 2010 the patient had an echocardiogram which was normal. On 28 September 2010 the subject was diagnosed with acute pericarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Palpitations chest tightness, heaviness Narrative:  g. Chest tightness, "heavy feeling", felt like heart palpitations but pulse ox read normally, felt need to take deep breaths to try to calm myself down, symptoms lasted 2 days; fatigue for 2-3 days; poor sleep for 3 nights (restless). Concerned given age and was seen at Urgent Care for EKG. All fine
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles(dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 03-JUN-2016, the patient was treated at an Internal Medicine office for the onset of severe vesicular rash, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days. Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2,2021 at 0830.  There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and dulled per instructions during 10/19/21 through November 1,2021. There are 27 vials that were not used and have been set aside to waste.
Patient with syncopal episode following vaccination.  Improved with rest and food.  Discharged to home.
From initial information received on 07/11/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a male correctional facility employee (age and date of birth not reported) received TD ADS ADULT, Lot # not reported, in error ID in 10/02.  The product that was supposed to be administered was Tubersol, as per the reporter. .1cc of TD ADS ADULT was administered to the pt in the arm. An unspecified time later, the pt sought treatment in the ER due to a localized reaction, which was described as "red lines/streaks going up his arm from the administration site". At the time of this report there was still a discolored, darkened area persisting at the site and the pt has been seen several times by the reporter for this problem. The pt has not recovered from these events.
Injection site pain; Severe chills; Joint pain; Muscle pain; Low grade fever; This is a spontaneous report received from a non-contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021, as a single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021, as a single dose for COVID-19 immunisation. On 15Mar2021, the patient experienced injection site pain, low grade fever, severe chills, joint pain and muscle pain. The patient reported injection site pain for 3 days, low grade fever for 2 days, severe chills for 3 hours occurring approximately 14 hours after injection, joint and muscle pain for 2 days. The patient did not receive any treatment for the reported events. The clinical outcome of the events injection site pain, severe chills, fever, joint pain and muscle pain was recovered.  No follow-up attempts are needed. No further information is expected.
pt recv vax 26FEB97 & approx 2-3wk later pt devel approx 50 lesions;4MAR97 pt varicella antibody titer was negative;
Fever for 3 days following vaccine with max temp of 101.3, rigors, chills, body aches, fatigue, congestion, sneezing, coughing and sore throat. At 7 days post vaccine, remaining symptoms include lingering cough and fatigue.
Flu shot was given in right shoulder - pain since day 2 and now having difficulty using (R) arm - pain is worst issue.