chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 24 year old daughter with no pertinent medical history or drug allergy who on 04-JUN-2008 was vaccinated with the first dose of GARDASIL {0.5 ml, lot number not reported} via IM route. There was no concomitant medication. The patient had had diarrhea since her first GARDASIL shot on 04-JUN-2008. She did receive her second GARDASIL shot on 04-AUG-2008. The consumer could not provide the lot numbers. No lab diagnostic test was performed. The patient sought unspecified medial attention. The patient's diarrhea was not improved or recovered as of 12-AUG-2008. Additional information has been requested.  12/3/08 Per parent pt has not sought medical tx for diarrhea, only informed provider.
Sore arm; Migraine; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Concomitant medications included cetirizine (CETIRIZINE) taken for an unknown indication from an unspecified date. 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 vaccination. On 06Apr2021 at 10:45, the patient experienced sore arm and migraine. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events sore arm and migraine was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
WOKE UP AT 3:00 A.M. WITH INTENSE PAIN IN ARM OF THE INJECTION AND SHIVERING.   TOOK ACETAMINOPHEN AND BUNDLED UP.   GOT UP ABOUT 9:00 A.M. AND TOOK IBUPROFEN EVERY 4 HOURS UNTIL BEDTIME.  WAS SORE, COLD AND ACHEY FOR REST OF DAY.   SLEPT GOOD THAT NIGHT.   IT WAS ALL OVER WHEN I WOKE UP THE SECOND MORNING AFTER INJECTION
pt recvd flu vax 5NOV91 & c/omuscle aches, n/v, coryza & low grade fever along w/generalized malaise & weakness;
Pain at site, muscular pain throughout body, chills, skin is really (uncomfortably) sensitive to the touch, my bladder kinda hurts, headache in the morning, cheeks really hot.
Onset of Hashimoto's Thyroiditis in 2005 which has continued to present.  Treatment continues through thyroid hormone supplementation.
Patient received vaccine outside of window making the dose invalid (vaccine had been out of ultra-freeze for >10 weeks).
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6198), in left arm and on 12Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; ATORVASTATIN; DOXAZOSIN MESYLATE; ASPIRIN (E.C.). The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive at home test but I never had a negative test since starting Paxlovid on 6/6/22. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received vaccine and took other medication in 2weeks. Anti-viral details were Brand was Paxlovid, Treatment start date was 06Jun2022 and stop date was 10Jun2022, Indication for Treatment of COVID-19. Cough, runny nose, low-grade fever, extreme tiredness. These symptoms are worse than original symptoms on 06Jun22. No AE treatment was received.
Patient stated on same day as immunization (4/20/2021) she experienced high fever (102.9 F), vomiting, diarrhea, excruciating headache, and a swollen injection site.  During the next day or two (4/21/2021 or 4/22/2021), she experienced shooting pain across her collarbone to her jawbone.  On 4/23/2021, she experienced blisters in her mouth on the roof of her mouth and under tongue.  She visited the emergency room on 4/24/2021 and received a prescription for lidocaine viscous 2% for mouth sores.
pt recvd vax;devel severe inject site rxn following vax;erythema, swelling & pain; also enlarged nodes & low grade fever;
Received Janssen vaccine on 3/7/21. Tested positive for COVID-19 by PCR on 7/12/21. Received monoclonal antibodies on 7/14/21.
I have significant tenderness in my left arm pit.  I cannot lie on that side to sleep and it hurts all day.  I put warm compresses on it to no avail.  It also appears to be a little swollen.
No ADR identified.  Patient is a homebound patient that the Agency asked us to vaccinate.  Patient contacted to see if she was interested in J and J.  She was and requested that we vaccinate her.  Upon documenting the vaccination, the immunization registry identified that the patient had dose one of Moderna on 5/5/2021 and did not notify staff administering the j and j vaccine.  Patient's primary care provider notified.
Chills overnight on day 1 of vaccine- no meds taken  Joint pain and muscle soreness since vaccine date 3/15. Took Advil a few times, but still the same.   Weakness has been worse since vaccine, but slight improvement as of date.   Fatigue- since vaccine but now improved.  Lack of appetite- since 3/9 /21 but worse for 2 weeks after vaccine date. Slight improvement since last week. Had lost 10 lbs from 3/15/21  Nausea/Dizziness- since 3/5/21 but got worse when received shot.  Now improved.  Mental fogness- 3/15 (date of vaccine) and had it for about 2 weeks. Now improved.
01/02/2021: On 12/30/2020 Noticed swelling in the lymph nodes at my right clavicle and right ear. The clavicle node swelling continues to increase and cause soreness (neck and right arm) .  01/04/2021: The swelling/knot remains, and I have an appointment with my PCP today.
Pt came in to pharmacy on 9/27/17. He said his arm is a bit itchy and red around injection site. I saw it was red and a bit (raised). I asked if he had taken anything, he said no. I advised him to put ice and if it gets worst to see MD or go to hospital.
Moderna vaccine given for 1st dose.. then patient came back for 2nd dose and we administered Pfizer vaccine by mistake.
Flu shot was given on top of shoulder, causing bruising with in 24 hrs. Shoulder pain increased with time, 2wks later I could not lift my arm. Reported injury to primary care, they had me come in immediately and sent me directly to the ER. Xrays were taken and I was sent home with a tramadol & Flexeril. Followed up with ortho & hospital. MRI approval is pending- initial diagnosis is bursitis.
Pt became dizzy and nauseated post vaccination, experienced cardiac dysrythmia, transported to hospital via EMS.
Syncope,  seizure like activity.  Negative scans and blood work in the Emergency Room on April 8.   Fatigue presently
SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious. This case, from the Others is linked to 20211245214.
pt recvd vax & was vomiting mult times, mom called ofc; brought pt in; MD noted voluminus emesis; very lethargic; sl full fontanel,dull TM'S; to er, admitted;
The child awoke, and fed.  At the end of the bottle she vomited.  Grandmother (a nurse) noted she felt warm, and gave her Tylenol.  Later in the morning she was not eating well.  Taking a long time to drink a bottle.  Mother checked her temp and it was 102.9.  Was again given Tylenol.  Later Temp noted to be 100.7.
Dose of 0.3 ml ordered. Reminder of vial had 3 doses- 3 doses given to other patients. RN drew up the reminder of what was left in vial 0.9 ml and administered to patient. The doctor was notified immediately and was monitored carefully. No adverse reaction has been noted. This was supposed to be the patient's second dose.
This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Lot number: EK5730), in right arm, on 05Jan2021 as dose 2, single (Lot number: EK9231), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 3d458A) at the age of 44 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: HUMALOG, start date: Jun2017; OZEMPIC, start date: May2019; PANTOPRAZOLE, start date: May2014; ATORVASTATIN, start date: Jan2019; HYDROCHLOROTHIAZIDE, start date: Jan2019; LOSARTAN, start date: Feb2020; INVOKANA [CANAGLIFLOZIN], start date: Feb2016; VITAMIN D NOS, start date: Jan2014; VITAMIN C [ASCORBIC ACID], start date: Feb2009. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022 at 10:00, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, Covid-19. The patient received Paxlovid Anti-viral details: product=COVID-19 Treatment, from 02May2022 to 06May2022 for treatment of COVID-19. 24 hrs. after patient stopped taking Paxlovid patient became more congested than while on treatment, running nose and more loose cough, body ache also was new since starting the treatment. Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Injection given at 905AM. Arm began swelling in first 5 minutes. Pt given BENADRYL and observed for 25 minutes.
Macropapular rash, urticaria, prickling, onset approximately 2-3 hours after receiving Influenza vaccination.
Focal seizures in the mouth area starting around 12 hours after shots, lasting 3 days. Under medication now. Possibly due to vaccines. Presently on phenobarbidtol.  Follow up on 11/21/2003: "Vaccine recipient did recover from the adverse events that were reported for this vaccination."
Achiness; Fever; Fatigue; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 06-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achiness), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, MYALGIA (Achiness), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.            No concomitant medication information was mentioned  No treatment medication information was mentioned  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received including no new information
After the vaccine I started feeling dizzy , and I was extremely tired the next day. I woke up probably about 4 in the morning and I woke up very nausea, had  diarrhea, and stomach cramping. I had body aches all over my body, I felt horrible, I also had a massive headache. It felt like I had the flu but it was painful. Following the vaccine I also had to get my left thyroid removed on May 25,2021.
21 hour after vaccine (before any other food/drink) developed urticaria, facial swelling, swollen harder and feet. Responded to Benadryl and Albuterol treatment. No fever, no new foods.
itchiness; redness; Headache; Arm was sore; knot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), INJECTION SITE MASS (knot at injection site), PRURITUS (itchiness), ERYTHEMA (redness) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), INJECTION SITE MASS (knot at injection site), ERYTHEMA (redness) and HEADACHE (Headache). On 15-Mar-2021, the patient experienced PRURITUS (itchiness). On 14-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore), INJECTION SITE MASS (knot at injection site), PRURITUS (itchiness) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications information was not reported.  Treatment information was not reported.
they tested another one and it was positive; they tested another one and it was positive; This is a spontaneous report from a contactable consumer living in a residence of assisted living. A patient of unspecified age and gender received COVID-19 Vaccine (unsure if BNT162B2 Pfizer-BioNTech or Moderna vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, on an unknown date after vaccination, the patient was tested for COVID-19 and was positive. The event onset date and outcome were unknown at the time of the report.  Information on lot/batch number has been requested.
pneumonia; kidney infection; severely dehydrated; extreme joint pain; fever; chills; uncontrollable shaking; Severe headache; nausea; vomiting; When Coughing, feel pain in uterus; When Coughing, feel pain in uterus; Very sick; weak; This is a spontaneous report from a contactable consumer, the patient. This 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533), via an unspecified route of administration in the left arm on 03Apr2021 10:00 (at the age of 30-year-old) as single dose for COVID-19 immunization. There is no medical history reported. Concomitant medication included celecoxib (CELEXA). The patient did not have any allergies to medications, food, or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E46955), via an unspecified route of administration in the left arm on 11Mar2021 10:00 (at the age of 30-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Two hours after the vaccination on 03Apr2021 at 12:00, the patient experienced extreme joint pain, fever, chills, uncontrollable shaking; severe headache, nausea and vomiting. No change after 3 days, she went to Emergency Room ended up with pneumonia, a kidney infection and severely dehydrated. She was hospitalized for one day (in Apr2021). When coughing, she feels pain in her uterus. She was very sick for 11 days after the vaccination and was still weak, and her joints continue to hurt. Therapeutic measures were taken included fluids, antibiotics, blood tests and nausea medications. Since the vaccination, the patient had been tested negative for COVID-19 virus via a nasal swab test on 06Apr2021. The patient had recovered with lasting effects from the extreme joint pain, fever, chills, uncontrollable shaking, severe headache, nausea, vomiting, pneumonia, a kidney infection, severely dehydrated, when coughing, feels pain in uterus, and very sick.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 1:11 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.08  Concomitant products were not provided.  On 28-Feb-2021, Excursion time was 09 AM,1 PM, temperature was 27,26 total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.   On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43, and 4 PM: 45  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Temperature recordings were taken using a temperature monitor at every hour.   After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.    It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.   Treatment medications were not reported.
DTAP was expired 07/07/19 and was given 07/19/19.
After returning home from vaccination the patient began to feel weak and tired. He checked his blood pressure and it was 78/37 with Hr of 65.  The following day his blood pressure remained low (systolic under 100) but the patient reported feeling a little better.
01/08/22 presents to EC ED for "cough congestion, fevers, nausea/ vomiting and fatigue". PMHx of " breast cancer in remission"
COVID Breakthrough- Patient presented to the ED on 3/19/22 with shortness of breath and cough. Tested positive for COVID on 3/22/22. No fever and patient has been on room air.
Information has been received from a Nurse Practitioner (N.P.) concerning a patient who was vaccinated with a dose of Gardasil. Subsequently the patient developed genital warts. The outcome of the patient was unknown. The NP reported that two other patients developed genital warts after receiving the Gardasil. She verbalized concern that she seen three episodes of genital warts developing soon after Gardasil. She believed the patient's immune systems can not handle the viral load. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. In follow up it was indicated that on 09-FEB-2007 patient was seen at planned parenthood clinic and advised she had visible Candyloma (as previous history). She was treated x2 with TCA 80% on 10-MAR-2007 and on 24-MAY-2007. The outcome was unknown for the events at the time of this report. Additional information is not expected.
Patient was anxious before the shot was given.  She was given orange juice and water to hydrate her just in case.  After the shot she passed out and was disoriented and nauseated when she came out.  Paramedics were called for evaluation and they took her to the hospital due to continued weakness and vomiting.
Immediately after administration, entire body started to tremble.  Continued to the entire time at facility, was sent home after 3 hours of observation.  Over the next few days, trembling improved.  One week ago, major entire body tremors  began, woken  up from a sound sleep. Very severe, could not function., all small movements such as typing impossible.  Over time, tremors has lessens but now chronic and  present.  Much fear and concern about taking second dose which is scheduled  for this coming Sunday , March 21st.  Concerned that this may be permanent.
Information has been received from a MA concerning a 46 month old white male with no known drug allergies who on 08/22/00 was vaccinated with a dose of varicella virus vaccine live (Lot # 634501/0537K).  On 06/06/03 the pt was seen in the physician's office with about 8-10 very itchy lesions and vesicles in the groin area for 4 days. It was reported that the symptoms started on 06/03/03.  The pt was diagnosed with varicella. There was no fever. The pt was treated with colloidal oatmeal bath (Aveeno), calamine lotion and Benadryl. It was noted that the pt's sibling had similar symptoms. It was unknown if the pt recovered. No product quality complaint was involved. It was also reported that 3 other pt's were vaccinated with a dose of varicella virus vaccine live and developed varicella (WAES # 0306USA02442, 0306USA02866 & 0306USA02868).  Additional information has been requested.
Patient reports she developed swelling and redness to the injection site soon after her vaccine, which then became a full-body rash. today she is complaining of increased swelling, redness, and pain to the injection site that is spreading up past her shoulder and into the axilla.