chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 13-JUL-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L003188 (also reported as "l003188" and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion was 672 hours and the lowest recorded temperature reported was 27 Fahrenheit (F) (-2.777777778 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Local reaction (L) upper arm/tricep area. 4 cm x 4 cm mildly erythema, swollen, no TTP. BENADRYL is given by mouth.
He got Covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He got Covid19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (He got Covid19). At the time of the report, COVID-19 (He got Covid19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) He got Covid 19, yesterday or 2 days ago.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller stated that her husband got Covid19,yesterday or 2 days ago, and now he was in quarantine for 10 days. Consent for Safety follow up could not be asked.  No concomitant medications were mentioned. No treatment details were reported.  This is an spontaneous case concerning an unknown years old, male patient with unknown clinical history who experienced the unexpected event of COVID-19 . The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge was not applicable since only information about one dose was disclosed The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report. Follow up states that patient's husband has covid and is in quarantine. Yesterday the clinic gave him the antibody IV. He was diagnosed on Sunday the 7th.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: follow up received  containing significant information in narrative.; Sender's Comments: This is an spontaneous case concerning an unknown years old, male patient with unknown clinical history who experienced the unexpected event of COVID-19. The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge was not applicable since only information about one dose was disclosed The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.
Still has nerve pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain, whiteheads (white head above eyebrow), eye swelling, skin red, eye pain, forehead headache and nerve pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: Still has nerve pain). The outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.   It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that painful, fast, lasting.  The reporter further stated that day 1 small white head above eyebrow and day 2 eye swollen shut and reddish skin and day 3 pain-eye, forehead and connected nerves. The doctor called as soon as possible saved his/her sight but still nerve pain many years later and also got shingles shots but concerned they were never tested on those who already had shingles.  The follow up would not possible as no contact details were available.
Underneath my arm hurting real bad; Pains in my breast sore to touch really tender; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 12Feb2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. She has never had a mammogram. Concomitant medications were not reported. The patient received the first dose of BNT162B2 on 12Feb2021. The patient started feeling underneath arm hurting really bad, pains in her breast was sore to the touch and really tender for three weeks. The patient received the second dose of BNT162B2 yesterday (12Mar2021). The outcome of events underneath arm hurting really bad, pains in breast was sore to the touch and really tender was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
We went to a drive through clinic. I asked if my 12 year old daughter was supposed to get the booster and they said yes. She is having fever of 103 and body aches. The major problem is, she is 12 and not supposed to get a booster per cdc recommendations. I trusted these people to know the rules and what they are doing.
drug use for unapproved indication; wart resolution following HPV vaccination; Literature Report:   Information has been received from the authors in a published literature article, refers to a 9 year old female patient with with a 4-month history of two 2-3 mm warts (verruca vulgaris) on the right 1st and 5th fingers. The patient's medical history and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot#, expiration date, and indication were not provided) for prophylaxis. Within one month of the second vaccination, the warts completely regressed with no recurrence noted 9 months after clearance and the patient's hands showed complete clearance (drug effective for unapproved indication).   The authors stated that several reports showed significant reduction or complete clearance of persistent warts with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) vaccine.  A copy of the published article is attached as further documentation of the patient's experience.
SHoulder Neck Hand joint pain for 7 days went to MD.  Diagnosis Bursitis, use Ibuprofen 800 mg every 8 hours and topical analgesic as needed.  Improved range of motion 08/25/2010.
Shingles rash on and around upper right arm and nearby torso with extreme itching.  Rash is in small half dollar size circles
painful little clot in her front leg; pain/ache; shortness of breath like wheezing; shortness of breath like wheezing; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A female patient (consumer) of an unspecified age received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 26Mar2021, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose 26Mar2021 and scheduled for the second dose on 21Apr2021, which was more than 21 days. Caller read the news about the adverse events with (Other company vaccine). They experienced pain/ache and shortness of breath like wheezing on an unspecified date in 2021. They also had a painful little clot in her front leg on an unspecified date in 2021. They wants to know if she can take the second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Elevated temp; Sore armpit; Night sweats; Left arm pit is also swollen; Chills; aches; Headache; Sore shoulder at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 11:00 (Lot number: EW0217) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN5318, Vaccine Administration Time: 09:00 AM), administration date: 16Feb2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Vaccine Administration Time: 09:00 AM), administration date: 27Jan2021, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 05Nov2021 23:00, outcome "recovered" (06Nov2021), described as "Chills"; PAIN (non-serious) with onset 05Nov2021 23:00, outcome "recovered" (06Nov2021), described as "aches"; HEADACHE (non-serious) with onset 05Nov2021 23:00, outcome "recovering", described as "Headache"; ARTHRALGIA (non-serious) with onset 05Nov2021 19:00, outcome "not recovered", described as "Sore shoulder at injection site"; BODY TEMPERATURE INCREASED (non-serious) with onset 07Nov2021, outcome "recovering", described as "Elevated temp"; AXILLARY PAIN (non-serious) with onset 06Nov2021, outcome "not recovered", described as "Sore armpit"; NIGHT SWEATS (non-serious) with onset 06Nov2021, outcome "recovering", described as "Night sweats"; PERIPHERAL SWELLING (non-serious) with onset 05Nov2021 23:00, outcome "recovering", described as "Left arm pit is also swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain, headache, arthralgia, body temperature increased, axillary pain, night sweats, peripheral swelling. Additional information: Patient had no known allergies. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Facility type vaccine: Workplace clinic  No follow-up attempts are possible. No further information is expected.
Child woke up in the morning with a mild headache; but 230PM child was running a 101.4 fever and was called to remove her from school. She also had site irritation.  By 5PM, child had temporary cloudy thinking.  By 6PM,s he had a migraine caliber headache with sensitivity to light and sound and still had a 101.4-101.8 fever.  Patient was given one dose of Tylenol and fever and headache did not return.  By 620PM, patient was throwing up and complaining of severe stomach pain.  Vomiting continued until approximately 10PM, until child went to sleep.  During her sleep, child moaned complaining of leg pain in both legs (assuming that part is unrelated to vaccine).  Woke up the next morning with very mild stomach pain only.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/18/21, 4/15/21, and 11/08/2021. Admitted 2/9 - 19/22 for acute on chronic COPD exacerbation, tested Covid+ 2/9. Presented back to ED 2/20/22 for worsening pain in abdomen 2/2 abdominal wall hematoma 2/2 anticoagulation, TX'd w/2 uRBCs and 1 uFFP. Course c/b acute on chronic hypoxic respiratory failure. Continued to decline with hypoxia and hypercapnia with worsening mentation. Transitioned to comfort care and transferred to local Care Unit. Expired on 3/01/22.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------  ACUTE NON ST ELEVATION MI 11/22/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA
This spontaneous report was received from a pharmacist refers to her 5 years old female child with no pertinent medical history and no drug reactions or allergies, who on an unknown date was vaccinated with a dose of VARIVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that on 02-AUG-2012, her child broke out in a rash that looked like chickenpox. Oatmeal bath was given as a treatment for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient contacted her mother, the pharmacist. The relatedness for patient broke out in a rash that looked like chicken pox was unknown for VARIVAX. This is one of several reports from the same source. Additional information has been requested.
Shot 1 May2022, hasnt received the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose intramuscularly into unknown arm on 10th May 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The case was self reported by the patient. The patient had yet to receive the second dose of Shingrix. Failed to ask the reporter if he had a record of the lot number he received. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
she just feels very weak now; room spinning; got very dizzy; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date not reported), via an unspecified route of administration on 29Dec2020 09:00 at a single dose in the left arm as COVID-19 vaccine. Medical history included blood pressure high (diagnosed a while ago at the time of the report), and she has been taking a medication for it for years. There were no concomitant medications. Patient said she had no new medications or other vaccinations administered with this vaccine. On 29Dec2020 22:00, he patient had a reaction where the room was spinning and she got very dizzy. She would like to know is that normal, since she has to go back for a second shot. She was given the vaccine by a nurse at the hospital she works as technician at which is not a military hospital. She said that the hospital is giving the vaccine to its employees. She got the vaccine yesterday morning around or after 09:00AM, and she was ok during the day. She said that the room spinning started before she went to bed at about 10:00PM, and when she got to her room she noticed everything was moving around. She said then she fell asleep, and it was better today, the room was not moving, she just felt very weak now (30Dec2020). Patient said as her treatment for room was spinning and she got very dizzy was that she fell asleep. The events room was spinning and she got very dizzy were recovering. The outcome of the event felt very weak was unknown.
Fever - 102 Extreme chills Body aches Fatigue Headache Nausea
No adverse event; Patient received First dose on 09-Dec-2021 and second dose on 13-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First dose on 09-Dec-2021 and second dose on 13-May-2022) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273  (batch nos. 027b21a and 013F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Migraine, Anemia, Chronic pain, Fibromyalgia and Arthritis. Concomitant products included SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), LANSOPRAZOLE (PREVACID) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 09-Dec-2021, the patient received first dose of mRNA-1273  (unknown route) 1 dosage form. On 13-May-2022, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 13-May-2022,  after starting mRNA-1273 the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First dose on 09-Dec-2021 and second dose on 13-May-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First dose on 09-Dec-2021 and second dose on 13-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First dose on 09-Dec-2021 and second dose on 13-May-2022).    No concomitant medications were reported.  No treatment medications were reported.
Second one, I had minimal side effects like somebody had hit you in the arm and my third one one I got more; This is a spontaneous report from a contactable other HCP. This female other HCP (Patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthmatic. Concomitant medication(s) included methotrexate (METHOTREXATE) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) for covid-19 immunisation. The patient had second one, she had minimal side effects like somebody had hit her in the arm and her third one she got more on an unspecified date. The outcome of the event was unknown.
One day after my first COVID19 vaccine, I experienced chills, headache, and myalgia when I woke up that day. I took two 500mg tablets of extra strength Acetaminophen to reduce the severity of my symptoms. And two more tablets six hours later to prevent further symptom severity. When I received my second dose one month later, began experiencing the same symptoms as before. But at 10:00pm of that day. And I experienced pain and discomfort at the injection sight. These symptoms were again reduced by appropriate doses and intervals of Acetaminophen. These general symptoms and injection site symptoms continued for one more day.
A nurse practitioner reported that a 16 month old female received a 3rd dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 11/19/02 in her left thigh. Within 4-5 hours of administration, the child developed hives on the opposite leg, which spread to the other leg and her trunk. She also developed swelling around the eyes. *F/UP report on 3/31/03: The urticaria resolved w/in 24 hrs of exam and the child recovered.*
3-18-21 2:46PM PT C/O 'RASH TO BOTH ARMS' DIME SIZED AREAS NOTED. NO SOB OR DYSPNEA, NO FACIAL, TONGUE OR THROAT EDEMA. A/O, PINK, W/D, RESP REG WITH EASE. PT STATES SHE 'FEELS OK TO GO HOME'. HUSBAND HERE TO DRIVE HER HOME. 'HAS BENARDYL AT HOME AND WILL TAKE IF NEEDED.'
pt recvd vax 22SEP95 & 3OCT95 pt exp pain @ inj site;4OCT95 pain was significantly worse & exp some swelling;4OCT95 inj site was tender to the touch, sl erythematous & felt sl warm;pain, induration & mild erythema effected this entire arm;
Sudden onset of expressive aphasia the next morning (0915)  after vaccination. Went to emergency room and diagnosed with stroke.
Large clumps of hair loss about 10 days after 2nd shot. lab results came back as auto immune disease that i didn't have before vaccination. Followed up with a dermatologist with a lateral biopsy. Diagnosis is in fact a rare auto immune disease called Lichen Plano Polaris. A form of scarring alopecia (permanent hair loss).
really sick; Initial information received on 15-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involved an unknown age patient who reported really sick (Illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(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 not reported) via unknown route at an unknown administration site.  On an unknown date, (latency unknown) the patient developed a non-serious event of being really sick (illness) after administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
My blood pressure rose to 180/120 and I felt like I had a stroke. The hospital said it was not a stroke but may have been a TIA.  My blood pressure is still elevated.  The hospital raised my blood pressure medication to double the dose I have been taking for over 10 years.  I have a follow up with my doctor. But most days I don?t feel well because my feet are very swollen and my head feels like I am going to faint.
Patient fainted/fell outside after receiving flu shot. Patient has eaten since 10 am, said was feeling dizzy. Had flu shot before, no previous reaction. Paramedic was called upon approval from pt. Pt received food and water. Confirmed with patient that she probably did not eat enough on that day and felt weak this reason for fainting.
Muscle and skin pain are the most tolling. I also have a full headache and some nausea. Tried some ibuprofen which may have slightly helped. But still feeling it.
BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient did not have any medical conditions and did not take any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 09-AUG-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced body aches. On 09-AUG-2021, the patient experienced chills. On 09-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 10-AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100.7 F, 99 F. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and the outcome of body aches and chills was not reported. This report was non-serious.
About 3 weeks after the vaccine, the patient developed a rash over the trunk of her body. It covered most of her torso. Her doctor gave her a MEDROL DOSE PACK to help clear up the rash.