chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; improper storage; This spontaneous report was received from an office manager and refers to a 12-year-old male. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On 18-NOV-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis. The vaccines was purchased with public and privet founds and were given in private doctor's office/ hospital. On unknown dates, the doses of vaccines experienced the temperature excursions. Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  This is one of several reports received from the same reporter.
Administered Gardasil 9 SYR ages 18-26 (1) OV , on today, 09/03/2021 and she fainted. I have never had a reaction to any vaccine.
Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 09-Jan-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was taken and symptoms have subsided. No relevant concomitant medications were reported.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Left deltoid-injection site.  Sore to touch, with tingling throughout for body  X 3 days.
Patient called pharmacy on 9/23/20 and reported that BOTH her arms were swollen
Patient has been feeling extremely fatigue, joints sore (knees, wrists), more depressed and has passed out twice since the 2nd Moderna vaccine. The patient has been seen by his PCP and has been tested for lyme as had a tick bite last year, but the bloodwork came back negative.  Pt also feels his normal pain medication (oxycodone 5mg) is not working as well for his back pain.  He said he will do yard work that he normally does, like mowing the lawn, and is extremely tired. No change in medication or health status other than noticing these symptoms.  The patient passed out once while raking leaves and another time on the porch and stood up and passed out.  The patient feels these symptoms are getting progressively worse and not getting any better.
Narrative: 74 yo M with PMH of asthma, received COVID-19 booster (3rd dose Pfizer) and within 4 hours had chest discomfort. Did not have any reaction to first two covid-19 vaccine doses. Evaluated by pulmonologist following 3rd dose,  pulmonologist attributed chest pain to worsening asthma. Symptoms resolved within 1 month.
Received covid shot #2 on 3/11/21 around 430 pm.  Major hives and welts and extreme itching around 1 pm on 3/14/21.  Thinking back to the first shot on 2/18/21, I had a rash on my stomach an hour after injection that was slightly itchy but went away after an hour.  Hives and itching were reduced after taking Benadryl and steroids.
4 days p/receiving flu vax pt was admitted to hosp 22OCT91 w/t100, severe h/a, and an abnormal LP which showed pleocytosis; cerebrospinal fluid culture was neg; pt recovered uneventfully, w/no neurologic sequelae;
Slight fever day after vaccine 2nd dose. Red rash appeared 2 days after below vaccination site. Red and itchy and remains over 2 weeks later
I started getting symptoms of a fever of 101 and also sinus infection symptoms. The fever was concerning so I went to the doctor and received a positive COVID test and was also diagnosed with a sinus infection. I was given amoxicillin. The fever lasted 3 days.
This case was reported by a consumer and described the occurrence of injection site erythema in a male patient who received SHINGRIX for prophylaxis. On 4th June 2018 17:30, the patient received SHINGRIX. In June 2018, 15 hrs after receiving SHINGRIX, the patient experienced injection site erythema, tiredness, general body pain, nausea and influenza like illness. On an unknown date, the outcome of the injection site erythema, tiredness, general body pain, nausea and influenza like illness were unknown. It was unknown if the reporter considered the injection site erythema, tiredness, general body pain, nausea and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 5th June 2018, at 8:30, the patient experienced redness at shot site, tiredness, body aches, little nauseated and the side effect feel flu like. The patient was able to function at work.
Next day, arm soreness and mild joint pain 4 days later--swollen lymph node 5 days later--increase in joint pain and muscle pain 20 Days later---deep muscle soreness and increase in joint pain
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient vvia a company representative 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 (dose number series-1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on NOV-2021 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 DEC-2021, the patient reported that "The vaccine really works. patient had vaccine in NOV-2021 and now laying here in bed with covid (suspected clinical vaccination failure) waiting for appointment for an antibody transfusion at 2". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208134; Sender's Comments: V0:20211248388-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Initial unsolicited report received from a pharmacist on 20 October 2015. This case involves a 70-year-old female patient who was vaccinated with a first dose of FLUZONE HD (batch number: UI442AA, expiration date: 6 April 2016, dose and route were not reported) in the right deltoid on 20 October 2015 at 12 noon. Illness at time of vaccination was none and patient had a history of high blood pressure, high cholesterol and no known allergies. Concomitant medications were not reported. On 20 October 2015, few hours following the vaccination, the patient called back to the pharmacy at 4 pm saying she was having difficulty swallowing. It was reported that her voice sounded fine. The patient required ER/Doctor visit. Laboratory investigations were reported none. The patient's corrective treatment includes Benadryl and she was advised to take medical treatment if not improved. The outcome of the event was reported as unknown. List of documents held by sender: none.
Nov 1 shot 2 pm? Chest pain 8 pm (6 hr after) itchy throat. Without cough fever Nov 2 when woke up, return to EH 10 am - BP standing, T standing -> 2 ER saw dr Nov 3, 5, 12 - rtn -> bronchitis fever dx inhaler if worsens.
Pt recvd 2 doses of Engerix-B & the 1st dose was uneventful; On 10OCT91 p/2nd dose pt exp itching @ site of inject, swollen @ site of inject, induration (3x2) @ site of inject & red warm @ site of inject;
Subcutaneous area of left upper arm was erythemic 30 mm across by 25 mm high, slightly raised and itchy.
Was off Jakafi for a couple of weeks for an unspecified reason; Experienced pain in the same shoulder pain that was miserable for the next 2 days; This spontaneous case, initially received on 27-Mar-2018, was reported by a physician and concerns a 74-year-old, elderly, male patient.    The patient's current condition included anemia (since an unspecified date). The concomitant medication included Vicodin (hydrocodone bitartrate, paracetamol), magnesium, vitamin d3 for unknown indications.  Since 22-Dec-2017, the patient was taking non-company suspect product Jakafi (ruxolitinib Phosphate, dose: 5 mg, route of administration: oral, frequency: qd (daily once), batch number, expiry date: not reported) for myelofibrosis.   On 05-Jan-2018, the patient was administered with INN Flu Vaccine Seasonal (Influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) as flu prophylaxis.  On 06-Jan-2018, the next day of vaccination, the patient experienced pain in the same shoulder (described as miserable for next 2 days). The patient consulted medical doctor and was prescribed with unspecified pain medication, which relieved the pain. On an unspecified date, during a follow-up, it was reported that, the patient was off from Jakafi regimen for an unspecified reason. Later, Jakafi 5 mg bid (twice-a-day) was included in the care plan. On an unspecified date, Jakafi 10 mg bid was initiated. On 16-Jan-2018, the patient had recovered from the event shoulder pain.   On 06-Feb-2018, the patient underwent unspecified blood tests, biopsy and chemotherapy.  The reporter assessed this case as non-serious and the causality of the event (shoulder pain) was considered as related to the flu shot.; Reporter's Comments: A 74-year-old elderly male patient, with concurrent condition anemia, was administered with suspect product INN Flu Vaccine Seasonal and co-suspect Jakafi and developed shoulder pain, the next day of vaccination. Considering the close temporal relationship and possibility of flu vaccine to cause the event, the causality is assessed as related. The event drug dose omission is assessed as not related, as it is related to the co-suspect drug Jakafi.
Patient was given PREVNAR in right thigh. Dad called and said she had local reaction on right side. Redness and warm to touch. Dad instructed to give Tylenol and put warm compress on right thigh. Call if worsens or persists.
Client had an intense cough, and felt a warn sensation around her shoulders and the back of her neck.
a few hrs p/vax pt devel elevated temp of 104.6R;this elevation lasted about 12hrs;pt was seen by pvt MD;17FEB96 inc temp was 102;no other concerns;by 19FEB95 pt was fine;
Hospitalization for COVID-19 infection after COVID-19 immunization is a reportable event.  This 79 year-old male with a history of advanced prostate cancer presented to the outpatient clinic with complaints of sore throat, hoarseness, and symptoms of an upper respiratory infection. Upon examination he was febrile with breathing difficulties requiring O2 at 2 L/min. Upon ambulation to the bathroom he desaturated to 82%. PCR testing for SARS-CoV-2 was positive. He was transferred to hospital and admitted. He was treated with dexamethasone 6mg daily for a total of 10 days and IV remdesivir for 5 days. Improvement in symptom severity and decrements of inflammatory markers ensued. With minimal symptoms he was discharged medically stable after 5 days with detailed follow-up healthcare plans in place.
Pts father called to report patient having "rash" on trunk, back and some on hands. Bumps described as tender. Attempted x3 to speak with patient directly but no answer to her phone #.
My son started not feeling well, losing weight and then started not remembering anything. He then went into DKA and we almost lost him. Now he has type one for the rest of his life. 3 months after the shot it started and then 5 months after vaccine the complete damage was done.
Vaccine was administered in the Left Deltoid via IM injection at 3:30 pm and as he was being monitored for adverse reaction @ 3:35 approximately he begean to c/o  tingling and numbness in his left arm.  As time progressed his symptoms worsened to more numbness and to response to painful stimulus in the L arm.  His BP was 200/102 and he was diapheretic.  He was taken to urgent care to be evaulated.
Local rxn. Antihistamine taken, 4cm round warm, fine, slight edema.
flu; Initial information was received on 23-Nov-2020 regarding an unsolicited valid non-serious case via consumer or non-health care professional (patient).   This case involves patient (age and gender unspecified) who experienced flu (influenza), while patient received INFLUENZA VACCINE, [Flu shot].   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the lot number for this case.
Thoracic spine pain, stiffness, inflammation; Amenorrhea, Cervical spine stiffness, SI Joint pain, inflammation, stiffness, Tension headaches, Asthma, Brain fog, Sinusitis, Extreme Fatigue, Welts on face
ACHES; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (ACHES) and PYREXIA (Fever) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (ACHES) and PYREXIA (Fever). At the time of the report, PAIN (ACHES) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
8FEB96 recvd vax & neg titer 5FEB96;12FEB96 noticed itching @ the site approx 1" redness w/little bumps @ site of inj-reported from by phone 13FEB96 seen by MD
Swelling and erythema of left upper arm and to elbow and below elbow to upper forearm, tender 48 hrs after Dtap given to pt.
On April 1 when I awoke I had pain at the injection site. It is red, swollen, about the size of a silver dollar. It began itching, and the itching has intensified. It feels like a bee is trapped in my arm. My entire arm is throbbing, the injection site is hot to the touch. I have been extremely tired since the vaccine, but the injection site was initially red, then calmed down after about 48 hours. I plan to call my doctor in the AM, but since this is not affecting my breathing I don't feel the need to go to the ER.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold/she is really cold), FATIGUE (feeling really tired), CHILLS (she is shivering) and NAUSEA (feeling nausea, requested for a bucket because was felling like throw up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 027B21A and 031A21A) for COVID-19 vaccination.Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.No Medical History information was reported.On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 15-Nov-2021, the patient started INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose. In November 2021, the patient experienced FEELING COLD (feeling cold/she is really cold), FATIGUE (feeling really tired), CHILLS (she is shivering) and NAUSEA (feeling nausea, requested for a bucket because was felling like throw up). At the time of the report, FEELING COLD (feeling cold/she is really cold), FATIGUE (feeling really tired), CHILLS (she is shivering) and NAUSEA (feeling nausea, requested for a bucket because was felling like throw up) had not resolved.Concomitant drugs were not reported. Treatment medications were not provided.It was reported that patient received Flu shot with booster dose at same time.This case was linked to MOD-2021-388600 (Patient Link).
Pt presented to the ED due to cough and shortness of breath.  Patient explains that she started developing a cough productive of yellow sputum 2 days ago, with gradually worsening shortness of breath, prompting her to come to the ED today for further evaluation.  She also complains of associated nausea, but denies any episode of vomiting.  Patient reports that she tried using her breathing treatments at home with no improvement of her symptoms.  She denies any fever, chest pain, diarrhea, or changes in bowel or bladder habits. Upon ambulating the patient in the room, she became hypoxic at 88% on room air. She did arrive tachycardic at 123 bpm and slightly hypertensive at 143/66. The patient was placed on a cardiac monitor, continuous pulse oximetry, and 2 L supplemental oxygen via nasal cannula with oxygen saturations noted at 95%. Multiple labs and a chest x-ray were ordered for further evaluation of her symptoms.   An EKG was obtained and showed normal sinus rhythm with a ventricular rate of 90, left axis deviation, normal intervals, peer 172, QRS 76, QTC 533, with no acute ischemic changes.   The chest x-ray was reviewed by the ED physician and read by the radiologist showing mild left midlung atelectasis or pneumonia.   COVID-19 is positive. Lactic acid is elevated at 2.7. Procalcitonin is elevated at 2.41. LD is elevated at 297. CRP is elevated at 4.76. Ferritin is normal at 80.5. CMP shows an elevated creatinine at 1.7, increased from baseline of 0.6, with a normal BUN of 14, and hyperglycemia at 212. CBC is essentially normal. Troponin is negative. RSV is negative. Influenza panel is negative.   An IV was established and she was given a 1 L NS bolus for hydration and lactic acidosis. She was also given 1 g Rocephin IVPB and 100 mg Doxycycline IV for bacterial pneumonia given her elevated procalcitonin.   Patient was admitted  for COVID-19, acute kidney injury, pneumonia, and lactic acidosis.  Patient left hospital against medical advice.
Increasing swelling of injection site to 3"x5", pain, itching, tenderness, heat, and continuing fever. A course of Keflex and high doses of Advil helped.
1 day after receiving vaccine: Very sore arm, nausea, fatigue 2-4 days after receiving vaccine: Flu like feeling (much worse than how I felt when I actually had COVID-19 in November of 2020). These symptoms lasted approximately a week or more. Since receiving the vaccine, I have had increased menstrual cramping and 2-3 menstrual cycles per month. I have had a menstrual cycle for 20 years now and have never been "off schedule", nor should I be as I am on oral birth control and have been for over 11 years.
Moderna COVID-19 Vaccine EUA adverse event.   Approximately 7 hours after the 1st COVID vaccination on 2/22/2021, patient developed symptoms of fatigue, aches, chills & fever. Her symptoms worsened into 2/23/21 with increasing shortness of breath. On arrival in the emergency center on 2/23/21,  she was hypoxic with  SpO2 81% on room air.  Oxygen supplement via nasal cannula was given which improved her oxygenation. Covid 19 test negative. Chest Xray shows pulmonary edema and CTA chest shows no PE.  She was admitted to the hospital and provided supportive care.   Pulmonary Edema and inflammatory process is likely associated with the vaccine. Patient appeared to be improving, however, on 2/26/21, she was working with Physical Therapy/Occupational Therapy and had a pulse ox reading of 75% on room air. She was on 10 Liters of oxygen via nasal cannula by the time she make it back to bed and her pulse ox was 89%. Neurology exam shortly afterward the above event demonstrated an NIHSS of 21.  Patient became non-verbal and stat imaging revealed an acute hemorrhage in the left occipatal lobe likely representing a SAH.  Patient then transferred to another hospital that could provide neurosurgical intervention.
About 10 days to 2 weeks after the 2nd Pfizer vaccine, my hair started to fall out. This was excessive hair loss  and unusual for me. The hair loss was accompanied by a flare up of scalp psoriasis. This continued for a  few months. During this time, I saw my dermatologist who prescribed a special shampoo which helped with the psoriasis, but the hair loss continued. The hair loss stopped about three months after the March 30, 2021 vaccine.  However, after my booster shot on12/18/2021, hair started falling out again and I?m still experiencing hair loss to date.
Shortness of breath; Dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and DIZZINESS (Dizzy spells) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and DIZZINESS (Dizzy spells). At the time of the report, DYSPNOEA (Shortness of breath) and DIZZINESS (Dizzy spells) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Myalgia, Arthralgia, Swelling/heat/redness/injection pain/ fatigue/lightheadedness/increased urination Narrative: Used OTC naproxen