chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and redness round site of MENACTRA vaccine 2 days after vaccine. Fever to "100-101". On 8/17/15-doctor saw patient. No redness or warmth at site. No fever. Advised to monitor symptoms and see Infectious Disease if symptoms persist.
This spontaneous report was received from a physician referring to a 4-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 16-MAR-2017, the patient was vaccinated with PROQUAD recombinant Human Albumin (rHA) (lot # M040141) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis, which was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007310: US-009507513-1705USA007309: US-009507513-1705USA007311: US-009507513-1705USA010146: US-009507513-1705USA010145: US-009507513-1705USA010143: US-009507513-1705USA010142: US-009507513-1705USA010147.
Patient reported severe pain, swelling and redness at the injection site that started the evening of 11/13/17 and continued until 11/15/17. No complaint during or in the 15 minutes after administration of the vaccine. Patient presented to the pharmacy on 11/15/2017 for consultation about the pain and other symptoms. The staff pharmacist evaluated the injection site and determined that mild redness and swelling was occurring. Patient reports improvement of symptoms overall since administration of the vaccine and symptoms peaked overnight on 11/13/17 and during the day on 11/14/17. Patient reports visiting her primary care physician regarding the symptoms.
Client presented to the COVID-19 Vaccination Clinic on 1/19/2022 for his second COVID-19 vaccine, but he is documented as having received the adult formulation of Pfizer with the lot number FJ5683, which would be an inappropriate vaccine type for his age. This error was one of several found as part of a routine audit, the majority of which were determined to be simple documentation errors and not vaccine administration errors.  However, the facility has been unable to determine which vaccine was actually received due to an inability to get in meaningful contact with the client's guardians. They were called and reached once, but they reported that they were busy and would call back, although they did not actually do so. In all, they were called three times (though voicemails were unable to be left, as the voicemail box was full), they were also emailed on 3/28/2022 and were sent a physical letter on 4/13/2022. The possibility of a vaccine administration error cannot be ruled out at this time. All staff at the COVID-19 Vaccination Clinic have been educated on a procedure designed to reduce vaccination and/or documentation errors: vaccination staff ask clients to confirm their name and DOB and then respond by speaking the client's age aloud and verbally confirming which vaccine the client is receiving. They will also verbally confirm the vaccine type aloud when they choose the vaccine type from the drop-down menu. The staff member who made the preponderance of the documentation errors was also individually coached regarding the accuracy of their vaccination recording practices.
Cries if he hears loud noises, severe temper tantrums, no self control, throws self on ground, met with his doctor who recommended specialist.  Met with specialist who gave DIAGNOSES: Encephalopathy manifesting central hypotonia and global developmental delay.
fever, h/a x 48hr;APAP 1-2 tsp q 4hr;
A report was received from a health care professional on 12/11/03 concerning approximately 10 children of unknown sex and less than 4 years of age who inadvertently received Fluvirin between 12/8/03 and 12/11/03. Between 12/8/03 and 12/11/03, approximately 10 children inadvertently received Fluvirin. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
1st day: injection site soreness, arm soreness, headache 2nd day: severe arm, shoulder, and back soreness, fatigue 3rd day: left axillary lymph node swelling, right submandibular lymph node swelling, fatigue
Initial report was received from a healthcare professional on 26 October 2011. A patient had received an injection of ADACEL (lot number, route and site of administration not reported). On an unspecified date, the patient developed a large reddened area, hot to the touch at the injection site and a blister at the center of area. The reported was only calling for a treatment plan and refused to provide further information. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: None.
pt went to bed w/o a fever;6:15AM woke up w/a weak cry & very hot;mom left room to get APAP & pt found having sz; while calling 911, pt lost consciousness; temp @ ER was 103.2;also had another sz in ambulance;
Fever - 100 degrees, moderate to severe flu-like symptoms, i.e. body aches.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, Fever, headache, chills and fever 102 - after 3nd dose Narrative: Tylenol and Motrin as needed
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (COVID Fogginess), INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine as 2nd dose) and PYREXIA (Fever - Temperature of 99.0F) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021 at 3:00 AM, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) .3 ml. On 21-Jan-2021, the patient experienced FEELING ABNORMAL (COVID Fogginess) and PYREXIA (Fever - Temperature of 99.0F). On 30-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine as 2nd dose). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 23-Jan-2021, FEELING ABNORMAL (COVID Fogginess) and PYREXIA (Fever - Temperature of 99.0F) had resolved. On 30-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine as 2nd dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 99.0 (Inconclusive) 99.0F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Added reporter information and event.
Several days after the vaccine developed two unusual erythematous skin lesions (bloody) in the folds of the left groin area. It was associated with an odor (from maceration?), and macular with one lesion having a  raised area. Widely scattered vesicular papules seen. Lesions were painless and approximately quater size on the superior fold and dime-size on the inferior fold. Pictures available upon request.
Pt recvd vax on 1JUL92 & & on 4JUL92 pt devel flu-like sx which included abdo cramps, diarrhea, nausea, vomiting, aching & a fever of 101; pt was treated w/Advil; w/in 16 hrs pt recovered;
exacerbation of mast cell disorder manifested sinus stuffiness, slightly SOB, facial erythema VS: B/P 122/82, P 84, Pulse ox 98%.
10/29/07-woke up at night (does not know time) left bicep hurt. Left Bicep became red & hot. 10/30/07- Left Bicep became swollen.
headache, chills fever lasting 8 hours. Then headache only for 10 hours. Tylenol taken 2x
Chills; Shakes; Fever; Vomiting; Reaction to Covid-19 Vaccine; low white blood cell count; This is a solicited report from a contactable consumer, the patient, based on information received by Pfizer e (Manufacturer Control No: 21K-163-3860957-00).   Solicited report from the by a consumer of a 66 year old male with events of CHILLS, SHAKES, FEVER and vomiting and non-serious reaction to covid-19 vaccine and low white blood cell count with venclexta (venetoclax). There was no reported medical history. In 2021, the patient experienced CHILLS, shakes, fever, vomiting, reaction to covid-19 vaccine and low white blood cell count. Covid-19 vaccine was also considered suspect.  The patient had reaction to the Pfizer COVID-19 Vaccine and was hospitalized with fever of 103, chills, shakes, and vomiting. His white blood cell count went low from 4.4 to 0.9. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. In 2021, he received 1st dose COVID-19 Vaccine manufactured by Pfizer. No concomitant drugs taken. He did not agree to have physician contacted.   Causality Assessment: The reporter's causality for the event(s) of Chills, Shakes, Fever, Vomiting, Reaction To Covid-19 vaccine and low white blood cell count was not provided. opinion is that there is no reasonable possibility that the events of Chills, Shakes, Fever, Vomiting, Reaction To Covid-19 Vaccine And Low White Blood Cell Count Are Related To Venclexta(Venetoclax).   The reporter's assessment of the causal relationship of chills, shaking, fever, vomiting, vaccination adverse reaction, and white blood cell count low with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on chronological connection to the vaccine and known product safety profile, there was a reasonable possibility that the reported events were related to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient returned to the pharmacy 2 hours after vaccination. Patient with symptoms of an allergic reaction. Presenting the following: numbing of face, chills, pain in the arm, respiratory distress, swollen arms and neck, trembling. Epi Pen and Benadryl administered by RPH. Patient stable. Ambulance came and took her to the hospital. At the moment awaiting status.
itchy bumps on her lip; itchy bumps on her lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Egg white allergy" (ongoing), notes: Caller states his wife has an egg white allergy and asks if it is a known component in the vaccine. The patient's concomitant medications were not reported. The following information was reported: LIP DISORDER (non-serious), LIP PRURITUS (non-serious), outcome "unknown" and all described as "itchy bumps on her lip".  Additional information: Caller stated his wife received her first dose and had itchy bumps on her lip. Caller wanted to know the chance of a more severe reaction with a second dose or would she have the same thing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received my vaccination in the morning via a shot in the upper left arm.  I felt completely fine while driving home and during the rest of the day.  I work from home and I returned to my home office right after the shot. I worked in my office (desk job) all day and did not exercise, stretch, etc.  In the evening my arm became sore around the injection location which I have heard is normal. The next day my arm did not hurt, but had a dis-location feeling as if my arm had ?popped? out of my shoulder and I had to raise my arm to ?pop? it back in place.   I figured this was part of the healing process. After two weeks my arm had not improved ? the dis-location feeling persisted and was occasionally painful so I went to my doctor. He told me it may be the result of inflammation caused by the shot and took an x-ray to ensure no bones were rubbing against each other.  The X-ray came back fine. He gave me some anti-inflammatory pills to take when I was experiencing pain.   About once every 1-2 weeks I do experience a sharp pain near the injection site that persists until I take the anti-inflammation medicine.  Most of the time it is not painful but still feels as though my shoulder is dis-located.  When I exercise my shoulder (yoga or resistance/weight training) I will quickly begin feeling pain in my shoulder near the injection site.   It has now been nearly 4 months and my shoulder has not improved. I still have to ?pop? my shoulder/arm back into place multiple times per day and experience pain when my shoulder is stressed from exercise or moderate/heavy lifting. This has never been an issue before. The dis-location sensation and intermittent pain started the same day I received my vaccine shot and I did not do anything physical that could have led to a shoulder/arm injury in the same location of my vaccine injection in the days leading up to or following the vaccine.
This report described the occurrence of chest pain in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. The patient received injections of Lymerix on 5/26/99, 6/28/99, and 5/9/00 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered foot swelling, joint pain, tingling, headaches, chest tightness with pain, stiff neck and memory loss beginning three days after first and second vaccinations. Treatment and outcomes of the alleged events were not reported. Medical records forwarded by the attorney indicated the patient, a 43 year old male, had a history of hypertension and hypercholesterolemia and was in relatively good health, with good control of his hypertension. He worked and had frequent exposure to the woods. In approximately May 2000, he developed severe acute headaches, associated with chest pain. The chest pain was pleuritic and non-exertional and resolved after taking about ten deep breaths. He saw a cardiologist regarding the chest pain in June 2000. An electrocardiogram and echocardiogram were normal. He also underwent a hematology consult on 6/26/00 because of complaints of extreme fatigue, malaise and shortness of breath, which also started intermittently in May 2000. These symptoms occurred with a stiff neck and the other symptoms of chest pain and headache. He reported to the hematologist that he had received Lymerix in May and June of 1999 and May 2000 and that he had several gout-like left foot pain shortly after the first two doses. The other symptoms occurred several weeks after receiving the third Lyme vaccine. From May, 2000 to June 2000 his hemoglobin began to decrease from 13.9g/dl to 10.9g/dl while his erythrocyte sedimentation rate also rose form 29 to 122 mm/hr. During this time his white blood cell count, platelets and liver function tests were normal. In addition the patient complained of tachycardia. The hematologist did not suspect a hematologic problem but thought the anemia was due to another underlying cause. In view of the patient's occupation, he felt the patient's multiple symptoms were most likely related to a tick related disease or possibly secondary to Lymerix. He was started on doxycycline. Two months later, on 8/17/00, his hemoglobin and sedimentation rate had improved, though he was still anemic. He underwent a bone marrow biopsy that day which was normal. He had a slightly low iron, with a normal ferritin and iron biding capacity. At that time he continued to complain of fatigue with myalgia and arthralgia. Additional lab values are available upon request. On 8/15/00 CTR scan of chest revealed a small 1-2 millimeter-sized pleural nodule in the right mid/lower lung anteriorly and posteriorly. This was followed by CT scan over the next year. It was unchanged suggesting a benign etiology.
Patient experienced a fever (101.3 F), substantial nausea and vomiting.  Starting approximately 10 hours post vaccination.
With in 2-3 days of the first Zoster Shingrix Vaccine on 05/31/2018 I began feeling mild flu like symptoms and stiff muscles, predominately the legs muscles. The flu like symptoms subsided but the stiff muscles continued making it difficult to perform my daily routines. The extreme rigid stiffness in my legs is at its worse when I first rise from a seated position. The second vaccine was administered on 08/16/2018. On 02/26/2019 I was diagnosed with Rheumatoid Arthritis. With in two months of my Rheumatoid Arthritis diagnosis additional autoimmune symptoms began to appear. To date we have tried multiple medications and continue to work to find an effective combination to allow the Rheumatoid Arthritis to go into remission. I had no Rheumatoid Arthritis or Autoimmune problems, nor family history prior to my Zoster Shingrix Vaccine.
Modern a COVID-19 EUA Headache, hot flashes, fatigue, nausea, yellow diarrhea, swollen arm, redness,  muscle aches,  joint pain
Pt received 3rd Hep B dose to Left thigh on 5/10/12 at 1:15pm. The following morning 5/11/12, child's Left thigh was 2" larger girth than Right thigh and had small blisters covering thigh towards knee. Mother took child to ER, received IV fluids and steroids. ER doctor determined Hep B vaccine allergy and instructed mom to refuse any additional vaccinations of Hep B.
Terrible chills, my teeth were chattering, could  not keep hands still without holding myself,  lasted 6 hours, second night I had body sweats throughout the night lasting 8 hours
No other AE; HBP calling to report an inadvertent administration of PROQUAD and VARIVAX to a patient on the same day.  HBP reporting a patient received both vaccines on 11/02/2023.  This was the first dose of both vaccines for this patient.; This spontaneous report was received from a nurse concerning a 12-month-old patient of unknown gender. The patient's concurrent condition, medical history, and concomitant medication were not provided.  On 02-NOV-2023, the patient was inadvertently vaccinated with the first dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PNEUMOVAX) injection (lot# W038809, expiry date: 04-JUN-2024; dose, route of administration and anatomical location not provided) and with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot# W024334, expiry date: 01-AUG-2024; dose, route of administration and anatomical location not provided); both as prophylaxis (accidental overdose). There were no symptoms or additional details provided. There was no other adverse event (AE) (no adverse event).
15 minutes following vaccine, patient experienced chest tightness, sensation of throat closing, and shortness of breath. No chest pain, dizziness, vomiting, chills, fever, cough, congestion. Patient brought immediately to on-site Urgent Care clinic. EKG revealed sinus tachycardia. Patient given 50mg Benadryl IM and 0.3mg epinephrine IM. Patient initially improved but then began to report chest tightness and more shortness of breath. Paramedics called and patient transported via ambulance to hospital for further treatment.
COVID arm; Injection site faded to a tan color; redness down the elbow and arm; hardness down the elbow and arm; Injection site Itchy; Arm at injection site hard, down to elbow and lower arm; arm at the injection site was red, down to elbow and lower arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm), VACCINATION SITE DISCOLOURATION (Injection site faded to a tan color), ERYTHEMA (redness down the elbow and arm), INDURATION (hardness down the elbow and arm) and VACCINATION SITE PRURITUS (Injection site Itchy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009CZIA and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (COVID arm), VACCINATION SITE DISCOLOURATION (Injection site faded to a tan color), ERYTHEMA (redness down the elbow and arm), INDURATION (hardness down the elbow and arm), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE INDURATION (Arm at injection site hard, down to elbow and lower arm) and VACCINATION SITE ERYTHEMA (arm at the injection site was red, down to elbow and lower arm). At the time of the report, VACCINATION COMPLICATION (COVID arm), VACCINATION SITE DISCOLOURATION (Injection site faded to a tan color), ERYTHEMA (redness down the elbow and arm), INDURATION (hardness down the elbow and arm), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE INDURATION (Arm at injection site hard, down to elbow and lower arm) and VACCINATION SITE ERYTHEMA (arm at the injection site was red, down to elbow and lower arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information is provided.
Itchy throat with cough and nausea, 50 mg Benadryl PO, 20 mg Pepcid PO
Itchiness all over. Mostly under bottom lip, hands and all over back. No hives or other physical symptoms that aren't included as common side effects. Time Noticed: 8pm, Peak itchiness 8:30pm Still feeling itchy at the moment.
Patient had redness, swelling and a lump around the injection site. She stated that those symptoms resolved after a day or two, but the lump moved down further to be directly above her elbow.
pt recvd vax; adm to hosp w/ febrile sz, T105.9 R;adm to hosp x 2 days;16jan condition resolved; discharged from hosp on 6feb; MD reported no sequela from event;