chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an allergic reaction/ high fever and a rash.; an allergic reaction/ high fever and a rash.; This spontaneous report was received from a male patient of unknown age, who was referring to himself. No information regarding his pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date (reported as the patient was a kid), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 1986, the patient had an allergic reaction. It was reported that he experienced high fever and rash. The outcome of the events was not reported.  The relatedness between the events and the suspect vaccine was not provided.
12 hrs after vaccine, site swollen, erythematous, site approx 10 cm x 5 cm, tender to palpation. Ice applied with clinical improvement.
Pt. broke out in a rash all over her trunk, arms, legs, and now face. Doesn't itch or hurt but reading about reactions and nothing else changing in her environment we are contributing this to the vaccine. She has only received 1 vaccine in her life at 12 months of age. She hasn't had any other shots.
Patient reported swollen lymph nodes (the size of grapefruit) under armpit and chest area. Patient couldn't move his hand and arm for 2 days with low-grade fever (101.9). Fever resolved with alternating Tylenol and Ibuprofen. Patient used hot and cold compresses. In addition, he had slurred speech. Per patient he had 3-4 appointments with his doctor. He was diagnosed with a type of cellulitis. Patient reported this incident to pharmacy on 01/17/2022. He's feeling better now.
Information has been received from a physician concerning a 4-year-old white male who on 30-MAY-2003 was vaccinated SC in the left arm with a first dose of Varivax (Lot # 644248/1145M). On 12-OCT-2006 the patient developed a rash consistent with a mild case of varicella (<25 lesions). Subsequently, the patient recovered. No complications were noted. Additional information has been requested.
Moderna vaccine administered at 1248. Patient reported left arm numbness walking to observation area. Symptom occurred within 30 seconds of administration. Verbalized mild dizziness. Paramedic called to assess. Vital signs taken. 146/100, HR 95. Continued observation x 1 hour. Refused to go to hospital at this time. Signed MEDICAL form. Advised to seek medical attention with any change in status. continue observation at this time 1400 for intermittent waves of dizziness. Patient verbalized she was feeling appropriate to leave. Released at 1408.
Headaches; Fevers; Chills; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Mar2021, the patient experienced headaches, fevers, chills and loss of appetite. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab for COVID-19 virus test on 03Apr2021 and 15Apr2021 and tested negative for both. The clinical outcome of the events headaches, fevers, chills and loss of appetite were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
aches, fever, sl chills, restlessness started 4hrs lasted 5 days, fungal ear infect 7days p/shot;ASA q 4-6hrs
See attached (back of form); INFLENZA GIVE at 1145Am. At approx 1245Am the patient had itching 1 Pm Felt weird. Went outside to get air Sit down with head between knees Fainted Nurse called 911 called. When Nurse arrived patient was in and out of conscientiousness; Smelling salts used. -medics arrived started IV fluids - Gave Benadryl Breathing poor - gave 02 B/P 215/120 HR 127; Stayed in ER until 6 Pm; While in Hospital had Cat Scan EKG. Placed on Heart Monitor and given more IV fluids for dehydration. Woke up next morning with Migraine went to MD. Had Sinus Infection. Placed on antibiotics 11/1/07 Patient doing fine
This patient received a pediatric Pfizer first dose instead of an adult Pfizer first dose that he should have gotten. Pt tolerated well. Mother was informed of the incorrect vaccine and was told to get him an adult second dose per CDC guidelines after 21 days.
Vaccine was given PCV 13 IM. Pt cried and went to sleep for 3-4 minutes. Then woke up with a staring episode then developed tonic and clonic movement pt given oxygen by mask then EPINEPHRINE IM 1:1000 0.3L IM then. DIAZOPAM rectal 0.9 ml x 1 (5m/l) seizure was resolved but started again after admit to ICU. Pt has hx of CP. Secondary to strep pneumonia meningitis.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Gave patient booster vaccine and patient fainted once seated at the observation area. Patient did warn the immunizer ahead of time that patient faints when given any vaccine. Patient fainted on the first vaccine but was fine on the 2nd dose Pfizer. Patient fainted for 1 minute and woke up feeling lightheaded. Gave patient orange juice and water. Patient was fine after 15 minutes.
Vial expired on 20-May-2022 was initialy stored in refrigerator on 7-Jun-2022 and was administered on 8-Jun-2022; No adverse event; Booster dose given after 19 days of expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose given after 19 days of expiration date.), PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was initialy stored in refrigerator on 7-Jun-2022 and was administered on 8-Jun-2022) and NO ADVERSE EVENT (No adverse event) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose given after 19 days of expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was initialy stored in refrigerator on 7-Jun-2022 and was administered on 8-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose given after 19 days of expiration date.), PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was initialy stored in refrigerator on 7-Jun-2022 and was administered on 8-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Booster dose given after 19 days of expiration date.) and PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was initialy stored in refrigerator on 7-Jun-2022 and was administered on 8-Jun-2022).    No concomitant medications were reported. It was reported that vial was initially stored in refrigerator on 07-Jun-2022. The vial did not undergo temperature excursions. No adverse event was reported. The expiration date of vial was reported as 20-May-2022. No treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Live follow-up contains: Patient demographics and suspect product details updated. On 02-Sep-2022: Live follow-up contains no new information.
experiencing in upper body chills; This is a spontaneous report from a contactable Pharmacist reporting for a patient. A 6-decade-old (early 50s) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on unknown date at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The Pharmacist reported two patients with delayed onset symptoms, he was not entirely sure if they were related to the vaccine. The Pharmacist wanted to know if there is any data on delayed onset side effects. 10 days after vaccine, the patient in early 50s and was experiencing in upper body chills on an unspecified date and negative for COVID on unknown date. The event outcome was unknown.  Information on the lot/batch number has been requested.
Please include ?Pfizer-BioNTech COVID-19 Vaccine EUA? in the first line of box #18 of the report form.  Mild pain around injection site (dose #1 &  dose #2) and mild diarrhea approximately 14 hours after dose #2 injection only.  Diarrhea persisted approximately 30 hours.
Patient Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant medication was reported.    Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022. No treatment information was reported. This case was reported for 6th patient out of 20 patients.
Started losing hair from Dec but in January 2022 we noticed patchy hair loss; BNT162B2 was administered after 42 days of primary dose; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 14-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 at 19:00 (Lot number: 32030BD) at the age of 13 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: N/A. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0181, Anatomical site: left arm), administration date: 26Jun2021, when the patient was 13 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Nov2021 at 19:00, outcome "unknown", described as "BNT162B2 was administered after 42 days of primary dose"; ALOPECIA AREATA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Started losing hair from Dec but in January 2022 we noticed patchy hair loss". The event "Started losing hair from Dec but in January 2022 we noticed patchy hair loss" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that one of the spots got bigger and got an appointment with her pediatrician and also with a dermatologist. Her pediatrician noted it as Alopecia. Dermatologist confirmed it as Alopecia areata. They had started the treatment for the patient. Note no one in the family had any history of Alopecia. The patient had thick and full hair but the vaccine had caused the autoimmune attacking hair follicle. Treatment for alopecia included steroid shots on her scalp where she had lost hair. Since the vaccination, the patient had been tested for COVID-19.
Rash on arms and legs, mostly on the legs with palpable petechie easily blanchable.
patient was administered HIB portion with 0.4% saline solution instead of using the DTaP/IPV, which was not given; HIB portion was administered without the DTaP/IPV portion; She reports patient had a knot on leg at injection site; Initial information received on 16-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who was administered hib portion with 0.4% saline solution instead of using the dtap/ipv, which was not given, hib portion was administered without the dtap/ipv portion and she reports patient had a knot on leg at injection site after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (UJ633AAB and expiry date 30-Jan-2023 )  via intramuscular route in the thigh nos for Immunization.  On an unknown date the reportedly patient was administered hib portion with 0.4% saline solution instead of using the dtap/ipv, which was not given (product preparation error) and  hib portion was administered without the dtap/ipv portion (incorrect dose administered) (unknown latency). On an unknown date the patient had a knot on leg at injection site (vaccination site mass) (unknown latency).  Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event. (She reports patient had a knot on leg at injection site).  At time of reporting, the outcome was Unknown for all the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approx. 8 hrs following vaccines administered developed flu-like symptoms, followed by pain, swelling and rash to upper arm around injection site. Given steroid ointment and po meds plus pain meds.
peripheral neuropathy with no feeling in her toes, feet and up to her waist; tremors to the 5th digits to bilateral hands; imbalanced gait; severe upper back pain; Severe neck pain; transverse myelitis with significant involvement; A spontaneous report was received from a physician concerning a 70-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced transverse myelitis with significant involvement, peripheral neuropathy with no feeling in her toes, feet and up to her waist, upper back pain, neck pain, tremors to the 5th digits to bilateral hands, and imbalanced gait.  The patient's medical history included breast cancer. No relevant concomitant medications were reported.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient began to experience severe upper back and neck pain. The patient's pain progressed to peripheral neuropathy with no feeling in her toes and feet, and up to her waist. She also had tremors to the 5th digits in both hands. On 12 Feb 2021, the patient was admitted to the hospital. The patient had transverse myelitis with significant involvement. She had an imbalanced gait and had involvement from C3-7 and T1. She was taking high doses of steroids- Dexamethasone 10mg/day. It is believed the patient had an exacerbated autoimmune reaction and that she will require surgical repair.  Action taken with mRNA-1273 in response to the events was not provided.  The outcomes of the events were not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Patient was sitting on chair for 15 minutes after vaccination to be observed for adverse reaction. Patient stood up from chair to pick her for phone on ground, and reported sudden dizziness. I asked patient to lay her back on ground. Patient reported she had fainted at blood exam before due to orthostatic hypotension.
Haemophilus influenzae type B meningitis CSF culture positive for H influenzae b. Had temporary paralysis of lower limbs after meningitis.
I was out for a walk, came home sat down on the couch for a couple hours. I went to get up my back locked up and I had to walk around to get the muscles to relax. I went to bed that night and when I got up and woke up it was locked up again. It hurt to move, walk and as I was walking trying to get the muscles to relax the pain moved from my lower back to my upper back By the time I got to my physician the next week the pain and spasms were going up and down my whole back. He prescribed FLEXERIL, diclofenac and prednisone for five days. My back feels better but the pain is now concentrated in my hips.
Nurse administering vaccine gave the patient the vaccine 2 COVID vaccines. 1 was meant for the patient and 1 one set aside for another patient. Pt felt no adverse effects at the time of the vaccination and during the monitoring period.
Nov 1 flu shot, several hours later weakness in left side - hip/across buttocks to mid section since Nov 2 continued weakness left side , hard to stand up from bed, sittings - poor strength in left side.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 72-year-old male patient 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because their facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient. No treatment information was provided. This case was linked to MOD-2022-501575 (Patient Link).
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Additional Details: Extreme sweating, nausea & short fainting spell. Gave patient water and sugary snack. Mentioned he may not have eaten enough that morning
A nurse reported that a 13 month old male received Prevnar and MMR II vaccines on 12/1/00 and within 2-3 days, post vax, he developed a high fever, wheezing, blue lips, and shallow breathing. He had trouble breathing and was taken to the ER. He recovered. Dyspnea is considered "Medically Important".
Inappropriate schedule of vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable.