chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got very sick for two days; headache; losing control of feet and speech; losing control of feet and speech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 31Aug2022 at 12:00 as dose 4 (booster), single (Lot number: FP715) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "loss of hearing 70 % right ear" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 27Jun2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 05Mar2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: GL9767, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 12Feb2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: ILLNESS (caused and prolonged hospitalization, disability) with onset 07Sep2022 at 16:00, outcome "not recovered", described as "Got very sick for two days"; HEADACHE (caused and prolonged hospitalization, disability) with onset 07Sep2022 at 16:00, outcome "not recovered"; LIMB DISCOMFORT (caused and prolonged hospitalization, disability), SPEECH DISORDER (caused and prolonged hospitalization, disability) all with onset 07Sep2022 at 16:00, outcome "not recovered" and all described as "losing control of feet and speech". The patient was hospitalized and prolonged hospitalization for illness, headache, limb discomfort, speech disorder (hospitalization duration: 12 day(s)). The events "got very sick for two days", "headache" and "losing control of feet and speech" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of illness, headache, limb discomfort, speech disorder.  Clinical course: Patient visited Public Health Clinic/facility for administration of COVID-19 vaccine. It was unknown if patient received other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Patient received other medication in two weeks. Patient got very sick for two days, had a bad headache for 3 days, started losing control of feet and speech and symptoms have worsened to wheelchair and feels like its in arms and head now. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19.
Increased menstrual bleeding following the vaccine. All typical menstruation symptoms which usually are not bad are now excessive.
Itching - rash - (face, neck, arms, legs). Funny taste tongue - salty. Face swollen, itching.
Nausea, fatigue. While these were present before the vaccine due to my pregnancy and hyper gravidarum, they became significantly worse after receiving the vaccine and persisted for nearly 48 hours.
pt recv vax 5JUN96;pt devel nausea, dizziness & an inj site rxn, characterized by redness, swelling, tenderness;noted 8-10cm erythematous area on the lt arm;pt tx w/DPH & recovered;
A report was received on 2/28/02 concerning a 75 year old male pt who experienced exacerbation of chronic obstructive pulmonary disease on 10/20/98 after receiving Fluvirin vaccine on 10/10/98. The event was considered serious as the pt was hospitalized. It is not known if the pt had recovered at the time of reporting the event. The reporter has assessed the causality as possibly related. No more info has been provided. ID no. HQ1160922MAY2001
Circle of inflammation at the injection site; Mild headache; Diarrhea; Lump at injection site; Arm soreness; arm weakness; Instant redness within 15 minutes; itching; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), LIMB DISCOMFORT (arm weakness), DIARRHOEA (Diarrhea), INJECTION SITE INFLAMMATION (Circle of inflammation at the injection site) and ERYTHEMA (Instant redness within 15 minutes) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Allergies to fillers and bonding agents.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), LIMB DISCOMFORT (arm weakness), ERYTHEMA (Instant redness within 15 minutes), PRURITUS (itching), FATIGUE (Fatigue) and INJECTION SITE INDURATION (Lump at injection site). On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Mild headache). On 21-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Circle of inflammation at the injection site). On 15-Jan-2021, HEADACHE (Mild headache) had resolved. On 17-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 18-Jan-2021, PAIN IN EXTREMITY (Arm soreness) had not resolved, LIMB DISCOMFORT (arm weakness), PRURITUS (itching), FATIGUE (Fatigue) and INJECTION SITE INDURATION (Lump at injection site) had resolved. At the time of the report, INJECTION SITE INFLAMMATION (Circle of inflammation at the injection site) outcome was unknown and ERYTHEMA (Instant redness within 15 minutes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
I received the vaccine at 12:45PM on 10-13-2004 At 10:40 PM the same day I  became extremely dizzy and weak, with rapid heart beat.  I suspected it was a reaction to the flu shot, and after talking to another person with the same symptoms, I am sure that it was.  I am reporting this to you for your records.
Presented with urticaria on arms, legs, neck & abdomen 30 min. post injection.
Pt recvd 1st dose of Hep B vax approx OCT91-following the vax pt devel a local rxn & urticaria on forearm & hand;
Patient received this first dose of Shingrix on 10-12-20 and on 10/14/20 he developed a rash that started on his low back and wrapped around to umbilica lasted for 2 wks.
Daptacel was given to a 4-year old female child and then it was realized that the dose expired on 23Oct2019, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that Daptacel was given to a 4-year old female child and then it was realized that the dose expired on 23-Oct-2019 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLUARIX); POLIO VACCINE INACT (IPV); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 01-Nov-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA and expiry date: 23-Oct-2019 via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  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 Directive and Module VI of the Practices. 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.
PATIENT REPORTED REDNESS & SWELLING NEAR INJECTION SITE DURING THE DAYS FOLLOWING VACCINE ADMINISTRATION.  DAY 6 AFTER VACCINATION, THE PATIENT NOTICED A NON-ITCHY, NON-PAINFUL RASH DEVELOPING ON THEIR TRUNK.
Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Nausea; Vomiting; Severe myalgias; Headache; This is a spontaneous report from a contactable physician reporting for herself. A 29-years-old female pregnant patient received the second dose of bnt162b2 (BNT162B2), lot number EL0142, via an unspecified route of administration from 18Jan2021 15:00 (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination.  Historical vaccine included first dose of bnt162b2 (BNT162B2), lot number EL1284 in the left arm. The patient's medical history was not reported.  Concomitant medication included multivitamin. The patient previously took  clarithromycin(BIAXIN) and experienced Known allergies: BIAXIN. No other vaccine was given in four weeks. The patient received the vaccine at a hospital. The patient's last menstrual date was 23Nov2020. Her Delivery date is 01Sep2021. Gestational period is 6. The mother was 8 Weeks pregnant at the onset of the event. On 19Jan2021 at 03:00 the patient experienced nausea, vomiting, severe myalgias and headache. Treatment included acetaminophen (TYLENOL) and antiemetic. The clinical outcomes of the events nausea, vomiting, severe myalgias and headache was recovering. The clinical outcome of the event "Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event" was unknown. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.
Covered in hives from head to toe, severely swollen hands, ears, and throat. Restricted airway, difficulty breathing. Took to hospital emergency room. Was treated with ZANTAC and prednisone. Was released that evening and treated with medicine for next 24 hours and he had no further problems.
Injections given on 09/19/2005, Mom brought child back in to clinic on Thursday with small amount of generalized swelling and redness, vital signs within normal limits.  No treatment given Mom instructed by doctor to use cool compresses and watch.
Suspected Vaccination Failure; had shingles; terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In September 2020, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported. The patient received shingles vaccine and she had shingles since the end of September 2020. The patient was still in terrible pain. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Pt had Pneumo 23 on 3/3/2020 24' Later 3/4 exp pain-swelling, redness 2" area left upper inner arm-not injection site Pt took Advil 800mg & Benadryl 50mg Pt reported reaction on 3/6 - SXS resolved 90% - no apt needed
The vaccine was given high on the left arm causing pain and decreased range of motion. The injection (quadrivalent type but not sure of brand/maker) was given around 1:45pm in the Employee Health and Wellness Flu vaccine clinic. The injection hurt a little more than normal but it wasn't until a couple hours later that my left arm begin to hurt more. Within 48 hrs I had decreased ROM.
High fever and chills running for 4.0 days now. Fever as high as 104 at times.
Extreme fatigue, body aches,  Fever started 24 hrs after injection body aches worsen  2 days after : body aches and fatigue lessen, fever has lowered
itching; breathing difficulties/ immediate breathing problems; coughing; increased hearth rate; Overdose; Inappropriate schedule of vaccine administered; allergic reactions to food; vocal cords are limits her swallowing capacity; vocal cords are limits her swallowing capacity; This repeated and was more severe; This is a spontaneous report from a contactable female consumer (patient). A 57-year-old non-pregnant female patient received first bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 06Mar2021 at 11:30 (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EK4176) via an unspecified route of administration, administered in left arm on 06Mar2021 (at the age of 57-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history included high blood pressure from an unknown date and unknown if ongoing. The patient had known allergies. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. Facility type vaccine was mentioned as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not covid prior vaccination and covid was not tested post vaccination. On 06Apr2021, immediate reaction was itching, breathing difficulties, coughing and increased hearth rate. Events overdose and Inappropriate schedule of vaccine administered. Emergency medical technician (EMT) was involved and administered two Benadryl pills and after 45 minutes patient was back to normal. This repeated and was more severe during the second dose of the vaccine. After two weeks, on an unspecified date in Apr2021, allergic reactions to food started. She can only eat very limited amount of bread cheese, and some select fruit. All other food caused itching, breathing problem and coughing. The patient went to a specialist and was prescribed allergy medication and the situation improved little. Whenever patient eats, companions will wait with Epipen and Benadryl pills. Her vocal cords limit her swallowing capacity and immediately breathing problems starts. These episodes last only 10-15 minutes but are increasingly concerned because if she experience these without any companion. Adverse event resulted in doctor or other healthcare professional office / clinic visit and Emergency room /department or urgent care and EMT and Doctor visit. The clinical outcome of events was not recovered and the events overdose and Inappropriate schedule of vaccine administered was unknown.    No follow-up attempts are needed. No further information is expected.
Patient came in on 10/27/17 with c/o redness, increased warmth, and pain at the site of injections (right deltoid). Afebrile, but has cellulitis at the site. Given BACTRIM DS bid x 10 days. She will f/u in 1 week for a recheck.
8 days after 1st dose of Moderna, experienced extreme itchiness, swelling, rash, bruising over large portion of arm surrounding injection site (upper L arm). Still present the next day (today)
Patient received J&J on 11/22/2021, he had Pfizer first dose on 10/18/2021.
high risk infant received 2 mo vaccine series while still inpatient in the NICU--including rotavirus which is our unit standard.  3 wks after vaccine  admin had complex surgery for severe micrognathia (jaw distraction, gastrostomy tube, and R inguinal hernia repair).  infant with abdominal distention and fever 4 weeks after vaccine administration, diagnosed with stage 2 NEC vs ischemia of ascending colon.  Received 10 days bowel rest and broad spectum antibioitcs and recovered without surgery.
Reporting fever in nursing toddler 30 mo old. Mom reports that fever developed in her nursing child 6 hours after first episode of breastfeeding on same date as Dose 2 of Pfizer's SAR-COV-2 vaccine.  Onset of fever was 10 hours after mother received the vaccine. Duration of fever in child lasted 24 hours and there were no other associated symptoms. I agreed to submit this report on Mom's behalf as a possible vaccine related event, though the mechanism for development of fever after ingestion of mom's milk isn't obvious to me.
"woke up and right side of jaw was swollen / left side of jaw swelling/swollen jaw until the nose; woke up and right side of jaw was red; woke up and right side of jaw was hot; alergic reaction in the face; redness and numb.; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE ("woke up and right side of jaw was swollen / left side of jaw swelling/swollen jaw until the nose), ORAL MUCOSAL ERYTHEMA (woke up and right side of jaw was red), FEELING HOT (woke up and right side of jaw was hot), HYPERSENSITIVITY (alergic reaction in the face) and HYPOAESTHESIA (redness and numb.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 040A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced HYPERSENSITIVITY (alergic reaction in the face) and HYPOAESTHESIA (redness and numb.). On an unknown date, the patient experienced SWELLING FACE ("woke up and right side of jaw was swollen / left side of jaw swelling/swollen jaw until the nose), ORAL MUCOSAL ERYTHEMA (woke up and right side of jaw was red) and FEELING HOT (woke up and right side of jaw was hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency. At the time of the report, SWELLING FACE ("woke up and right side of jaw was swollen / left side of jaw swelling/swollen jaw until the nose), ORAL MUCOSAL ERYTHEMA (woke up and right side of jaw was red), FEELING HOT (woke up and right side of jaw was hot), HYPERSENSITIVITY (alergic reaction in the face) and HYPOAESTHESIA (redness and numb.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Significant follow-up received, events updated
Myalgia, Arthralgia, WARMTH, TENDERNESS, AND REDNESS AT INJECTION SITE Narrative:
Sharp Pain/Swelling of Lymph nodes in right underarm. This appeared two days after getting the vaccine and was gone on its own by day 6 after getting the vaccine. The injection site was very swollen and hot for 7 days after the vaccine, but went away on its own.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included hives (developed due to wheat allergy in 2018). Concurrent medical conditions included allergy to grains (developed in 2018 (last year)). On 4th January 2019, the patient received the 1st dose of SHINGRIX. On 4th January 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache and stomach pain. In January 2019, the patient experienced hives, pruritus and papular rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm, headache, stomach pain, pruritus and papular rash were unknown and the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the pain in arm, headache, stomach pain, hives, pruritus and papular rash to be related to SHINGRIX. Additional details were provided as follows: The patient has never had allergies before, but last year (in 2018), he developed a wheat allergy that results in hives similar to what he had recently. The patient received SHINGRIX in left deltoid and experienced arm soreness, headache and stomach pain that night. About 29 hours after the vaccination, he developed hives on he neck, head and back that appeared as itching, raised bumps. He took some Benadryl and the hives resolved in about an hour.
On taking 2-200mg of Aleve, with no prior allergies, I went into analyphatic shock and was rushed to hospital unconscious.
Pain injection site; arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 09Jan2021 (Lot number: EK9231) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "3rd stage kidney disease" (unspecified if ongoing), notes: Verbatim: 3rd stage kidney disease; "stent in her heart" (unspecified if ongoing), notes: Verbatim: stent in her heart; "a fib" (unspecified if ongoing), notes: Verbatim: a fib; "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: FLECAINIDE taken for cardiac fibrillation; PRAVASTATIN; AMLODIPINE; CARVEDILOL; ELIQUIS; FISH OIL; C-VITAMIN; VITAMIN D 2000; CINNAMON; CALCIUM; TYLENOL ACHES & STRAINS taken for pain. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Jan2021, outcome "not recovered", described as "Pain injection site"; PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "arm was sore". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The patient is calling about the Pfizer covid vaccine. The caller received the first dose on 09Jan2021 and her second dose on 30Jan2021. The patient went to pharmacy and was talking to her pharmacist about this event and the pharmacist told her she should call Pfizer and report it. After the caller received her first dose, the first night the caller's arm was really sore so she took a couple of Tylenol and the soreness never went away and now its down to her elbow. The patient took extra strength Tylenol, the Equate brand, and it helped with the pain but the pain didn't ever really go away. Lot 9FE3331A, expiration date Apr2021, it was not expired at the time of the caller taking it. Patient had taken second dose of vaccine on 30Jan2021 (lot no: EL9265). Patient had not received any prior vaccination within 4 weeks. Patient did not administer additional vaccines on same date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Pt stated her arm got really red and swollen from sight to her elbow on (L) arm sub q.
pt recvd vax & had pallor, lethargy on day of inject; t 100.2 w/ some twitching of rt arm; admitted to hosp for observation;