chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AT 9 PM the night of 4/3/2021, I began to experience a headache.  It got worse over the next hour.  I took Tylenol and went to sleep. I awoke the next morning in pain.  My entire body hurt especially the joints and specifically in the back left low back region..  I was very weak, tired, had a terrible headache, no appetite and felt exhausted.  The headache last 3 days.  The immense pain, especially in my low back last for two days.  The fatigue last for 4 days.  Tylenol, ibuprofen, and Tramadol were used for symptoms.  The pain did not ease with one dose of Tramadol, after speaking with my NP, I took two Tramadol and that seemed to help ease the pain.  It did not take it away entirely.  I did have a small amount of pain at the injection site.   The night of the 8th day after vaccination, I experienced severe itching  and redness on my chest.  This lasted through the night and into the morning.
Pt recvd vax & approx 2 hrs later pt exp paralysis of the rt lower extremity, numbness in the rt upper extremity & loss of sensation in the upper & lower extremities; pt was adm to the hosp & was discharged 2 days later;
My arm at the injection site turned hot and red. It was shining and burning and had a lump the size of a golf ball.; My arm at the injection site turned hot and red. It was shining and burning and had a lump the size of a golf ball.; My arm at the injection site turned hot and red. It was shining and burning and had a lump the size of a golf ball./Arm continues to have aump the size of a dime; It was shining and burning and had a lump the size of a golf ball.; This is a spontaneous report from a contactable other hcp (patient). A 35-years-old female patient (non-pregnant) received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 21May2021 05:30 (at the age of 35-years-old) as single dose for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included autoimmune thyroiditis from an unknown date and unknown if ongoing Verbatim: Hashimotos Thyroiditis complete thyroid removal, food allergy from an unknown date and unknown if ongoing Chocolate , allergy to plants from an unknown date and unknown if ongoing pine Tress, dust allergy from an unknown date and unknown if ongoing Dust, seasonal allergy from an unknown date and unknown if ongoing Grass, covid-19 from an unknown date and unknown if ongoing, thyroidectomy from an unknown date and unknown if ongoing  Verbatim: Hashimotos Thyroiditis complete thyroid removal. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination.  The patient was diagnosed with COVID-19 prior to vaccination. The patient stated "My arm at the injection site turned hot and red. It was shining and burning and had a lump the size of a golf ball (on an unspecified date)." Arm continues to have aump the size of a dime but no pain on an unspecified date. Since the vaccination, has the patient been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Jun2021 Nasal swab. Device date was 05Jun2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Rash that started on forehead and has spread to the rest of the face and down onto the chest.  The rash began right after vaccine and has continued to present day- 8/17/21.  Patient has taken prescribed corticosteroid with no relief.  Rash continues to spread.  Rash is red and is also around the eyes.  Patient reported some mornings the rash has caused her eyes to be swollen
Breakthrough case admission after 5 vaccines Moderna 1/14/21 lot# 012L20A;  Moderna 2/11/21 lot# 039K20A; Moderna 12/9/21 lot# 060H21Q;  Moderna 7/10/22 lot# 0144B22A;  Pfizer 11/13/22 lot# GH9702
Treatment of COVID-19; Treatment of COVID-19; Dose 3 Moderna, Dose 4 BNT16B2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 14:00 as dose 4 (booster), single (Lot number: G49694) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Lot number: 030L20A), in left arm, on 24Feb2021 as dose 2, single (Lot number: 001A21A), in left arm and on 09Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PMDD" (unspecified if ongoing); "Known allergies: Citalopram and benzocaine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022 at 14:00, outcome "unknown", described as "Dose 3 Moderna, Dose 4 BNT16B2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 30Aug2023 to 03Sep2023.
Please be advised, vaccine was not administered at our facility. I know that this patient received Dtap/IPV combination vaccine, but I am unsure if it was Kinrix or Quadracel. This patient experienced a large local reaction consistent of redness and swelling. Seen at Urgent Care on 10/3, where it was determined that no cellulitis component was present to the reaction, and continued monitoring was recommended.
This spontaneous report was received from a pharmacy technician (healthcare worker) refers to a patient of unknown age and gender. The healthcare worker reported that on 30-DEC-2013, the patient was vaccinated with a dose of GARDASIL (lot # 1073AA, expiry 11-OCT-2013). No adverse event reported. Additional information is not expected.
adjuvant portions of Shingrix were mixed and administered to a patient without the lyophilized powder reconstitution; adjuvant portions of Shingrix were mixed and administered to a patient without the lyophilized powder reconstitution; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number XL7RB) for prophylaxis.   On 15-MAY-2023, the patient received Shingrix. On 15-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: adjuvant portions of Shingrix were mixed and administered to a patient without the lyophilized powder reconstitution) and inappropriate dose of vaccine administered (Verbatim: adjuvant portions of Shingrix were mixed and administered to a patient without the lyophilized powder reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-May-2023 No expiration date was reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. The patient received two adjuvant portions of Shingrix were mixed without the lyophilized powder reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
On April 23,2021 patient was at her home and started complaining of shortness of breath and chest pain. She called 911 and they responded to her residence at 0500 a.m. While being assessed, patient collapsed. She was asystolic. CPR was started but to no avail. She was transported to the coroner's office where an autopsy was performed. She had bilateral pulmonary thromboemboli. There were not deep vein thromboses found in her legs.
Vomiting  Extreme weakness  Day after (16th)broke out in hives/rash. Not in atm where administered but all over stomach, back, chest and neck. Not itching more burning.  18th- hives part is gone but redness is still all over. Feels like a sunburn.
Developed joint pain in left hip and radiating down into left knee, also pain in left ankle.  Also, painful red raised bumps appeared on front of leg just below left knee.  Pain made it difficult to sleep for two nights from onset.  Joint pain in hip, knee, and ankle are still persisting to the present time, with pain intensity going from moderate to more serious.  Painful red raised bumps on lower leg are still present but are not as painful to the touch.  Joint pain in the left leg improves when I walk around, but gets worse with being seated or lying down for any length of time.
patient stated her face got red, she had redness and swelling at injection site, didn't specify which arm or arms, back pain, nauseated and her heart racing when she tried "to do anything"
RIGHT ARM HOT TO TOUCH, REDNESS, BELOW DELTOID TO 2 INCHES BELOW ELBOW; C/O ITCH, HIVE, SOB; REQUESTED TO HAVE PCP EVALUATION, COUNSELED -  10/28/11 FOLLOW UP MEDICAL EVAL, REQUIRED STEROID INTERVENTION
Rheumatoid arthritis; Blood pressure; Heart problems; She has blockage in her ear now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 31-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "Blood pressure"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart problems"; EAR DISORDER (non-serious), outcome "unknown", described as "She has blockage in her ear now". The events "rheumatoid arthritis", "blood pressure", "heart problems" and "she has blockage in her ear now" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red area overlying covid vaccination site.  She complains of redness around the vaccination site after the second Moderna vaccination received about a week ago.  Over the past 3 days has developed redness and slight itchy sensation over the area.  Feels slightly warm. No tenderness.  She otherwise feels well.  No other skin lesions, no myalgias/arthralgias. Vaccine not received at our clinic - came in for a PCP visit after noticed rash.
Second dose was given 23 days after first one; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given 23 days after first one) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given 23 days after first one). On 27-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given 23 days after first one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.
Never reacted to a vaccine like this before.; lip sore/pain is horrible; Numbness; lips swollen; throbbing; burning lips; cracks on the sides of the mouth; so red it looks like it has blisters; especially on the bottom lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP PAIN (lip sore/pain is horrible), HYPOAESTHESIA ORAL (Numbness), LIP SWELLING (lips swollen), PAIN (throbbing) and ORAL DISCOMFORT (burning lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced LIP PAIN (lip sore/pain is horrible), HYPOAESTHESIA ORAL (Numbness), LIP SWELLING (lips swollen), PAIN (throbbing), ORAL DISCOMFORT (burning lips), CHAPPED LIPS (cracks on the sides of the mouth), ANGULAR CHEILITIS (so red it looks like it has blisters) and LIP ERYTHEMA (especially on the bottom lip). On 16-Apr-2021, the patient experienced ALLERGY TO VACCINE (Never reacted to a vaccine like this before.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, LIP PAIN (lip sore/pain is horrible), HYPOAESTHESIA ORAL (Numbness), LIP SWELLING (lips swollen), PAIN (throbbing), ORAL DISCOMFORT (burning lips), CHAPPED LIPS (cracks on the sides of the mouth), ANGULAR CHEILITIS (so red it looks like it has blisters), LIP ERYTHEMA (especially on the bottom lip) and ALLERGY TO VACCINE (Never reacted to a vaccine like this before.) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Patient stated that she had this same reactions on NOV-2020 when she had COVID-19. She was refused to be treated by urgent care as the reactions were around the mouth area.   This case was linked to MOD-2021-211729 (Patient Link).
Headache, Nausea, Vomiting, Chills, body aches, tiredness, difficulty breathing, paleness, weakness, dizziness, redness and tenderness at injection site, fever. Needed to be hospitalized.  8/6/09 Hospital record received DOS 8/4/09. Assessment: Fever, possible reaction to 'TDP' immunization. Patient presents with fever, chills, and 'flu'. Sweating, shortness of breath, headache. Right arm pain. Mild distress, anxious.
No adverse event; Moderna monovalent vaccine was administered 2 days after use by date to 2 patients; Date the vial was initially stored in the refrigerator on 18Aug2022 and Date of administration of vaccine on 19Sep2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and Date of administration of vaccine on 19Sep2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and Date of administration of vaccine on 19Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and Date of administration of vaccine on 19Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and Date of administration of vaccine on 19Sep2022).    No concomitant medications were provided. It was reported that the vial size was 5.5mL and it was an individual vial. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-649978 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-649978:Patient 2
patient has been having severe tenderness near the injection site since then, that has led to weakness of her arm, especially when abducting.
Pain in right leg; Neck is itching and irritating; Irritating like a ship of glass poking in her skin; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in right leg), PRURITUS (Neck is itching and irritating) and SKIN IRRITATION (Irritating like a ship of glass poking in her skin) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure management.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in right leg), PRURITUS (Neck is itching and irritating) and SKIN IRRITATION (Irritating like a ship of glass poking in her skin). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in right leg), PRURITUS (Neck is itching and irritating) and SKIN IRRITATION (Irritating like a ship of glass poking in her skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2008, the male patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date in 2013, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Papular lesions hand thigh, buttock appeared 11/14/04  lesions almost gone.
My left arm began to ache.  Also had numbness /needles running up from shoulder to hand.  As if a nerve was affected.  These symptoms continue to this day 7 weeks later.  Need to take ibuprofen every night to handle the pain.
PATIENT IS AFRAID OF NEEDLES AND WAS DIZZY AFTER INJECTION. PATIENT HAD TO BE LAID DOWN FOR 30 MINUTES AND FIRST RESPONDERS CAME TO ASSESS PATIENT'S CONDITION. WAS TOLD PATIENT IS FINE AND PATIENT LEFT WHEN HE NO LONGER EXPERIENCED DIZZINESS
Received vaccine about 5:00 PM and within a few minutes experienced a burning like sensation on left side of chest area (sort of using icy hot or vicks or similar product) inside body  and did tell the nurse after a few minutes. Stayed for 30 minute post observation. No reaction in throat and generally feel ok otherwise, it is not a continuous symptom but seems to come and go throughout day. Did reach out to PCP the next morning and said to monitor systems. Reached out next day to ask about Benadryl and did take 1 dose which relieved symptoms. This is now day 3 and the symptom persists and feel in back area.
33 female who has had the flu-shot today at 8 am. She now states she is itching, there is no visible rash. She had similar itching last year after the shot and the a visible hives the next morning and had visible hives. She today slowly develops itching this afternoon, there is no lip swelling, mental status change, wheezing nausea or other sign of allergy. Symptoms began gradually and she finished some of her duties then presents to the Emergency Department as and arm of the Employee Health Clinic. Had the same symptoms last year that resolved with diphenhydramine, but did not like the sedation with diphenhydramine. Ranitidine was dispensed with recurrence of symptoms not found in notes.
Rectal Bleeding; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , solution for injection, lot number: EN5318, expiration date not reported), via an unspecified route of administration on the right arm on 02Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included osteoporosis and allergic reaction to penicillin. The patient is not pregnant. The patient has no prior COVID vaccination. There was no other vaccine given within four weeks. Concomitant medication included atorvastatin, calcium, magnesium. The patient experienced rectal bleeding on 03Feb2021 09:00. Patient reported that she had her first shot yesterday morning and today when she went to the bathroom she has rectal bleeding, bright red blood, which is not normal for her. The patient was not tested for COVID post vaccination. Outcome of the event was unknown.
Pt recvd vax on 14FEB91 & on 26FEB91 the pt devel enlarged lymph nodes & a rash; next day presented to ER, & it was noted pt devel lymphadenopathy in the occipital area & rash; dx rubella;
Patient reported a rash and fever/body aches. Started on 9-14-18 and lasted until 9-21-18. When he presented to the pharmacy on 9-22-18 he looked fine and was not complaining of any issues.