chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Serum stung going into arm. Was advised that taking benedryl when I came home from clinic a good idea due to allergy risk. The next day my arm muscle and left shoulder exhibited some pain, eased with advil, also had some fatigue late in day Monday developed a hard lump in muscle of left arm at site of injection with a large red bruise type feature and itching. Currently no rash, just pain in arm with itching. Did not contact physician, but will by Thursday if symptoms continue.
sinus infection; feeling cold; throat soreness; chills; fever; throwed up couple of times; muscle pain,body is hurting; head was hurting every day; cough; difficulty to breath; "I am sick for the whole month.; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), DYSPNOEA (difficulty to breath), ILLNESS ("I am sick for the whole month.   ), RHINORRHOEA (runny nose) and FEELING COLD (feeling cold) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced COUGH (cough), DYSPNOEA (difficulty to breath), ILLNESS ("I am sick for the whole month.   ), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (throat soreness), CHILLS (chills), PYREXIA (fever), VOMITING (throwed up couple of times), MYALGIA (muscle pain,body is hurting) and HEADACHE (head was hurting every day). On 07-May-2021, the patient experienced FEELING COLD (feeling cold). On an unknown date, the patient experienced SINUSITIS (sinus infection). At the time of the report, COUGH (cough), DYSPNOEA (difficulty to breath), ILLNESS ("I am sick for the whole month.   ), RHINORRHOEA (runny nose), FEELING COLD (feeling cold), OROPHARYNGEAL PAIN (throat soreness), SINUSITIS (sinus infection), CHILLS (chills), PYREXIA (fever), VOMITING (throwed up couple of times), MYALGIA (muscle pain,body is hurting) and HEADACHE (head was hurting every day) outcome was unknown.            Treatment included amoxycillin antibiotics for10 days, for possible diagnosis as sinus infection.  No concomitant medication was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-117971 (Patient Link).
Patient stated he couldn't move his right shoulder or arm in the air.  Able to move his fingers.
MODERNA BRAND COVID VACCINE WAS GIVEN TO THIS 15 YEAR OLD PATIENT. MODERNA IS NOT CURRENLY INDICATED FOR THIS AGE.  THE MEDICAL ASSISTANT GAVE MODERNA INSTEAD OF PFIZER.  NO SIDE EFFECT OR ADVERSE EVENT NOTED. PARENT WAS NOTIFIED.
Patient had a delayed adverse reaction one week after vaccination was given. She complained of a red, raised and warm area at site of vaccination. Patient was instructed to use cold compressed and acetaminophen. Benadryl was suggested for an allergic reaction/ more severe reaction. Patient was instructed to follow up with PCP and go to ER if condition gets worse/ patient notices signs and symptoms of severe allergic reaction.
Patient had no adverse reaction to the vaccine however, she tested positive to Covid 19 on 5/14/2021.
Patient became lightheaded and dizzy after vaccine administration, pale and diaphoretic, patient was laid down immediately on the exam table, a cool paper towel placed on his forehead, patient felt nauseous, was placed on his right side, emesis bag placed beneath him, he dry heaved and coughed once, did not vomit. Patient recovered, and left with mother without incident
Client received MCV4 on 5/14/08.  Dad RTC to p/u new short record & report large swollen area on LA.
I developed severe headaches and muscle aches. I had a mild cough, did not have a fever. I called my PCP and I was prescribed Paxlovid. I did a home COVID-19 test on 01/19/2023. I took the Paxlovid medication for five days.  I have recovered from my symptoms.
Two days after receiving the COVID vaccine, patient developed a rash to his bilateral arms and legs.  The rash has caused moderate itching.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 06-JUN-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
This is a spontaneous report from a non-contactable consumer (patient)   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced dick was hard on an unspecified date. The outcome was unknown.    Additional Context: The caller saw where the covid 19 vaccines boosters will be on hold and be recalled, is this true? The vaccine has MRNA and it is going to change your DNA, is that correct? The caller stated that this agent doesn't know shit. The caller's mentioned his dick was hard and that this agent wouldn't know what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was fine with no issues after administration around 3:30pm. Patient came back to the store later on in the evening after 7 pm reporting that she was itchy and a little red on her chest. She reported her throat being scratchy. Patient reported that she hadn't taken anything and wasn't sure what was going on and felt she may be having a reaction to the vaccine. Asked patient if they had trouble breathing or and swelling of tongue/throat or tightening of the airway which she reported no. Counseled patient to take benadryl for the hives and if symptoms worsen or she is having trouble breathing to go to the ER. Asked patient to verify correct information and to provide us with a doctor's contact to reach out to.
pt recvd vax; that day began to exp dizziness, malaise & low grade fever;
Patient received Janssen COVID vaccine on 3/14/21. On 8/10/21, patient was admitted to our facility for COVID PNA with acute hypoxic respiratory failure (COVID status positive 8/10/21).  As of today (8/14/21), patient is still admitted in the inpatient unit med/surg floor.
She has been running a low grade fever off and on; has had an eczema outbreak; This is a spontaneous report from a contactable consumer (mother reported for her daughter). A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date, as unknown, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that my daughter got the Pfizer vaccine a week ago yesterday. She has been running a low-grade fever off and on and has had an eczema outbreak. caller states her daughter has already reported her symptoms. She was asking that whether it was normal or not. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Left arm pain which feels tight; Left arm pain which feels tight, is hard to move and very painful; Left arm pain which feels tight/ very painful; Experiencing nausea; Experiencing vomiting; Experiencing headaches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Left arm pain which feels tight), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm pain which feels tight, is hard to move and very painful), PAIN IN EXTREMITY (Left arm pain which feels tight/ very painful), NAUSEA (Experiencing nausea) and VOMITING (Experiencing vomiting) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included HYDROCODONE for an unknown indication.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced MUSCLE TIGHTNESS (Left arm pain which feels tight), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm pain which feels tight, is hard to move and very painful), PAIN IN EXTREMITY (Left arm pain which feels tight/ very painful), NAUSEA (Experiencing nausea), VOMITING (Experiencing vomiting) and HEADACHE (Experiencing headaches). At the time of the report, MUSCLE TIGHTNESS (Left arm pain which feels tight), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm pain which feels tight, is hard to move and very painful) and PAIN IN EXTREMITY (Left arm pain which feels tight/ very painful) had not resolved and NAUSEA (Experiencing nausea), VOMITING (Experiencing vomiting) and HEADACHE (Experiencing headaches) had resolved.            No treatment information was provided.
Developed change in mental status and became unresponsive. No SOB. No edema. Was administered O2. 911 called and sent to ER for further evaluation. Patient has fully recovered.
arm became swollen and also had hives. The hives and swelling got worse throughout the day with some throbbing.  The day after the injection I could barely lift my arm. I also has an extremely stiff neck to where it was difficult to move it. This was a day or so after the injection to right about a week or so after. Also a very bad headache
Initial misuse report received from a healthcare professional on 10 September 2013. This is an invalid case as individual patient identifiers are missing. It was reported that sterile water was used to reconstitute ACT-HIB and was administered to the patients. No adverse event was reported. List of documents held by sender: none.
Moderate/Severe headache Nausea Emesis x1 Diarrhea Dizziness Fatigue Body Aches Fever (100.8 oral 1h after antipyretic)  Treatment: Rest Fluids Benadryl and Tylenol for headache, nausea, body ache
?Moderna COVID?19 Vaccine EUA?  Delayed adverse reaction 5days after injection in right arm. AE to include swollen lymph nodes in right arm pit with sharp piercing pain lasting more than 4days after onset. Delayed adverse reaction 7days after injection in right arm to include large red, itchy, swollen circle around injection site.
left axilla and breast pain grade 3 left lymph node pain grade 3 left axilla and bilateral breast lymphedema grade 3 back pain grade 3 flu like symptoms grade 2 chills grade 1 night sweats grade 3 started on prednisone 20mg BID.  I am now day5 and can put on a bra swelling and pain beginning to lesson
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Pt came back 30 minutes after injection with a slight rash/redness of face. She purchased benadryl and said she felt fine other than that
Patient came to a Flu Clinic. She received the shot approximately at 11:00am. In 15 minutes she felt funny, "not right", "out of it". She complained of a headache and numbness in upper part of face which spread to lower face. BP was 144/80 then changed to 184/84, 190/84, 194/86 as she sat there for one hour with monitoring. Pulse was irregular (70s-80s). Her physicians where called promptly. Her medical physician was not in but her cardiologist called us back. The physician decided to have the patient go to his office at 3pm. I called the patient in the evening and the next day and she said she felt fine at this point. She slept well during the night. Doctor thoroughly evaluated her. She did not receive any medication treatments.
Initial report was received from a non-healthcare professional on 12 November 2013. A female patient (no details provided), with no reported personal and family medical history, and no reported concomitant therapy, had received her dose of MENACTRA (lot number, route and anatomical site of administration not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced lightheadedness, seizure-like symptoms, confusion and rash. No further information was provided. The outcome was unknown. Documents held by sender: None. Follow-up information was received from a healthcare professional on 15 December 2013. The 15-year-old female patient had received first dose of MENACTRA batch number- U4657AA, intramuscularly in left arm on an unspecified date. The patient had no medical history, no illness at the time of vaccination, no other vaccination within 4 week of vaccination, no other medication and no other adverse event following prior vaccination. On an unspecified date, 3 minutes after vaccination the patient was not feeling quite well. Patient had increased in blood pressure was lightheaded, dizzy, and as thing progressed become clammy, noted to be tachycardic and hypertensive. The patient also developed rash on anterior chest, on forehead around the ear and on back. And patient complain of stiff leg and had difficulty in walking. She was crying and also had hyperreflexia, tingle sensation on hands, hyperreflexia of lower extremities, jerking/tremors of hands, arms, legs and allergic reaction. Patient's corrective treatment include 50 mg of BENADRYL, 125 mg of SOLU-MEDROL and 20 mg of PEPCID. Laboratory test include blood pressure 143/77, repeated 130/73, pulse was 122, temperature was 98.3, respiration was 16. On an unspecified date the patient had recovered from the event. Documents held by sender: None.
itching was already in my throat, genitals, buttocks; itching was already in throat, genitals, buttocks; I am getting pumps; I am desperate; not stopped itching all over my body/ itching was already in throat, genitals, buttocks; The initial case was missing the following minimum criteria: [Info not qualifying for AE reporting - All other sources]. Upon receipt of follow-up information of 25Mar2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 10:00 (Batch/Lot number: unknown) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion , Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 04May2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported: THROAT IRRITATION (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "itching was already in my throat, genitals, buttocks"; PRURITUS GENITAL (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "itching was already in throat, genitals, buttocks"; ABSCESS (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "I am getting pumps"; FEELING OF DESPAIR (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "I am desperate"; PRURITUS (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "not stopped itching all over my body/ itching was already in throat, genitals, buttocks". The events "itching was already in my throat, genitals, buttocks", "itching was already in throat, genitals, buttocks", "i am getting pumps", "i am desperate" and "not stopped itching all over my body/ itching was already in throat, genitals, buttocks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of throat irritation, pruritus genital, abscess, feeling of despair, pruritus.  Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed was the patient diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
fainted; lightheaded; fever; feeling weak/feels weak; Sunday felt bad; glands felt swollen; body aches; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her second dose of the COVID-19 vaccine on 19Mar2021 and stated that when she woke up Saturday morning, she took acetaminophen (TYLENOL), was experiencing being lightheaded and fainted, she needed help getting back into bed, slept all day had fever 101.0 to 102.0, feeling weak. On Sunday felt bad, that night fever was 99.0. On Monday, glands felt swollen, body aches and headache. And today feels weak, but no fever. The patient underwent lab tests and procedures which included body temperature: 101.0 to 102.0 and 99.0 on an unspecified date. Therapeutic measures were taken as a result of fever and headache. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
L leg erythematous induration area 3" in diameter around, tender to touch. No /// or /// on palpation, no red streaks from induration.
BY NOON THE DAY AFTER INJECTION, DEVELOPED FEVER, ARM PAIN, COULDN'T LIFT ARM OR BEND ELBOW. VOMITED X 1. EXAM AT ER REVEALED TENDER AREA OF ERYTHEMA OF LEFT LATERAL ARM NEAR DELTOID MUSCLE. WARM TO TOUCH, ELEVATED WBC AND CRP. CT SCAN SHOWED LOCALIZED EDEMA, TACHYCARDIC.
RIGHT SHOULDER WAS BOTHERING; CHEST PAIN; BACK PROBLEMS; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (BACK PROBLEMS), MUSCULOSKELETAL DISCOMFORT (RIGHT SHOULDER WAS BOTHERING) and CHEST PAIN (CHEST PAIN) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No known allergies and relevant medical history reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 18-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULOSKELETAL DISCOMFORT (BACK PROBLEMS). In June 2022, the patient experienced MUSCULOSKELETAL DISCOMFORT (RIGHT SHOULDER WAS BOTHERING) and CHEST PAIN (CHEST PAIN). The patient was treated with NITROGLYCERIN at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (BACK PROBLEMS), MUSCULOSKELETAL DISCOMFORT (RIGHT SHOULDER WAS BOTHERING) and CHEST PAIN (CHEST PAIN) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, Blood test: Did not find anything wrong. In June 2022, Electrocardiogram: Did not find anything wrong.         No concomitant drugs taken by the patient.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient received first booster dose on 27-Oct-2021 and second booster dose on 18-Apr-2022.  Reporter causality was not reported for back discomfort and not related for other events with respect to HUMIRA (ADALIMUMAB).
Mild rash at injection site. Recommended called MD and OTC hydrocortisone 1% crm at MD approval.
Pt reports she has never had chicken Pox - titer - neg. Pt given vaccine 3/29/07. Pt broke out with 15-20 chicken pox lesion 4-15-07. Lesions on 4/27/07 scabbed over
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 28-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (shingles back in 2017). Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received in November 2018, refer case US2019GSK015292). In January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced fatigue, fever and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fatigue, fever and general body pain were recovered/resolved. It was unknown if the reporter considered the fatigue, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, could be 27 or 28yrs. The patient 28 year old who was now in healthy condition. The patient received a dose of SHINGRIX and experienced mild fever, body aches and fatigue. The patient wanted to know how long would SHINGRIX be effective for the patient to prevent a shingles flare up. All side effects subsided within 24-48 hours. This case was 1 of the 2 cases, reported by the same reporter for the same patient.