chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 3, I had high fever of 101degF for 24 hours; Low grade fever; My headaches were really bad. They're getting better now; really bad nausea; Then I felt tired; chills; body aches; very weak in the evening; had stomach aches every time I eat; got my period again on the 7th day; diarrhea on and off; overall not feeling well.; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off) and MALAISE (overall not feeling well.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off), MALAISE (overall not feeling well.), PYREXIA (Day 3, I had high fever of 101degF for 24 hours), NAUSEA (really bad nausea), FATIGUE (Then I felt tired), CHILLS (chills), MYALGIA (body aches), PYREXIA (Low grade fever) and HEADACHE (My headaches were really bad. They're getting better now). At the time of the report, ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off), MALAISE (overall not feeling well.), PYREXIA (Day 3, I had high fever of 101degF for 24 hours), NAUSEA (really bad nausea), FATIGUE (Then I felt tired), CHILLS (chills), MYALGIA (body aches), PYREXIA (Low grade fever) and HEADACHE (My headaches were really bad. They're getting better now) outcome was unknown.            Treatment includes Tylenol. Patient had intestinal issues everytime she had virus. Patient also felt like she was going to pass out.
seven days after injection, redness/swelling/tenderness at injection site x 48 hours
Arm extremely sore (could not move) ran slight fever, very lethargic,  Slept for about 2 days after shot.  No appetite Then a rash developed across chest and back that lasted for approximately 5 days
A welt about 4inches from top to bottom and about 6 inches from side to side on my arm at injection site. Swelling, hot to touch, tight extremely itchy and painful.
Patient came to pharmacy counter about 10 min after shot-to report a burning feeling, no redness or swelling noted. On Sat 9/22, pt came to pharmacy & the inner portion of upper arm was a bit swollen, red and warm to the touch. On 9/24/19 pt called and stated doing much better and report is no more swelling, no warmth to touch & only a bruise 2 inches past injection site yellowish in color. Pt. Did not seek Medical attention as she felt not necessary.
I became sick with it; problem in my eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 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: ILLNESS (non-serious) with onset Oct2023, outcome "unknown", described as "I became sick with it"; EYE DISORDER (non-serious) with onset Oct2023, outcome "unknown", described as "problem in my eyes". Therapeutic measures were taken as a result of eye disorder.  Additional information: Patient got a shot of vaccine, last not this past Friday, the Friday before patient became sick with it, patient figured it was just a reaction but patient's two friends got the same thing (no details and information available). So, patient's brother didn't get it and was told not to get it. Patient had some problem in eyes and had to use magnifying glass.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Painful swelling in lymph nodes under armpit of the injected arm; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date, and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the left arm on unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced painful swelling in lymph nodes under armpit of the injected arm. No therapeutic measures were taken as a result of the event. The clinical outcome of painful swelling in lymph nodes under armpit of the injected arm was recovering.   No follow up attempts are possible; Information about lot number cannot be obtained.
Lg. amt. of swelling around injection site. Knee cap swollen and swelling increased over course if X 2 d and increased up leg to hip and down to knee. Tx: Zyrtec 1 1/2 tsp BID X 4 days, after which child returned to normal. Methotrexate given same R arm.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Lot number: EW0177) and on 17May2021 as dose 2, single (Lot number: EW0171) at the age of 18 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Lot number: 051F21A) for covid-19 immunisation. The patient's relevant medical history included: "MDD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "Migraine" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Montelukast, reaction(s): "Allergy"; Chlorhexidine gluconate, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient had no other medication in 2weeks.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
1535, pneumovax (lot # 0620F,Merck) was administered IM to Left Deltoid. At 1540, pt coughed and then grabbed her throat and stated she could not breath.  Pt was laid in prone position, crash cart brought to room, Physician called, PB 113/74, O2 satuartion 99% on room air, resp. mildly labored but lungs sound were clear. Patient returned to normal breathing pattern.  Stated that at first she did not feel she could get air out, then she could not get air in.  Some in sternal discomfort mentioned, stated felt "sore."  Patient monitored approximately 35 minutes, no additional distress noted, 1620 BP 108/73, p72, O2 100% on room air.  Epi not administered.  Pt never lost consciousness.
- severe itchiness and hives, not limited to any particular areas of body - more severe at evening / night but ongoing all day, daily since onset and still currently occurring - taking 40mg of Zyrtec daily since 1/4/22 by recommendation of doctor (communicated through messages, no in person visit) - no improvement in symptoms since onset, but Zyrtec reduces severity while in effect
right cheek tightening up; This spontaneous case was reported by a pharmacist and describes the occurrence of MUSCLE TIGHTNESS (right cheek tightening up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Tension.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MUSCLE TIGHTNESS (right cheek tightening up). On 03-Mar-2021, MUSCLE TIGHTNESS (right cheek tightening up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No new information was provided.
Redness, warmth, pain, RUE measuring 9.5cm x 15.0 cm noted on 1-17-2021 continues with redness (fading) on 1-21-2021 warmth. Denies pain unless bumped. Resident afebrile. Size remains unchanged
Swollen lymph nodes and edema in armpit on same side as injection appeared 2 days after injection; Swollen lymph nodes and edema in armpit on same side as injection appeared 2 days after injection; dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 10:30 (Lot number: FL3197) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high BP" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 23Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01Mar2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 10:30, outcome "unknown", described as "dose number=3"; LYMPHADENOPATHY (non-serious), OEDEMA (non-serious) all with onset 24Dec2021 04:30, outcome "not recovered" and all described as "Swollen lymph nodes and edema in armpit on same side as injection appeared 2 days after injection". Therapeutic measures were not taken as a result of lymphadenopathy, oedema.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines in 4 weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination.  Follow-Up: Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-JUL-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dosage not reported) via subcutaneous (as per prescribing information recommendation). No adverse effects were reported. As of 19-JUL-2016, the cumulative/total excursion time: 23 hours and 10 minutes, highest temperature reached: 8.2F. No Product Quality Complaint (PQC) was involved. This is one of several cases received from the same source. Additional information has been requested.
Rash all over body - gave 1/2 tsp Benadryl time course of rash - 20 min.
Patient had a raised purple spot at the site of injection; surrounded by a rash. Diameter of 2-3 inches - contacted patient for a follow up 10/3/11 and rash continues to lessen/improve.
After five days, I experienced a lot of pain and was hospitalized. The pain returned and I was recently hospitalized as well. I feel heart pains and don't feel the same, fatigue and extreme nervous.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In or about 2014, a physician at an office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In or about 2014, the patient was treated by the same physician. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
No additional AE information; the patient received a dose of improperly stored PEDVAXHIB.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was provided.   On 14-MAY-2020, the patient received a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 dose, lot# S023218 with expiration date: 04-MAR-2022; route and strength were unknown) for prophylaxis (incorrect product storage). No additional adverse event (AE) information.  Administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 47 degrees fahrenheit (F) (63.3F) for 4 hours. There was no previous temperature excursion. The digital data logger was involved to capture the temperature excursion.
Teammate complained of numbing of her face, Left Upper Quad.   TM was given 50 mg of Benadryl.  Her husband drove her home. She was symptom free @04:00 Thursday April 8th.
Abnormal periods; Body aches; Chills; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration, in left arm on 31Mar2021 (at the age of 32-years-old) as single dose for COVID-19 immunisation. The patient had no medical history and did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced chills, body aches, nausea and abnormal periods. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of chills, body aches, nausea and abnormal periods were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Mom brought child to clinic today for immun.; states w/ childs 2m shots she cried for 2 hrs non-stop.Developed rash on rt thigh;unable to console child.
previous Covid vaccine administration gave skin lesion; This is a spontaneous report from a contactable Other HCP (Nurse).   Nurse reported for A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: El1284; Expiry date: unknown) intramuscularly administered in the left arm on 08Jan2021 at 10:30 as a single dose for COVID-19 immunization. The patient medical history concomitant medications were not reported. The patient did not have any other vaccines in four weeks. It was unknown if the patient had any other vaccines in two weeks. The patient did not have COVID prior to vaccination. COVID was not tested post vaccination. On an unspecified date in Jan2021, patient experienced skin lesion. Patient had not tested positive post vaccination. The patient did not receive any treatment. The clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Have developed what seems like essential tremor in both hands/arms; also felt on lower lip on/off; involuntary arm movement at night.
fever of 102.8 body aches, fatigue and dizziness on Friday evening 1/15 and 1/16 Saturday.  Sunday 1/17 with low grade temp of 100.3 and fatigue.
Lower part of my head is swollen in the back; This is a spontaneous report from a contactable consumer (patient, "I am Dental"). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included none. Concomitant medication included hydrochlorothiazide, famotidine, and montelukast. The patient experienced lower part of head was swollen in the back on 07Jan2021. The patient stated, "I got my first vaccine on 22nd (22Dec2020) and I been feeling fine until this morning when I woke up and lower part of my head is swollen in the back so I don't know it's something related or not." Patient also stated, "Because I am in healthcare and I deal with lot of saliva all day working on teeth." No treatment received for the event. The outcome of the event was not recovered.
Approximately one week after administration of second covid vaccine client, with no previous history of hallucinations, began to experience auditory, visual and tactile hallucinations. Hallucinations have been increasing in frequency and severity over the past three weeks.
Delayed allergic reaction at injection site - red, raised, hard, warm to touch, and itchy. Not painful.; red; raised, hard; warm to touch; itchy; This is a spontaneous report from a contactable other health professional (HCP). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on arm left on 04Jan2021 at a single dose for COVID-19 immunization. Medical history included obesity and known allergies to penicillin, both from an unknown date and unknown if ongoing. Concomitant medication included phentermine. The patient experienced a delayed allergic reaction at injection site - red, raised, hard, warm to touch, and itchy, not painful on 12Jan2021. Therapeutic measures were taken as a result of delayed allergic reaction at injection site - red, raised, hard, warm to touch, and itchy. The outcome of the events was recovering.
Information has been received from a health professional concerning a 39 year old male with irritable bowel syndrome, anxiety, arthritis, and no known drug allergies who on 07-NOV-2007 was vaccinated in the deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658451/0963U). Concomitant suspect therapy included finasteride, tablet. Other concomitant therapy included EFFEXOR and PROTONIX. On 07-NOV-2007, the patient experienced a fever, difficulty breathing, soreness of the arm, and difficulty moving the arm. On 12-NOV-2007, the patient was seen in the office and has another appointment to be seen again. No laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. No product quality was involved. Additional information is not expected. This is in follow-up to report (s) previously submitted on 7/10/2008.  Follow-up information received from a medical assistant indicated that he was a 39 year old male patient, weighing 175.8 pounds and 69 inches in height, who in the afternoon of 07-NOV-2007, was vaccinated with the first dose of PNEUMOVAX (Lot # 658451/0963U), 0.5 mL in the left deltoid.  There was an unspecified physical symptom at the time of vaccination.  On 08-NOV-2007 at 2:30 AM, the patient experience fever, soreness to left deltoid, decrease PPT 63%, redness to left deltoid, headache.  Treatment given to the patient was : TORADOL 60 mg, NAPROXEN 300 mg, VENTOLIN HFA and PREDNISONE.
pt recv vax 2JUL97 & shortly p/vax pt devel sever nausea;9JUL97 pt visited ER c/o n/v & anorexia;pt exp also dehydration & electrolyte abnormality d/t nausea & exp diarrhea off & on;
Child developed body aches, nausea, vomiting, head pain, neck pain and fever within 24 hours of vaccine administration. No preceding sick symptoms.
Pain; Myalgia; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, myalgia and fatigue. On an unknown date, the outcome of the pain, myalgia and fatigue were unknown.   It was unknown if the reporter considered the pain, myalgia and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The reporter did not reported a specific number of patients, did not have information regarding lot or expiry date or patient specific details. The reporter reported pain, fatigue, myalgia from Medical Information requested for a different inquiry, from lot of patients. The reporter denied permission to follow up.
I had a baseball sized raised bump at the injection site that was red. I took Tylenol for it. I had diarrhea and nausea. It was like having the flu. My head hurt, I wanted to sleep and I felt lethargic. I also had muscle and joint pain.
"VERY BAD PAIN STARTED WITHIN 40 HOURS OF 2ND SHOT"  OPPOSITE ARM FROM WHERE SHOT WAS GIVEN. PULSING PAIN IN ARMPIT, WEAKNESS , TINGLING RIGHT ARM.  HAS HAD ABOUT 50% IMPROVEMENT BUT WEAKNESS /TINGLING STILL THERE.
Fever, chills, vertigo, dizziness, extreme fatigue, intense headache not relieved by medication, body aches not relieved by medication. Took Ibuprofen and Tyelnol, slept. Lasted 48 hours
Legs, arms and feet have a "sunburn" sensation. Or, a feeling of having icy/hot cream on skin - hot, but cool sensation. Skin is not temperature hot to the touch, there is no rash, or redness, no swelling. It's been a daily sensation since the 2nd shot (over 4 weeks now). Skin is extra sensitive washing in shower, and has disrupted sleep with a feeling like my legs/arms/feet are on fire. Tylenol did not have any impact, Benadryl helped mildly, but nothing long-term or completely.