chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received 0.25ml of Moderna bivalent vaccine; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: follow-up received, updated narrative.
?Moderna COVID-19  Morning after receiving vaccine I experienced  severe body aches and a headache. After walking into another room felt faint so went to sit down, got very sweaty & loss conscious. After waking up, I was unable to speak or see anything for  several moments.
No symptoms until the day after. Fever symptoms appeared around 3am Fever with nausea and fatigue Took 400 Tylenol to reduce fever and bed rest to help with nausea and fatigue. Although nauseated, food consumption is normal and no signs of vomiting.
This case was reported by a other health professional via call center representative and described the occurrence of stomach pain in a 13-year-old male patient who received BOOSTRIX. On 2nd February 2018, the patient received BOOSTRIX. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain was unknown. It was unknown if the reporter considered the stomach pain to be related to BOOSTRIX. Additional details were provided as follows: This case was reported by an occupational therapist. The reporter was the patient's mother who reported that the patient had the BOOSTRIX vaccine six days ago and had been experiencing severe stomach pains. The caller was being transferred and the caller was no longer on the line. The reporter had been provided the phone number.
This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CHILLS (Extreme chills), PYREXIA (Fever that went to 103.5), PAIN (Extreme body aches), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a 70-year-old male 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 reported.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced CHILLS (Extreme chills), PYREXIA (Fever that went to 103.5), PAIN (Extreme body aches), MYALGIA (Muscle aches), FATIGUE (Fatigue), GAIT DISTURBANCE (cant walk) and BALANCE DISORDER (Lost control of body). On an unknown date, the patient experienced SITTING DISABILITY (cant sit up) and EATING DISORDER (cant eat). The patient was treated with MELOXICAM at an unspecified dose and frequency. At the time of the report, CHILLS (Extreme chills), PYREXIA (Fever that went to 103.5), PAIN (Extreme body aches), MYALGIA (Muscle aches), FATIGUE (Fatigue), SITTING DISABILITY (cant sit up), EATING DISORDER (cant eat), GAIT DISTURBANCE (cant walk) and BALANCE DISORDER (Lost control of body) outcome was unknown.        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 concomitant products were reported.  Treatment medications include meloxicam and steroid shots.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
LUMP IN THE ARM; RIGHT ARM IS SORE; PAIN IN SITE OF INJECTION; FATIGUE; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sick, and concurrent conditions included: fibromyalgia, diabetic, and cardiomyopathy, and other pre-existing medical conditions included: The patient had no known allergies. The patient experienced sick when treated with influenza vaccine.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced loss of energy. On an unspecified date, the patient experienced lump in the arm, right arm is sore, and pain in site of injection. The action taken with covid-19 vaccine was not applicable. The patient recovered from lump in the arm, and pain in site of injection, and had not recovered from fatigue, loss of energy, and right arm is sore. This report was non-serious.
Patient felt flushed, turned red all over face, chest/torso, etc. and developed wheezing within 5 min of administration of vaccines.  Developed approximately 2.5cm diameter area of redness around site of Varivax injection.  Patient was given Allegra 30mg PO then Benadryl 25mg IM without much improvement, then given epinephrine 1:1000 0.2mg subcutaneous and he felt much better within a few minutes.  Released to home. This is in follow-up to report(s) previously submitted on 5/28/2008. Information has been received from a medical assistant concerning an 8 year old male with seasonal allergies and asthma and a history of pulmonary stenosis requiring surgery at 8 years old, eye surgery at 4 1/2 years old and a previous vaccination adverse reaction (not known) who 03-MAR-2006 was vaccinated IM with his second dose of VAQTA (lot# 658036/0495U). The patient had allergic rhinitis at the time of vaccination. Suspect vaccination administered on that same day included the second SC dose of VARIVAX (lot# 659066/1359U). Other concomitant drug therapy included montelukast sodium (MSD), ZYRTEC and lisinopril. Prior to leaving the office that day, the patient experienced difficulty breathing and developed a rash all over. The patient sought medical attention in the office at the time of reaction. No labs or diagnostic studies were performed. The patient was treated with ALLEGRA and montelukast sodium (MSD). He was then given BENADRYL and epinephrine that resolved his symptoms. The patient was discharged home. The medical assistant mentioned that the patient had a similar reaction with previous vaccination, but the patient's mother could not remember when or what vaccination was given. It was noted that the patient received his first IM dose of VAQTA on 12-NOV-2004 and his first SC dose of VARIVAX on 01-AUG-2000. There was no product quality complaint. Follow-up information from the reporting medical assistant indicated that on 03-MAR-2008 at 13:30 the patient was vaccinated SC with the second dose of VARIVAX (lot# 659066/1359U) in the left arm. Suspect vaccination administered on 03-MAR-2008 at 13:30 included the second IM dose of VAQTA (lot# 658036/0495U) in the right arm. On that same day at 13:35 about 5 minutes after the injections, the patient turned red in the face and torso, felt flushed and developed wheezing. The patient also developed an approximately 2.5 cm diameter area of redness around the site of the VARIVAX (left arm) and not the other injection site (right arm). The patient responded to BENADRYL 25 mg IM and EPI-PEN SC 0.2 mg. On 17-MAR-2008 a skin testing results with a pediatric allergist revealed that the patient was highly reactive to gelatin. It was noted that the reaction was similar to the adverse event(s) prior to the second vaccination with VARIVAX. Additional information has been requested.
A few hours after the Moderna COVID-19 Vaccine EUA, I began to get a severe headache. It got worse and worse, and the pain was felt behind my eyes, in my cheeks, teeth, jaw, temples, skull. I thought it was a migraine and it lasted the entire next day. I felt felt nauseated. All in all the very severe pain lasted about 28-30 hours.   I had had a mile headache and soreness at the injection sight after my first injection.
This spontaneous report was received from a pharmacist referring to a 12 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 28-JUN-2018, the patient was vaccinated with an expired dose of GARDASIL 9 lot # M018810 with expiration date 28-MAY-2018, intramuscularly, for prophylaxis. No adverse effect was reported.
C/O fever, chills, body aches, nausea, (-) emesis, (-) diarrhea, (-) sore throat - started 3/26.
3" x 4" area on the right deltoid that has redness, swelling, warmth, and tenderness at the injection site. Advised mom that this is consistent with a local reaction and treatment includes cold compress and rest.
Right arm muscle soreness, started at 11pm on 5/16. Chills , fever,  swelling & redness  at injection point,  diarrhea, headache & nausea 5/17-18.  Contacted -Virtual doctor. Instructed to apply warm compress on swollen area , continue taking Tylenol as needed. Received a prescription for Doxycycline Hyclate..
Fever - 99.9 at 1:30 am on May 1-18 - very weak - couldn't walk - at 1:30 pm had to get help with neighbors to take him to car to emegency room, there he was diagnosed as very weak - after 7 hrs - he was able to get up and walk a little - little weak next day May 2-18 - on Thursday he felt a lot better - he will not get second shot. Sore arm - red - swollen for 4 days.
Tingling to numbing sensation along left arm into fingers of left hand particularly in my index, middle and ring fingers. This occurrence happened about 30 minutes after the injection however the numbness is still felt in my fingers today, 4/12 still primarily in the index, middle, and ring fingers.   I also experience swelling, size of golf ball at the injection site apparent about twelve hours after the shot. The injection site was sensitive to touch about 3 hours after the shot then gradually becoming worse as the day progressed peaking after 24 hours. It's still tender to touch on 4/12 but only when pressure is applied to the area.
Left ear pain several days after vaccine; Left ear pain several days after vaccine, progressed to TMJ; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 29Apr2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. On 01May2021 at 10:00, the patient experienced left ear pain several days after vaccine and progressed to TMJ (temporomandibular joint). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left ear pain several days after vaccine and progressed to TMJ were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
On 1-5-2021, the employee received the above immunizations at approximately 4:435pm. The employee reported chest tightness, left arm numbness, increased heart rate, throat felt like it was closing up, and headache. The employee called the supervisor at 4:53 pm.  The supervisor instructed the employee to go to the emergency department and the employee said she would go to the urgent care. At 5:29pm the supervisor texted the employee and the employee said she went to the urgent care but the urgent care sent her to the emergency department. however the employee decided not to go and instead went home and took Motrin and Benadryl. At 7:20 pm the supervisor contacted the employee via text message and asked her how she was feeling and she stated she was starting to feel better. On 1-6-2021 the supervisor texted the employee and the employee said she was feeling better.
sharp pain in her head; high blood pressure; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.   A 59-year-old female patient received first dose of 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 and concomitant medications were not reported.  The patient reported that she ended in the emergency room (ER) because of a sharp pain in her head and high blood pressure up to 4 days after getting the first dose of vaccine. The patient outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
allergic to something in the vaccine; Myoclonic jerking; I felt very hot; I started shaking uncontrollably.; Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar; This is a spontaneous report from a contactable consumer.   A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 at 16:00 (at the age of 64)(Batch/Lot Number: EN6205) as a single dose for covid-19 immunisation .  The vaccination was given at a hospital. There were no other vaccinations given within 4 weeks. The patient was not diagnosed with COVID prior to vaccination. Medical history included breast cancer and an allergy to sulfa drugs. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY); levothyroxine, liothyronine (NP THYROID). On 25Feb2021, about 2 hours after the vaccination (18:30) I felt very hot. I was not running a fever. I started shaking uncontrollably. The shaking was not chills. My husband took me to the emergency room. This was their summary. Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar level; Myoclonic jerking; Vaccine reaction I saw my general practitioner the following day and everything was back to normal. I am allergic to something in the vaccine and I am afraid to get the 2nd dose. No treatment was given for the events.The outcome of the events was recovered. The patient was not tested for COVID post vaccination.
I felt lousy, with chills, fever, and nausea. Had several bouts of vomiting with out any food in my stomach. (Dry-heaving) I just tried to sleep and get over it. By about noon the next day I was feeling almost back to normal.
pt recv vax; fever of 103 lasting approx 2 days; truncal ataxia noted; gross tremor/bobbing of trunk; difficulty sitting unassisted; favors lt hand, move uncoordinated;
Fever, body ache, headache, back ache, joint pain, chills, shakes, painful lump under arm pit, lump at injection sight, swollen arm, red rash, generalized itching around arm, itching over entire body, red spots spreaded
Possible seizure or TIA with extreme pain to entire body, unresponsiveness, unable to speak or verbalize anything, unable to move body or limbs, unable to show emotion, only able to sip small amounts of water or cranberry juice through a straw. This occurred the entire day on Tuesday, March 8, 2022, the day after the booster vaccination. She was able to speak a word or two with slurred speech and move her hands and react to touch on her legs and feet the next day, Wednesday, March 9,2022. She has slowly regained a very small amount of speech but remains in alot of bodily pain and can only have liquids now as nourishment.
Staff followed correct policy & workflow for reconciling vaccines & manually checking Data for any recent bivalent covid booster. Mom provided a picture of the patients current covid vaccine card. Both workflows provided proof that patients last covid vaccine was 3/2022 therefore staff administered a bivalent booster 3/2/2023. When parent got home, her husband reminded her that patient had already received a bivalent booster 11/2022. This reminded mom that she had 2 pictures of the patients covid vaccine card in her phone, an old covid vaccine card & a more recent one that listed the 11/2022 vaccine. Staff failed to enter 11/2022 covid vaccine manually into Data. Patient, parent & PCP are aware of the this.
Client call at 1:20 pm, states "had a rash in her chest, face and arms, her BP 130/100 and felt nauseated", assess by MD. Treatment: Tylenol and fluids, to come back if increases in nausea and/or emesis
Pt. was fine after vaccines were given, but passed out and fell out the chair in clinic room and hit his head on the children's chair next to him. Unsure if the vaccine caused the fainting spell or child was very nervous knowing had to receive vaccines and fainted due to this reason? Pt. was out for approx. 30-45 sec or less. Child; pale, clammy and was given peanut butter crackers and a drink. Nurse practitioner examined the child's eyes for PERRLA and for alertness while here at the health dept. that day.
A report received from a health professional on 10/29/2002, concerning approximately 25 vaccinees of unknown demography who experienced swelling, redness and soreness at the injection site an unknown time after receiving the Fluvirin vaccine between 10/14/2002 and 10/29/2002. Between 10/14/2002 and 10/29/2002, approximately 25 patients reported having swelling, redness and soreness at the injection site after receiving the Fluvirin vaccine.  The reporter stated that she has been administering the influenza vaccine for many years and that she has seen now an exceptionally high incidence of local reactions in her vaccinees.  Her estimation was that approximately 50% of the vaccinees experienced local reactions.  The reporter has assessed the relationship of the vaccine to the events as probable.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), INJECTION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE RASH (Vaccination site rash) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included CLONAZEPAM, METOPROLOL SUCCINATE (TOPROL XL), ESCITALOPRAM OXALATE (LEXAPRO), ATORVASTATIN CALCIUM (LIPITOR), AZELASTINE HCL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), INJECTION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE RASH (Vaccination site rash). At the time of the report, PAIN IN EXTREMITY (Pain in arm), INJECTION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE RASH (Vaccination site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: follow up added
9 hours after the vaccine, I felt a heaviness in my chest and it radiated to both arm pits. The feeling felt like a weight on my chest.  Uncomfortable pressure.  It lasted for 72 hours from 4/10/2021- 4/13-2021. Saw my doctor on 4/15,/2021. EKG , H2O, BP and  breathing test. (All normal results) By the time I could get an appointment with my the doctor, all symptoms were gone.
I started having a itchy and rash feelings on my wrist. On my left a little before it spread to my right arm. It spread up the dorsal aspects of my left arm. It spread to my chest and up neck to my face. The itching was so bad I wanted to scratch my face offs. I took Benadryl and it was not helpful. It made me foggy. I was not making sense to speak, and I noticed my tongue was so dry and thick. I was unable to speak, and my lips started to swell. I thought it was because of the medicine and was in need of Urgent care. I received a shot and prescription of steroids. I had to follow up with and allergist. Within 24hrs of the steroid shot I was back to normal.
ARM PAIN AT INJECTION SITE, LIGHT-HEADNESS, DRY-MOUTH, TIREDNESS/WEAKNESS.
The adult patient wasn given a paedriatic dose by error. The vaccine was processed correctly, however, the pharmacist grabbed the incorrect vial and drew the dose.
improper administration injected "too high"; arm hurt; thought this was strong immune reaction; pruritis at vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (improper administration injected "too high"), PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (thought this was strong immune reaction) and VACCINATION SITE PRURITUS (pruritis at vaccine site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (thought this was strong immune reaction) and VACCINATION SITE PRURITUS (pruritis at vaccine site). On 29-Oct-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (improper administration injected "too high"). On 29-Oct-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (improper administration injected "too high") had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (thought this was strong immune reaction) and VACCINATION SITE PRURITUS (pruritis at vaccine site) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
Developed covid arm upon awakening the day after vaccine. On Friday when I woke up at 6am, my back and abdomen had hives. (red blotches non puritic)  It is 3pm 3 days after vaccine and rash persists. I have taken an antihistamine  to decrease effects.
04/15- fever, very sore arm. Sore arm lasted till 4/18 4/20- swollen lymph node on vaccine side (left)