chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; chills.; This is a spontaneous report from a contactable other hcp (nurse). A female patient of an unspecified age received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6202), dose 1 via an unspecified route of administration, administered in Deltoid Left on 20Feb2021 as DOSE 1, SINGLE for covid-19 immunisation; Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications include dexamethasone acetate (DECADRON [DEXAMETHASONE ACETATE]), via an unspecified route of administration from 26Feb2021 (Batch/Lot number was not reported) to 28Feb2021, and then today she had to restart Decadron for 3 days, so 9Mar2021-11Mar2021 for migraine and allergies were not reported. The patient experienced body aches, chills on Feb2021. Caller will have second Pfizer Covid vaccine on 13Mar2021. Caller started taking Decadron for Migraines today, 09Mar2021 until 11Mar2021. Asking if Decadron will interfere with the vaccine. Caller started taking Decadron for Migraines/ Asking if Decadron will interfere with the vaccine and also asking did she deactivate it by taking the Decadron or will it with the second round or what. The patient clarifies that she had Chills and Body Aches after the first vaccine; however, she does not want to complete a safety report, she just wants to know about the Decadron. The patient took her first vaccine on 20Feb2021. A few days later, she took Decadron, which is a steroid, from 26Feb to 28Feb2021. Also she took one today, with an additional 2 doses in the next 3 days (that's 09Mar to 11Mar, in total) before her next vaccine dose and Caller started taking Decadron for Migraines today, 09Mar2021 until 11Mar2021. Asking if  will interfere with the vaccine which will be on 13Mar2021. She was also asking whether this would affect her having been vaccinated. The clinical outcome for the event was unknown.   No follow-up attempts are possible. No further information is expected.
CLIENT RECEIVED DOSE NUMBER 5. DOCUMENTS AT THE TIME SHOWED CLIENT NEEDED DOSE NUMBER 4 BUT THE DOCUMENTS MOM HAD SHOWED ON 2 DIFFERENT ONE OF THEM SHOWED HE ONLY HAD 3 AND THE OTHER SHOWED HE HAD ONE 8-2-2022. CLIENT'S MOTHER STATED PEDIATRICIAN ALSO TOLD HER THAT THE CLIENT NEED HIS 4TH DOSE BUT AFTER ADMINISTRATION AND LOOKING AT DOCUMENTS CLIENT RECEIVED IT ON 8-2-2022 AND SHOULD NOT HAVE RECEIVED ANOTHER ONE.
Breakthrough case admission after three vaccines Moderna 12/29/20 Lot# 026L20A;  Moderna 1/28/21 Lot# 030L20A;  Moderna 12/30/21 Lot# 013H21B
Pt had the vaccine on 12/16/11 left deltoid since then about 2-3 days after injection started to have a "cramping" pain from the injection site to the elbow along the outside of the arm. Sometimes improves if she rubs the area. Worse when lying on that side or reaching around to hook bra strap. No numbness, tingling & loss of strength, or sx involving the forearm no pain at rest. Otherwise feels well.
On 10/26/2022 the patient above received a .5 ml dose of Moderna Monovalent instead of the intended dose of Moderna Bivalent .5 ml vaccine. After the administration the patient waited in the office lobby for 15 minutes and did not have any side effects or reactions to the vaccine.
that day had soreness of right arm - felt ill. Site red following pneumococcal vaccine adm. Rash chest - back and shoulder
7.5 x 5 cm red area at inject site. Right gluteus area. Not tender, not warm . afebrile. Pt with no other c/o.
Tingling toes started around 12:50-1:00 pm  Heavy feeling in chest about 20 minutes after injection   Heaviness in both arms within 30 mins after injection   Pressure in chest next morning    Burning, intense itching , hot inflammation around injection site next morning
Extreme weakness and fatigue fever headache loss of taste  Unable to eat or drink due to extreme weakness  I literally couldn?t move out of bed since Wednesday night still in bed as of this morning  with extreme weakness headache loss of appetite loss of taste
high heart rate of over 115, at 5:00 am following day.  went to ER, rate down to 105 sent home.  that evening at about 6:OO PM heart rate went from 140 - 148 with laying down and temperature of 101.3 and a headache.  this lasted about 3 hours with gradual going down to normal temp and headache gone.  heart rate still up at about 90 with normal  resting rate of before at 74 - 80.
local swelling, redness, itchiness, warmth of L deltoid injection site starting same day of injection (6/8). 3 days later (6/11) pt reports reaction as getting smaller and less itchy over time. pt reported resolution of other side effects such as fever, body aches which also started day of injection (6/8). denies chest pain, SOB, dyspnea, dysphagia, or other signs of systemic allergic reactions. site assessed for signs of infection by nursing and PCP. advised to take OTC benadryl and/or tylenol and continue to ice
5 hours after second injection had injection site pain, fever, dizziness and syncope. Referred to PCP for further evaluation.
Pain at left arm where first dose vaccine was administered; This is a spontaneous report from a non-contactable consumer(Patient).   A 30-years-old male patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 01Mar2021 15:15 as 1st dose, single for covid-19 immunisation. The patient did not receive any other vaccine. The patient medical history and concomitant medications was not reported. It was reported that, Pain at left arm where first dose vaccine was administered. Pain has persisted for greater than 14 hours at time of reporting. No treatment was received. Outcome of the event was resolving.    No follow up attempts are possible. No further information is expected.
"swollen and painful right cervical lymph node "; hardness of right cervical lymph node; cannot raise head; mild swollen of left cervical lymph node; pass out; lot of fatigue; lost of appetite; nausea; minor fever; shivering throbbing headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ), PYREXIA (minor fever), HEADACHE (shivering throbbing headache) and PAIN IN EXTREMITY (sore arm ). On 29-Apr-2021, the patient experienced LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node), HEAD DISCOMFORT (cannot raise head) and LYMPHADENOPATHY (mild swollen of left cervical lymph node). On 24-Apr-2021, PAIN IN EXTREMITY (sore arm ) had resolved. On 25-Apr-2021, LOSS OF CONSCIOUSNESS (pass out), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ) and PYREXIA (minor fever) had resolved. On 01-May-2021, LYMPHADENOPATHY (mild swollen of left cervical lymph node) had resolved. At the time of the report, LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node) and HEAD DISCOMFORT (cannot raise head) outcome was unknown.            the swelling and  hardness of right cervical lymph node was the cause of clinic visit, the Physician said it was "benign", no treatment for it. This symptoms still bothering the patient. Patient assumed that was previously exposed COVID-19 in March2020 but had no confirmed results, his test was suspended and was not repeated.   Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided. The concomitant taken by the patient was, vitamin C , vitamin D , man's 50 plus gummy, risperidone.
15 minutes after receiving shot, became light-headed, noticed hive-like rash on both upper arms.  Patient describes feeling warm, diaphoretic, facial pallor noted.  Patient reported back to clinic, seen by physician's assistant and assessed heart rate, blood pressure and remained in office for observation.  Patient reports symptoms subsided around 10:30AM.
Pt has a PMH of CAD s/p MI and a stent in 2005, chronic diastolic CHF, and chronic A-fib. He returned the previous day from a trip overseas. Last night he was very confused per the wife and could not answer questions appropriately. He has chills, a dry cough, and loose stools and is positive for COVID-19 in the ER.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant mediations was provided. On 12-JAN-2016, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) injection, lot # L024123, expiration date 30-DEC-2016 (dose and route were not reported). No adverse effects were reported. The vaccine was kept at 17.2 Fahrenheit (F) for 2 hours. Additional information has been requested.
Intramuscular administration of Rotarix.; This case was reported by a other health professional via call center representative and described the occurrence of wrong route of administration in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number Z5R33, expiry date 23rd February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 8th November 2022, the patient received the 2nd dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 8th November 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Nov-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow-up by safety team. The reporter consented to follow-up. Additional supportive information: The patient received Rotarix vaccine intramuscularly instead of orally, which led to wrong route of administration.
Blurred vision that gets worse as I become tired; Blurred vision that gets worse as I become tired; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 02Mar2021 at 10:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medication in two weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN), sulfur (MANUFACTURER UNKNOWN) and iodine (MANUFACTURER UNKNOWN) for an unknown indication and experienced drug allergy. On 03Mar2021 at 14:30, the patient experienced blurred vision that gets worse as become tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blurred vision that gets worse as become tired was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
PT WENT BACK TO SCHOOL & STARTED C/O TIGHTNESS IN CHEST/ WHEEZING/ COUGH. O2 SAT BEGAN TO DECREASE 97% TO 85%. SCHOOL NURSE STARTED OXYGEN, CALLED 911, GAVE EPI-PEN DOSE, MOM GAVE 25MG BENADRYL. EMS STARTED ALBUTEROL NEB TREATMENT & TRANSPORTED TO ER.
Decreased function of right extremity. Radiating pain and aches from injection site, down to lower extremity, through the vertebrae, and into rib cage.
RASH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious.
"side effects are minor, but bothersome."; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("side effects are minor, but bothersome.") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("side effects are minor, but bothersome."). At the time of the report, VACCINATION COMPLICATION ("side effects are minor, but bothersome.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The student was vaccinated 7 months ago. The reaction is just being reported to staff now because she is due for her second dose. Mother works where clinic was held last June. Mother reports that 3-4 days post vaccination with first dose of HPV9 (Gardasil), patient started with diffuse hair loss that began  as "not clumps, just diffuse spots". Patient complained to mom but was not worried about it because she has thick hair. Mother then noticed hair brush full of hair which lasted a few weeks. Took her to pediatrician a few weeks later and doctor did not associate hair loss with HPV vaccination, just cyclical shedding/coincidence. Doctor ordered some blood work, which came back normal. Hair loss has stopped but has subsequently been experiencing prolonged menses which were normal prior to this. This has caused anemia for which she is being treated for since November 2017.
Client state "notice bumps on body and itchy" on 4/14/09. Seen by ER physician and prescribed BENADRYL by mouth. Client came to clinic today 4/20/2009 to report bumps previously on body from 4/14/09. States feeling better today.
Narrative: Patient reported lightheadedness and dizziness following administration of first dose of Pfizer covid vaccine. Patient was able to be released with no intervention.
blood appeared in the urination as well; burning pain while they urinated; loss their appetite; FATIGUE; Chills; Muscle pain; Joint pain; Headache; nausea; vomiting; fever up to 101 degrees; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (blood appeared in the urination as well), DYSURIA (burning pain while they urinated), DECREASED APPETITE (loss their appetite), FATIGUE (FATIGUE) and CHILLS (Chills) in an 82-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 was provided by the reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HAEMATURIA (blood appeared in the urination as well), DYSURIA (burning pain while they urinated), DECREASED APPETITE (loss their appetite), FATIGUE (FATIGUE), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever up to 101 degrees). At the time of the report, HAEMATURIA (blood appeared in the urination as well), DYSURIA (burning pain while they urinated), DECREASED APPETITE (loss their appetite), FATIGUE (FATIGUE), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever up to 101 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: high (High) 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Varicella-like rash. At time of visit (4:00PM) 6 vesicles noted.
coughing; laryngitis type of thing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (laryngitis type of thing) and COUGH (coughing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced COUGH (coughing). In November 2021, the patient experienced OROPHARYNGEAL DISCOMFORT (laryngitis type of thing). At the time of the report, OROPHARYNGEAL DISCOMFORT (laryngitis type of thing) and COUGH (coughing) outcome was unknown. Patient reports laryngitis type of thing going for about a week now. Patient thinks she may have COVID-19 and had herself tested on 08-Nov-2021 but still with no results. Patient wants to know what the symptoms of COVID-19 are and if she is contagious.No concomitant medications were reported.No treatment information was provided.
Pt's father called on 4/9/21 afternoon and stated patient received dose 1 of Pfizer vaccine on 4/7/21 at stadium. On 4/8/21 pt.'s father states pt has fever, chills, some SOB and chest pain but feels better today (4/9/21). Pt's father also state patient took Tylenol for fever. Advised pt.'s father to take pt to the ED for evaluation and contact PCP. Pt's father verbalized understanding.
Client upper arms flush red and chest.  Is complaining of feeling warm and headache. EMS evaluated Bp122/90, lung sounds clear.  Instructed to either see PCP or go to ER.  Client called Dermatologist and showed her doctor her chest in between EMS check.  Derm. doctor instructed her to take benadryl Client to be driven home by family.  Instructed if does not improve with benadryl to go to ER.
Fever, injection sites are red and hard 3 cm bilateral painful indurated areas of anterior thighs.
Headache.  Body ache.  Feverish feeling.   Insomnia.  Racing/confusing thoughts.  Trouble concentrating.
Information has been received from a physician concerning a 9 year old female who on 01/26/1998 was vaccinated with a dose of varicella virus vaccine live.  Subsequently the patient developed chickenpox with 10 lesions on her torso.  The patient was a febrile.  Unspecified medical attention was sought and no treatment was required.  At the time of the report the patient had not yet recovered.  There was no product quality complaint involved.  Additional information has been requested.
L arm with redness, warmth and itching from shoulder to elbow. Started on Keflex 5/16/02 MD thought reaction to DTaP not IPV.
Child seen in clinic, several reddened sores with fluid, some slightly crusted bumps on abdomen, upper arm, swollen gland, reddened throat. Diagnosed with chicken pox. Fever prior to break out and itching. Diagnosis based on visual inspection.
She had a fever of 101 F; pain in underarm; chest pain; pain in her arm; Left arm where the injection was administered was itchy; She hasn't slept all night; Nausea; Has been throwing up since yesterday; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), INSOMNIA (She hasn't slept all night), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE PRURITUS (Left arm where the injection was administered was itchy) and AXILLARY PAIN (pain in underarm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart murmur and Hypertension.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INSOMNIA (She hasn't slept all night), VACCINATION SITE PRURITUS (Left arm where the injection was administered was itchy), NAUSEA (Nausea) and VOMITING (Has been throwing up since yesterday). On 08-Jan-2021, the patient experienced CHEST PAIN (chest pain), PAIN IN EXTREMITY (pain in her arm) and AXILLARY PAIN (pain in underarm). On 08-Jan-2021 at 3:00 AM, the patient experienced PYREXIA (She had a fever of 101 F). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 07-Jan-2021, VACCINATION SITE PRURITUS (Left arm where the injection was administered was itchy) had resolved. At the time of the report, CHEST PAIN (chest pain), INSOMNIA (She hasn't slept all night), PAIN IN EXTREMITY (pain in her arm), AXILLARY PAIN (pain in underarm), NAUSEA (Nausea) and VOMITING (Has been throwing up since yesterday) had not resolved and PYREXIA (She had a fever of 101 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 101 °F (High) 101°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported using High Blood Pressure pills (unspecified) concomitantly.; 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.
Nurse manager discovered during a chart audit on November 3rd the nurse at clinic administered a dose of Moderna to this patient past the recommended date after puncture.  It was discovered the vial was punctured on 10/26/21 and put back in the fridge at 2-8 degrees C.   The same vial was then punctured again on 11/03/2021 and dose administered to this patient.  Patient remained in clinic x 20 minutes with no reports of reaction.