chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administration of ROTARIX vaccination as intramuscular injection (oral immunization route). Facility made immediate phone call to pharmaceutical manufacturer regarding incident. Upon the advice of the pharmaceutical representative, the patient was brought back into our facility the following day for administration of the oral vaccine ROTARIX. Based on the recommendations from the American Academy of Pediatrics "... previous immunization with a dose that was .... Administered by a non-standard route should not be counted, and the person should be immunized as recommended for age". No signs of adverse reaction was noted. IM injection site 'erythema and swelling of shot sites has resolved' documentation noted upon return visit by pediatric physician. If you have any further questions, please do not hesitate to contact me.
This is a spontaneous report from a contactable physician communicated to a Merck sales representative based on the information received by Pfizer from Merck & Co., Inc. (Service Request Number: 1-10332411622). An infant patient of unknown age and ethnicity received PREVNAR, on an unspecified date for immunization. Medical history and concomitant medications were unknown. On an unspecified date, the patient developed a rash on the right side of the face, which then moved to the left side. The clinical outcome of rash on the right side of the face, which then moved to the left side was unknown. No follow-up attempts possible. No further information expected.
Stiff and swollen around right knee cap front and back. Sometimes limping on the right leg. Symptoms are intermediate and affected by cold and damp weather.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No Treatment information was provided.
On day after shot, Low grade fever (100°), chills, slight headache, shot location arm pain, extreme fatigue (slept for hours)  Second day fever was gone and only slightly tired. By 3rd day only thing was a little pain at shot site.
This spontaneous report was received from a medical assistant and refers to a 2 year old, female patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapies or medical history provided. On 13-NOV-2015 at 2 pm., the patient was vaccinated with improperly stored dose of VARIVAX lot # L013068 in the right thigh for prophylaxis (dose, route of administration and expiration date were not reported). The vaccination was in privates doctor's office and administered VARIVAX was purchase with public funds. The patient did not have any illnesses at the time of vaccination. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion that the administered VARIVAX experienced were not reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004105: US-009507513-1702USA004106: US-009507513-1702USA004107: US-009507513-1702USA004108: US-009507513-1702USA004109: US-009507513-1702USA004110: US-009507513-1702USA004103: US-009507513-1611USA008278.
CHEST PAIN, PAIN IN LEFT ARM, PAIN IN BACK, LIGHTHEADIDNESS, PASSING OUT - 15 OCT 2021 BLOOD LOSS IN HANDS AND FEET WHEN EXPOSED TO COLD - SECONDARY ONSET REYNAUDS - 3 NOV 2021 ERRATIC AND HIGH HEART RATE WHEN RUNNING - 20 OCT 2021 TO CURRENT CHEST PAIN, PAIN LEFT ARMY, PAIN IN BACK, HEADACHE, 20 MIN PASSING OUT EPISODE, LIGHT HEADINESS - 24 JAN 2022 NERVE PAIN ACROSS BACK AND ARMS, TINGLING IN FEET AND HANDS, CONSTANT HEADACHE, DECLINED COGNITIVE FUNCTION, DIFFICULTY SWALLOWING, LIGHTHEADIDNESS, DIFFICULTY STANDING, LOSS OF BALANCE, DIARRIA, LOSS OF SENSATION OF BEING HUNGRY OR FULL, WEIGHT LOSS AND WEIGHT GAIN OF 15+ LBS IN 3 WEEK PERIODS, SKIN RASH ON LEGS THAT APPEARS AND DISAPPEARS,  muscle fasciculations, Dysesthesia,   suspect small fiber and autonomic neuropathy, dyspnea on exertion, exercise intolerance and other dysautonomic/small fiber symptoms
Soreness on first day/Aches and body pain; Chills; Low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EP6955) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Soreness on first day/Aches and body pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever".  Additional information: No underlying conditions. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
developing a rash over various parts of my body- back, arms, legs, stomach, head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 13:00 (Lot number: ER8727) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 26Mar2021, outcome "not recovered", described as "developing a rash over various parts of my body- back, arms, legs, stomach, head". The event "developing a rash over various parts of my body- back, arms, legs, stomach, head" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications within 2 weeks of vaccination. Cream was treatment received for adverse event. The patient was not diagnosed with COVID-19 Prior to vaccination and was been tested since vaccination. No follow-up attempts are possible. No further information is expected.
Administered Pfizer covid vaccine for 6 months-4 year dose instead of the 5-11 year dose.
collapsed/From  toilet to his bed where he essentially collapsed; could not stand; couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (collapsed/From  toilet to his bed where he essentially collapsed), DYSSTASIA (could not stand) and GAIT DISTURBANCE (couldn't walk) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 032F21A, 001A21A and 0011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia and Walker user.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced LOSS OF CONSCIOUSNESS (collapsed/From  toilet to his bed where he essentially collapsed), DYSSTASIA (could not stand) and GAIT DISTURBANCE (couldn't walk). At the time of the report, LOSS OF CONSCIOUSNESS (collapsed/From  toilet to his bed where he essentially collapsed), DYSSTASIA (could not stand) and GAIT DISTURBANCE (couldn't walk) outcome was unknown.            The concomitant medication was not reported. The treatment medication was not reported. The patients wife reported that her husband received 4 doses of the Moderna covid19 vaccine by intramuscular injection. He had no problems after receiving the first three doses. He had a history of dementia and normally ambulates with a walker. Today as reported he was using the toilet, but could not stand from the toilet on his own. He normally was able to do this quickly, but it took him about 20 minutes to stand from the toilet today. He was eventually able to make it from the toilet to his bed where he essentially collapsed. This occurred about an hour ago as reported. He had not taken any medications or treatments for his symptoms. The contact had called his neurologist and PCP leaving messages. The patients wife was not concerned for stroke or heart attack at this time.
Nausea and vomiting for 48 hours, followed by 48 hours of fatigue.
Pfizer 5-11yr  0.2 dose was given to patient  vaccine needed to be diluted  but was not diluted
Eyelids slightly pink with nausea about 15 minutes after vaccine.  One hour later, eyelids, ears, face-red.  Body itchy with pink papules.  Given Benadryl.  Seen in ER, symptoms resolved after 1-2 hours.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 54-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment details were provided.  Reporter confirmed that patient had been administered doses while the temperature excursion assessment was ongoing.
Soreness; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), PYREXIA (Fever) and CHILLS (Chills) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (Soreness), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Soreness), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
Arm was sore; Chills; This is a spontaneous report from Pfizer sponsored program from a contactable consumer reported for a patient (reporter's husband). This is the 2nd of 2 reports, for the 2nd dose.   A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 16Mar2021 (Lot Number: EN6206) at single dose for covid-19 immunisation.  The patient medical history was not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9266) on 16Feb2021 at single dose for covid-19 immunisation and experienced just a little soreness. Concomitant drugs were not reported. His arm was sore and he kind of had chills for a couple hours after the second shot. That was his reaction. With the second shot everything happened the same day and was over by the next day, it was even 16Mar2021 that same day he was okay. His soreness recovered completely, it was gone. Events was recovered on 16Mar2021. Causality is N/A.                    No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021393005 same patient, different drug(dose)/event.
Developed double vision, weakness and unsteady gait on 11/13/08 and was admitted to Hospital. History of URI for 2 days with cough. CVA was r/o by MRI and CT. Transferred to Hospital on 11/17/08 and diagnosed with GBS - Miller Fisher variant. Given IV Ig. Discharged 11/25/08 to Rehab. Still requiring maximum assistance and still with blurred vision and diplopia. 12/04/08-records received for DOS 11/18-11/25/08-DC summary not available. Prsented with C/O numbness to upper extremities progressing upwards and blurred vision. Unable to stand. Numbness descending. IVIG treatment.
COVID 19 Treatment; COVID 19 Treatment; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 11:00 as dose 1, single (Lot number: HD9876) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 14Sep2022 at 12:15 as dose 5 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: COVID-19 VACCINE taken for covid-19 immunisation as dose 1, single as dose 2, single as dose 3 (booster), single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate schedule of vaccine administered". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
On March 6, I experienced swelling of the face, hands, throat accompanied by hives/rash over body.
headache and shooting pain in her left forehead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "headache and shooting pain in her left forehead".  Additional information: The agent provides that the patient is reporting that after having the Pfizer Biontech COVID-19 vaccine she is experiencing headache and shooting pain in her left forehead. The caller refers it feels almost like a lightning bolt and it is getting its getting more frequent. She started experiencing this headache one week after getting the second dose of the Pfizer Biontech COVID-19 vaccine. "It does not happen every day, its sporadically and randomly. Caller also states that seven people she has talked to have referred getting headache since they got their shots. The caller wants to know if there are reports of headache. The caller asked if these headaches can lead to stroke or brain aneurisms, are there reports of strokes or brain aneurisms as side effect of the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300266912 same , different patient.;US-PFIZER INC-202300266906 same SD/AE, different patient.;US-PFIZER INC-202300266915 same SD/AE, different patient.;US-PFIZER INC-202300266914 same SD/AE, different patient.;US-PFIZER INC-202300266911 same SD/AE, different patient;US-PFIZER INC-202300266913 same SD/AE, different patient;US-PFIZER INC-202300266910 same SD/AE, different patient.;
About 21 minutes after the shot  I felt a hot flash from my toes up to my head and I started to become unable to swallow. My ears felt as if they were going to burst out of my head and started getting worse.  I could still breathe but couldn?t swallow hardly at all.  My mouth felt really dry.  I was rushed to the ER by my boss and they gave me a steroid injection and a bit later gave me  two Benadryl that I had a difficult time swallowing.  They kept me there for a couple hours and releases me as I told them that I felt like I was able to swallow again and my ears felt normal again.  Followed up with my Dr. the next day.
ARM SORENESS FIRST 12 HRS. NEXT 24 HRS SEVERE HEADACHES, MYALGIAS, CHILLS ALTERNATING WITH SWEATS. NAUSEA AND VOMITING X1. TOOK TYLENOL AND ZOFRAN.
Tested positive for COVID-19 on 4/6/2022. Symptoms included severe lethargy, loss of taste/smell, severe sinus congestion.
Bell's Palsy (left-sided) - diagnosed on 1/14/2021.  Onset of symptoms on 1/11/2021 with altered taste, earache. Progressed to left facial muscle weakness on 1/13/2021. Visited urgent care on 1/14/2021 where diagnosis was made. Received Prednisone 50mg for 5 days, Valacyclovir 1g TID for 7 days. Earache resolved. Facial weakness continued to worsen from 1/14 - 1/18 despite steroid treatment reaching minimal movement of left facial muscles, able to close left eye with difficulty. Left sided loss of taste still present. At follow-up appointment on 1/21/2021 with PCP, patient was prescribed additional steroid taper for 7 days.
This is a spontaneous report from a contactable nurse. This is fourth of the five reports by the same reporter. A nurse reported on behalf of a 4-year-old male patient who received a 5th dose of pneumococcal conjugate vaccine (previously received 4 doses of pneumococcal conjugate vaccine (dates unknown). The patient received a dose of PREVNAR13 (lot number915065) on 01MAR2011 via an intramuscular route of administration in the right arm. The patient had no relevant medical history or relevant concomitant medications. Drug allergies or re4levant family history was  denied. ON an unspecified date, the patient had a reaction at the injection site characterized by pain and red ness at the site. Relevant laboratory dates was unknown. The patient recovered from the events. The nurse does not wish to be contacted for additional information. Follow-up attempts completed. No further information expected. Follow-up (28APR2011): New information reported from a  contactable nurse includes: patient's date of birth and gender, lot number, medical history, product details, and event details leading to the additional codes of vaccination site pain and redness, and outcome.
Patient was given fifth Dtap dose a month too early, no adverse reaction, no action necessary.
Received HAV and HPV9 vaccines on 6-2-16 at 3PM, went overnight to grandmother's home and woke up with rash "bumps". Mom brought child to ER and doctor stated had allergic reaction. Rx steroids.
On 9-25-10 lips started burning, swelling got the flu like-symptoms, eyes were watering, legs are now swelling - more than normal swelling - on 9-26-10, felt worse - lips started peeling, and con't swelling, cracking.
Headache, Myalgia, Diarrhea, CHILLS, TOTAL BODY ACHES Narrative:
This non-valid spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates in 2018, patients were vaccinated with an improperly stored dose of ROTATEQ (lot # N024295 exp 24-MAR-2019) and an improperly stored dose of GARDASIL 9 (lot #N020353 exp 28-APR-2020 and lot #N017686 exp 02-FEB-2020, for prophylaxis (dosage schedule not provided). The administered doses of the vaccines experienced a temperature excursion of 47 degrees F to 77 degrees F (49.1 degrees F) for 1 hour, from 21-MAR-2018 to 17-MAY-2018, as recorded by a data logger. The vaccines had had previous temperature excursion of 47 degrees F to 77 degrees F for 30 minutes, on an unspecified date.  There was no adverse effect reported. No product quality complaint was involved.
pt vax in 3/97 & in 3/98 pt presented @ the m.d. ofc herpes zoster w/approx 30 lesions
After administering vaccines, I was updating electronic system and noticed that Hib vaccine was not in inventory. I checked expirations again and realized that the Hib vaccine expiration date was misread and actually expired March 22, 2021. I immediately contact the NP and reported the error, discussed the process and next steps. I then contacted mom,  and reported to her the Hib error. I explained the vaccine was expired and that it was discussed with NP, reported that receiving the expired vacc is not harmful to baby and that the dose may need to be repeated. Mom stated she understood and had further questions about Haemophilus influenza type B and baby's risk because because they are planning to travel soon. I recommended to mom that she speak with NP for more information. Mom agreed and I contacted NP to ask that she reach out to mom, NP agreed.
Ringing in both ears; Soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in both ears) and MYALGIA (Soreness in injection arm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concomitant products included FINASTERIDE (PROPECIA) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced MYALGIA (Soreness in injection arm). On 23-Jul-2021, the patient experienced TINNITUS (Ringing in both ears). At the time of the report, TINNITUS (Ringing in both ears) and MYALGIA (Soreness in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.