chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an unknown amount dripped out of the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 2R375, expiry date 28-MAY-2024) for prophylaxis.   On 21-JUN-2023, the patient received Shingrix. On 21-JUN-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: an unknown amount dripped out of the injection site). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 22-Jun-2023 The pharmacist only had the patient's initials and stated that the approximate age was 60 years. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The pharmacist was administering a dose of Shingrix and an unknown amount dripped out of the injection site, which led to incomplete dose administered.
Pt had hives next night after Td injection, given Benadryl 25mg to take.
Dose 1 - I had increased body wide nerve pain. At that time, they thought I had fibromyalgia and the shot caused a flare up.  Dose 2 - I had very severe body wide nerve pain, vertigo, terrible migraines, vision issues, confusion, short term memory loss and grasping for words and increased muscle weakness. It kind of mirrored a stroke. The pain was a 10/10. It was basically like all of my symptoms were getting progressively worse over the weeks. It's gotten better, but the symptoms are definitely still there. My neurologist increased the dosage of a few of my meds. At this time, they're basically managing my symptoms, but we do not have a definite source for the issue. However, the vaccine definitely caused the flare up because nothing else in my life has changed.
Reporting administration error.  We contacted Pfizer for expiration dates, pfizer vaccine specialist advised expiration dates and deemed vaccines viable at the time of vaccine administration.  Pfizer vaccine vials only include manufacturer dates on the box and vials. Therefore, we contacted pfizer to attain expirations dates directly from them.    No adverse reaction reported from the patient at the time of vaccination and no adverse reaction  reported since given the vaccine.
Sore arm for 72 hours Body aches, joint pain and fatigue starting at 27 hours post vaccination that lasted 12 hours
Immediately after receiving the vaccine (within one to two minutes), I felt extremely light headed. I have never experienced anything like this before. I sat for a couple of minutes, and decided I didn't feel normal, and went up to the counter at the pharmacy and told the employee that I felt light headed. She asked the pharmacist who was standing nearby, and he said sometimes people are excited when they get the vaccine and this can happen. (I wasn't excited about getting the vaccine, but figured he knew what he was talking about.) I lived less than a mile away, so after my allotted time, even though I wasn't feeling normal, I drove home. After about 20 minutes, I felt tingling in my legs. I was laying in my bed as I didn't feel well, and looked under the covers, and I had a flat, red rash up and down both of my legs, with the rash extending to my feet. My brother is a retired radiologist in another state, so I called him. I took a picture of my legs, and sent it to him via the phone. He immediately said that he felt like I was having an allergic reaction, and to go take one or two Benadryls  immediately.  I ran downstairs and took one dose, and within 20-25 minutes the rash stopped. He asked me if I had heart palpitations, or trouble breathing, or a sense of doom. I didn't have any of those symptoms. He told me to call 911 immediately if any of those symptoms appeared. It was terrifying. After researching on the CDC website, it said even a mild allergic reaction was serious, and that I shouldn't take the second dose. Yesterday, (5/7/21), I called the CDC and chatted with someone and she suggested that I report this incident.
I was sore for a few days and then three days later it had very clear lines of demarcation around the edges. it had sharp edges. it was a mottled gray color. there was also distinct bruising down to 2 inches from my elbow.  it took 2 weeks to go away. Pictures can be provided upon request.
Satellite lesions (chest, back, upper arm - some w/fluid filling). Saw MD at a hospital. 7-9 pustules on back, some on chest 4 on neck, 1 on nose, 1 large on shoulder. As of 4/1/03 PT has developed 1-2 more at right ear, 2 more on chest.
This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (headache). At the time of the report, NAUSEA (Nausea) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.
I took the flu shot around 7:30 a.m. on Thurs. Oct. 27-16 about 15-20 min. after the shot, I start to feel tight in chest, and my face was warm and red and itching. I was itching all over when I got home 30 min later my face was broke out and I started having muscle spasms in my heart and both sides of my chest. I took BENADRYL, TYLENOL. I went back to the clinic on Fri. Oct 28th. I saw doctor, I was given Methylprednisolone. I am better but not completely well. I am still having minor muscle spasms. My face is still broke out, not as bad. As of 11-14-16 I am better. For 2 wks. after flu shot I was very sick.
FEELING WORSE; FEVER; FATIGUE; PAIN AT INJECTION SITE; SHIVERING; SORE ALL OVER; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 72 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 31-MAR-2021 at 13:30 on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced sore all over. On 01-APR-2021, the subject experienced shivering. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021, the subject experienced pain at injection site. On 01-APR-2021 07:00, the subject experienced feeling worse. On 01-APR-2021 07:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling worse, and the outcome of fever, shivering, fatigue, pain at injection site and sore all over was not reported. This report was non-serious.
Itchy, red, raised area surrounding injection site. 8 days post vaccination. Painful to touch
Received Tdap vaccination on 4/16/19. On 4/17/19 noticed area was red, itchy, and swollen (to be expected, but severity new reaction for me). Over next several days/weeks, developed a large lump under skin that was approx. 3x3. Area of redness continued with itchiness, and lump/abscess. Physician notified but was told she didn't need to examine to just put ice on site. The abscess or lump is still present under skin as of today 5/6/19 with redness and peeling skin at injection site. I have pictures if needed of my arm since day after vaccination.
No additional AEs; Caller reported vaccine administered after temperature excursions.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 09-AUG-2023 the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X011979 and expiration date 18-JUL-2024, 0.5 milliliter, intramuscularly for prophylaxis (dose number and site of administration were not provided) (product storage error and no adverse event). The temperature excursion lasted for 1 hour and 5 minutes in 18.3 degrees Fahrenheit (F). No previous excursion was observed.
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. No laboratory provided by reporter Treatment information was not provided.
01/17/04   red fine rash, raised on shoulders and flank (went away with Benedryl) 02/04/04 generalized itchy skin rash (treated with epi, benedryl, and prednisone) 02/07/04  Admitted to hospital - scattered red rash, itchy over entire body (treated with epi, decadron, solumedrol, pepsid, benedryl) diagnosed as urticaria  02/10/04 referred to dermatologist - diagnosis made was urticaria secondary to smallpox vaccination. The hospital discharge summary received on 3/3/04 states an allergic reaction.
pt recv vax & 45min p/vax c/o sore arm, warmth, soreness @ area upon eval arm inj site warm, swollen to 3" size, firm @ site as well;called MD who ordered to apply ice to area;pt to take DPH;
Information has been received from a licensed practical nurse concerning a patient who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL. Subsequently on an unspecified date, the patient had ASCUS on Pap which was negative for high risk and low risk HPV. At the time of this report, the patient's outcome was unknown. No further information is available.
rash and bluish feet the evening of  vaccines.  Rash gone in 15 minutes. No fever baby acting normally
Baseball size inflammation at vaccination site (L) thigh. Reaction occurred 3-4 hours post vaccination. Relief from swelling and redness 30 minutes after BENADRYL was administered.
A non-serious spontaneous report of a child with history of wheezing got H1N1 LAIV was received from a physician concerning a 36-month-old female. Patient had a history of intermittent wheezing; diagnosed as asthma two weeks ago. The patient is now taking budesonide. On 13-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved.
several min p/vax pt c/o abd pain, lassitude & vomiting;this was soon complicated by a thready pulse, cold & clammy skin, perioral cyanosis, limited responsiveness;
Body aches lasting three days, ibuprofen taken every 6 hours Sore throat Low grade fever on second night
not feeling too great; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. This patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient experienced not feeling too great on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Initial report received from a health care professional on 14 November 2011. The reporter also reported another adverse event, which was captured in case number 2011-11079. An unidentified patient (age and sex not reported) received an intramuscular injection (site not reported) of FLUZONE, sanofi pasteur Inc. lot number UH477AC, on an unknown date. The patient's medical history and concomitant medications were unknown. It was unknown if the patient had any adverse events following prior vaccinations. The patient had no illness at the time of vaccination. On an unknown date, the patient developed numbness on the back of the arm where the injection was given, swelling of the arm and cellulitis. The patient was seen in the Emergency Room (ER) where treatment was given but not specified. The patient had no diagnostic or laboratory testing performed. The outcome was reported as unknown. Documents held by sender: None.
2-day history of progressive chest pain, 2 days after receiving his second dose of the Moderna vaccine.
Information has been received from a physician concerning 2 patients who were vaccinated with Gardasil (lot# not reported).  Per the reporter, both patients experienced syncope after receiving the Gardasil.  The patients sought unspecified medical attention.  Additional information has been requested.
Immediate reaction within 4-5 hours of vaccination was raised red rash, in clusters, on front and back of legs, and on back. Rash had tiny small clear heads.  Within 24 hours had a low grade temperature of 101 degrees.  The rash continued for 3 days, and the elevated temperature lasted for 2 days.  Son became very irritable. Called nurse and she said not reaction to MMR, but to treat with Benadryl and cool bath.
Per individual's mother; noted a temp. of 100.3F the following morning (Sunday 12/11/2011) and given Tylenol & temp went down to 99F. On Monday morning, an approximate 9cmX13cm irregular shape redness noted at injection site & mother drew outline in order to monitor for growth, then mother left a message for physician. At 3:15 on 12/12/2011, mother brought child to physician's office, RN Supervisor triage & noted current oral temp 98.8F, injection site had 11.5X15.5cm erythema which was slightly warm to touch.  Child was then seen by physician.
Onset of sx were swelling and pain of left arm. Pt went to ED 10/12 with worsening swelling and pain, axillary adenopathy and inability of moving arm due to pain. Pt was dx'd with acute inflammatory process following vaccinations and also had dx of gout. She was advised to apply ice, take NSAIDS, and pain medications. Pt recieved Toradol and was given RX for indomethacin and oxycodone. Pt returned to ED on 10/14 for continued sx- markedly pain, swellin gand erythema to the left deltoid area. Sx were moderate to severe. Pt had an IV established, and as advised to continue ibuprofen, and to f/u with PCP in 1-2 days. Pt recieved Bactrim for possible mild cellulitis and had a normal ultrasound of left arm. Pt had OV 10/25 with PCP. Pt's sx had resolved in her arm. PCP advised pt to finish abx and rest.
Pt rec'd Td 0.5ml IM Rt deltoid post suffering laceration finger from metal gate. Last Td > 10 yrs. AFter approx 2 days injection site became swollen, red, hot-no improvements post 8 days. Pt on antibiotic and was given Medrol.
Chills and fever for 3 days.  Runny nose and congestion.  Started Amoxicillin  500mg  twice a day1/2/2021
had COVID; had COVID; This is a spontaneous report from a contactable consumer or other non-HCP. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced had covid and was given Plasma on 11Mar2021. The patient underwent lab tests and procedures which included covid-19: positive. The reporter indicated that her husband was told to wait three months to get the second dose of the vaccine and they were trying to schedule an appointment for the patient to get his second dose. Therapeutic measures were taken as a result of covid. The outcome of event was unknown. Information related to lot/batch number has been requested.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Slight back muscle pains and low fever 1 day after vaccine, rash, hard swelling and stiffness below deltoid and and bicep area 2-3 days after, soft swelling on tricep and elbow area 4-5 days after.
pt recvd vax & 2 wks later exp mild diarrhea, nausea, fatigue;
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by a physical therapist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.   No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No information was reported on date of the storage of vaccine in refrigerator. The vial did not undergo any temperature excursions. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant live follow up received
Fever, chills, body aches, intense headache, nausea, fatigue, arm soreness at injection site & through the upper part of arm. I received the shot on the morning of 3/12 & the reactions started that evening. Although lessening in severity each day, it lasted  at least 4 days.  Acetaminophen was taken as directed on bottle & by the nurse who gave the shot.
Fever of 101, severe chills, muscle aches, lethargy. Lasted from about 8PM the day of the vaccine until the next morning.
12 hours after injection- generalized body rash on torso, arms and legs- not on face.. Significant arm pain, arm pit pain.  48 hours post injection-  generalize swelling of arm pit, with swelling to left pectoral and trapezoid muscles.
This spontaneous report as received from a physician refers to an unknown number of unspecified patients (information about the patients' gender and age was not reported). Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unknown dates in 2016 (reported as started in February 2016), the patients were vaccinated with improperly stored VAQTA (lot # L015460, expiration date: 20-JUL-2017; lot # M011116, expiration date: 17-JUL-2017; doses and routes of administration were not reported). The vaccine was stored at 51 degrees Fahrenheit for a time frame of 126 hours and 34.3 degrees Fahrenheit for a time frame of 19.94 days. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) on 19-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnant before getting the vaccine. Initial exposure to GARDASIL was at 33 week(s) gestation. The patient's LMP was on approximately 01-FEB-2012 and EDD was on approximately 07-NOV-2012. The patient was exposed to GARDASIL during trimester 3. The outcome of the patient was unknown. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning a 33 year-old female patient with a history of 1 previous pregnancies and 2 live births. Previously, the patient had given birth to female infant weighing 6 lb 2 oz on 29-SEP-2009 via C-section (38th week). Other relevant history was described as none known. The patient was not smoking and not using alcohol or drugs. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) intramuscular on 19-SEP-2012. Concomitant medications included: generic prenatal vitamins (unspecified) and DIFLUCAN. The patient had been pregnant (LMP 02-FEB-2012, previously reported 01-FEB-2012) before vaccination. Method of confirmation: urine/serum pregnancy test (no details specified). Other lab test included: blood grouping on 31-MAY-2012 (result:0Rh +); glucose test on 15-AUG-2012 (108 negative);maternal serum alpha fetoprotein test (MSAFP) on 11-JUN-2012) (negative); B-streptococcal test on 14-OCT-2012 (negative) and ultrasound 01-OCT-2012 (NL). The patient gave birth to a male infant on 03-NOV-2012 via c-section, at 38 weeks and 4 days of gestation. There was no complication during delivery, the patient was not admitted to a hospital (or her stay was not prolonged). The baby was reported to be normal, with no congenital anomalies, weighing 6lb 8oz, length 19 inches. Apgar score was 8 after 1 minute and 9 after 5 minutes. No neonatal problems were reported. Causality for live birth via c-section was not reported. Upon internal review, the patient's live birth via C-section was determined to be another medically significant event. Additional information is not expected.
This spontaneous report as received from a Medical Assistant refers to a male patient of currently 27 year old with acute myeloid leukaemia, aseptic necrosis of the bone, osteoarthritis of pelvic region and thigh, clindamycin and sulfa allergy and a history of bone marrow transplant. On 27-APR-1988, the patient was vaccinated with the first dose of M-M-R II (dose and route not reported). On an unspecified date, the patient had antineoplastic chemotherapy (unspecified), a bone marrow transplant and a blood transfusion for possibly one of his following diagnoses: acute myeloid leukemia, aseptic necrosis of the bone, osteoarthritis of pelvic region and thigh, and bone marrow transplant. On 11-MAR-2002, the patient was then administered a second dose of M-M-R II (dose and route were not reported). On an unspecified date, after the second dose of M-M-R II, the patient had negative titers for measles and mumps. The patient was currently in remission for the diagnoses listed above. No treatment was given for the events. The patient sought medical attention as he contacted the office to be revaccinated with M-M-R II. No PQC was involved. The outcome of the events was not reported. The relationship of the events with of M-M-R II (dose and route were not reported) was unknown. Additional information has been requested.
BUMPS ON LEGS, RASH LIKE THE ITCHING, HIVE AFTER SCRATCHING. IMMUNIZATIONS WERE GIVE IN UPPER LEFT AND RIGHT ARMS LASTED UNTIL 1 AM WHEN MOTHER RETURNED FROM PHARMACY TO BUY BENADRY. CHILD ASLEEP NO TREATMENT, NO RESPIRATORY DISTRESS.