chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child pulled out the Infanrix (DTaP)# 4 shot with her left hand, while doing this, the needle scratched her thigh causing a small superficial bleeding. I stopped the minor bleeding immediately with a pressure bandage.Mother used her left hand to hold child's arms and right hand to hold child's legs.
The pt experienced sore shoulders following the vax that never stopped hurting. The vax was  received in the Fall of 1999 and the pain continued until 2/00. The pt received 2 cortisone shots in the left shoulder, and one in the right shoulder in 9/00. The pt still has pain in the shoulder where the Lyme Disease vax was given.
REDNESS AT INJECTION SITE THEN THE FOLLOWING DAY A RED, WARM VERTICLE LINE FROM INJECTION SITE APPROX. 4 INCHES LONG: FEVER ON AND OFF. IMROVEMENT THE FOLLOWING DAY. ADVISED PT MOTHER TO CALL FAMILY PHYSICIAN TO LET THEM KNOW..MOTHER STATED PT'S OFFICE HAD BEEN EXPOSED TO THE FLU THE PREVIOUS WEEK.
Moderate macular rash with localized smaller area of induration - resolved with topical steroids.
Pt described arm as being sore (more sore than what she previously experienced) and about a 3 inch diameter rash around injection site.  She showed me the area and it was ~ 2 inches in diameter and slightly red. Pt remarked it had improved from yesterday. I recommended pt contact MD for guidance as to whether antibiotics would be required. Spoke with pt 12/15/22 and pt reports no soreness and redness cleared up.
Tingling, feeling on fire, 104 temp, chills, dehydrated, and tremors in arms and shoulders
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 15-JUL-2013, the patient was administered with a dose of VARIVAX (merck) (Lot # H012351, expiry date 21-JUN-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
loss of pigment in the skin; This spontaneous case was reported by a consumer and describes the occurrence of VITILIGO (loss of pigment in the skin) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CICLOSPORIN (RESTASIS) for Eye abnormality NOS.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VITILIGO (loss of pigment in the skin). At the time of the report, VITILIGO (loss of pigment in the skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No lab data has been provided by the reporter.
Bilateral forearm and hand tingling about 24 hours post vaccination. Hands began to stiffen up to point of inability to open and close fingers. Episode lasted 8 hours. No current symptoms.
loss of sense of taste; loss of sense of smell; weakness; myalgia; not feeling well; Positive COVID 19 result; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID 19 result) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Taking medication for blood pressure) and Cholesterol (Taking medication for cholesterol). Concomitant products included VITAMIN C [ASCORBIC ACID], vitamin d and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced COVID-19 (Positive COVID 19 result). At the time of the report, COVID-19 (Positive COVID 19 result) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test positive: positive. On 18-Jan-2021, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medications also included unspecified medication for cholesterol and blood pressure.
Headache, chills, sever muscle ache, fatigue, redness and hardness at the site of injection for 4 days The redness at the site of injection lasted for about a week.
SWOLLEN MOUTH, EVERY 4-6 HOUR LEFT SIDE LUNG DISCOMFORT BELOW THE RIB BUT ABOVE THE STOMACH.  ULCER LIKE PAIN AND DISCOMFORT EVERY 4-6 HOURS, LESS SLEEP LIKE 5 HOURS DAILY.
This spontaneous report was received from a licensed practical nurse and refers to a unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored VAQTA (lot# L014068, expiration date 02-NOV-2017, dose, site and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
1010 Post vaccination reports feeling lightheaded w/hx of similar event post blood draws. Medical monitoring x 30 min, symptoms improved after rest, po hydration/ orange juice; vitals assessed: BP 110/80 P83 RR 18 O2 sat 98% RA.  Released from facility w/self.
Pruritus (diffuse); swelling (R) arm Treatment with Diphenhydramine
8/27/21 pt brought to ED with SOB; states he had a negative COVID test at an urgent care center; 8/28/21 pt had a positive COVID test in the hospital; given remdesivir, dexamethasone, ABX, O2 supplementation; required BiPAP; pt continued to worsen; respiratory status declined requiring intubation with mechanical ventilation; pt found without a pulse and in asystole; code called, ACLS protocol implemented with results; pt expired in the hospital
Immediately after administering DTaP vax, the inject site region became erythematous. Ice pack was applied for 5 mins of every hr. Redness gone in 2 days.
Patient presented to ED after a fall from his couch. He states he was feeling weaker than usual, he rolled off the couch while trying to get up and fell on the floor.  Denies any dizziness, HA or loss of consciousness.  Constitutional: Positive for fatigue and fever. Negative for appetite change, chills, diaphoresis and unexpected weight change.  HENT: Negative for congestion.   Respiratory: Positive for cough and chest tightness. Negative for shortness of breath and wheezing.   Cardiovascular: Negative for chest pain, palpitations and leg swelling.  Gastrointestinal: Positive for nausea. Negative for abdominal pain, blood in stool, constipation, diarrhea and vomiting.   He did not require treatment for COVID19 infection. Falls were thought to be due to presyncope with possible BPPV. Originally had acute rehab recs, but he improved clinically while inpatient and will discharge home with his wife and son who understand his isolation precautions.  Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Aches, pain, chills, nausea, fever, soreness at injection site, dizziness. Excruciating pain at sites of old injuries/surgeries. Weakness in right leg/foot, migraines and headaches, strange bruising appearing on opposite arm from injection (right upper arm) 4 inches long by 2 inches wide. Strange red/purple mottling of skin. Falls due to dizziness. Still suffering from reaction 6 days later and hasn't ended as of the time of this report. Some reactions lighten and then return, but have been continuous. Doctor appointment made on day 6 (today) after speaking with nurse on the phone. Doctor will see him on Wednesday  5/5.
High fever, vomiting, headache, body and muscle pain, chill tremors for 24 hours
Pt received COVID 19 Vaccine today.  Approx. 10 mins after administration, pt reported "I feel chills and tingling lips."     Pt reports, "I ate a full breakfast at 1030 today" No h/o DM.   NO shortness of breath NO CP (pain 0/10) NO dizziness NO Nausea/Vomiting No vision changes  No itching or hives reported or observed.     At 1245, pt states, "my tongue feels tingly and my lips feel numb.  I feel like I have a lump in my throat."     See VS flowsheet for vitals during monitoring period.    PMH reported:  COPD MEDS reported:  Amlodipine, Gabapentin, Nortriptyline, Levothyroxine   1300: Maryam, ED Charge RN called for report and patient needing to be transferred for higher level of care post COVID 19 vaccine.  1310 approx.:  HarmPt received COVID 19 Vaccine today.  Approx. 10 mins after administration, pt reported "I feel chills and tingling lips."     Pt reports, "I ate a full breakfast at 1030 today" No h/o DM.   NO shortness of breath NO CP (pain 0/10) NO dizziness NO Nausea/Vomiting No vision changes  No itching or hives reported or observed.     At 1245, pt states, "my tongue feels tingly and my lips feel numb.  I feel like I have a lump in my throat."     See VS flowsheet for vitals during monitoring period.    PMH reported:  COPD MEDS reported:  Amlodipine, Gabapentin, Nortriptyline, Levothyroxine   1300: Maryam, ED Charge RN called for report and patient needing to be transferred for higher level of care post COVID 19 vaccine.  1310 approx.:  Harmony, RN from ED came to safely transport pt to ED.     No family at bedside.   Pt a good historian w/ stable VS when transported to ED.   RN from ED came to safely transport pt to ED.     No family at bedside.   Pt a good historian w/ stable VS when transported to ED.
pt recv vax 17OCt97;states pain in arm started Tuesday AM 21OCt97 & progressively moved to shoulder;seen by PMD  & referred to specialist in another county d/t improvement;states has knot in arm but RN unable to feel today;
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-FEB-2016 the patient received the first dose of HAVRIX (lot#, dose and route not reported). On 30-JUN-2016 (two months earlier than schedule date) the patient inadvertently received the second dose of VAQTA (lot# M012261, expiration date 01-FEB-2018, a dose, route not reported). Concomitant therapy was not reported. No adverse events were reported. Additional information has been requested.
inadvertently administered tenivac instead of daptacel; missed dose with no reported adverse event.; Initial information was received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 01358211.  This case involves a 4 years old female patient who was inadvertently administered Tenivac instead of Diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] missed dose with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Nov-2022 the patient inadvertently administered Tenivac instead of Daptacel (with unknown strength, dose, lot number and expiration date) with no reported adverse event (product dose omission issue) (unknown latency).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Non reported Narrative:  A 90yo male with history of COPD, Seizure, HTN, CKD, Anemia,  Age Related Cognitive Decline, Chronic Diastolic Heart Failure, Hyperlipidemia,  Cerebrovascular Accident and with functional decline Per vaccine administration  nursing documentation, He received first Covid-19 vaccine on January 13, 2021 and the second shot on February 3, 2021 without complications, per policy and procedure.
Information has been received from a nurse practitioner concerning a 24 year old female volunteer with unknown medical history who on 06-NOV-2006 was vaccinated SC in the left deltoid with a 0.5 ml first dose of Varivax (lot 3 651280/0408R). It was unknown if there was illness at the time of vaccination. Two days after the injection, on 08-NOV-2006 she experienced soreness, redness and pox marks (also reported as fluid filled vesicles) across her chest and abdomen. She did not have a fever. The patient recovered spontaneously 10 days later on 18-NOV-2006 (also reported as on an unknown date) and the pox crusted over. It was reported that the patient's symptoms were observed by a relative who is a nurse, not by clinic personnel. There were no labs performed. There was no product quality complaint involved. It was unknown if the patient had any adverse experiences following prior vaccination. No further information was available. Additional information is not expected.
Constipation for 3 days, fatigue, edema, headache for 7 days, it slowly starts to feel better on the date of 8.
This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 27-AUG-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a health professional refers to a 4 year old patient. On 02-MAY-2014 the patient was vaccinated with M-M-R II (lot # was reported as J010933 (invalid), expiration date was reported as 06-SEP-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. Lot number J010933 is an invalid lot number for M-M-R II. This is one of several reports received from the same source. Additional information is not expected.
Information has been received from a registered nurse concerning an 8 year old white female with medical history or allergies who on 18-MAR-1997 was vaccinated SC on right arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 620624/1538D). There was no illness at the time of vaccination. On 29-APR-2004, the patient come home from school with medical case of few spots that eventually crusted and went away. No medical attention was sought. Additional information has been requested.
Administered the Moderna Covid-19 vaccine to a 17-year-old patient; A spontaneous report was received from a pharmacist concerning a 17 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not reported.Concomitant medications were not reported.   On 11 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection at the age of 17. The patient did not showed any adverse reactions.  Action taken with mRNA-1273 in response to the events was not reported .   The event, administered Moderna Covid- 19 vaccine to a 17-year old was considered resolved on 11 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (vaccine was administrated for 17-years old patient) for mRNA-1273, lot # 026L20A.  There were no reported AEs associated with this case of product administered to patient of inappropriate age. The reported event is unlisted and company causality was assessed s not applicable.
103F fever, full body tremors, body aches and headache,  4 hours past injection. Fever lasted 9 hours from 4/5 pm until 4/6 am and returned approximately 20 hours after first starting. Second fever round was at 101F and lasted from 4/6 afternoon until 4/7 am.   Visit on 4/8 to the emergency room for severe dizziness and disorientation. Dizziness was in waves and lasted for most of the day into the next day and has tapered off over the last 2 weeks.
Feeling horrible and is on bed; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling horrible and is on bed) and FATIGUE (Feeling very tired) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MALAISE (Feeling horrible and is on bed) and FATIGUE (Feeling very tired). At the time of the report, MALAISE (Feeling horrible and is on bed) and FATIGUE (Feeling very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.   No treatment information was provided.
blood pressure increased; Really bad headache; Felt drained; Sick to stomach; Arms felt like they were 50 pounds; Felt kind of funny; felt sick/felt terrible; Little discomfort in arm; Fever; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had experienced fever (pyrexia), discomfort in arm  pain, felt terrible and sick, drained, sick to stomach, really bad headache, arms felt like they were 50 pounds, and felt kind of funny.  The patient's medical history and concomitant product use were not provided by the reporter.  On 28 Dec 2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the first night after receiving the vaccine, the patient reported they had a little fever, little discomfort in arm and felt sick and terrible.  The patient's temperature was 99.5 and 100 degrees Fahrenheit. On 29 Dec 2020, patient  felt ok.  However, on 30 Dec 2020, the patient continued to run a fever, felt sick and drained, had a really bad headache, sick to her stomach,  arms felt like they weighed 50 pounds, and they felt kind of funny.  At one point the patient's blood pressure was 186/106 and had been high on and off since being vaccinated.  At the time of the report, the patient stated that while they were feeling better, they are still experiencing these symptoms.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, had a little fever, little discomfort in arm, felt terrible and sick, drained, sick to stomach, really bad headache, arms felt like they were 50 pounds, and felt kind of funny, was unknown.; Reporter'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.
chest and axillary adenopathy; Tender clavicular; This is a spontaneous report from contactable healthcare professional (patient). This 45-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot 9231) intramuscular, in left arm, on 30Dec2020 at 17:45, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included allergy to sulfamethoxazole (BACTRIM). The patient had no COVID19 prior vaccination and was not tested after vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (DAYSEE) 0.15-0.03 (unspecified unit and frequency). On 02Jan2021 the patient experienced chest and axillary adenopathy and tender clavicular. No treatment was given. The events had not yet resolved at the time of report.
Missed work due to post-vaccination headache, nausea and vomiting. Seen and treated by PCP.
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On 13-Aug-2022, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) was resolving.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported.  The reporter causality for the event of COVID with HUMIRA was not provided.  No treatment information was reported.  CC: This spontaneous case concerns a 35 year old female patient, with a relevant history of adalimumab use for rheumatoid arthritis, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after the second dose of mRNA-1273 vaccine administration.  No treatment medications were reported. The ongoing COVID-19 pandemic and history of history of adalimumab use (immunosuppressant) could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 35 year old female patient, with a relevant history of adalimumab use for rheumatoid arthritis, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after the second dose of mRNA-1273 vaccine administration.  No treatment medications were reported. The ongoing COVID-19 pandemic and history of history of adalimumab use (immunosuppressant) could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pain at the injection site, some swelling there, lumps under the skin, some pain with use of deltoid. No treatment as of 11/02/2017.
The patient presented to the pharmacy on Tuesday October 11th requesting a flu shot.  She stated that last week she received her COVID booster and next week she was interested in receiving her Shingles vaccine.  She asked me if it was OK to received the flu shot in between the two. I responded that it was OK and proceeded to have her fill out the consent form.  She also asked if we were giving flu shots and if they were free with insurance which I confirmed both.  She filled out the consent form and checked off that she was receiving the flu shot.  After administering it, the patient left with no issues.  This is not to report any adverse event from the vaccine, but rather that I realized after administering the vaccine, she had actually already received her flu shot on 9/20/22 at our location.  So after today, she received two flu shots unknowingly to me until we attempted to bill her plan.  I am unaware if the patient has any type of cognitive/memory impairment.