chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they have administered expired pentacel to a patient with no reported adverse event; Initial information received on 21-Jul-2022 regarding an unsolicited valid  non-serious case received from other health professional.   This case involves 2 months old female patient who was administered expired diphtheria/tetanus/5 hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE all for Prophylactic vaccination.  On 15-Jul-2022, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ530AAA, expiry date: 10-Jul-2022, Vial UJ530AA Expiration: 10-Jul-2022 Diluent U6985AA Expiration: 10-Jul-2022) via intramuscular route in the left deltoid for immunization (expired product administered, latency: same day).  No adverse event reported.   Action taken: Not applicable.   Outcome: Unknown for the event they have administered expired pentacel to a patient with no reported adverse event.    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 guidelines. 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.
while vaccinating a patient with Arexvy, a couple drops squirted out at the end onto pharmacist's glove; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4ak57, expiry date 23-MAR-2025) for prophylaxis.   On 13-OCT-2023, the patient received Arexvy. On 13-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: while vaccinating a patient with Arexvy, a couple drops squirted out at the end onto pharmacist's glove). The outcome of the incomplete dose administered was unknown.  Additional Information: GSK Receipt Date: 18-OCT-2023 The registered pharmacist (RPH) reported that while vaccinating a patient with Arexvy, a couple drops squirted out at the end onto pharmacist's glove (not onto patient) due to needle leakage, which led to incomplete dose administered. Consent tot follow-up granted.
Patch is itchy; Classic of Covid arm, described as red patch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Patch is itchy) and VACCINATION SITE ERYTHEMA (Classic of Covid arm, described as red patch) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Patch is itchy) and VACCINATION SITE ERYTHEMA (Classic of Covid arm, described as red patch). At the time of the report, VACCINATION SITE PRURITUS (Patch is itchy) and VACCINATION SITE ERYTHEMA (Classic of Covid arm, described as red patch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Pt w/ hx of allergies to shrimp (severe), codeine (rxn unspecified), morphine (rxn unspecified). PMH includes Thyroid disease, Obesity, Migraines, Hypercholesterolemia, Hernia, Gestational DM, GERD, Depression, Asthma, Arthritis, fibrocystic breast. s/p sterilization and C-section in 2011. Current Medications:  Stem Release 3 supplement for abdominal pain other medications prescribed but not filled at the pharmacy ~30 mins post vaccination, pt c/o itching of the left arm and between her toes on both feet (no rash, redness or warmth).  Vitals @12pm BP 142/84, HR 66 -- > @12:15 138/83, 68. Pt denied any other new/abnormal sxs - no SOB, chest pain, fever, palpitations. Pt declined Benadryl PO, and during assessment period, stated that itchiness is fading. Pt brought to recliner chair, encouraged pt to drink more water. 45mins post vaccination pt verbalized resolution of sxs. Per NP instruction, pt OK to be released from clinic. Pt left clinic in steady gait, AxOx4.
Patient is experiencing trembling in the upper torsal 2 hours after given the fluvirin vaccine.  Patient is experiencing some chills and cold.
Information has been received from a physician for GARDASIL, a pregnancy registry product, concerning a 24 year old female with no pertinent medical history and no drug reactions/allergies who was vaccinated in June 2008 and on 11-AUG-2009 with a dose of GARDASIL. There was no concomitant medication. On 11-AUG-2009, the patient had a positive urine pregnancy test. The estimated gestational age at the time of this reporting was four weeks. The last menstruation period was approximately 12-JUL-2009 and the estimated delivery date would be approximately 18-APR-2010. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Follow-up information has been received concerning a female patient with no significant past medical history and one elective termination who in June 2008 was vaccinated with the first dose of GARDASIL somewhere else and on 11-AUG-2009 was vaccinated with the second 0.5 ml dose of GARDASIL (Lot# 659655/0940X). There were no concomitant therapies. On 21-AUG-2009 ultrasound was performed which revealed that the dating was 6 2/7 weeks. On 31-AUG-2009 the patient signed the consent form for the Merck registry for GARDASIL. Follow-up information has been received indicated that the patient aborted her pregnancy due to personal reasons. Upon internal review, the aborted pregnancy was considered to be an other important medical event. Additional information has been requested.
almost immed itching under arm, around inj site lt deltoid h/a w/in 2hr;w/in 3-4hr ringing in ears, dizziness;itching persisted entire time;malaise entire time;sl hoarseness;no wheezing;diarrhea in AM of 10/13;
Information has been received from a physician concerning his wife who in approximately 1989 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. It was reported that the patient had pneumovax 17 prior to receiving pneumococcal vaccine 23 polyvalent. The patient developed some kind of rash for which she had to take steroids after receiving the pneumococcal vaccine 23 polyvalent. The physician indicated that it was a really bad adverse event. The physician did not want to file an adverse event and would barely give his name. Unspecified medical attention was sought. Additional information has been requested.
Whole body rash started on 4/12/2021, 10 days after receiving the vaccine shot. It's itchy and looks a bit scary. But starting from the third day after it occurred, it became less itchy.
fever, chills, aches, severe headache, nausea, vomiting, diarrhea and extreme fatigue
patient had a Moderna vaccine at 11:00 am then at 11:05 am while in the observation area the patient had a syncopal episode and then he was arousable approximately 2 min later.  was able to transferred to a stretcher and feet elevate . patient was observed for 30 min.  patient was able to exit facility without assistance.
I thought I was reacting to my allergies to the oak pollen, my nose was a bit runny. Throughout the night I started to cough causing my throat to get irritated, I got a little weak from the coughing. I called the COVID-19 hotline and discussed my symptoms with the on-call nurse. We decided against my getting a prescription for PAXLOVID as my symptoms were mild. I took MUCINEX and other over the counter medications.
At 1130 CMA drew lipid panel. Reports child did well. At 1137 1st HPV vaccine given by CMA followed by flu vaccine, then Tdap and finally MCV+. Shots were completed by 1140 child was sitting in chair and layed her head back. She shook for about 30 seconds per CMA then sat up and complained of a headache. RN pulled into room. Child sitting in chair, face pale initial automatic BP 69/39 (R) arm. Rechecked BP q 3min. CRNP at bedside.
Large red area around injection site. Warm to touch, tender and itchy. Applied ice and took benadryl.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients' medical history was not reported. In approximately 2015 (reported as since 01-JUL-2015), the patients were vaccinated with doses of GARDASIL lot # K004215, expiration date 05-MAY-2017; K004205, expiration date 12-JAN-2017; lot # K006960, expiration date 19-FEB-2017 (dose, route and site of administration were not reported) which were exposed to the temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Systemic: PT FELL WHILE LEAVING STORE AFTER GIVING VACCINE; NORMAL VITAL SIGNS-Medium, Additional Details: PT FELL AFTER LEAVING STORE. CALLED 911 WHO CAME NORMAL VITAL SIGNS
had a swollen lymph node under the right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 (Lot number: EN6205, Expiration Date: Jun2021) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing), notes: The patient had immuno therapy cancer treatment on 12Aug2021.; "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes; "Neuropathy" (unspecified if ongoing), notes: The patient has neuropathy and is on insulin; "Triglycerides high" (unspecified if ongoing), notes: Verbatim: Triglycerides high; "Atrial fibrillation" (unspecified if ongoing), notes: Verbatim: Atrial fibrillation; "immunocompromised" (unspecified if ongoing); "multiple myeloma" (unspecified if ongoing). Concomitant medication(s) included: DARZALEX; DEXAMETHASONE; SINGULAIR; BENADRYL; TYLENOL. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "not recovered", described as "had a swollen lymph node under the right arm". Additional information: Why was the patient taking covid 19 vaccine (Verbatim): immunocompromised. Concomitant Products Darzalex: injection in stomach. Other Conditions: direct result of Chemo in the beginning. Investigation Assessment: No. The patient got the two doses and had a swollen lymph node under the right arm which was the same arm he received the vaccines in. The lymph node swelling started a couple of days after the first day after the patient received the first dose. It comes and goes and the Nurse Practitioner said it wasn't unusual. This never went away before the second dose. They ordered an ultrasound for it but they haven't scheduled it yet. First Dose: Received 20Mar2021, lot EN6205, NDC unknown and expiration date Jun2021. The caller later clarifies and confirms that she received her first dose on 25Mar2021, not 20Mar2021 as previously reported. History: The patient had to take steroids, antihistamines, and Tylenol before his cancer treatment. The patient had neuropathy and was on insulin. An hour before Darzalex he takes dexamethasone, Singulair, benadryl, and Tylenol. The patient had multiple myeloma and was a diabetic. The patient had immuno therapy cancer treatment on 12Aug2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101134797 same reporter/drug/event, different patient
Excess snot production, congestion, cough, body aches, low grade fever, hot flashes, chills  As of 3/7/2021 still experiencing excess snot production, congestion, body aches, hot flashes, cough
The vaccine was given past it's refrigeration expiration date, the date on the vial was still within date.
PATIENT IN CLINIC REQUESTING COVID AND FLU VACCINE. UPON ENTERING VACCINES IN THE SYSTEM, NURSE NOTICED FLU VACCINE ALREADY GIVEN, PER THE SYSTEM, ON 10/06/2022.
Pt was seen by Dr. on 11/24/14 and given injection. Flu and PNEUMOVAX were given (Rt) arm and Tdap given (Lt) arm. Pt had severe pain 2 days after injections and has slowly improved with NAPROSYN, heat. Pt stated having trouble lifting arm due to pain and "feels weak". Pt referred to physical therapy, TYLENOL, ADVIL, heat, ROM exercises, walking wall. Pt was seen 11/26/14, 12/1/14 and 12/8/14.
Epiploic appendagitis diagnosed through CT scan on 5/7 I had been in pain since Tues early hours after receiving the vaccine.  However, the most acute symptoms were Tues evening through Wed. morning.  Pain was pretty severe and I visited my primary care doctor on Thursday morning, and she referred me for a CT scan.
Diarrhea; Nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (vomiting) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O31L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (vomiting). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 09-Mar-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, NAUSEA (Nausea) and VOMITING (vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown by the reporter,Expiration date is not provided. He did not provide any information for her health care provider. He consented for follow up with safety. He agreed on follow up with her Health Care Provider. Treatment medication include Imodium, Ibuprofen
Varicella Information has been received from a physician concerning a 12 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination that day included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn ) (+) rubella virus vaccine live (Wistar RA 27/3) (MS). On 18-OCT-2005 the patient started getting lesion on his left forearm that spread to his trunk. He had greater than 20 lesions. Unspecified medical attention was sought. The patient was diagnosed with chickenpox. He missed two days of school. At the time of the report the patient have recovered and he had returned to school. No treatment was given. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a male physician in his early sixties who on approximately 17 Dec 2006 vaccinated himself SC in the abdomen with a dose of Zostavax. There was no concomitant medication. On approximately17 Dec 2006, the patient developed a localized reaction with redness and itching. Unspecified medical attention was sought and no treatment was required. No diagnostic laboratory tests were performed. At the time of the report, the physician had not recovered. A product quality complaint was not involved. Additional information has been requested.
Initial report was received on 15 September 2011 from a health care professional. A 66-year-old male patient had received an intramuscular right deltoid injection of FLUZONE HIGH-DOSE, lot number UH457AA on 13 September 2011 and two days later his right knee became red and swollen. He was evaluated by a physician and prescribed prednisone. Laboratory and diagnostic test data was reported as "none". Concurrent illness, concomitant medications and past medical history were reported as "none". Outcome was unknown. Documents held by sender: None.
Severe sore throat post booster; Swelling on left side of neck post booster; This spontaneous case was reported by a pharmacist and describes the occurrence of OROPHARYNGEAL PAIN (Severe sore throat post booster) and SWELLING (Swelling on left side of neck post booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Severe sore throat post booster) and SWELLING (Swelling on left side of neck post booster). At the time of the report, OROPHARYNGEAL PAIN (Severe sore throat post booster) and SWELLING (Swelling on left side of neck post booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient's son has Covid for the second time.  No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
This spontaneous report as received from medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on an unknown date unspecified number of patients were inadvertently vaccinated with VAQTA (dose, lot#, route of administration and anatomical location was unknown) that had been improperly stored. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 12 year old female who in approximately August 2008, 2 months ago, was vaccinated with GARDASIL as her first dose. Subsequently the patient experienced a fever for 2 days. She also had not had a menstrual period since she received the dose 2 months ago and in the past week she had been vomiting and nauseous. The patient had not recovered. It was confirmed that the patient was not pregnant. The patient had not sought medical attention. Physician can be contacted. No further information was provided. Additional information has been requested.
Low BP (85/60), increased pulse, cold, clammy, entire injection arm was swollen.
Flu vaccine was given at pharmacy, I received a notice of administration date, but don't have lot number or site of administration.  Mom called my office the next day.  He developed hives on his face and swollen hands about an hour after administration.  That resolved, but the next day he had significant abdominal pain that lasted 2 days.  All symptoms have resolved now.
migraine; fibromyalgia; big red ring around the arm; There was a big red ring around the arm along with swelling as well; stabbing pain on the downside of my left body, down my leg, stayed on the left of my body; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), FIBROMYALGIA (fibromyalgia), VACCINATION SITE ERYTHEMA (big red ring around the arm), VACCINATION SITE SWELLING (There was a big red ring around the arm along with swelling as well) and MYALGIA (stabbing pain on the downside of my left body, down my leg, stayed on the left of my body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21X and 042A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM (LORAZEPAM A) for Anxiety and Sleep disorder, TRAMADOL HYDROCHLORIDE (TRAMADOL [TRAMADOL HYDROCHLORIDE]) for Fibromyalgia.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MIGRAINE (migraine), FIBROMYALGIA (fibromyalgia), VACCINATION SITE ERYTHEMA (big red ring around the arm), VACCINATION SITE SWELLING (There was a big red ring around the arm along with swelling as well), MYALGIA (stabbing pain on the downside of my left body, down my leg, stayed on the left of my body), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, MIGRAINE (migraine), FIBROMYALGIA (fibromyalgia), VACCINATION SITE ERYTHEMA (big red ring around the arm), VACCINATION SITE SWELLING (There was a big red ring around the arm along with swelling as well), MYALGIA (stabbing pain on the downside of my left body, down my leg, stayed on the left of my body), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 118/93 (normal) 118/93. On an unknown date, Blood pressure measurement: 115-125/90-95 (normal) 115-125/90-95 and 140-150/115 (High) 140-150/115. On an unknown date, Heart rate: 110 (High) 110.         No treatment medication information was provided.  Action taken with mRNA-1273 in response to the drug was not applicable.    This case was linked to MOD-2021-095451 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: No new information was added; Sender's Comments:  MOD-2021-095451:
developed redness,slight swelling and warm to the touch at injection site one week after injection.  the redness is spreading a bit each day.    it started out the size of a quarter and now(4 days later) it is about 3 inches across and 3 inches tall.
This spontaneous report as received from a nurse refers to a 11 month old patient. On 23-MAY-2006 the patient was vaccinated with dose 1 of (Merck) VARIVAX (dose, route and lot# was not reported) and dose 1 of MMR II (dose, route and lot# was not reported), "which was before the minimum recommended age". No adverse effects reported. Additional information is not expected.
I recvd the shot on Monday. On Tuesday I woke up with a fever of 100.3. Took Aleve. About two hours later fever went up to 101.7. Took a Tylenol. Fever stayed around 100.7 until about 5pm when I took another Tylenol. Muscle aches and general fatigue. Wednesday evening my arm swelled at injection site and is very hot to the touch. Will monitor and if it?s worse I will call doctor tomorrow. No itching just pain and hot to the touch.
pt recv vax; broke out w/ chicken pox body rash of fluid-filled vesicles w/ greater than 100 lesions;also devel fever; recovered in 1 wk;