chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a HCP administered to a patient a pentacel vaccine that  was expired, no adverse event; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case from a non-health care professional.  This case involves a two-month-old patient (gender was not reported) who was vaccinated with a 0.5 ml dose of expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot C5544AA and expiration date 06-Oct-2019) via an intramuscular route in the left vastus lateralis on 08-Oct-2019 for prophylactic vaccination.  Medical history was not reported and concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  No adverse event was reported at the time of reporting.  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 Directive and Module VI of the 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.
Facial swelling on right side of mouth and lips; took 3 benadryl 25mg liquid capsules at 9:00 pm.
p/recv vax pt devel severe local & systemic react, w/fever 103 & very swollen, red, warm to touch & painful arm;
Patient received Pfizer COVID vaccine on 3/2/21 and 3/23/21. On 12/31/21, patient received a positive COVID result from at home testing. On 1/3/22, patient admitted for acute hypoxic respiratory failure and viral sepsis with COVID-19 pneumonia. Patient was started on remdesivir and dexamethasone. As of today (1/5/22), patient is still admitted in our med/surg unit, anticipated to be discharged home tomorrow.
Woke at 3am with facial swelling. Parent gave BENADRYL with reduction of swelling. No difficulty or obstruction to breathing. 8/18/11 still has swelling but decreasing in amount.
According to Dr, the patient started feeling bad 2-3 days after vaccine and tested positive for Covid-19 on 3/15 and is now in the ICU.
swollen arm; arm has circular rash on injection site; rash from shoulder down to the elbows; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE RASH (arm has circular rash on injection site) and RASH (rash from shoulder down to the elbows) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE RASH (arm has circular rash on injection site) and RASH (rash from shoulder down to the elbows). At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE RASH (arm has circular rash on injection site) and RASH (rash from shoulder down to the elbows) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Pt returned to pharmacy stating her left upper arm was red and warm to the touch. Pt reported no pain, itchiness, swelling, spreading, or any other symptoms. Pt is unsure when symptoms started - sometime between Thursday and Friday.
Sore throat common; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat common) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat common). At the time of the report, OROPHARYNGEAL PAIN (Sore throat common) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No Treatment information was reported   Reporter did not allow further contact
rt arm erythema, induration, hot, scratchmarks covering almost whole back area of arm;
Pt had a fever over 102 degrees, he had shaking and chills, a cough, headache, vomiting's, nausea, Red and bruised looking  toes, feet swollen and eye sight loss in the left eye
Two separate events, approximately 1 week after injection and 2 weeks after injection. Symptoms; vomiting and diarrhea, unable to keep food down for a period of 2 &1/2 days each event. At the moment I am symptom free. I am seeing a physician for an issue with similar symptoms that have been under control for months using  Creon DR. The speed at which the symptoms progressed and the dissimilarity in what I typically experience is what is prompting my VAERS notification.  I cannot say with certainty that the symptoms experienced were wholly or remotely caused by the vaccine.
Symptoms began 24-48 hours after vaccine administered. Fever, headache, malaise, nausea, localized swelling , redness, lymphadenopathy of axilla.
Fever; Tiredness; Chills; Nausea; Flu like symptoms; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), NAUSEA (Nausea), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tiredness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A or 039L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 03-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On 04-Feb-2021, the patient experienced FATIGUE (Tiredness). On 05-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), NAUSEA (Nausea), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Tiredness) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 99.9-99.3 °f 99.9-99.3 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Alvin and Benadryl for treatment.   This case was linked to MOD-2021-014794 (Linked Report).; Sender's Comments:  MOD-2021-014794:Same patient, 2nd dose of Moderna Covid-19 vaccine
Pt. complained of 12-24 hrs after receiving Pneumovax patient complained of swelling, redness, warmth from deltoid to elbow.  And ached also. Resolved 72 hr after shot.
Patient reported "pins and needles" in Left Arm the 2nd night after receiving the Arexvy in her left deltoid.  She was lying on her left arm in bed for about 30 minutes prior to the pins and needles. She has since recovered and notices no lasting issues. She was encouraged to contact staff if she notices any lasting issues or if this occurs again.
I've had a massive rash across my breast, the main one is between the breast, is the is the biggest one, 3 inches by 5, Across all the lower back to the top of the buttocks, my elbows, heels, A little bit in my scalp/ It dries and oozes; miserable; rash itches; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of RASH (I've had a massive rash across my breast, the main one is between the breast, is the is the biggest one, 3 inches by 5, Across all the lower back to the top of the buttocks, my elbows, heels, A little bit in my scalp/ It dries and oozes), FEELING ABNORMAL (miserable), RASH PRURITIC (rash itches) and INSOMNIA (can't sleep) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Question:Was there parental vaccine exposure?Answer:No.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (I've had a massive rash across my breast, the main one is between the breast, is the is the biggest one, 3 inches by 5, Across all the lower back to the top of the buttocks, my elbows, heels, A little bit in my scalp/ It dries and oozes), FEELING ABNORMAL (miserable), RASH PRURITIC (rash itches) and INSOMNIA (can't sleep). At the time of the report, RASH (I've had a massive rash across my breast, the main one is between the breast, is the is the biggest one, 3 inches by 5, Across all the lower back to the top of the buttocks, my elbows, heels, A little bit in my scalp/ It dries and oozes) and FEELING ABNORMAL (miserable) had not resolved and RASH PRURITIC (rash itches) and INSOMNIA (can't sleep) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicine were reported. No treatment medicine were reported.
chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). This 52-year-old female HCP reported for herself that she received 1st dose of BNT162B2 intramuscular at left arm on 28Dec2020 08:30 AM for Covid-19 immunization. Medical history included COVID-19 and concomitant drugs were not provided. The patient did not realize vaccine should be taken 90 days after a covid infection tested positive on 12Jan2020. The patient received vaccine on 28Dec2020, she experienced 103.8, fatigue, body aches, headache, nausea, and some chest tightness on 29Dec2020 at 09:00 AM. No treatment was received. The outcome of the events was resolving. The events were reported non-serious.  Information about lot/batch number has been requested.
Patient felt dizzy as she was sitting down/lethargic. Told patient to remain in chair, placed legs on chair, and took HR and BP (had someone call 911 as this was happening). Ambulance came and patient refused to go with them as she stated ?she felt better? VS were rechecked by ambulance and stated as stable.
severe headaches; Concussion; This is a spontaneous report obtained from a contactable Health Care Professional through a Pfizer sales representative.   A 19-year-old female patient received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced severe headaches and concussion. Clinical outcome of the adverse events was unknown at time of this report.   The information on the lot number has been requested.
Patient experienced a rash over their eyes after leaving the vaccination clinic. Patient was prescribed Prednisone by their provider which cleared up the rash.
Burning pain at injection site within 5 minutes of injection, followed by dizziness and sweating. Next day had numbness in feet, severe knee pain, and severe itching at injection site, but no sign of rash or swelling. Extreme fatigue and difficulty walking. Numbness, knee pain and fatigue improved over course of 3-4 weeks, although there are still occasional bouts of numbness and knee pain as well as buzzing sensations in left knee 8 months later. Itching and pain at injection site improved somewhat but still significant flares  8 months later.
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06EZ1A) for COVID-19 vaccination.     No medical history was reported by patient.  Concurrent medical conditions included COPD, Constipation, Heart disorder, Anxiety, GERD and Spasticity. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for COPD, ISOSORBIDE for Cardiac disorder, LUBIPROSTONE (AMITIZA) for Constipation, PANTOPRAZOL [PANTOPRAZOLE] for GERD, ACETYLSALICYLIC ACID (ASPIRINE) for Heart disorder, BACLOFEN for Spasticity, PARACETAMOL (TYLENOL) for an unknown indication.    On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            Patient took diazepine as a concomitant medication for anxiety  No treatment medication was reported by patient.
Patient had a CVA, no left side movement. Unknown date of occurrence, discharged from hospital 4/15/2021.  Patient works for DOT who held a clinic at their site. DOT HR Director informed us of this event. Unable to share much information.
Pt was seen by eye doctor 3 days after receiving flu shot with complaint of blurry vision. Eye doctor diagnosed pt with a swollen optic nerve. Pt treated with steroids.
This spontaneous report as received from two nurses refers to a 30-year-old male patient. The patient had no illness at the time of the vaccination, birth defects, medical conditions and pre-existing physician-diagnosed allergies. On 10-NOV-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB injection, lot # M029233, expiration date 09-AUG-2018, intramuscularly in the right arm for prophylaxis. On the same date, the patient was vaccinated also with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, influenza virus vaccine (unspecified), hepatitis a virus vaccine (unspecified) and hepatitis a virus vaccine (unspecified), hepatitis b virus vaccine. The reporter stated that the patient received the pediatric dose of the vaccine instead of a dose for an adult due to medication error that occurred during dispensing and administration. Wrong dose was given to the patient because another nurse did not verify the vaccination, because it was an adult patient.
Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 26-Dec-2022. Concurrent medical conditions included Pain in arm, Painful arm and Pain in upper extremities. Concomitant products included IBUPROFEN for Pain in arm, SPIRONOLACTONE, CARIPRAZINE HYDROCHLORIDE (VRAYLAR) and LAMOTRIGINE for an unknown indication.    On 01-Aug-2023, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2023, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had little nauseous, then very nauseous, then passed out and it's like hit on head.  It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available No treatment medications were reported. Company comment- This is a spontaneous case concerning a 33-year-old- female patient with no relevant medical history reported who experienced the serious (medically significant) and unexpected event of loss of consciousness after a dose of mRNA-1273 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. It was reported patient felt a little nauseous, then very nauseous, and then passed out and hit her head. No further details were provided for medical review. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Persistent for 5 days Nausea, Vomiting, diarrhea, Fever, Chills, and muscle pain (Back)
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event .     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
lt arm became increasingly red & swollen over 3 days, small blisters over inj site gradually resolved over next few days w/local cool compresses & antipyretics;skin peeled off later;
pt recvd vax & approx 5 days later pt devel lesions above the inj site;No further details were provided;
Onset 11.22.99 severe headache with vomiting related to severity of headache. lasted approx 36 hours. Little relief with Motrin & Tylenol. No fever, no other symptoms.
Started having rash, itchness, and light patches from back to thigh, on random spots. Pt woke up at 4pm on 07/032021 from the back itchness, conditions are getting better but will seek medical attention at a urgent clinic after visiting the pharmacy.
Sharp, stabbing unilateral headaches lasting 1-3 seconds, initially 2/day, now 15/day.  Different from baseline headache type.  Started day after second dose.
diarrhea; could not move the arm where the vaccine was administered; headaches; nausea; fever of 103-104.1°F; arm where the vaccine was administered was swollen; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (could not move the arm where the vaccine was administered), HEADACHE (headaches), NAUSEA (nausea) and PYREXIA (fever of 103-104.1°F) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 24-Jan-2021, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (could not move the arm where the vaccine was administered), HEADACHE (headaches), NAUSEA (nausea), PYREXIA (fever of 103-104.1°F) and VACCINATION SITE SWELLING (arm where the vaccine was administered was swollen). At the time of the report, DIARRHOEA (diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (could not move the arm where the vaccine was administered), HEADACHE (headaches), NAUSEA (nausea), PYREXIA (fever of 103-104.1°F) and VACCINATION SITE SWELLING (arm where the vaccine was administered was swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No relevant Concomitant medications  were provided.  Treatment was not provided. Action taken with mRNA-1273 in response to the events was not applicable..
Lymph nodes are swollen and painful  in left arm pit. Some swollen and red at injection site. Tired.
Information has been received from an other health professional referring to unspecified number of unspecified patients. No concurrent condition or medical history was reported. On unspecified dates since 09-MAR-2015, the patients were vaccinated with doses of (Merck) PROQUAD (dose and route were unknown, lot# was reported as K008579 exp 13-DEC-2015, K019100 exp 15-APR-2016). No adverse effects reported. This is one of several reports from the same reporter (1505USA005155, 1505USA003305). Additional information has been requested.
On 4/3/00 the pt was brought by parents back. The mother states the child started breaking out with red spots about 15 minutes after returning home. Edema was noted in both ankles, multi papule and purpura spots noted on both legs and abdominal area.  Rash  resembled bruises. The size of papules were from 1 to 2 mm to 20 mm. Color varied from red to darker purple to brownish yellow. No temp was noted.
This spontaneous report as received from a female consumer of unknown age regarding herself. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, the patient developed a small bruise and golf ball sized lump, redness and small blisters all around the injection site. The patient also reported her lymph nodes, in the arm the vaccine was administered in, were tender and sore. At the time of the report, the outcome of the events was not reported. Additional information is not expected.
body pain; fever at 101 deg F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain) and PYREXIA (fever at 101 deg F) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN (body pain) and PYREXIA (fever at 101 deg F). At the time of the report, PAIN (body pain) and PYREXIA (fever at 101 deg F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 101 (High) degree at 11pm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported patient took acetaminophen for treatment
14MAY93 recvd vax devel fever on 15MAY93; temp not taken; called MD had some crying throughout weekend, vomiting also; to MD today for adtl assessment; was difficult to arouse day of shots;
We arrived on 02/10/2021 to give second doses. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per CDC recommendations, they should have received their second doses. The director and the physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6 week window at this facility.
Patient initially experienced tachycardia (HR >110 bpm). She reported that she's not feeling too well and that her heart is beating so fast. This occurred within the 15 min monitoring period post vaccination. Checked her bp and reading was 199/100. checked it once again after 15 mins and it was at 188/89.  15 mins after paramedics came, her bp was still at 190/89 and HR of 117bpm, O2 sat 99%. Patient was still not feeling too well, although conscious and was able to communicate with me and the paramedics.