chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced sudden dizziness and nausea within 5 minutes of receiving Janssen COVID-19 immunization. Gave her water, crackers and cold/wet rags for her forehead as she felt hot. Took her temperature, returned normal. Gave her a trash can to keep near. Kept an eye on the patient and realized she was getting red in the face and more dizzy than she had been. Went out and stood next to patient, with her mom on her other side. Began to experience light sensitivity, feeling like the room was spinning. Patient almost fell out of the chair while sitting still. Mom used a personal pulse oximeter on patient, all results normal. Asked the patient about other symptoms, such as chest/abdominal/leg pain, headache, shortness of breath. Patient reported a headache, dizziness, nausea and leg numbness roughly 30 minutes following the vaccine. I recommended going to the ER, mom believed it would pass with time, but insisted she never responds this way to immunizations. Patient began to experience stabbing chest and abdominal pain around 45 minutes. Patient's mom was still hesitant to take her to the ER immediately on her own and asked us to call her PCP. He wanted the patient to go to the ER. Patient believed she would fall if she stood, offered to get a motorized cart, wheelchair or call an ambulance to transport her. Both patient and mom requested the ambulance. Asked a technician to check patient medications and allergies for EMTs, retook the patient's temperature which was normal again. Stayed with patient until EMTs arrived, reported all symptoms patient was experiencing.
Has cold; chills; muscle pain; joint pain; Fatigue; headache; fever ( do not know how much); This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Has cold), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced NASOPHARYNGITIS (Has cold), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (Fatigue), HEADACHE (headache) and PYREXIA (fever ( do not know how much)). The patient was treated with PARACETAMOL (TYLENOL) on 22-Apr-2021 at a dose of 2 dosage form. At the time of the report, NASOPHARYNGITIS (Has cold), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (Fatigue), HEADACHE (headache) and PYREXIA (fever ( do not know how much)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.
pt woke up w/pain @ inj site;next day mom noticed inj site rt upper arm swollen & red;presents to clinic today w/rt upper arm inj site swollen & red & hot to touch (area 4 inches in diameter);
Second breakout of large itchy lumps on my right arm. Breakout three weeks ago that lasted approximately one week. The lumps have now returned on my arm and on my throat.
Complain of not feeling well directly after vaccination. Became pale in face and hands. Vomited.  Vital signs within normal range. No other complaints. Monitored for 30 minutes. Color returned and patient felt better. Left with father under own accord.
Pt had second dose of Covid vaccine this morning. Pt was monitored for 15 minutes with no adverse reactions. Pt calls office 40 minutes after checking out stating when she got home the left side of her face was tingling. Pt not experiencing sob or difficulty breathing. Per Doctor advise pt to take 25 mg of Benadryl monitor self, if symptoms worsen call the office, if sob or difficulty breathing call 911. Pt verbalized understanding of these instructions.
Sudden profound chills, impressive headache and large muscles aches. 2 ASA taken and immediate bed rest. Symptoms subsided without complications within about 2 and 1/2 hrs. No further side affects.
Patient received a Shingrix vaccine on 10/10/19 in the left arm. On 10/13/19, she called the pharmacy and reported that she had been experiencing a red, hot, swollen, itchy rash from the injection site to nearly her elbow. She also reported a knot under the skin at the injection site. Employee advised her to take Tylenol and Benadryl and use an ice pack for the injection site reaction.
Myalgia, Fever & NauseaVomiting Narrative:  Employee reports chills, nausea, fever, and body aches on 1/25/21. Same day as injection
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 16-NOV-2012, patient received improperly stored VARIVAX dose 2, from  lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Arm and neck was stiff and unable to use. Lasted approx. 2 days. Treated with NSAIDs.
This spontaneous report was received from a registered nurse refers to multiple, different unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored (-14 degrees Celsius (C), for 2 hours and 48 minutes) VARIVAX injection, lot # L029466, expiry date 06-AUG-2017, (dose and frequency not reported). Vaccine had previous temperature excursion (-14 C) for 32.5 hours, with call because of "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. Follow up information has been received from the nurse on 11-MAR-2016. She provided the patients identifiers. On 16-FEB-2016, a patient of unknown age and gender received one dose of improperly stored VARIVAX (stored in -14 degrees C, for 56 hours). This same vaccine was previously exposed to a high temperature of -14C for a cumulative total of 91 hours, 18 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a seven-year-old male. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 13-Dec-2010, the patient received expired FLUMIST. 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. Additional information received on 09-Mar-2011 and incorporated into case: no late occurring adverse events.
Localized 3 1/2 cm round red hot raised area within 1 hr of shot - pounding headache - ecchymosis below injection site - head and neck pain. Developed GI upset, temp 99.9 for 24 hours - redness and ecchymosis remains at site 10/18/07. Other symptoms resolved.
Five days after vaccine shot, patient experienced extreme dizziness which lessened each day but lasted 10 days.  There were three episodes of confusion.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 28-AUG-2012, the patient was inoculated at a pharmacy with ZOSTAVAX for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route of administration, site of administration and lot number were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2014, the patient was treated by a physician, for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Under age of 18 were inadvertently given their series of Moderna vaccine; A spontaneous report was received from a nurse concerning a 16-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) under the age of 18 (inappropriate age at vaccine administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012L20A) for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 010M20A) for prophylaxis of COVID-19 infection.  The patient under the age of 18 (16  years female) Inadvertently received both doses of Moderna vaccine (inappropriate age at vaccine administration). No adverse reactions were reported.  Treatment details if provided or No treatment information was provided.   Action taken is not applicable  The outcome of the event, patient under the age of 18 was inadvertently given their series of Moderna vaccine was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for  mRNA-1273, who received both doses (batch number: 012L20A and 010M20A) with no associated AEs.  Causality for this medication error is not applicable.
sensitive at injection site; soreness at injection site; not inflamed but bumpy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DYSAESTHESIA (sensitive at injection site), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE RASH (not inflamed but bumpy) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004CZ1A and 021BZ1A) for COVID-19 vaccination.     no medical history information was reported.  Concomitant products included IBUPROFEN for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced VACCINATION SITE DYSAESTHESIA (sensitive at injection site), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE RASH (not inflamed but bumpy). At the time of the report, VACCINATION SITE DYSAESTHESIA (sensitive at injection site), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE RASH (not inflamed but bumpy) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessment. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable patient noted that second shot was administered after a band-aid was applied. Patient also noted he received a gel injection to the knee on 21Apr2021 but didn't know what it was. no treatment information was reported.
Within 5 minutes after receiving DTAP child had a large area around injection site on left deltoid that was red, raised and welted. Child was given benadryl 1 tsp and was monitored for 30 minutes. Ice was applied to area. This was childs 4th dose of DTAP. No respiratory distress, child alert and oriented. Parent was given instructions on increased signs of distress to take child to ER. Instructed to monitor child closely for the next 24 hours. Was able to reach mother after several days of attempts on 8-5-04. Mother states child was fine, she had run a slight fever for the first 24 hours and she had given tylenol and another dose of benadryl. Area on left deltoid was now normal.
Patient complained of chills, sweats, light headedness and fever that evening at work. She reported not feeling well enough to eat anything. The next morning she became ill at work and passed out. She was transported to emergency.
Tinnitus in ears. Happened after first shot (3/31/21) and has continued since.
Second vaccine on 2/2/21. On 2/4/21 started having cough, SOA, chills, HA, fatigue, and muscle aches. Went to urgent care.
Headache, Fever, Rash, malaise, aches Narrative: Pt reported itchy rash, malaise, aches, headache, fever on same day after given covid vaccine. Pt did not take any treatment medications.
Patient had her 2nd dose of Moderna COVID vaccine on 3/29. Starting 4/8, she was having shortness of breath on exertion with a mild cough. On 4/11, her husband states that he saw her sitting down watching TV, then he heard a thud in the next room and went in to see her on the floor and she started crying for help which led to him calling the paramedics. The paramedics noticed the patient was in PEA and resuscitated her and brought her to the ER. The patient appeared to have an NSTEMI and she was diagnosed with a pulmonary embolism that led to the cardiac arrest event. Patient was taking to cath lab and was found to have normal coronary arteries with no evidence of coronary artery disease. Patient was also in sepsis and had an extensive bilateral pneumonia. Patient is currently inpatient and intubated.
10/26/2006 pt gripping sensation in stomach, 1/2-1 hour duration 24 hours after inoculation, site of injection warm, tender and edematous. Pts normal temp 98.6, her temp 99.2. Pt c/o skin tender to touch, muscle and body aches 4 hours.
Several hours after receiving immunization employee reported having chills, fever , extreme fatigue, malaise, tingling in left arm.  Employee took Ibuprofen 400 mg, went to bed; symptoms were gone when she got up the next morning.
pt recv vax & exp a lack of response & had to be revaccinated w/vax;
no adverse effect; patient was inadvertently adminstered a dose of MMR II which expired on 04-DEC-2019; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were not reported. On 18-DEC-2019 the patient was inadvertently vaccinated a dose (1 dosage form) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), lot number N034002 and expiry date 04-DEC-2019 (strength, route and anatomical location were not reported) (expired product administered). No adverse events were reported. No product quality complaint (PQC) was reported.
Lump on Left Armpit; Lump on Left Armpit that is tender and hurts. Suspect to be Lymphnode; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 13May2021 at 14:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies. Concomitant medications included paracetamol (TYLENOL) for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 22Apr2021 at 15:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 14May2021 at 10:15, the patient experienced a lump on the left armpit that was tender and hurt and was suspected to be a lymph node. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. The patient had been tested for COVID post-vaccination. On an unknown date in May2021, the patient underwent nasal swab test named MAP test and the result was pending. The clinical outcome of the events lump on the left armpit and armpit was tender were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
joint pain in right shoulder causing issues with using my right arm as normal; joint pain in right shoulder causing issues with using my right arm as normal; This is a spontaneous report from a contactable nurse (patient).  A non-pregnant female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:), intramuscularly in the right arm on 17Dec2020 at 07:30 at a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included polycystic kidney disease from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing.  Concomitant medications included tolvaptan (JYNARQUE), lisinopril (MANUFACTURER UNKNOWN), amlodipine besilate (NORVASC); all taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of vaccination. On 17Dec2020 at 07:30, the patient experienced: joint pain in right shoulder causing issues with using my right arm as normal (medically significant). The adverse event resulted in a visit to a doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of joint pain in right shoulder causing issues with using my right arm as normal; which included ongoing physical therapy. The patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140), intramuscularly in the left arm on 07Jan2021 at 07:30. The clinical outcome of the events was not recovered.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
nauseous; sick on his stomach; feeling gauged; feeling really really tired; redness of the arm; swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips), NAUSEA (nauseous), ABDOMINAL DISCOMFORT (sick on his stomach), VACCINATION SITE ERYTHEMA (redness of the arm) and FEELING ABNORMAL (feeling gauged) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced LIP SWELLING (swollen lips) and VACCINATION SITE ERYTHEMA (redness of the arm). On 02-Apr-2021, the patient experienced NAUSEA (nauseous), ABDOMINAL DISCOMFORT (sick on his stomach), FEELING ABNORMAL (feeling gauged) and FATIGUE (feeling really really tired). At the time of the report, LIP SWELLING (swollen lips), NAUSEA (nauseous), ABDOMINAL DISCOMFORT (sick on his stomach), VACCINATION SITE ERYTHEMA (redness of the arm), FEELING ABNORMAL (feeling gauged) and FATIGUE (feeling really really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Patient reports local reaction after receiving the vaccine. On Friday 3/22 she came back into the pharmacy and showed the area of vaccination which was still red about 2 inches around injection site. She reports on Thursday 3/21 not being able to really even lift her arm. She states the area was extremely swollen and red.
Diagnosed with CSR eye condition two weeks after the vaccine and few months later started developing significant eye floaters.
sluggish; chills; tired; sore arm; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (sluggish), CHILLS (chills), FATIGUE (tired), PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease, Myasthenia gravis and Autoimmune disorder NOS. Concomitant products included PREDNISONE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (sluggish), CHILLS (chills), FATIGUE (tired), PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever). At the time of the report, SLUGGISHNESS (sluggish), CHILLS (chills), FATIGUE (tired), PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever) had resolved.            It was reported that the events lasted for a day and half. The patient reported taking IDD treatments before the second vaccination dose.  No treatment medications were reported.
I had an existing mild rash after I ate crabs  on 12/18/20. I never had allergies to any food.  My rash got worse 6 hours after receiving dose yesterday. Both ears are swollen and red. Rashes behind ear look like hives, welt-looking. It spread to my neck and upper back area. Took Benadryl and it slightly improved. Also applied Cortisone cream. Took Zyrtec as well. Slighty better. It's been 24 hours since injection.