chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left deltoid red, swollen, itching started at 1:00p after injection given on 5/16/07.
Left arm, shoulder, neck pain, fatigue, chills  headache.   pain, swelling and tenderness of armpit.  Improving but not fully recovered
red rash extending down arm approx. 6"/Rash; hot arm; sore when moving arm; Hardness at the injection site; Rash at the injection site; Swelling on the site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash extending down arm approx. 6"/Rash), FEELING HOT (hot arm), MYALGIA (sore when moving arm), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thrombocytopenia and Osteoporosis. Concomitant products included METOPROLOL TARTRATE for Heart disorder, LORAZEPAM for Sleep difficult, RALOXIFENE for Supplementation therapy and Supplementation therapy, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and SALMON OIL for Vitamin supplementation, VITAMINS NOS for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling on the site). On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash extending down arm approx. 6"/Rash), FEELING HOT (hot arm) and MYALGIA (sore when moving arm). On 30-Jan-2021, VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling on the site) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash extending down arm approx. 6"/Rash), FEELING HOT (hot arm) and MYALGIA (sore when moving arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   For treatment patient applied cold compresses   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information added include patient demographics, medical history, concomitants, and some new events.
Fevers- 102 max, Full body rash, severe occipital headache, vomiting, bronchospastic cough, decreased oxygen saturations, mild pulmonary edema, myalgias, arthralgias, severe fatigue and weakness. Severe symptoms lasting 10 days, moderate symptoms additional 1week and mild residual symptoms 1 week.  Totally recovery from symptoms ~ 21 days
Patient had COVID pneumonia in January 2021. Readmitted 2/10 for nausea/vomiting found to be in DKA. Treated with IV insulin, fluids, pressors and admitted to ICU. DKA resolved but continued to have ongoing nausea and dysphagia. EGD showed possible candidiasis, GI symptoms started to improve and was discharged home 2/24 with O2, life care, home health care. Patient recorded deceased 02/26/2021.
Weakness; Fever; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weakness) and PYREXIA (Fever) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Coronary artery disease since 01-Apr-2004, Sulfonamide allergy (Sulfa) and Allergy to antibiotic (Levaquin). Concomitant products included CLOPIDOGREL and ACETYLSALICYLIC ACID (ECOTRIN) for Coronary artery disease, LISINOPRIL and AMLODIPINE for Hypertension, ROSUVASTATIN for an unknown indication.   On 30-Dec-2020 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced ASTHENIA (Weakness) and PYREXIA (Fever). On 05-Feb-2021, PYREXIA (Fever) had resolved. On 28-Feb-2021, ASTHENIA (Weakness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, AST/ALT ratio: (High) Mild elevation. On an unknown date, Body temperature: 100 and 100.2. On an unknown date, C-reactive protein increased: (High) elevated. On an unknown date, Red blood cell sedimentation rate increased: (High) Elevated. On an unknown date, White blood cell count: 12000 (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include Tylenol. Action taken with mRNA-1273 in response to the events was  not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Updated patient demographics and medical history. New concomitant medication added. The outcome of the event changed from unknown to recovered.
After patient went to car, felt flushed and faint, developed severe lower back pain. BP-110/42, pulse 50. Laid pt down in vehicle. After 10 minutes, symptoms gone, still weak, BP-132/70, pulse-60. Came in health dept and stayed 30 min. better and left with husband.
Influenza vaccination was given in left deltoid, and a few hours later, patient had pain radiating down her left side to her hand. this lasted 3 days before resolving.
red streaks down the arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: red streaks down the arm). The outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.     It was unknown if the company considered the erythema of extremities to be related to Shingrix.   Additional Information: GSK receipt date: 18- JUL-2023 Pharmacist stated that a patient reported to her that after receiving her dose of Shingrix she had red streaks down her arm. The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up.
The day after vaccination the patient woke up with a rash that resembled a mosquito bite on the back and lateral abdomen.  They were red, itchy, slightly raised and approximately 4mm.  This rash was along the waist line with approximately 7 to 9 lesions.  Some of these lesions were sorrounded by swelling measuring approximately 20mm to 30mm.  In the four days following vaccination the patient would have a new lesion each day.
pt was given vax 25OCT94 p/ 6 to 8 hrs of being given vax pt devel cough, SOB & vomited; (sx worsen p/next days); 2 to 3 days later was taken to MD; pt stopped breathing many times; @ present has congestion poss some wheezing;devel diarrhea
c/o no appetite,nausea,fatigue, weak, cold sweat, epigstric pain, redness on both eyes with visual change sicne 21May2021(s/p J&J Vaccination).
for approx 1 wk p/receiving vax pt was listless, lethargic, cried frequently, very cranky, eating & drinking poorly; rt leg was red & inflamed from hip to knee; temp was 101.4 despite getting APAP;
No patients experienced symptoms; Improperly stored dose of PROQUAD was administered  to the patient on 01-JUN-2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 01-JUN-2020, dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously, lot # S031705 and expiration date 06-APR-2021 (dose and frequency were not reported) as prophylaxis, which was improperly stored in a temperature of 17.2°F in a timeframe of 14 hours and 2 minutes and reconstituted with a properly stored sterile diluent (STERILE DILUENT MRK INJ HH) was administered to the patient.   It was reported that the call was made due to data logger and no previous temperature excursion occurred.  No adverse symptoms were reported for the patient.  This is one of several reports received from the same reporter.
Case number PHEH2016US009056, is an initial spontaneous report received from a pharmacist on 11 Apr 2016. This report refers to a 16 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) 0.5 ml intramuscularly in Sep 2015. On 11 Apr 2016, the patient tested positive for flu B (vaccination failure). Outcome of the events was not reported. Seriousness of the events was reported as non serious. Causality was not reported. Seriousness of the events Influenza B virus test positive and vaccination failure was upgraded based on the available information in the source document.
Hep. B immunization administered.  Mom was holding baby upright comforting her when it appeared that she was not breathing.  Baby vigorously rubbed and slowly responded.  Several more such episodes followed total of at least 7.  911 was contacted.  Baby was responsive and alert when paramedics arrived.  Baby was transported to area hospital and admitted to NICU for further testing.
There was a soreness and then over to the side of the shot I noticed my arm was sore and on Monday evening, it was a little pink and on Tuesday morning, Oct 31, it was a darker pink, about the size of an egg. Itches. Still a pink tonight. Haven't done anything yet as I'm waiting to see if it disappears in the next day or so.
Around 6pm I started to feel light headed and had a headache by 7:30pm my body ached and I had chills. By 10pm my temperature was 100 degrees F, it was uncomfortable to stand, I felt nauseous, aches, and continued to have chills
Injection site pain; Arm pain; Tiredness; Headache; Muscle pain; Joint pain; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 09:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, and adhesive allergy. 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 received unspecified medication within two weeks of vaccination. On 09Apr2021 at 17:00, the patient experienced injection site pain and arm pain, tiredness, headache, muscle pain, joint pain, nausea and vomiting, diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain and arm pain, tiredness, headache, muscle pain, joint pain, nausea and vomiting, diarrhea were resolved on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Developed new subjective tinnitus tones shortly after receiving first vaccination does. Tinnitus is loud and reacts to broad-spectrum environmental noises with a low-pitched chirping noise. Tone began the day of the vaccine and has steadily worsened every day since.
stroke; This is a spontaneous report from a contactable other hcp. The other hcp reported for both the husband and wife, this is the case for wife. A female patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stroke on unspecified date and died. It was not reported if an autopsy was performed.  Information about batch/lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Cerebrovascular accident and the suspect drug bnt162b2. 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.,Linked Report(s) : US-PFIZER INC-2021856461 Same reporter/ drug/event, different patients; Reported Cause(s) of Death: stroke
Patient presented to public health vaccination site requesting second Jynneos dose. Patient's first dose was on 10/18/22 meaning he is on his 23rd day after the first dose. Patient stated he had traveled a long distance to get to the site and transportation is difficult for him. Patient requests his second dose be given early. MD  consulted and approved second dose be given today due to transportation barriers. Patient received dose. No complications.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/16/2023 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/16/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/16/2023 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/16/2023 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/16/2023 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/16/2023 ANEMIA
she is not doing well/Feels worse than when she had Covid; she has a terrible headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 11May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nyquil; Dayquil; Advil. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she is not doing well/Feels worse than when she had Covid"; HEADACHE (non-serious), outcome "unknown", described as "she has a terrible headache"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient stated she was not doing well. She stated that she has a terrible headache and chills. She felt worse than when she had covid in November. Caller stated she took Nyquil, Dayquil and Advil when she had covid. Caller reported that she has not taken anything to treat her side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a licensed nurse practitioner refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with unspecified number of improperly stored doses of GARDASIL lot#K010215, expiry date 05-MAY-2017, (dose, frequency and route of administration were not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Thi sis one of two reports received from the same reporter. Additional information has been requested.
Patient received vaccine on Saturday 1/28. Patient called pharmacy on Monday 1/30 to report that the site of injection was swollen and hot to the touch and she couldn't raise her arm.
patient just felt terrible and reporter said well if you get to feeling any worse; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Pfizer Program.  A female patient received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "patient just felt terrible and reporter said well if you get to feeling any worse".  Additional information: The reporter consider that the causality of the event was related to suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A mother reported that her son, now 35 years old, received an injection of Tri-immunol vaccine and subsequently, developed autism. The mother attributes the development of autism to the receipt of Tri-immunol. No further information was available at the date of this report.
Knot on left thigh at injection site, warm, tender. Per MD appears to be small, calcified hematoma, no signs of infection.
The patient came in today around 4:45pm (1/25/17) stating that she has been in pain (shoulder pain) for 2 weeks after receiving a flu shot at our pharmacy. She also states that she hasn't been sleeping well and that her range of motion is now limited. She had a physical done at her MD's on 1/18/17, states the RN looked at her shoulder and told her the injection was "placed too high", as in too close to the joint of the shoulder instead of her deltoid muscle. The patient was seen again today by her doctor and he said that the injection was placed in the joint, and that she should contact us to file an incident report. MD also suggested Ibuprofen or naproxen to her by mouth, also use heat and cold on the injection site. The patient says there is no swelling in her arm or rash. MD also suggested that she go to physical therapy to help with range of motion, which has become limited after the shot. The patient states that she cannot commit to physical therapy right now due to cost, and doesn't want any medical bills.
Fifteen minutes post vax, pt developed redness at the site of injection which was reported as about 2" in diameter. The pt sought unspecified medical attention. Addtl info has been requested.
Patient got a 4th dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 12-JAN-2022, the patient received the 4th dose of Engerix B pediatric. On 12-JAN-2022, an unknown time after receiving Engerix B pediatric, the patient experienced extra dose administered (Verbatim: Patient got a 4th dose of Engerix-B). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt Date: 11-APR-2023 The patient had been asymptomatic since receiving Engerix-B dose. The reporter consented to follow up. The reporter reported a patient who received an extra dose of Engerix-B, which led to extra dose administered.
This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a female patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 17th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 2 days after receiving SHINGRIX, the patient experienced vesicular rash, skin lesion and erythema of extremities. On an unknown date, the outcome of the vesicular rash, skin lesion and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the vesicular rash, skin lesion and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced shingle-like lesions on arm distal to injection site. 2 to 3 days after receiving SHINGRIX, the patient noticed redness and lesions appeared. The patient's condition was stable at the reporting date with all symptoms resolved without any treatment. No further details were reported regarding the event. The healthcare professional had declined permission for further contact by safety.
BLURRY VISION; DIZZINESS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced dizziness. On 27-MAY-2021, the subject experienced severe headache. On 04-JUN-2021, the subject experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, blurry vision, and dizziness. This report was non-serious.
1330: immunizations given  1420:infant with stridor, breathsound equal, in 26% o2 with sao2 in mid 90,s. retractions substernal subcostal intercostal mild to moderate. Dr. at bedside and notified. Plan to continue to monitor closely. 1720: infant stridorous, desaturating, pale. Placed in bed, suctioned nares and os for nothing. Dr. at bedside. Placed on Hi-flow cannula in 2L then increased to 3L when infant continued to desaturate and require high oxygen. APN and Dr. at bedside.; 1850: continues to desaturate, apneic, pale, lethargic. Dr. at bedside and positioning infant in chin-tilt position to keep airway open and sats up. Dr. at bedside, orders received. Intubated after 6 attempts by Dr. with 3.0 ETT taped at 8 cm at lip, placed on vent.
POISON IVY (WORST CASE EVER HAD); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included poison ivy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced poison ivy (worst case ever had). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from poison ivy (worst case ever had). This report was non-serious.
Fever started at 102 but went all the way up to 103.5. Patient had a fever from Friday 06/18 until Sunday 06/20. Body ache, loss of appetite and diarrhea.
Fatigue, lack of energy, abdominal pain, pain in knee joints, nausea, diarrhea, near fainting, lack of appetite.