chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 48 year old female patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Lymph Node Swelling-Severe
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 29.76 on 15-Apr-2021.  Concomitant products were not provided.  On 06-Apr-2021, Vaccine was moved to fridge, On 15-Apr-2021, 18 Vial was moved to clinic and Excursion time was 09:00 AM and temperature was reported as 34. Total doses given for the day 188 and Vaccine BUD date was reported as 09-May-2021  Condition of vaccine prior to administration was not frozen. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Morning after receiving vaccine awoke to find numerous "hives" in scalp - under arms, stomach/abdomen with itch. Mouth and throat also itched and felt slightly swollen - did not affect breathing. Self administered BENADRYL - condition resolved.
Almost fainted; Dizziness; Weakness; Difficulty breathing; Increased heart rate; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost fainted), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Difficulty breathing) and HEART RATE INCREASED (Increased heart rate) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRESYNCOPE (Almost fainted), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Increased heart rate) and NAUSEA (Nauseous). At the time of the report, PRESYNCOPE (Almost fainted), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Increased heart rate) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment included Tylenol.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
2days p/vax pt presented w/painful lt arm, raised red area approx 4'' across, slightly warm to touch.
The Moderna booster (.25ml) made my ears red and gave me feeling of pressure in head; later, it accelerated my heartbeat, gave me chills and aches the same day (evening and through the night). The following morning, after a sleepless night during which my heart seemed to be reacting to the vaccine, I experienced nausea near breakfast time and blacked out while standing (and fell) for a matter of three seconds or so.
Pt recvd vax 27APR92 & following vax exp numerous unspecified reactions & subsequently recovered; No further details were provided;
Sharp pains in upper arm at the site of the injection; loss of range of motion; severe sharp pain when reaching, stretching left arm and shoulder.
Swelling, tenderness, body aches, sweats, elevated blood sugars since injection.  Streak from the Left Lateral Deltoid toward the axilla and his axilla is sore.
redness and mild swelling of the left upper extremity,  redness noted about 10 x 8 cm. inner circle redness about 3 x 3 cm. also pt reports left axilla tenderness and mild swelling of stenocleidomastoid on left side.
Patient received a dose from an expired vial. Vial had been expired for 2 days.
patient was vaccinated with a 4th dose of Pfizer-BioNTech vaccine after having received his third dose on 1/5/22.  This incident took place at an assisted living facility where pt. resides.  Staff brought pt. in for vaccination, instead of another resident of similar age and name.  No adverse effects reported by the patient within the past 2 weeks.
Patient found out that she was pregnant on 4.7.21 - unsure how far along she is due to irregular menses.  LMP about 3 months prior.   Patient called nurse triage on 4.9.21 - with complain of intermittent sharp/severe right upper abdominal pain x3 days.  Went to ED - ED 4/9 note:  Given the on visualized pregnancy did order repeat quantitative beta-hCG to be obtaining 48 hours.  Also instructed the patient to follow-up closely with her OBGYN for repeat evaluation and possible repeat ultrasound.  Also messaged her OBGYN regarding this and the need for close follow-up.  I explained the reasons that require a return visit to the emergency department and the patient verbalized understanding.   Symptoms:  4 weeks pregnant. Received 1st Moderna vaccine yesterday morning. Body aches, temp of 100.3. Has a slight stomach ache on 4/9/21 and went to ED because of pregnancy. Wondered if abdominal pain could be from vaccine.
9.5 cm x 14 cm redness and mild swelling to left upper outer arm.
This individual's first does of the COVID19 vaccine was Moderna. They received a dose of the Pfizer COVID19 vaccine on their second dose appointment.
Pt admitted to the hospital on 6/23, and tested positive for COVID on the same day. She was fully vaccinated with Moderna on 2/11/2021 and 3/11/2021.
This case was received from a health care professional on August 2009. A 51-year-old female patient, with a history of multiple food and drug allergies, received the following vaccines on 28 July 2009: ADACEL (lot number C32500AA) and PNEUMOVAX 23 (Merck, lot number 0310Y). She was also taking an ALBUTEROL rescue inhaler concomitantly. Two days post vaccination, on 30 July 2009, the patient experienced headache, neck pain, jaw pain, and a localized injection site reaction. Six days post-vaccination, on 03 August 2009, she complained of abdominal upset and numbness of the ankle, foot and leg. The patient sought medical attention for the event; no additional information was provided. Follow up information received on 29 September 2009 from a health care professional who stated that the patient did not have an illness at the time of vaccination. The patient received ADACEL intramuscularly in the right upper extremity and PNEUMOVAX 23 intramuscularly in the left upper extremity. The patient was reported as recovered.
side of the neck and ear ache; Nose draining; Sore Throat; Cannot swallow; Felt like hot iron stuck on the face; Eyes clumpy and hard to open mornings; Bell's Palsy; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (stage 4 of unspecified cancer). Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (side of the neck and ear ache), RHINORRHOEA (Nose draining), OROPHARYNGEAL PAIN (Sore Throat), DYSPHAGIA (Cannot swallow), BURNING SENSATION (Felt like hot iron stuck on the face) and ABNORMAL SENSATION IN EYE (Eyes clumpy and hard to open mornings). At the time of the report, FACIAL PARALYSIS (Bell's Palsy), PAIN (side of the neck and ear ache), RHINORRHOEA (Nose draining), OROPHARYNGEAL PAIN (Sore Throat), DYSPHAGIA (Cannot swallow), BURNING SENSATION (Felt like hot iron stuck on the face) and ABNORMAL SENSATION IN EYE (Eyes clumpy and hard to open mornings) 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.   The patient's Primary Care Physician and Oncologist recommended not to have the second dose. Treatment included prednisone for 5 days, flonase, and ice pack to open the eyes.  Patient stated that her Primary Care Physician and Oncologist recommended not to have the second dose.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Patient stated that her Primary Care Physician and Oncologist recommended not to have the second dose; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Redness at the injection site; Itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PRURITUS (Itchiness at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PRURITUS (Itchiness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PRURITUS (Itchiness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported
This spontaneous report was received from a consumer refers to her daughter of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL dose 1 (strength, route, lot # were not reported). Her second dose was 4 months after the first dose and the third dose was 10 months after the first dose. The patient received 3 doses of GARDASIL but they were not given on the recommended schedule. Concomitant therapy was not reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Patient was given 0.2 ml of the 10 mcg/0.2 ml concentration (for ages 5-11) rather than 3 mcg/0.2 ml.
I received the covid booster shot on Jan 3, 2022.  On Jan 4, 2022, I woke up with swollen lymph nodes under my left arm pit and on my neck.  I went to the doctor on Jan 4, 2022, and the dr said lymph node swelling was common.  I was also achy and felt sick.    The dr said to call if the lymph nodes got bigger.  The armpit swelling of lymph node disappeared within two days but my neck was swollen even bigger within a week and a half so I returned to the dr.   on Jan 14, 2022.  She sent me to get an ultrasound where they found fluid on my thyroid ( 8 nodules)  One of the nodules had swelled up after the shot.
5 hours after being given the shot, uncontrollable tremors began. Muscles began tensing up, tunnel vision started, extreme dizziness, vomiting, severe weakness in muscles, and fainting. These lasted for about 2 hours before decreasing in severity but continued to be present until about 10:30pm, 13 and a half hours after receiving the shot. Nothing was done to treat the symptoms. As of 12:30pm on 3/10, some minor symptoms are still present, such as muscle weakness and pain, severe migraine, and dizziness.
Administration dose was .05 ml instead of .5ml, patient was called back in the same day and .45 ml was given to complete dose #1 dose.
Soreness / Pain; Swelling; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were not recovered/not resolved.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows:   The patient reported for herself/himself. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced side effects of soreness, swelling and pain.  The patient asked what could be done to calm this reaction.
Spontaneous urticaria approximately 1 week post vaccination. Ongoing, responds to Diphenhydramine. No specific location on body: it?s completely random as to where the urticaria pops up. Dermatographia (head to toe) and pruritis on palms of hands is also present.
When patient came in 2 days after I administered immunizations to have her TB test read, she showed me right arm and it had redness and swelling. The redness was about 5 inches in length. I told her it could have been from the DTaP and she said she red the print out on possible effects.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 19.18 on 14-Feb-2021 and 19.27 on 21-Mar-2021.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 02 PM and 03 PM temperature was 32 and 35, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine date was 10-Mar-2021. On 21-Mar-2021, Excursion time was 09 AM,10 AM and 11 AM temperature was 34 and 32, total doses given for the day was 94, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 16-Mar-2021, vial was moved to clinic on 21-Mar-2021. 10 vials were sent to clinic. Vaccine date was 15-Apr-2021. On 21-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 32, 11 AM: 34, 12 AM: 43, 1PM: 40, 2 PM: 40, 3 PM: 41, 4 PM: 41 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
COUGH AND DECREASED INTAKE STARTED 11/17/2022 GRADUALLY DECOMPENSATED TO FALLING, WEAK, NOT EATING/DRINKING. ER 11/30/22 ADMITTED  AND DIAGNOSED WITH GUILLIAN-BARRE SYNDROME IVIG, THERAPIES, GABEPENTIN, PT, OT, PM AND R
Fever 101 started 5APR92 Sunday 103-till Wed; 3APR92 Fri noc & Sat very irritable-crying; no relief w/APAP; 8APR92 to MD office put on Amox-general purpose no noted illness;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 15-FEB-2017 at 13:01, the patient was vaccinated with improperly stored VARIVAX injection (lot # M018436) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704U.
For 2 straight months after the 2nd shot of the Moderna Vaccine I had a terrible 24 hour headache, which was made worse by lying down. The same type of headache I had when I had COVID in April of 2020. I had an MRI, MRV, and LP to make sure there were no other issues. All my tests came out negative. I ended up on Nabumetone and Nortriptyline, after 2 weeks of these medicines I was feeling better.
pt recvd vax & pt devel a rash over a 5 inch area;No further details were provided;
unable to walk; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk) and FATIGUE (extreme fatigue) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   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)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced GAIT INABILITY (unable to walk) and FATIGUE (extreme fatigue). At the time of the report, GAIT INABILITY (unable to walk) and FATIGUE (extreme fatigue) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient had extreme fatigue and unable to walk for 24 hrs after each dose of Moderna Covid-19 vaccine. No treatment medication were provided.
Immediate dizzy, nausea, malaise, fatigue; After 72 hours painful chapped lips, canker sore and bleeding gums. Rash on chest area.