chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GAVE PT IMMUNIZATION, WITHIN 1-2 MIN PT STARTED TO FEEL LIGHTHEADED, FELT WARM. OFFERED PT WATER (ACCEPTED), FANNED PT TO KEEP COOL. STARTED TO PASS OUT. CALLED 911. OFFERED PT HAD ANOTHER WATER & CONTINUED TO FAN. EYES FLUTTERED AND HEAD SHOOK FOR A FEW SECONDS. LOSS OF COLOR. PT WAS COHERENT THE WHOLE TIME AND ABLE TO CONVERSE WITH ME. EMS ARRIVED, ADMINISTERED OXYGEN AND STARTED AN IV. TOOK PT TO HOSPITAL. FATHER CALLED AT APPOXIMATELY 1230PM, SAID PATIENT HAD BEEN DISCHARGED AND THEY WERE ON THEIR WAY HOME.
Information has been received from a registered nurse concerning a female patient between 60-70 years old with penicillin allergy who "6 year ago", on approximately 2004 was vaccinated with a first dose of 0.5 ml of PNEUMOVAX 23 (Lot#Unknown), second dose on 20-OCT-2010 (lot no. 665902/1426Y), IM respectively. The registered nurse stated that the patient had experienced local reaction at site of injection after receiving second dose of PNEUMOVAX 23. On 22-OCT-2010 the patient had complained of redness, swelling, warmth and red bumpy rash around site of injection. The patient had been diagnosed during office visit with cellulitis and prescribed Z-PAK. All drop down boxes had referred to this patient. At the time of the report the patient's outcome was recovering. Follow-up information has been received from the physician, who reported that the patient experienced local cellulitis. At the time of the report the patient had recovered. No further information is available.
Left arm was sore after receiving 1st dose n 22Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm was sore after receiving 1st dose n 22Feb2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 022M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Left arm was sore after receiving 1st dose n 22Feb2021). At the time of the report, PAIN IN EXTREMITY (Left arm was sore after receiving 1st dose n 22Feb2021) outcome was unknown. Not Provided          Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
feel crappy 24 hrs after my second Shingles injection/ to feel bad; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 24 hrs after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter asked was it normal to feel crappy 24 houses after my second Shingles Injection. The reporter did not consent to follow up.
Information has been received from a consumer concerning her 13 month old son with no pertinent medical history, drug reactions/allergies or concomitant medication usage, who on 05-DEC-2007 was vaccinated (route and site not reported) with PEDVAXHIB (OMPC) (lot # not reported).  On the same day, the patient was concomitantly vaccinated with other vaccines, reporter did specify which ones.  In December 2007 (exact date not reported), the patient experienced redness at the injection site, prolonged crying and was irritable.  The consumer reported that patient received one of the recalled lot's but did not have lot number.  Patient did receive unspecified medical attention.  No diagnostic lab test were performed.  At the time of this report the patient had not recovered.  No additional information is expected.
I had flu symptoms on 11/11, the day after my vaccination which was expected. The flu symptoms were gone the morning of 11/12, but throughout the day I developed an itchy rash. On the morning of 11/13 the rash was widespread over my body. It was very itchy and sore. My right eye was swollen and couldn?t be fully opened. My lower lip was also very swollen. Benadryl and Claritin helped calm the rash but did not resolve it. Throughout the day I also developed joint pain, especially in my hands and wrists but also in my knees. On the morning of 11/14 the joint pain was much worse. Throughout the day I was unable to use my hands for everyday tasks such as opening doorknobs or typing. I also developed a sore throat in the right side of my throat. The rash remained but was concentrated on my head and neck as well as my ankles and feet.
arm is swollen; arm in throbbing pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen) and PAIN (arm in throbbing pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Uknkown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is swollen) and PAIN (arm in throbbing pain). At the time of the report, PERIPHERAL SWELLING (arm is swollen) and PAIN (arm in throbbing pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
witnessed resp arrest w/cyanosis/flaccidity.  Full recovery after 10 sec CPR. Shock/Collapse
Syncope after injection, swelling of area within 48 hours, since then and for at least 4 weeks, intermittent episodes of weakness and parasthesias of lower ext. and face. Some intermittent tachycardia also.
On 8/22/21 @11pm  patient presented to the ED at a local hospital with shortness of breath, palpitations, and throbbing chest pain. EKG revealed ST elevation  and labs remarkable for elevated troponin . Patient was urgently taken to another hospital and taken to cath lab on  8/23 @2am and diagnosed with myopericarditis with no intervention needed. Patient was admitted to the ICU after for monitoring and discharged on 8/24/21 in stable condition with a prescription for colchicine and ibuprofen.
This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): MOD22-017955 (Moderna). A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), on 17Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches and pains"; PYREXIA (non-serious), outcome "unknown", described as "a little fever". Therapeutic measures were not taken as a result of headache, pain, pyrexia. Additional information: After receiving the dose of the Moderna vaccine, the patient experienced headache, body aches and pains, and a little fever. These symptoms were constant, and similar to what she experienced after the Pfizer vaccine. The patient had not taken any medications or treatments for symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
headache; sweats; Chills, so bad that my teeth were rattling; fever; muscle aches; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 10Feb2021 02:15 PM (Batch/Lot number was not reported) as single dose for covid-19 immunization. Patient was non-pregnant at the time of vaccination. Medical history included neuropathy and diabetes. The patient's concomitant medications was not reported. On 11Feb2021 patient experienced chills, fever, headache, muscle aches, sweats and exhaustion which lasted until Saturday 13Feb2021 and then patient was fine for several days but on the night of 17Feb at 8PM, again with the chills, so bad that patient's teeth were rattling, headache and sweats all this lasted until 3 AM then patient had aches and exhaustion for several days". The treatment was not received for the adverse events. Outcome of headache and sweats was recovered on an unspecified date and rest of the event was recovered on 13Feb2021.  No follow up attempts are needed. No further information is expected.
pt recv vax 7APR98 & exp severe rxn to vax per friend;pt is shaking & appear to be having spasms, which started p/vax;PHN advised to to see MD or go to ER;dx poss rxn to drug screen done;
herpes zoster/blisters on left side of torso, back and spine; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 09-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequently after receiving zoster vaccine live (ZOSTAVAX), the patient suffered blisters on left side of torso, back and spine and was diagnosed with Herpes Zoster. As a result of these symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations were not present prior to using zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX) vaccine, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered serious, progressive, permanent, and incurable injuries. The outcome of the event of shingles was considered as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of shingles was considered to be disabling event.
Headache, Fever, "low grade fever, chills, fatigue, and headache. I went to bed early and felt better this morning. Only residual feeling I have today is arm discomfort at injection site."
0.5 mL of Moderna (6 months to 5-year-old) IM given to an 81 year old expecting the bivalent vaccine.  No adverse reaction noted while patient being monitored.  Patient to be notified.
Site: Pain at Injection Site-Mild, Additional Details: Patient reported bleeding and pain at injection site
Patient name and date of birth was entered incorrectly the first dose due to language barrier. When processing the second dose it was not flagged that the first dose was entered with incorrect patient information and was given on day 14 instead of on day 21. Nurse caught it when speaking with the patient and she provided her vaccine card. Patient was notified.
Over 3 hours of extreme crying, arching back, and puking. Unable to calm down. Face turning extremely red. Swollen leg. Started at 6 pm and lasted until 9 pm. Next day she was very fussy as well. I called the doctor and they wont do anything for her.
Information has been received from a physician concerning a 32 year old Indian female who in 1995 was vaccinated with a first, second and third dose of Hep B. Subsequent laboratory evaluation revealed a positive Hep B  surface antigent test. Hep B core antibody was neg. Hepatitis B surface antibody was pos. The pt was negative for hepatitis A and C.  No further information is available.
This spontaneous case received from a medical assistant referred to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. From 18-NOV-2016 to 30-NOV-2016, the patients were administered improperly stored PROQUAD (lot number: M029598, expiry date: 10-DEC-2017). No adverse events were reported by the patients. The vaccine was stored at 0.1C for 1 hour and 16 minutes. There was no previous temperature excursions and call was because of data logger. This is one of the two reported received from the same reporter. Additional information has been requested.
Flu like symptoms; Positive for COVID; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and CORONAVIRUS TEST POSITIVE (Positive for COVID) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, 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 INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion hospitalization) and CORONAVIRUS TEST POSITIVE (Positive for COVID) (seriousness criterion hospitalization). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and CORONAVIRUS TEST POSITIVE (Positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Coronavirus test positive: positive (Positive) Positive.         No concomitant Medications were provided. No treatment Medications were provided.  The patient received two doses of moderna vaccine in January 2021 and had been doing ok. The patient was nowin the hospital with positive covid and flu like symptoms.  The patient got COVID After the Vaccine.  Very limited information regarding these events has been provided at this time. This Spontaneous report also states that two doses are given on the same month with no specified day (unknown batch lot#). No further information is expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. This Spontaneous report also states that two doses are given on the same month with no specified day (unknown batch lot#). No further information is expected.
They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001m21a) for COVID-19 vaccination.     Allergies (medications, food and other products) were unknown. It was unknown if the patient ever had COVID + test or diagnosis. Medical Hx: Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination was not provided. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine were unknown.     On 09-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the HCP wanted to know what to do with the 4 patients that they administered a Moderna COVID-19 vaccine after the 30 day by use date, by mistake.  Date the vial was initially stored in the refrigerator was reported as 06-Apr-2022. The vial did not undergo any temperature excursions. No treatment medications were provided.
Became unresponsive to tactile stimuli, irregular respiration, & heart rate of 60-90; Rushed to ER; upon arrival became responsive & VS stabilized; This event lasted approx 5-6min.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 59-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that because their facility was not been able to download the digital data logger, they have been put on hold at the movement and were not administering the Moderna COVID-19 vaccine to the patients until an assessment was made. The reporter also stated that there had been no power outages that would have impacted the Moderna vaccine. The reporter stated that however, because their facility was unable to download the digital data logger, they treated this issue as a temperature excursion. It was also reported that the data logger which was unable to download was for the months of Dec-2021, Jan-2022 and Feb-2022. Reporter stated that no adverse reactions were reported by any patients.  No concomitant medications were reported.  No treatment medications were reported.
Nausea, vomiting, diarrhea, bloating, severe intestinal cramping, chills, lightheaded, lethargy, splotchy skin on face.
About 10 hours after injection, started getting a headache.  Woke up at 2 am sweating, with body aches, a migraine, and was very thirsty.  Went back to bed- sleeping on/off until 8:00 am.  Had a very bad migraine, body hurt all over, and I was very weak.  I had a fever of 101 as taken at 8:15 am the morning after Covid# 2.  Could only eat 5 bites of breakfast, then went back to bed.  All day long, I was weak and had a low-level migraine.  All symptoms went away at 5 pm that day.  I felt good, until...  At 10:30 pm that night, the day AFTER the shot, I started to shake and was very cold.  I shook for about an hour, took a Tylenol (500mg) and then fell asleep.  Woke up at 6:00 am and felt great.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 85-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and activities of daily living impaired. On an unknown date, the outcome of the pain in arm and activities of daily living impaired were unknown. It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: This case was received via chat. The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced arm pain which limited activity for approximately 3 weeks following administration of the dose of SHINGRIX. The HCP did not have access to the lot number or expiration date of SHINGRIX or further patient details at the time of reporting.
Patient received FLUZONE Intradermal vaccine on 9/10/13 at 11am. On evening of 9/11/13 patient starting getting symptoms of swollen lips and macular rash. On 9/12/13 MD prescribed Prednisone. Later that evening symptoms started to get better.