chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 23-MAY-2016, the patient was vaccinated with a dose of improperly stored unspecified HPV vaccine (unknown if it was GARDASIL or GARDASIL 9) and lot number K010215 with expiration date of 05-APR-2017 (dose, route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 544 hours and at the lowest recorded temperature of 32 (0 Celsius degrees) for 168 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Hives, sudden onset, given BENADRYL 50 mg IM, DECADRON 4 mg IM.
This spontaneous report as received from a nurse refers to a 17 year old patient of an unknown gender. On 27-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Immediately after administering the vaccine, the patient was asked how he felt. Patient stated he felt "Okay". Patient was informed of possible side effect he might experience from the vaccine. After, being informed of possible side effects, the patient was asked how he felt; the patient stated "okay". The patient walked from the vaccination room to a chair in the waiting area and sat down. After a couple minutes the patient was asked again how he felt. He stated "Okay". After approximately 10 minutes after administration of vaccine the patient moved from the chair he had been sitting in to one closer to the pharmacy. The patient was asked again how he felt; the patient stated, "I'm starting to feel funny." Patient was asked if he wanted water. He stated, "Yes". A second pharmacist was asked for assistance when the first was getting water. The patient was given an ice pack along with the water. The ice pack was placed on the back of the patient?s neck while he was sitting in the chair. The second pharmacist grabbed a blood pressure cuff to check the patient's blood pressure. The patient stated, ?I feel like I?m going to pass out.? While the second pharmacist checked the patient?s blood pressure, the first pharmacist went to get the Nurse Practitioner from the Convenient Care within the store for assistance with the patient. While the first pharmacist was getting the nurse practitioner, the patient passed out and was not responding to the second pharmacist. The third pharmacist on staff immediately called 911 for assistance. The nurse practitioner and first pharmacist arrived back to the patient. The nurse practitioner rubbed the patient?s sternum and checked for his blood pressure and pulse. The patient?s legs were raised and placed on a second chair. The patient regained consciousness. The patient was very pale and sweating. He was alert and could answer questions. After a few minutes emergency services arrived. They talked with the patient for roughly 10-15 minutes. After that the paramedics left and had the patient remain for a few more minutes. The patient?s wife was with him and they left the store at 1:59pm.
Body between very hot and chills Lymph nodes swollen Extreme headache weak entire body pain
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 28 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 18-FEB-2014, the patient was vaccinated with MMR II (Lot number J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
pt recv vax 14DEC95&20DEC95 pt exp a h/a,lt ear pain&devel a rash on forehead&near lt eye;presented to MD who dx w/herpes zoster in ophthalmic branch;tx w/zovirax;
underneath of arm had swollen lymph node; hard bump under my skin; sore to touch; Temperature was 99F; something under the armpit is still bugging me; Dull headache; Feeling tired; big red circle that was raised; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (underneath of arm had swollen lymph node), VACCINATION SITE MASS (hard bump under my skin), PARAESTHESIA (sore to touch), BODY TEMPERATURE (Temperature was 99F) and AXILLARY PAIN (something under the armpit is still bugging me) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (underneath of arm had swollen lymph node), VACCINATION SITE MASS (hard bump under my skin), PARAESTHESIA (sore to touch), BODY TEMPERATURE (Temperature was 99F), AXILLARY PAIN (something under the armpit is still bugging me), HEADACHE (Dull headache), FATIGUE (Feeling tired) and ERYTHEMA (big red circle that was raised). At the time of the report, LYMPHADENOPATHY (underneath of arm had swollen lymph node), VACCINATION SITE MASS (hard bump under my skin), PARAESTHESIA (sore to touch), BODY TEMPERATURE (Temperature was 99F), AXILLARY PAIN (something under the armpit is still bugging me), HEADACHE (Dull headache), FATIGUE (Feeling tired) and ERYTHEMA (big red circle that was raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.   Reporter did not allow further contact; 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.
This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (felt terrible), chills, myalgia (body aches all over) and nausea (nausea, the whole bit) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced feeling abnormal (felt terrible), chills, myalgia (body aches all over) and nausea (nausea, the whole bit). At the time of the report, feeling abnormal (felt terrible), chills, myalgia (body aches all over) and nausea (nausea, the whole bit) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
pt recv vax 14APR94 & mom reports that pt devel sz;mom now seeing another MD since JAN96;
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
shaking chills; fever; blistering on her feet and hands; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 IMMUNIZATION. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "shaking chills"; PYREXIA (non-serious), outcome "recovered", described as "fever"; BLISTER (non-serious), outcome "recovered", described as "blistering on her feet and hands". It was unknown if therapeutic measures were taken as a result of chills, pyrexia, blister. Additional information: Patient experienced shaking chills, fever, and blistering on her feet and hands after receiving the Pfizer Covid vaccine.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
The immune system was going crazy with this reaction; Allergic reaction (massive); Rash all over (severe); This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 23Apr2021 (Lot# EW0172), as single dose, for COVID-19 immunisation. Medical history included seasonal allergy, rubber sensitivity, drug hypersensitivity. Concomitant medication included multivitamins. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EW0150) at 51 years for COVID-19 immunisation. The patient experienced a massive allergic reaction with rash all over (severe) on 26Apr2021. The immune system was going crazy with this reaction. Rash was described as rash on her whole body which started around her thigh area, the rash was really severe and all blow-up. The events required physician office visit. Therapeutic measures were taken as a result of the events and included treatment with Prednisone. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient is complaining of weakness in legs and dizziness since receiving her flu shot on 10/8/17.
This case was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, fatigue, pain, swollen joint, walking difficulty, decrease hand grasp, back pain, sinus problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information in the form of medical records was received on 22 September 2008. Medical history noted by the subject included recurring flu, asthma, frequent pneumonia, anaphylactic shock to penicillin and vomiting with codeine. Also mentioned was a small lump in the left breast (cyst-date no specified). An x-ray of the right hip and pelvis due to chronic pain performed on 07 February 2005 was unremarkable. An x-ray of the right knee performed on the same date showed narrowing of the medial compartment of the knee joint and was otherwise unremarkable. It was documented that the subject uses NASOCORT for sinus problems. In the course of review of medical records, it was noted that the subject was at some point diagnosed with reflux and was given PRILOSEC as treatment. This was not indicated as an adverse event at this time. The PRILOSEC seemed to improve the subjects symptoms. Also in the course of review, it was noted that the subjects hearing was tested on 26 February 2008 and found to be at normal thresholds. An exam dated 11 February 2008 for nasal problems noted hearing loss, chronic otitis externa, allergic rhinitis and rhinitis medicamentosa, but did not indicate these specifically as events or related symptoms to claimed events. Follow up information was received on 07 November 2008 via an interview between lawyers and the subject. The subject received the first and second doses of LYMERIX on 16 May 2001 and 13 June 2001. In May 2001, she developed joint pain. In June 2001, she developed fatigue and flu-like symptoms. In 2001 she experienced forgetfulness and hot flashes. In 2005 she developed bursitis, dyslexia, and mononucleosis. In 2006/2007, she was diagnosed with plantar fasciitis. On unspecified dates she experienced depression and weight gain. Treatment included glucosamine chondroitin, ALEVE, cortisone, clonazepam, and CELEXA. Dyslexia was assessed by GSK to be medically significant. With the exception of flu-like symptoms and mononucleosis, the events were unresolved at the time of reporting.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 23-OCT-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Approximately 48 hours after receiving the vaccine, I developed a full body rash, some hives and itching.  It covered arms, legs and torso with the worst discomfort in the groin area.  (Wife described area affected as a map of the lymph system.)  Rash continued for three days at which time I contacted my doctor who told me during a video office visit it would probably go away in a few days and it did without treatment of any kind.
same night nausea and vomited. 12 days later 1/2/21 woke up with stiff knees/wrists and joint pain swelling
Flu vaccine given IM in L arm. c/o soreness, tenderness L arm and L side of L breast. Also c/o sweats, nausea. Symptoms began 6-8 hrs after injection lasted for 48 hours.
pt went to ER 1 days p/vax were given for sz, was told it was febrile
EXTREME tinnitus-I cannot sleep, concentrate, or function!  I have cut out alcohol and caffeine, and will be trying "maskers" (hearing aids) to try and help.  This is absolutely the worst thing I have been through!
Tinnitus in one ear (right). I have a history of tinnitus but only in the left ear-- which is a result of TMJ but only on that side. This tinnitus in my right ear is completely different than that
arm soreness; back aches; chills; headache; fever 101.3; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), BACK PAIN (back aches), CHILLS (chills) and PYREXIA (fever 101.3) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included ALBUTEROL [SALBUTAMOL], VITAMIN B12 [VITAMIN B12 NOS] and VITAMIN D3 for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), BACK PAIN (back aches), CHILLS (chills) and PYREXIA (fever 101.3). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. On 19-Feb-2021, PAIN IN EXTREMITY (arm soreness) and BACK PAIN (back aches) had resolved. At the time of the report, CHILLS (chills) and PYREXIA (fever 101.3) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Initial report received from an investigator on 28 May 2010 under the reference number FUF16. A 69-year-old male subject experienced a rotator cuff injury - left shoulder 161 days after receiving an intramuscular left deltoid injection of H1N1, 3.8 mcg HA, lot number UD12414, reconstituted with PBS diluent, lot number UD12820, on 10 November 2009. The subject did not receive AF03 adjuvant. On 20 April 2010 he was admitted to the hospital for surgery to repair a left rotator cuff injury. He was treated with oxycodone and hydrocodone postoperatively for pain relief. The event was considered to be resolved on 21 April 2010. Medical records had been requested. According to the investigator, the event was not related to the study vaccine or the concomitant medications. Unblinding information was received on 28 May 2010. Follow-up information was received from an investigator on 13 July 2010 provided that there was no ongoing medical history and/or complementary investigations. There were no medical records available as of 13 July 2010. Documents held by sender: None.
Narrative:  Pt is a 67 year old female with multiple medical problems including a PMHx of HCV cirrhosis who came in for an appointment at the liver clinic. Pt received her COVID booster the day prior and developed a fever. She was found to have a fever of 100.4 and reported chills. Due to pandemic she requested to be seen in the ED. She was given oral fluids and TYLENOL which resolved her  symptoms. Per October 5, 2021 ER documentation , the patient's CC included mild muscle aches, fever and lightheadedness. ER physician note also documented the patient had aches plus fever with a discharge diagnosis of "vaccine side effect" . The patient was discharged with TYLENOL 1 gm every 8 hours while having pain,  drink 2 - 4 liters of water a day and with written instructions that included list of symptoms to have her return to the ER, if thery occur .
Shortness of breath and feeling of chest tightness and cinjestion. Coughing and feeling as though coughing is necessary to breathe fully.
cheek drooping, face hanging, lip pulling and eye won't close, lip twitch, headache; Nausea; rash chest, neck, full body; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (cheek drooping, face hanging, lip pulling and eye won't close, lip twitch, headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced RASH (rash chest, neck, full body). On 21-Mar-2021, the patient experienced NAUSEA (Nausea). On 25-Mar-2021, the patient experienced FACIAL PARALYSIS (cheek drooping, face hanging, lip pulling and eye won't close, lip twitch, headache) (seriousness criteria disability and medically significant). On 18-Mar-2021, RASH (rash chest, neck, full body) had resolved. On 27-Mar-2021, NAUSEA (Nausea) had resolved. At the time of the report, FACIAL PARALYSIS (cheek drooping, face hanging, lip pulling and eye won't close, lip twitch, headache) 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.   Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Member received wrong dose of covid vaccine booster. Vial was diluted by staff, should not have been diluted.
About 12 hrs. following shot woke with racing heart rate and fever of 102. Took TYLENOL. Fever and rapid heart rate gone in about 6 hrs. Sore arm at needlestick site for 5 days - red, swollen.
48 hours after the vaccine was administered I had itching on my hands, face and feet. tingling numbness in the hands. a lot of itching in parts of the body.
Patient received Menactra 12-31-2015 in afternoon, patient returned to pharmacy 5 days later (1-5-2016) and had red injection site reaction on left arm. It is warm to touch, she saw her personal physician who advised her to use hyrdocortisone cream on it. Questioned patient, no rash anywhere else on body and no anaphylactic reaction either.
Patient experienced dizziness.  Patient was a bit disoriented.   Patient was observed and given some food (potato chips) and water.  Symptoms resolved.
5 patients received a Moderna booster shot of 0.5ml (not 0.25ml); This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)). On 29-Oct-2021, ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.