chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 06-JUN-2017 the patient was vaccinated with a dose of improperly stored VARIVAX lot # L040419 for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000408: US-009507513-1706USA004091: US-009507513-1707USA000410: US-009507513-1707USA000411: US-009507513-1707USA000407: US-009507513-1707USA000409.
Developed L chest pain and headache late in evening 5-4-21 and diagnosed with pulmonary embolis 5-4-21. He was treated initially with high-intensity heparin nomogram and converted on 5-5-21 to oral apixaban. He has done well with this therapy.  His risk factors for PE include immobility; however, the risk of a thrombotic event in quadriplegic patients should be that of the general population after the first year of disability, and he has been immobile for around 2.5 years. He has no known underlying malignancy, and his recent imaging of his chest and head are reassuring in this regard. The patient received his Moderna COVID-19 vaccine 12-23-20 and 2-2-21 with vascular events having been reported as being more common following this immunization. Without a clear cause for his PE, this will be reported on VAERS.
Tiredness and with no energy; All the body was shaking; Blurry vision; Cough; Nausea; Fever; Headaches; body aches; Chills; Red eyes; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Tiredness and with no energy), TREMOR (All the body was shaking), VISION BLURRED (Blurry vision), COUGH (Cough) and OCULAR HYPERAEMIA (Red eyes) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced OCULAR HYPERAEMIA (Red eyes). On 27-Feb-2021, the patient experienced ASTHENIA (Tiredness and with no energy), TREMOR (All the body was shaking), VISION BLURRED (Blurry vision), COUGH (Cough), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (body aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Tiredness and with no energy), TREMOR (All the body was shaking), VISION BLURRED (Blurry vision), COUGH (Cough), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (body aches) and CHILLS (Chills) had resolved and OCULAR HYPERAEMIA (Red eyes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: updated vaccine information( dose 2).
Extreme swollen face from neck up.  On a road trip at the time, stopped at urgent care where I received a steroid shot.  Occurred again 3 days later, recited another steroid shot at another urgent care. Occurred 4 days later where I saw my now retired dermatologist, Dr. PRIVATE who gave me another steroid shot.
who presents to the Emergency Department with a chief complaint of abdominal pain, nausea, vomiting currently on antibiotics for a bladder infection also incidentally found to be Covid +2 days ago in the ED. She had a history of Covid in June, and is also fully vaccinated and states that she does have chronic occasional pain in her left lower abdomen but the pain seems to be a little bit worse this morning. She feels like her lower abdomen is "in knots".
Twin RX given high up in left shoulder. I immediately felt burning, stinging, severe pain, numbness and tingling all the way down my arm. Now, 2 weeks later, pain with certain movements, limited range of motion, hurts when lying on side.
Swelling of left forearm and elbow requiring vascular study for blood clot, Joint injection to left elbow . Swelling of entire upper extremity, US elbow. prednisone 20mg for 5 days and doxycycline 100 mg 10 days . Severe overall join pain , right knee swelling 9 days after injection. Six days after injection the  left arm started swelling with burning pain at injection site to left arm.
Information has been received from a registered pharmacist concerning a 22 year old female employee who handles the intact ZOSTAVAX vaccine (Oka/Merck) vials storage purposes only (does not administer the vaccine), and on 13-JAN-2009 was diagnosed with shingles. Vesicular rash distributed on the left abdomen. The patient was seen by her unspecified physician and was prescribed VALTREX. The pharmacist stated that she felt that handling the vaccine vials may be related to the development of shingles. Patient not recovered. Follow up information was received from the registered pharmacist reported that the patient was a pharmacy technician who developed shingles in January 2009. The patient was enrolled in the Program to identify VZV is present and if it is present identify if it is associated with the wild- type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. Subsequently the patient recovered. Additional information has been requested.
Patient got vaccine 8/10/17. That night Lt upper arm sore. Worse. L arm. Tried cold pack. Arm swollen left UE internal aspect pink 7 x 3 cm and soft tissue swell 10 x 1.5 cm. Decreased ROM left shoulder with rib duration and forward arc. No axillary lymphadenopathy. Plan: Ice q 2h for 10-15 min. Work note. F/u if worse.
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 17th May 2018, the patient received the 2nd dose of SHINGRIX. On 18th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site rash and injection site discoloration were not recovered/not resolved. The reporter considered the injection site rash to be related to SHINGRIX. It was unknown if the reporter considered the injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: The patient did not received any other vaccine. The patient reported that, she had a bad rash that was 3 inches across and two inches wide the day after she had the SHINGRIX vaccine. It was been 2 weeks and she still sees the mark (injection site discoloration latency less than a month) where she had the rash. The patient had denied permission to contact their physician.
muscle soreness at injection site with loss of range of motion X 30 hours; fatigue Narrative:  teleophone call
pt recv vax; c/o red, large, painful lump to 2+cm;
Chills extreme fatigue body aches head aches loss of appetite cough and chest congestion
2 months p/vax & exp herpes zoster (shingles); further details have been requested;
Patient got dizzy about 3 minutes, and also fainted about 3 times (in and out).
One day post vax pt developed "severe" cellulitis. She was seen by MD 3/29/01 and prescribed Keflex 500mg qid for 14 days. This is 1 of 2 pts from this facility who developed cellulitis following receipt of Pnu-Immune 23 lot # 471-040. Follow-up info recvd from the reporter on 5/18/01 provided the following information: time of immunization, addtl concomitant meds, no laboratory tests required and that the pt recovered.
Rebound of Covid (positive test) 4 days after testing negative after Paxlovid treatment; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP7534), in right arm, on 07Apr2021 as dose 2, single (Lot number: ER8737), in right arm, on 25Aug2021 as dose 3 (booster), single (Lot number: EW0183), in right arm and on 27Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Roux-n-y weight loss surgery", start date: 2009 (unspecified if ongoing); "breast cancer", start date: 2021 (unspecified if ongoing). Concomitant medication(s) included: BENZONATATE, start date: 21Aug2022; GUAIFENESIN & CODEINE, stop date: 20Aug2022; ONDANSETRON; ALBUTEROL [SALBUTAMOL]; ANASTROZOLE; LEVOTHYROXINE; SUMATRIPTAN; PRILOSEC [OMEPRAZOLE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "recovering", described as "Rebound of Covid (positive test) 4 days after testing negative after Paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative, notes: Rebound of Covid (positive test) 4 days after testing negative after Paxlovid; (30Aug2022) Positive, notes: Rebound of Covid (positive test) 4 days after testing negative after Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical Course: It was reported that, patient took other medication in 2 weeks. Rebound of Covid (positive test) 4 days after testing negative after Paxlovid treatment. No known allergies. Patient was treated with Paxlovid from 21Aug2022 to 25Aug2022
AFLURA - substantial pain in shoulder 1 hour after injection, limited range of motion. Returned to near normal after 24 hours. Severe chills and shakes approximately 4 hours after injection - lasted approximately 4 hours. Eye crusting and substantial redness ( not tears - but don't have a better description) starting approx 3-4 hours after injection. Lasted approximately 4-6 hours. Male age 59 - never had a reaction to the flu shot before. Previous brands administered unknown.
Severe body aches; fever of 102 all day the following day and continuing; Nausea; Loss of appetite; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 18:30 hrs (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Mar2021 at 18:30 hrs (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 24Mar2021 at 05:00 hrs, the patient experienced severe body aches, fever of 102 (unspecified unit) all day the following day continuing, loss of appetite and nausea. The events did not result in a doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care The patient did not receive any treatment for the events. The clinical outcome for the events severe body aches, fever of 102, loss of appetite and nausea was not recovered at the time of the report.   Information about lot/batch number cannot be obtained. No further information expected.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatment medications were reported.
pt recv vax & 2-3 min later pt found sitting in the care & was rigid, jerking  & unresponsive;pt observed 4-5min post vax was sitting in the care pale & somewhat diaphoretic but responsive;
received only a partial (unknown volume) of Shingrix today when the needle leaked; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-JUN-2023, the patient received Shingrix. On 22-JUN-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: received only a partial (unknown volume) of Shingrix today when the needle leaked). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 22-JUN-2023 The reporter was the health care professional (pharmacist).  No Product quality complaint (PQC), it was ruled out. Nothing else was reported. A patient received only a partial (unknown volume) of Shingrix when the needle leaked, which led to incomplete dose administered.
Cellulitis type skin reaction that extened from the top of the shoulder to the elbow.
2 days after vaccine administration, patient began experiencing swelling, redness, and pain in legs from her knees to her ankles.  She also experienced red, painful hands, without any swelling.  This happened for several days with each day progressively getting worse to a point in which she could not walk. She also reports experiencing hot and cold flashes but no fever and had GI upset. Within the last few days she has been starting to feel better and has been able to walk again, but reports that her feet feel like "there in cement". Patient has been elevating her feet and drinking plenty of water to help with the swelling. She has been very against going to the hospital or calling her prescriber, despite being very scared about the situation.
I did get COVID with a positive COVID-19 test. I had symptoms of lethargic for one day, headache, and runny nose. I started getting symptoms of rash on my waistline that spread to the back of my waistline to my legs. I was moving around from leg to leg to different spots. It could not be due to household allergies due to not changing anything. I went to my doctor and took Prednisone. I got really dizzy, lethargic, and sleepy. It cleared but then came back. This did not start until after COVID. The rash is still continuing to this day and I do have an appointment with a dermatologist. I have gained some weight which could be due to Prednisone which I can not eat like I use to and I feel full.
Patient called to report that she felt unbalanced on 10/09/2022 morning (1 day after she got the shots). She didn't fall but she just felt dizzy and fainting. I advised her to drink a lot of fluids, have some rest & take Tylenol when needed. Checked o patient after few hours, she was doing better.
fatigue; arm was sore where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and VACCINATION SITE PAIN (arm was sore where I got the shot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history information was reported.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (fatigue) and VACCINATION SITE PAIN (arm was sore where I got the shot). At the time of the report, FATIGUE (fatigue) and VACCINATION SITE PAIN (arm was sore where I got the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and VACCINATION SITE PAIN (arm was sore where I got the shot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history information was reported.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (fatigue) and VACCINATION SITE PAIN (arm was sore where I got the shot). At the time of the report, FATIGUE (fatigue) and VACCINATION SITE PAIN (arm was sore where I got the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Fever, body aches, fatigue, sore lymph nodes at left of neck. Sore at vaccination site.  I did not have the fever, aches, etc  reaction from first shot but my arm was sore.  I expect this to resolve on its own. I just had the shot today.
may90 pt vax hepta B. pt ex h/a for few days. 01jun90 pt 2nd vax. pt ex h/a for month, dull ache in right eye. treated w/ pres. drug.
Patient received first dose Pfizer vaccine at 2:03pm. Patient went to the restroom post observation period and noticed red hives on her neck and face. She reported back to the nursing staff for assessment. Patient had no itching, no swelling of the throat or tongue, no difficulty breathing and no other symptoms. She was instructed to wait an additional 30 minutes. Redness of the hives improved and patient chose to leave with her husband. Patient was instructed to take diphenhydramine and to call 911 if symptoms worsened.
Sl. swelling several hrs. after injection. Redness and warmth and itch the next AM.
My right eye twitched extensively (but not continuously) for approximately 3 weeks.  This also occurred during a time when I was under a lot of work stress and not getting much sleep, so I initially attributed the twitch to those factors.  I did not seek medical treatment, believe it would eventually resolve on its own.  I was prompted to enter this report by a family member who noted the correlation in time to my vaccination.  The twitch stopped after 3 weeks.  I have not yet had my second shot to see if it would happen again.
Within the hour after receiving the flu shot in my left arm, my shoulder became painful with active movement. Specifically, abduction of the left shoulder caused severe pain even with passive movement. This pain was significant for several days to the point that I was unable to use my left arm to do anything. Opening the car door, driving, getting into bed, putting on clothing was painful. Symptoms improved gradually so that I am able to use my arm, but I am not able to work out yet. Range of motion is still limited by pain 2 weeks after the vaccine. Treatment has included advil, ice, and rest.
Covid-19 Breakthrough. 1st vaccine received on 07/30/2021. 54 y/o PMHx ETOH abuse, Back pain, GERD, Kidney stone, Gastric ulcers and smoking presents to ED Acted by police with primary complaint of inability to care for herself, abdominal pain, nausea, vomiting and diarrhea. Per patient, boyfriend passed away 4 days ago and she has been isolating herself in her room drinking alcohol. Of note, patient tested Covid-19 + 2 weeks prior and symptoms resolved after 5 days. Patient afebrile, room air sat 97% and CXR -no acute findings.
still has some blotches on her skin; Shingles on her left leg; Very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Very painful), ERYTHEMA (still has some blotches on her skin) and RASH (Shingles on her left leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 007B21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Very painful) and RASH (Shingles on her left leg). On an unknown date, the patient experienced ERYTHEMA (still has some blotches on her skin). The patient was treated with GABAPENTIN ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, PAIN (Very painful), ERYTHEMA (still has some blotches on her skin) and RASH (Shingles on her left leg) was resolving.            No concomitant medication was reported.
10/8/22 towards the evening, my arm became very red, hard, hot and swollen, about a 3 inch radius around the point of the vaccine. I sprayed lidocaine on the spot to relieve the pain which did cool it down. In January, I broke out in hives, big red whelps all over my torso. At the end of February, I went to see a Dermatologist. He sent me to an Allergy and Asthma doctor. I was prescribed about five antihistamines to take daily. I still have these whelps.
4" diameter red, swollen area on arm a.m. low-grade temp and area hot to touch p.m., didn't feel well fine by next morning