chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient stated she developed a fever of 101 degrees for more than 24 hours, severe chills, runny, watery eyes, mild cough, nausea, severe body aches, and a large red lump at the injection site
Patient states that arm was hot to the touch, itching, painful, red splotches running down arm from where injection site was. Patient reports no fever.
none. it was a syringe failure. inject into the Left deltoid and the plunger will not pushed in. when force, the needle retract and the vaccine was seen on the outside of the arm instead of inside the arm.  She may have gotten a possible < 0.1ml of vaccine.  as per patient, she wants to get it over with so we gave her the full dose (0.3ml) into the Right deltoid . she waited the standard 15 mins and has no adverse reaction.
Joint pain; I started feelings like I am having flu like symptoms like chills; Body fatigue; This is a spontaneous report from a contactable consumer.  A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported ), via an unspecified route of administration on the upper arm on 23Dec2020 at a single dose for COvid-19 immunization. Medical history included triglycerides (abnormal).  Concomitant medication included eicosapentaenoic acid ethyl ester (VASCEPA) for triglycerides. The patient is a dialysis technician in a dialysis Unit. The vaccine was given in a facility. The patient got the Covid Vaccine on 23Dec2020 and its like more than a week now, on an unspecified date, he felt joint pain, body fatigue and two nights ago, he started feelings like he was having flu like symptoms like chills he took his temperature and its normal so he doesnt know if there is a reported reactions like this that he was feeling and he would like to know what does he needs to do, to know anything and an advice. He was scheduled for the blood work done at this month. The patient was taking only paracetamol (TYLENOL) for his joint pain, and chills and that's the only thing that he is experiencing right now. The consumer did not undergo emergency room or physician office. Outcome of the event chills was not recovered, while for the other events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Stiff neck, body ache, severe headache, fever 102, vertigo, extreme fatigue. Stiff neck, body ache (extreme in joints) and fever resolved in 4 days, vertigo and fatigue took 6 weeks to resolve and I still don't feel "normal".
COVID-19 infection; COVID-19 infection; This is a spontaneous report from a contactable consumer. A non-pregnant 49-year-old male patient received bnt162b2 (Formulation: Solution for injection) via unspecified route of administration on unspecified in Mar2021 (Lot number and expiration date: not reported, age at vaccination: 49-year-old) as single dose (dose number unknown) for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. On unspecified in Aug2021, patient experienced COVID-19 infection. Lab test included COVID-19: positive on Aug2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Treatment adverse event was unknown. COVID was not present prior vaccination. COVID was tested post vaccination. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
The patient got the second Moderna COVID vaccine on 4/9/2021.  Then 1 week later on 4/16/2021, she developed pain in left calf that got progressively worse.  Then came to ER on 4/18/2021 and was diagnosed with thrombosis/occlusion in left popliteal artery.   She was admitted and put on IV heparin.  This was thrombolyzed by interventional radiology on 4/19/2021.   She was discharged on 4/23/2021.  She has had resolution of pain in the left leg.  She has never had this before.  She does have some apical hypokinesis on echocardiogram but that is not really new.  EF 45%.  Now is on warfarin.
cardiac arrest; This case has been considered invalid as Unidentifiable reporter and Reporter with No First-hand knowledge. Upon follow up on 23Jan2023, this case has been considered as valid all required information as new reporter added.  This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death, hospitalization, medically significant), outcome "fatal". Therapeutic measures were taken as a result of cardiac arrest. The patient date of death was unknown. Reported cause of death: "cardiac arrest". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, an association between the reported events Cardiac Arrest and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: cardiac arrest
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On 06-NOV-2012 the patient was vaccinated with his first dose of GARDASIL. On 09-APR-2013 the patient was given a dose of CERVARIX (instead of GARDASIL). No product confusion just medication error. No adverse event reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
12 hours post vaccine, onset of headache, extreme fatigue, fever up to 100.3°, body aches, heart rate up to 130bpm, and severe chills. Day after, chills subsided, temp and heart rate gradually back to normal. Day 2 almost normal
On 19 October 2007 patient received MMRV, on 26 October 2007. Generalized lesions developed, on 2 November 2007 lesions have scabbed over.
PATIENT RECEIVED THE 2ND DOSE OF MODERNA AT 21 DAYS VS 28 DAY GRACE PERIOD
Tiredness; Slight Fever 97.7 to 99.1; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced tiredness and fever. On an unknown date, the outcome of the tiredness and fever were unknown.   It was unknown if the reporter considered the tiredness and fever to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine in left arm and experienced slight fever when his usual temperature went from 97.7 to 99.1 degree ferenheit and tiredness. The reporter stated he wanted to know how long side effects would last. The reporter did not consent to follow up. This case was linked to case US2020121805, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020121805:wife's case , original: HUSBAND´S CASE
No adverse event; A 7-month-old patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A 7-month-old patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 214K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (A 7-month-old patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A 7-month-old patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A 7-month-old patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine).    Concomitant product use was not provided by the reporter.  Patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine on 9-June-2023 and 12-JUL-2023. The lot number was the same for both doses. Expiry date of suspect vaccine was 29-Aug-2023.  Treatment information was not provided.
Numbness and strong pain in right arm (arm in which patient was vaccinated) starting 4 days after vaccination.  Also some pain in upper right back area starting at this time.  Also rash on right arm and palm of right hand and tightened muscles in right arm.  (Patient had received four (4) prior doses of the original Pfizer COVID-19 vaccine - two primary vaccinations followed by two boosters - and was mildly ill after these doses, but then recovered completely.  The booster that seemingly caused the most recent effects was the recent Omicron-targeting Pfizer  booster.)  Patient received chiropractic treatment on 12/20, 12/21 and 12/22 for this issue; partial success in relieving pain.
big white circle in the arm of where the injection site and it has the diameter of 1.5 inches; painful right after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (painful right after the shot) and VACCINATION SITE RASH (big white circle in the arm of where the injection site and it has the diameter of 1.5 inches) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (painful right after the shot). On 19-Apr-2021, the patient experienced VACCINATION SITE RASH (big white circle in the arm of where the injection site and it has the diameter of 1.5 inches). At the time of the report, VACCINATION SITE PAIN (painful right after the shot) was resolving and VACCINATION SITE RASH (big white circle in the arm of where the injection site and it has the diameter of 1.5 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 08-Apr-2021, patient experienced painful right after the shot until 19-Apr-2021, the pain becomes dull. Patient stated that no medication was taken for the pain. Concomitant medications were not provided.
My left arm on day 6,7,8 became hot and very itchy.  It was swollen and very red.  It was like I had one huge welt that split into two over those three days.  Very painful.  It was strange because it occurred 6 days after the shot.
Diarrhea, headache, chills, body aches, chest pain, shortness of breath, finger on hands and toes get cold. All the symptoms happened at 4:30pm.
PATIENT PRESENTED WITH RED WARM RASH THAT SHE STATES HAS SPREAD. AT CENTER OF RASH IS WHAT LOOKS LIKE AN INSECT BITE. IT IS NOT LOCATED NEAR THE INJECTION SITE. THE INJECTION SITE ITSELF LOOKS NORMAL. I INSTRUCTED HER TO SEEK MEDICAL ATTENTION AS SHE STATED IT HAS SPREAD AND IS NOT IMPROVING.
Tingling and pain in left arm and left leg.  Tingling on left side of face.  Pain in left hand and swelling.
About 09:00 AM had flu and pneumococcal vaccine administered. Both arms were stiff. About 1200 noon, pt started to get tremor in left arm that slowly worsened and spread through left torso section. Pt went to ER at about 1800 and was given Diazepam and Hydrocodone and the tremor subsided. Follow up call given on 11/14/07 and pt said has recovered.
Patient sat for a few minutes.  Got up to go to the restroom and felt light headed and dizzy.  He was hot then cold.
This case was reported by a pharmacist via call center representative and described the occurrence of attention deficit/hyperactivity disorder in a 60-year-old female patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. Co-suspect products included FLUCELVAX for prophylaxis. On 5th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and FLUCELVAX. On 5th October 2018, 30 min after receiving SHINGRIX, the patient experienced attention deficit/hyperactivity disorder, mental concentration difficult and anxiety. On an unknown date, the outcome of the attention deficit/hyperactivity disorder, mental concentration difficult and anxiety were recovered/resolved. It was unknown if the reporter considered the attention deficit/hyperactivity disorder, mental concentration difficult and anxiety to be related to SHINGRIX. Additional details were provided as follows: The reporter stated 30 minutes after receiving the 1st dose of SHINGRIX in right arm, the patient experienced ADHD-like symptoms, trouble concentrating and anxiety. The patient also received FLUCELVAX on the same day. It was unknown if the reporter considered the attention deficit/hyperactivity disorder, mental concentration difficult and anxiety to be related to FLUCELVAX as well.
C/O back pain, pain in arms and legs "mouth feels funny" was given MENACTRA, GARDASIL and FLUZONE vaccines on same day. Sharp pains and redness to right leg. Temp 101 Generalized body aches and fatigue transient rash to underside of left upper arm that appears hive-like. Med difficulty breathing. Has hit of asthma. Peak flow decreased from 500- 370.
The day after the injection, I did have significant soreness in my arm. I had a slight fever, but it was never over 100. I also had chills and extreme fatigue. I had body aches everywhere as well. This occurred with both doses. After about 2 weeks, I went to the doctor because I was still feeling really bad. Everything had resolved except for the body aches. I was given steroids (methylprednisolone). I was given a refill on the steroid pack and was told that the next time I took the vaccine, I should take this the night after the injection. The second time was not as lengthy as the first due to this advice.
pt recv vax 23SEP96 & 27SEP96 pt devel watery blisters all over body w/in 1/2h time period;30SEP MD dx infotogis, ATB prescribed;pt being treated for bolosa impetigo;MD felt septicemia;rash caused by something else;also had welts;
Pt experienced onset of severe headache, left sided extending to left back of neck, around 2:45pm Took 2 Tylenol PM at that time, laid down then took 2 more around 4 PM. The pain was not relieved by medication. Pt stayed home and laid around and dozed. The pain did not keep her awake. The pain finally went away around 10 am on 1/28/2006. No problem since then.
Diarrhea, NauseaVomiting, CRAMPING Narrative:  Other Relevant History:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Crying out of pain), INSOMNIA (Terrible pain at night that I cant even sleep), PAIN IN EXTREMITY (Leg pain), BACK PAIN (Back pain) and MYALGIA (Muscle pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced INSOMNIA (Terrible pain at night that I cant even sleep), PAIN IN EXTREMITY (Leg pain), BACK PAIN (Back pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN (Crying out of pain). The patient was treated with ACETAMINOPHEN for Pain, at a dose of 500 milligram twice a day and IBUPROFEN for Pain, at a dose of 800 milligram as necessary. At the time of the report, PAIN (Crying out of pain), INSOMNIA (Terrible pain at night that I cant even sleep), PAIN IN EXTREMITY (Leg pain), BACK PAIN (Back pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown and CHILLS (Chills) and NAUSEA (Nausea) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient wished that she could never got this vaccine. Patient  went to saw the doctor and he told that it was a pinch nerve. Concomitant product included high blood pressure medicine, medicine for diabetes and medicine for cholesterol.
0930 - rec'd MMR.  1345 - stated throat hoarse with itching (hairball feeling).  1730 - called PCP with s/s - told to report to ER.  1812 - triaged in ED - given 0.3mg EPI/PEPCID 20mg po prednisone 40 every day x5 days - scrip given.  2015 - D/C ED - improved condition.
Mouth hurt very bad.; I was having an autoimmune reaction to the vaccine; I woke up and my lips abs tongue were swollen; I woke up and my lips abs tongue were swollen; I could smile and it hurt to talk.; I went to ER because my throat was also starting to hurt; This is a spontaneous report from a contactable consumer (patient).  A 37-year-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Mar2021 at 11:00 in left arm at single dose for COVID-19 immunisation (lot number was En6202). Medical history included Inflammatory bowel disease (IBD), chronic anemia, l5-s1 disc herniation, obesity, Gastrooesophageal reflux disease (GERD), migraine, known allergies: benzoyl peroxide and Cefalexin, mouth ulcers. Historical vaccine included first dose of received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Feb2021 at 11:00 in right arm at single dose for COVID-19 immunisation (lot_number En6203). The patient was not pregnant at the time of vaccination. Concomitant medications included chlorthalidone; budesonide; ferrous sulfate. The patient had 2-3 mouth ulcers already forming when she received 2nd shot; the patient had IBD and mouth ulcers often happen to her. On 21Mar2021, the patient woke up and her lips abs tongue were swollen. The patient could smile and it hurt to talk. Mouth hurt very bad. The patient went to ER because her throat was also starting to hurt and she was worried it would swell like her lips. ER doctor said the patient was having an autoimmune reaction to the vaccine on 21Mar2021 at 07:00. The patient was no treated for the events. The patient recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.
Blood pressure increase; UTI; Elevated hct and hgb; Presence of huge lymph nodes - LEFT; Dizziness; Weakness; Hard; Palpitation; Left arm soreness; Left arm hurts when raised especially the elbow; Swollen on the left forearm; Swollen on the elbow; Joint ache; Muscle ache; A spontaneous report was received from a healthcare professional concerning a 51-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle ache, joint ache, left arm soreness, left arm hurts when raised especially the elbow, swollen on the left upper arm, swollen on the left forearm, swollen on the elbow, hard, palpitation, dizziness, weakness, presence of huge lymph nodes - left, multiple lymph nodes in the clavicle and armpit, uti , swollen lymph nodes on her left axilla.  The patient's medical history was not provided. Concomitant medications reported were Multivitamins for supplemental purposes, Vitamin D3 for drug use for unknown indication.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced the events muscle ache. joint ache, left arm soreness, left arm hurts when raised especially the elbow, swollen on the left upper arm, swollen on the left forearm, swollen on the elbow, hard. On 22 Jan 2021, the patient experienced the event(s) palpitation. elevated heart rate, dizziness, weakness. On 24 Jan 2021, the patient experienced the event(s) presence of huge lymph nodes - left . On 28 Jan 2021, the patient experienced the event(s) bp 199 133. multiple lymph nodes in the clavicle and armpit, elevated hct and hgb. On 29 Jan 2021, the patient experienced the event(s) elevated ferritin level. decreased vitamin d, uti, sinus rhythm abnormality in her t-wave. On 2 Feb 2021, the patient experienced the event(s) swollen lymph nodes on her left axilla. laboratory exams performed to further diagnose the event were blood pressure 199/133, CT scan lung multiple lymph nodes on the clavicle and armpit area, electrocardiogram Sinus Rhythm abnormality in her T-Wave, elevated hematocrit ,hemoglobin, heart rate, ultrasound and mammogram, elevated serum ferritin , urinalysis, decreased vitamin D. Treatment details included Was under Amlodipine and Antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event muscle ache, joint ache was considered resolved on 23 Jan 2021.The outcome of events, left arm soreness, left arm hurts when raised especially the elbow,swollen on the left upper arm,swollen on the left forearm,swollen on the elbow, hard, palpitation, dizziness, weakness, presence of huge lymph nodes - left,multiple lymph nodes in the clavicle and armpit, uti, swollen lymph nodes on her left axilla was considered not resolved.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Myalgia, Arthralgia, fatigue Narrative:  Received COVID vaccine 01/07/2021. Received Hep B vaccine 01/12/2021.