chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose number: 3; Fever; Aches; Chills / Shivers; Sweats; Migraine; Muscle aches; Loss of appetite; Arm soreness; Started feeling sick that night / Too sick to leave bed the entire day; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient.   A 23-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 27Nov2021 at 11:00 (Batch/Lot number: FH8027) at the age of 23 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: CLARAVIS. Vaccination history included: COVID-19 vaccine (DOSE 1, SINGLE; Lot Number: UNKNOWN; Route of administration: Unspecified; MANUFACTURER UNKNOWN), administration date: unknown, single for COVID-19 immunisation and COVID-19 vaccine (DOSE 2, SINGLE; Lot Number: UNKNOWN; Route of administration: Unspecified; MANUFACTURER UNKNOWN), administration date: unknown, single for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), PAIN (non-serious), CHILLS (non-serious), HYPERHIDROSIS (non-serious), MIGRAINE (non-serious), MYALGIA (non-serious), DECREASED APPETITE (non-serious), PAIN IN EXTREMITY (non-serious), all with onset 28Nov2021 at 04:00, outcome "recovered" (an unknown date in Nov2021), all described as "fever, aches, chills / shivers, sweats, migraine, muscle aches, loss of appetite, arm soreness"; MALAISE (non-serious) with onset an unknown date in Nov2021, outcome "recovered" (an unknown date in Nov2021), described as "started feeling sick that night / too sick to leave bed the entire day". Therapeutic measures were not taken as a result of pyrexia, pain, chills, hyperhidrosis, migraine, myalgia, decreased appetite, pain in extremity, malaise.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. This was the patient's booster shot which happened on the 27Nov2021 at 11:00, it was not until late in the night at 04:00 in which it really took a turn for the worse. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
left arm is weak; weakness comes and goes; after a week or two, the dizziness was intermittent; the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way; tingling; electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling), ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day), MUSCULAR WEAKNESS (left arm is weak) and ASTHENIA (weakness comes and goes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling) and ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day). On an unknown date, the patient experienced MUSCULAR WEAKNESS (left arm is weak), ASTHENIA (weakness comes and goes) and DIZZINESS (after a week or two, the dizziness was intermittent). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling), ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day), MUSCULAR WEAKNESS (left arm is weak), ASTHENIA (weakness comes and goes) and DIZZINESS (after a week or two, the dizziness was intermittent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes: OTC Supplements and OTC Allergy medicine
The symptoms began on June 28th. I had a 103.5-degree fever, chest congestion, cough, malaise, and fatigue. I also had an additional loss of smell. I lost my sense of smell in COVID-19 episode in March of 2020. On June 30th, I had a positive COVID-19 test. On July 1st, I began taking PAXLOVID and MUCINEX DM. I also took TYLENOL as needed. The fever resolved after two to three days. The other symptoms, except for headache and fatigue, resolved by July 8th when I tested negative. As of July 26th, I am slowly coming back from fatigue and able to do most chores including horse care and weed eating. I only have an occasional headache.
1 week after the injection, the patients daughter reported that she had heat and a large area of redness, from the injection site to the elbow from the day of the injection to present. No SOB, nausea, headache reported.
PATIENT STARTED TO FEEL "LIKE THE ROOM WAS SPINNING" SO SHE LAID DOWN ON THE FLOOR. HER HUSBAND CAME AND GOT ME AND WHEN I WENT OVER TO CHECK ON HER SHE HAD BLACKED OUT. I GRABBED HER SHOULDER AND CALLED HER BY NAME AND SHE WOKE UP WITHIN A FEW SECONDS. SHE WAS EXTREMELY DIZZY AND HOT SO WE GOT HER AN ICE PACK TO COOL DOWN AND SHE REMAINED LAYING ON THE FLOOR FOR APPROXIMATELY 5 MINUTES UNTIL SHE WAS NO LONGER DIZZY. SHE SAID SHE GETS THIS VASOVAGAL REACTION ANYTIME SHE GETS A SHOT OR BLOOD DRAWS. AFTER 5 MINUTES, SHE WAS ABLE TO BE SEATED IN THE CHAIR WHERE I WATCHED HER FOR 15 MINUTES MORE. SHE WAS OKAY WHEN SHE LEFT.
injection site was pink; Soreness; nausea; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (injection site was pink), PAIN (Soreness), NAUSEA (nausea) and FATIGUE (tiredness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Diabetes.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (injection site was pink), PAIN (Soreness), NAUSEA (nausea) and FATIGUE (tiredness). At the time of the report, VACCINATION SITE DISCOLOURATION (injection site was pink), PAIN (Soreness), NAUSEA (nausea) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatments medications were reported.
Night of shot felt feverish (clammy and alternating sweats and chills) no fever. Very painful around shot area. Swelling increased for five days even with icing the area and ibuprofen.  Bruising started on day three and spread until day five.  On day five (peak of reaction) the swollen/red area was five inches tall and 3 1/2 inches across in the area between elbow and shoulder.  Did not know how to measure how elevated the swelling was, but guesstimate is about 100 mL worth of liquid in the area.  Starting on day five the bruising and swelling started migrating down the arm towards the wrist and also started moving to the inside of the arm.  But second week knots (sort of like bath beads) started forming and moving down the fore arm.  Took about 3 1/2 weeks for the knots/beads to go away completely.
was administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The pharmacist reported use of Shingrix dose to a patient and the vaccine was already expired on 17th October 2021, which led to expired vaccine used. The reporter consented to follow up via email.
some pain in my left shoulder; severe pain in my lower back; significant nausea; This is a spontaneous report from a contactable physician (patient).  An 82-year-old female patient received second dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on 10Feb2021 12:00 at single dose on right arm for covid-19 immunisation.  Medical history included ongoing allergy to perfumes/scents, ongoing allergy to linseed oil, ongoing chronic osteoarthritis (six joint replacements), GERD, hypertension.  Concomitant medication included duloxetine hydrochloride (CYMBALTA), enalapril, ferrous sulfate, gabapentin. The patient previously received first dose of bnt162b2 on 20Jan2021 11:00 for covid-19 immunisation and experienced no adverse event. The patient stated that, "I had no reaction, not even a sore arm, after the first shot.  However, for two days (Feb2021) so far after the second shot I have severe pain in my lower back, some pain in my left shoulder, and significant nausea." No treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The outcome of the events was not resolved.   Information on Lot/Batch number has been requested.
his arm to armpit region swollen, sore and pinkish; his arm to armpit region swollen, sore and pinkish; his arm to armpit region swollen, sore and pinkish/ swollen axillary my armpit area and tenderness and redness; swollen axillary my armpit area and tenderness and redness; He was not particular if it was a swollen lymph node/ swollen axillary my armpit area swollen axillary my armpit area and tenderness and redness; chills and fatigue; chills and fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Sep2021 (Lot number: FC3183) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single), administration date: 07Jan2021, for Covid-19 Immunization, reaction(s): "chills", "fatigue"; Bnt162b2 (Dose 1, Single), for Covid-19 Immunization, reaction(s): "chills", "fatigue". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Oct2021, outcome "not recovered", described as "He was not particular if it was a swollen lymph node/ swollen axillary my armpit area swollen axillary my armpit area and tenderness and redness"; CHILLS (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "not recovered" and all described as "chills and fatigue"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 01Oct2021, outcome "not recovered" and all described as "his arm to armpit region swollen, sore and pinkish"; ERYTHEMA (non-serious) with onset 01Oct2021, outcome "not recovered", described as "his arm to armpit region swollen, sore and pinkish/ swollen axillary my armpit area and tenderness and redness"; TENDERNESS (non-serious) with onset 01Oct2021, outcome "not recovered", described as "swollen axillary my armpit area and tenderness and redness".  Additional Information: Reported patient woke up with his arm to armpit region swollen, sore and pinkish. He was not particular if it was a swollen lymph node. Reactogenicity profile within seven days of the booster dose was typically mild to moderate, with frequency of reactions similar to or lower than after the primary vaccination series. Symptoms after the booster shot was just a little bit of fatigue itself and patient did wake up today on third day after with swelling under my armpit and tenderness and redness.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021006181 same patient, events with dose 3/ booster
Mom states pt awoke w/a hard cry @ 4AM high pitched cry for @ least 10 min @ the most & fever 104; pt given Tempra & bathed in lukewarm bath till fever reduced; @ 830AM fever was 101;
Cyst under right arm pit, Knee/toe/back pain, right arm tingling (falling asleep) at night, red painful bumps on legs, bumps in mouth, tired. Doxycycline started on 09Jul21.  X-rays and bloodwork scheduled.
Warm rash on arm at injection site, patient visited her doctor and was checked out and released.
Severe general muscle pain of the shoulder muscle that lasted 2 days. Continued sharp pain only at the immediate area where the shot was administered, especially when raising the arm.
Client received dose 1 of the Moderna COVID vaccine (lot 016C21A, exp 5/22/2021) at 1300. At 1305, patient's husband told EMT and PHN that the patient was not feeling well. Patient reported feeling anxious, nauseous, tremulous with blurry vision. Patient reported a history of syncope related to anxiety. Patient denied medical conditions or allergies. Patient takes vitamins. Vital signs: O2 99%, pulse 70, respirations 12, blood pressure 114/72. At 1310, EMT and PHN monitored patient as she transferred unassisted from the chair in the observation area to the zero-gravity recliner laying down. Patient reported she had eaten breakfast and did not work out previous to coming. At 1315, vital signs O2 99%, pulse 57, respirations 12, blood pressure 112/74. PHN offered Benadryl but patient declined. PHN encouraged patient to follow up with her provider and when to contact 911. Patient reported feeling better with symptoms improved. Patient ate a cookie, drank water, both from the vaccine site, and her own Gatorade. Patient requested to sit up, EMT positioned the patient sitting up at 1325. Patient reported mild dizziness, tingling in her feet, difficulty focusing visually, nausea returned, and new left leg numbness. Vital signs: pulse 69, O2 99%, blood pressure 118/84, respirations 12. PHN encouraged patient to drink water. Patient reported having similar reactions when anxious in the past. Patient focused on breathing and meditation to ease anxiety. Patient reported wanting to leave, PHN encouraged patient to wait for 30min since start of symptoms. Patient declined. PHN encouraged patient to follow up with her provider and when to call ED. Patient's husband left to bring the car up to the front curb. EMT walked patient out to the car. patient left walking with steady gait at 1337.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 25-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
Pain left shoulder continuing 9 days scale 1-10 (4-5) constant.
103 fever, hives all over arms, face brightened & local rxn 3 min p/immun; all s/s gone w/in 1 hr. Later in day had a low grade fever. Saw Md advised Tylenol no further f/u necessary.
A report has been received from a Physician concerning a 15 year old, female subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 15-Jan-2014. It was reported by Physician that eight patients were received expired FLUMIST on 15-Jan-2014. The outcome of the event of RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Immediately upon injection I experienced a strong metallic taste in my mouth and a sharp pressure in my head that ended up becoming quite a headache. I experienced a rapid heartbeat, which came and went for hours and then days. And I became sweaty, clammy, and unstable. I had to sit for 30 minutes because I am in the allergy group. During those 30 minutes I started to experience, muscle weakness and muscle fail to respond in my large muscle group and it radiated to the point at the 45 minute mark, I had difficulty walking to my car. My headache got worse and I just felt weak. At the 2 hour mark, I had a fever and general discomfort where I took Tylenol and the pain got worse at the 4 hour mark I took oxycodone I had that I never took but was prescribe. I was nauseous and shaky and overwhelmingly sleepy that I ended up sleeping for 5 hours and only waking up to take Tylenol because the chills and fever were so intense. The headache persisted from the pressure and the muscle weakness continued and got worse. Then going forward I continued to experience all of these symptoms for weeks in addition to the anxiety which I kept calling a physical anxiety, because nothing was bothering me mentally but it was all the physical symptoms get with anxiety. It was very disruptive. The heart rate was unstable and uneven for months off and on. and then I would have longer and longer periods through cycling with the effects, and they kept coming back. It took 6 months for the muscle weakness to resolve and the chills and fever to resolve. A year later I am still not back to normal, and even in the injection site pain is coming back. Again all these symptoms keep coming back and going away. But the problem is that it keeps coming back.
Non raised circular rash (10cm) around injection site.  Not swollen. No inflamation. No pain. Has lasted and just today beginning to fade. No other rashes on other parts of body.
At about 2Pm experienced pain and heaviness in left arm  shortly after radiating to back and abdomen . Then dizzy and weak. About 2:30 experienced chills followed by several episodes of severe projectile vomiting and diaphoresis. At 3 pm called Dr. service. Continued to vomit while waiting for return call. Dr called 20 min later recommended to go to hospital if throat felt tight. I continued to vomit or dry heave until 10 Pm have temp 100.4. Called daughter to stay with me in case needed to call 911. I had chills headache for hours. At 930 pm daughter said my lips and surrounding mouth was blue. Pulse oximeter read 78  Braething ok felt this was due to low bp at that time I was very cold could not get warm.  Vomiting subsides about 10:30pm. With intermittent chills x24 hrs.T99.4 next day. Remained in bed. Took about 4 days to feel better.The experience felt like I had been poisoned.
Patient hasn't received 2nd dose past 36 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose past 36 days) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose past 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose past 36 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication reported.  Patient received first dose of vaccine in January and hadn't received  2nd dose past 36 days.   Reporter did not allow further contact
Local, confluent, erythemic, itchy, raised area confined to upper, left arm/deltoid.
Weakness, fatigue, body aches, neck pain, daily fever beginning 48 hours after vaccine. Daily fever (triggers body aches) starting each morning with regular temperature increasing to 101.5 (max) every day around 4pm. Cross reactive antibody of epstein barr virus (mono). Positive EBV IVCA Igm 3 weeks and 2 days post vaccine.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Larger than normal swelling, almost "spider" web type spread.