chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sweating; Muscle weakness; Feeling hot; excessive thrist; could not sleep all night; went to the bathroom several times; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), MUSCULAR WEAKNESS (Muscle weakness), FEELING HOT (Feeling hot), THIRST (excessive thrist) and INSOMNIA (could not sleep all night) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema on 10-Oct-1988. Concurrent medical conditions included Allergy to antibiotic (bactrim) and Lactose intolerance. Concomitant products included VITAMIN B COMPLEX and CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMIN & CHONDROITIN) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced HYPERHIDROSIS (sweating). 14-Jan-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), FEELING HOT (Feeling hot), THIRST (excessive thrist), INSOMNIA (could not sleep all night), POLLAKIURIA (went to the bathroom several times), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 16-Jan-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HYPERHIDROSIS (sweating), MUSCULAR WEAKNESS (Muscle weakness), FEELING HOT (Feeling hot), THIRST (excessive thrist), INSOMNIA (could not sleep all night), POLLAKIURIA (went to the bathroom several times) and HEADACHE (Headache) had not resolved.            Concomitant medication include: Multivitamins, glucosamin chondritin, vitamin b complex as nutrients no treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Added contact information patient  relevant history,  concomitant medication, events. updated patient contact information and demographics.; 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. Causality for Inappropriate schedule of product administration is not applicable.
I received my third dose on 06/08/22 and developed a rash at the injection site which lasted about a week. I took Benadryl and I used a cream to help with the itching. Dose 2 I received on 09/21/21 and developed welts and hives that lasted two weeks. I saw my doctor and they recommended taking Benadryl. Dose 1 I received on 08/15/21 and developed blisters on my legs which lasted two weeks. I saw my doctor and was prescribed a cream to help with the symptoms.
Vertigo and rapid heart rate 3 days after vaccine. Has not completely subsided one month later.
Breakthrough case. Took a cruise 1 day after 2 booster. Tested positive for COVID 1 month later. Did a home test, positive. Called Dr. and was prescribed Paxlovid. Took for 5 days, had fever and it started going down. A week and a half later, I was still testing positive, but had no symptoms.
This spontaneous report was received from a physician via a field representative, concerning a 67 year old male patient. The patient's medical history, concurrent conditions, drug reactions or allergies were unknown by the reporter. His concomitant medications included atorvastatin, gabapentin, furosemide (manufacturer unknown), meloxicam, SINGULAIR, omeprazole, doxycycline, and tramadol hydrochloride. In about April 2017, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose, route of administration, and anatomical location were not provided), for prophylaxis; concomitantly administered with a sterile diluent (manufacturer unknown). On an unspecified date in 2017, after vaccination, the patient developed an itching feeling on his trunk and what felt like a band tie around his chest feeling; so he sought medical attention and had a physician office visit but no treatment was given for the events and no laboratory diagnostic studies were performed. No product quality complaint (PQC) was involved. At the time of this report, the patient had recovered from the pruritus and the chest discomfort. The causal relationship between the pruritus and chest discomfort with ZOSTAVAX was not provided.
Narrative:  Patient presented for shingrex vaccine on 11/18/2020. reports a rash from the injection in the area where the vaccine was administered. A rash is a common side effect with the Shingrix vaccine, "erythema at injection site (38% to 39%), swelling at injection site (23% to 31%). "Per provider: " ASSESSMENT: 1. Probable drug reaction to Shingrix vaccine based on timing and rash."
I got diagnosed with fibromyalgia on Friday April 15, 2022. Symptoms are overall widespread pain, join pain and inflammation, brain fog, short term memory is affected, sometimes in different parts of my body feels dullness as if just vaccinated, anxiety, lethargy, and trouble sleeping. I was sent to physical therapy for 4 months.
Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician. This case is linked to case 2018SA237938, 2018SA237767, 2018SA237939. This case involves a 14 years old female patient who received 0.5 ml FLUZONE QUADRIVALENT (lot detail UI982AC, expiry date 30 June 2019) in left arm on 20 August 2018. This is actual medication error case due to Incorrect product storage as FLUZONE QUADRIVALENT given to 4 patients after shipment of vaccine shipped on Saturday and not received until the following Tuesday/improper storage these doses cannot be counted as valid. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Rash & UrticariaPruritus Narrative:  Other Relevant History:
12:45 pm Infanrix (DTAP) given IM LL.  PPD placed.  Crying subsided after 30 seconds.  1:15 pm became very agitated.  Round roused red areas noted inner thigh left leg.  Doctor attended.  1:25 red areas abating - still crying lesser degree.  Benadryl 12.5mg given po.  1:37 sleeping - no redness on leg.  Epinephrine 1000 0.1 cc given sc.  Walking and baby.  Talking with patient's father.  No further problems.
About 1 week after second dose, pronounced awareness of heartbeat and feeling of irregular heartbeat. Over next couple of weeks, significant increase in tiredness, shortness of breath during minor tasks, periodic dull pain in chest. Symptoms increased over subsequent weeks, but have leveled off or slightly decreased in the past week.
Info has been received from a healthcare worker concerning a 30 year old female with no allergies or medical history, who on 6/14/05 was vaccinated, SC, with a second 0.5 mL dose of varicella virus vaccine live. Concomitant therapy included "Zelmore". In approx. 1/06, the pt had blood work performed and she found out that she was negative for immunity to varicella. Unspecified medical attention was sought. At the time of the report, the pt had not recovered. A product quality complaint was not involved. No further info is available.
soreness on her arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "soreness on her arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Second dose of the vaccinewhich is an ongoing cutaneous rash all over the body; This is a spontaneous report from a contactable consumer (patient) via Pfizer- sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19 from Dec2020 to Dec2020. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on Feb2021 for COVID-19 Immunization and No reaction reported. Patient received second dose last Mar2021. She cannot remember the exact dates on when she received the first and second dose of the vaccine. Patient report very bad reaction after receiving the second dose of the vaccine which is an ongoing cutaneous rash all over the body on an unspecified date in 2021. The patient underwent lab tests and procedures which included Had Covid: Positive (She also mentioned that she had Covid last December 2020). The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
my left arm developed a rash and a red bruise the size of a dime.local pharmacist recommend a cortizone ointment [2nd injection] had loose bowel movements with 2nd dose.
Pain in left arm and  can?t move certain ways. I?m afraid to get the 2nd. Do you recommend?
Client complains of dry, hacking cough, recurrent fever, chills, stuffy nose since since second dose of COVID Pfizer vaccine.
development of unexplained chest pain shortly after Pfizer vaccination, second Pfizer vaccine given 4 JUN 2021 - same lot number as initial. chest pain has continued to recur multiple times per week despite negative workup to include normal echocardiogram, EKG's, troponins, CXR, trial of PPIs etc.
Had the following events:  muscle & joint pain, persistent tiredness for 4 days following  the shot. On the 3rd day following the shot I started sneezing regularly and having a stuffy head & runny nose. This lasted about 4 days. After  the sneezing started  to subside I started  experiencing a nasty head cold which then traveled to my chest and lasted for about 5 days.  Was coughing all day long.  Once those symptoms started to subside, about 2 and a half weeks after the shot, I broke out in a body rash which I'm still dealing with today and seems to be getting  a little  worse.  I'm currently at a dermatologist in the waiting room filling out this report.  The rash is very itchy & at times a tad painful.
Received vaccine after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Haemophilus influenzae type b vaccine (batch number 242A7) for prophylaxis.   On 31-DEC-2022, the patient received Haemophilus influenzae type b vaccine. On an unknown date, an unknown time after receiving Haemophilus influenzae type b vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccine after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter US-GSK-US2023AMR065353:same reporter
I was schedule for my vaccinations. The vaccinations were schedule to occur on campus. My first vaccination was scheduled for Sunday, Feb 14th, 2021, at 315pm.  My second vaccination was scheduled for Friday, Mar 5th, 2021, at 10am. I didn't realize until I was receiving a follow-up exam with my primary physician on 3.8.2021 that my second vaccine was administered at the 19 day mark, rather than after 21 days, as per Pfizer vaccination protocol. This must have also occurred with many other vaccine recipients who received their initial vaccination on the same day as I received mine.  While there have been no adverse effects that I can tell, I was instructed by my doctor to report the issue.
9/1/2021  - post vaccine ~ 7 hours: lethargy, muscle and body aches - extremely painful, hurt to sleep, chest pressure, shortness of breath, heart palpitations.  48 hours post vaccine - all symptoms except SOB, chest pressure and heart palps resolved.  Sought Cardiovascular work up - EKG normal, resting heart rate 100 (completely abnormal for myself), elevated BP.  Per Cardiologist - presentation appeared to be in line with myocarditis.  Recommended f/u if symptoms do not resolve.
PATIENT CALLED COMPLAINING OF SWELLING AND REDNESS FROM INJECTION SITE DOWN TO HER ELBOW. ALSO COMPLAINED OF HEADACHE SO BAD COULDN'T GET OUT OF BED FOR DAYS.
Fever chills and fatigue, injection site pain Narrative:  tylenol and ice recommended
10/27/04: Pt given immunizations. 10/29/04, parent returned to clinic to have child's PPD reading at that time.  Mother of child showed this writer pt's left upper arm, redness, warmth and tenderness and edema present 4.5x1.5 inch. Notified PA, evaluation of child done. Diagnosis of cellulitis of left upper arm and treated with Cephalexin antibiotics. Therapy for 2 days. Pt to follow up in 2 weeks.
Fever 12 horus after vaccine , myalgias and achign joints. No shortness of breath, no hives, no warm or red joints.
A 17 month old patient recievd Quadracel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00580846) and transmitted to Sanofi on 28-Apr-2021.  This case involves a 17-month-old male patient who received a 0.5 mL dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5763AA and expiry date: 26-Aug-2022) via an intramuscular route in an unknown administration site for prophylactic vaccination on 28-Apr-2021 (product administered to patient of inappropriate age) .  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error case due to extra dose administered (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Adverse Events: Trouble breathing, discomfort in chest/lung area. Trouble sleeping, discomfort in chest/lung area. Severe fatigue. Rapid heart rate and irregular heartbeats. Pulsing/throbbing in neck - left side. Nausea/dizziness. Lymph nodes under arms tender/swollen, discomfort. Symptoms began 2 days after 2nd vaccine dose. Treatment (Ongoing - symptoms persist): Several visits to primary care physician. Several EKG's. One visit to Urgent Care. Two visits to the ER. Blood work.  Chest X-ray. Carotid artery ultrasound. Assigned a vascular surgeon, consult appointment and follow-up appointments.  Assigned a cardiologist, consult appointment and follow-up appointments.  Wore a heart monitor for 2 weeks.  Stress ECHO test. Ultrasound both legs in ER to check for blood clots (found none).  Outcome (Ongoing - symptoms persist): Follow-up appointments with cardiologist, monitoring and consulting with both PCP and vascular surgeon. Monitoring and treating with medication for now. Follow-up appointments with Vascular surgeon. Increased {doubled} cholesterol meds/Crestor.  Symptoms continue, ongoing.
Erythema, induration 3cm X 4cm diameter, tender to palpation, pruritic. Started Ceclor antibiotics for concern of reaction vs reaction.
pain in my left arm where paramedic made the injection; temperature went up at 14.00 PM until 38,1 C, early this afternoon; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in my left arm where paramedic made the injection) and BODY TEMPERATURE INCREASED (temperature went up at 14.00 PM until 38,1 C, early this afternoon) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in my left arm where paramedic made the injection) and BODY TEMPERATURE INCREASED (temperature went up at 14.00 PM until 38,1 C, early this afternoon). At the time of the report, VACCINATION SITE PAIN (pain in my left arm where paramedic made the injection) and BODY TEMPERATURE INCREASED (temperature went up at 14.00 PM until 38,1 C, early this afternoon) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment Drug was provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Still hot at the site; At the site it is still red, a circle of 2.5 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Still hot at the site) and VACCINATION SITE ERYTHEMA (At the site it is still red, a circle of 2.5 inches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, HYDROCHLOROTHIAZIDE, HYDROXYZINE and PANTOPRAZOLE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Still hot at the site) and VACCINATION SITE ERYTHEMA (At the site it is still red, a circle of 2.5 inches). At the time of the report, VACCINATION SITE WARMTH (Still hot at the site) and VACCINATION SITE ERYTHEMA (At the site it is still red, a circle of 2.5 inches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not use any treatment medication.; 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.
Developed low grade fever few hours after vaccination and high grade fever, 103 degrees after and seizure 2 days after the vaccination.
For around 5-minute duration: - Stomach knot - Sudden strong sweating in the upper part of my body including my forehead, felt very hot - Dizziness  Never experienced such symptoms before in my life
Information has been received from a physician's assistant concerning a female who was vaccinated with her first dose of Gardasil. Subsequently the patient experienced "coagulation" (not further specified). The patient needed to return to see the physician's assistant on several occasions for unknown treatment or follow-up. Subsequently, the patient recovered from "coagulation". "Coagulation" was determined to be an other important medical event by the reporting physician's assistant. Additional information is not expected.
VIOLENT VOMITING AND DIARRHEA: started approximately 12hrs after administration of injection.  nausea started approximately 9pm that evening followed by first vomiting at 10:45pm with diarrhea shortly after.  Both continued for 4hrs. : patient went to ER for IV and anti-nausea medication.  Was in ER for 1-1/2hr.  Following was sore muscles, sore throat, sore ribs.
Damage to my kidneys; itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunization. Medical history included, patient had COVID-19 virus on an unspecified date in Jul2020, about 2 weeks after patient stooped having symptoms on an unspecified date in 2020, and started to get itching on arms and other parts of body. Long story short, several months later doctor and patient determined that the virus damaged the kidneys. Patient was in stage 3 of kidney failure. Concomitant medications were not reported. In late Mar2021, Patient got the first dose of Pfizer vaccine. After a couple of days of vaccination on an unspecified date in 2021, Patient got more intense itching and also determined that the vaccine caused more damage to kidneys. Patient questioned how can patient help determine why it caused damage. The event damage to my kidneys was assessed as serious - Medically Significant. The patient underwent lab test and procedure which included COVID-19 test resulted as COVID-19 Virus on an unspecified date in Jul2020. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Pt recvd DTP/HIB/OPV on 7APR92 & cried unconsolably for about 6 hrs which started about 4 hrs p/vax; pt fell asleep, mom states probably from exhaustion; then pt cried on & off x 3 days; mom called MD p/2 hrs of crying;