chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SLEEPLESSNESS; SWEATING; EXTREME MUSCLE CRAMPING; CHILLS; EXTREME MUSCLE PAIN; FEVER; HEADACHE; NAUSEA; PAINFUL INJECTION SITE; INJECTION SITE SWELLING; OFF LABEL USE; INCORRECT ROUTE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, subcutaneous, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On APR-2021, the subject experienced sleeplessness. On APR-2021, the subject experienced sweating. On APR-2021, the subject experienced extreme muscle cramping. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced extreme muscle pain. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced painful injection site. On APR-2021, the subject experienced injection site swelling. On APR-2021, the subject experienced off label use. On APR-2021, the subject experienced incorrect route of drug administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme muscle pain, chills, sweating, fever, headache, nausea, sleeplessness, painful injection site, incorrect route of drug administration, injection site swelling, extreme muscle cramping and off label use was not reported. This report was non-serious. This case, from the same reporter is linked.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
increased blood pressure; . This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 10:15 (Lot number: EN6205) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR [ATORVASTATIN] taken for blood cholesterol (ongoing); ULORIC (ongoing). Past drug history included: Lipitor, notes: Started 10 years ago, 5 years ago at a minimum, states let's just say 10 years. Vaccination history included: Bnt162b2 (First vaccine dose received on 14Feb2021, LOT:EL9266, Left Arm), administration date: 14Feb2021, when the patient was 62 years old, for Covid-19 immunisation. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 15Mar2021, outcome "not recovered", described as "increased blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased.  Additional information: Caller states that he is calling about the Pfizer Covid 19 Vaccine. Caller states that first of all he called yesterday and they took his information and he was on hold for 2 hours to get an agent and got cut off. No reference number available. Caller states that is alright, he just wanted to save some time entering information, not a problem. Caller states that he had his second vaccine on Monday 15Mar2021. States his blood pressure normally runs 117/76-77 but since the vaccine on Monday it is running 135/87 and is constantly up. He states the he wants to know if it is from the vaccine, maybe it is his immune system causing it? States the vaccine is the only thing that is different or could be causing it.  Treatment: None, states he doesn't not take blood pressure medication.  Clarifies that Monday evening it started, Tuesday he was taking a reading. States that the reason he took his blood pressure is because he keeps track of it anyway, he was not feeling strange or anything. States that he takes it [blood pressure] in the morning and afternoon and it doesn't change throughout the day. Clarifies that Monday evening the elevated blood pressure started, but he took his blood pressure for the first time on Tuesday morning. No Prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
pain at the injection site; tired for part of the day; This is a spontaneous report from a contactable consumer. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 05Jun2021 (at the age of 12-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medication within two 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 an unknown date in May2021 (at the age of 12-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 06Jun2021, the patient experienced pain at the injection site and was tired for part of the day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event pain at the injection site and tired for part of the day was recovered on 06Jun2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm pain , swelling, hardness Felt cold all night Upon rising, sudden  and severe diaphoresis, wave of nausea (without vomiting), passed out cold onto bathroom floor. Woke up disoriented sometime later (Time out?)  Felt "off" all day with a headache in the back of my head Went to bed early Friday night due to feeling tired felt relatively normal by saturday afternoon. (Vaccine was Th. morning)
delayed cutaneous hypersensitivity at injection site.  redness, itchiness, and mild soreness.  redness measures ~3 inches across.  first appeared around 9am on 4/14/21 (today) and still ongoing.
About a week after the moderna vaccine, I took my humira injection (which I administer in my stomach).  Later that day, my left arm started hurting.  It swelled up and developed a large red circle.  At times it itched a little.  Other times it felt like a bruise.  It went away after a week.  I was afraid that the humira medication was interacting adversely with the covid vaccine.  I saw on line that this was called "co-vid arm" and that other people have developed it.
This spontaneous report as received from a registered pharmacist via a company representative refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot number, expiry date and route not reported). The pharmacist reported that on unspecified dated, an unknown number of patients experienced a rash like injections site reactions, which included bubbling after receipt of ZOSTAVAX. The outcome of rash like injections site reactions, which included bubbling was reported as recovered (date unspecified). The patient sought medical attention, called the pharmacy. The causality was not reported. No further information is available.
Noticed on 3/16 the injection site had a little redness and a little itch.  It did hurt to scratch it. About the size of a nickel. By 3/17 am the injection site was much larger, very red, raised, and itched very bad.  It hurt more to scratch it. About the size of a half dollar. Today, 3/18, the injection site is large, very red, raised,  and still itches bad.  It is larger than a half dollar now.  Almost 2 half dollars. I have done my very best to not scratch it and have been advised to take Benadryl and use a cortisone cream.
My second dose of Pfizer was on 5/7/21 and I started getting a headache from 5/14/21. It is still going on as of 6/26/21.
atient felt subjective swelling and parasthesias in her tongue within first 30 minutes and eventually sensation of swelling in her throat within 60 minutes. There were no other secondary systemic/organs affected apart from mild transient hypertension. Given the strong concern for subjective airway compromise, I directed the administration of epi which the patient said she felt her throat relax after adminstration. 911 was called and patient was transported to ED.
Burst blood vessel in left palm. Pinky and ring finger bruising and numbness, and sudden strong pain similar to a Charlie horse felt throughout said areas. Dull tingling in fingers.
2days later, left arm and shoulder were swollen, erythematous, warm and painful.
started experiencing the pain in the back, a throbbing  pain, started in the bottom and going up; a throbbing pain, unbearable pain, started in the bottom and going up like a someone is hitting her; Unintelligible liver pain; Chest pain; could not breath/shortness of breath; blood pressure was low; chest wall were tightening up; like a someone is hitting her; This spontaneous case was reported by a pharmacist and describes the occurrence of BACK PAIN (started experiencing the pain in the back, a throbbing  pain, started in the bottom and going up), PAIN (a throbbing pain, unbearable pain, started in the bottom and going up like a someone is hitting her), HEPATIC PAIN (Unintelligible liver pain), CHEST PAIN (Chest pain) and DYSPNOEA (could not breath/shortness of breath) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient didn't have any allergies, no health problems, no diabetes. No other medical history was reported.    On 07-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2022, the patient experienced BACK PAIN (started experiencing the pain in the back, a throbbing  pain, started in the bottom and going up), PAIN (a throbbing pain, unbearable pain, started in the bottom and going up like a someone is hitting her), HEPATIC PAIN (Unintelligible liver pain), CHEST PAIN (Chest pain), DYSPNOEA (could not breath/shortness of breath), HYPOTENSION (blood pressure was low), CHEST DISCOMFORT (chest wall were tightening up) and FEELING ABNORMAL (like a someone is hitting her). On 07-May-2022, BACK PAIN (started experiencing the pain in the back, a throbbing  pain, started in the bottom and going up), PAIN (a throbbing pain, unbearable pain, started in the bottom and going up like a someone is hitting her), HEPATIC PAIN (Unintelligible liver pain), CHEST PAIN (Chest pain), DYSPNOEA (could not breath/shortness of breath), HYPOTENSION (blood pressure was low), CHEST DISCOMFORT (chest wall were tightening up) and FEELING ABNORMAL (like a someone is hitting her) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-1 test: positive (Positive) Positive. On 07-May-2022, Blood pressure measurement: low (Low) Low. On 07-May-2022, Heart rate: 85 85. On 07-May-2022, Oxygen saturation: 66 (Low) 66.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After the first booster patient got no problem.   No concomitant medications were reported.  After 5 to 10 minutes of the second booster, the patient experienced adverse events. Patient reported breathing deeply, felled better after sitting for 2 or 3 minutes.  Treatments taken were a glass water, and breath deeply in and out. Patient recovered from the events after 10 minutes.  The doctor suggested ECG to know if there was blood clot.
Initial and follow up information has been received from a health professional concerning an 44 yr old female with no reported medical history who on 29Oct04 was vaccinated IM in left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). Subsequently the pt developed redness, pain and swelling. In follow up, the healthcare professional reported that on 29Oct04 the pt developed redness, pain and swelling at the left deltoid injection site. It was reported that there was no concomitant medication and no lab diagnostic tests were performed. It was also reported that the pt fully recovered. No product quality complaint was involved. It was also reported that three other pt's experienced adverse events following admin of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P) (WAES0411USA02642, 0411USA03941, and 0411USA03942). Additional information has been requested.
Information has been received from office manager concerning a patient who on an unspecified date was vaccinated with GARDASIL. On unspecified date the patient experienced a rash at the injection site for 2 weeks. The patient contacted office. On unknown date, the patient recovered. Additional information has been requested.
This spontaneous report was received from a healthcare worker referring to a 3 month old patient of unknown gender. The patients' concurrent conditions and medical history were not provided. On 23-OCT-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
One day post vax pt developed generalized shaking, anxiety, headache, itching, and tightness is throat. Pt was seen in ER and treated with Prednisone, Benadryl and Zyrtec. Pt was referred to allergist for testing.
On Thursday, 11/18/21, I used the walk in service for vaccinations/immunizations. It was understood that my 8yo daughter was given the COVID Jr vaccine in the right arm and seasonal flu shot in the left arm. Today, 11/19/2021, I received a phone call from my local Pharmacy Manager,  calling to report that there was human error and that in fact my daughter DID NOT get the Covid vaccine but was given 2 flu shots. He asked about any symptoms which I explained that she reported right there after her shot in the right arm that her arm was burning. I gave my daughter Tylenol when we got home and she went straight to bed tired. She woke up this morning with sore arms and given another dose of Tylenol. Once I had received this information from pharmacist, I called Public Health, my child's school, and my daughters drs office for guidance. The school nurse took her vitals and screened her and reported that there were no other symptoms but soreness. Public Health informed me that they would be reaching out to the office to inquire if they would be completing a VARES but that either way they would do the same. At this time there have been no other symptoms but was told by pharmacist and Public Health that it can be 24-48hrs after.
Approximately 30 minutes after vaccine administered, I started to experience nausea. In another 20 minutes I started to have head pain. Within the next 2 hours I developed a fever, aches, chills, intensified headache, more severe nausea, and overall fatigue. These symptoms lasted through to the next day around 8 pm when I was finally able to sit up and walk around a bit.
Patient was given a Moderna Vaccine and is under the age of 18; no s/s of adverse reaction
Redness, warm. To lunch 11:30pm. Redness minimal , no resp. problem
- development of initial rashes on back and 1 side of torso 3 days after booster - rashes continue to develop 4, 5,  6, and 7 days after booster - development of headaches 7 days after booster
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients that received vaccines from the affected lots after the temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients that received vaccines from the affected lots after the temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients that received vaccines from the affected lots after the temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.The correct number of patients that received vaccines from the affected lots after the temperature excursion occurred was only 3 (three). No concomitant medication was reported. No treatment information was reported.Most recent FOLLOW-UP information incorporated above includes:On 12-Nov-2021: Follow-up received contains significant information. No of patients received expired product has been updated.On 12-Nov-2021: Follow up information received contains No New Information.
pt recvd vax & exp t103 & fusiness; pt was admitted to hosp for septic work up; temp returned to nl w/in 24 hrs of admission; pt was nursing well;
Breakthrough case admission after 5 vaccines Moderna 2/24/21 Lot# 024M20A;  Moderna 3/24/21 Lot# 007B21A;  Moderna 11/10/21 Lot# 077c21B;  Moderna 4/27/22 Lot# 056M21A;  Moderna 9/23/22 Lot# as7140C
Mother states the pt had a rash the night of 8/23/2000 after receiving the Hep A. Was not seen in the ER or clinic. Treated at home with cream. States cleared after 1 week.
Patient returned to the vaccine clinic a couple of hours after receiving vaccine with complaints of itching of hands, face, and neck. Patient refused diphenhydramine and stated it was the end of her shift and she was going home.
had exposure to family member positive for COVID. Tested due to exposure, had no symptoms. Tested positive on 3/30/2021.  Dept. Health verified tested for variant strain
had nausea and feels like vomiting; stated that her nose is running; has allergies; legs are all shaky; weak; gets cold chills down her legs to feet; aches in everything; cannot seem to do anything; she feels faint and has absolutely no stamina; extremely fatigued; can hardly stay awake; first couple of days had a splitting headache; aches in her muscles, joints and everything; aches in her muscles, joints and everything; This is a spontaneous report from a non-contactable consumer (patient).   A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on 20Apr2021 as Dose 2, single for COVID-19 immunization. Medical history and family history was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date for Covid-19 immunization. The patient's concomitant medications were not reported. After taking second dose of vaccine on 20Apr2021, the patient had splitting headache and aches in her muscles, joints and everything for first couple of days. The patient stated that kind of pain has gone away but had slight headache up until today (At the time of reporting). The patient was extremely fatigued and can hardly stay awake. The patient reported that a lot of her symptoms are kind of common and she cannot differentiate. She had nausea and feels like vomiting. Her nose was running, and she does not know if it was her allergies. The patient was weak, and her legs were really shaky. Therefore, the patient was bothered. She felt fainted and has absolutely no stamina. The patient stated that, when she does one thing, a little physical exertion and she was done, and she could not seem to get her stamina back like she could not seem to do anything. The patient was still having side effects. The outcome of adverse events (spitting headache, aches in her muscles, joints and everything) was recovering and outcome of other events was not recovered at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Whole body aches and lethargy that started approximately 3 am on 1/1/21.  Severe injection site pain starting approximately 9 pm on 12/31/20.
pt recv vax 19MAY97 & 20MAY97 pt devel a fever up to 103;
.8cm erythematous hot circular area @ site of inject; dec of motion of the arm (only 90 degrees) because of pain; 31JAN94 8cm red induration, tender;
Patient experienced dizziness, head pressure, and nausea.  She states she felt like her tongue felt weird, on exam her tongue was not swollen or discolored, etc.  She waited an additional 15 minutes past the 30 minutes after the vaccine and felt much better.  Vital signs were all normal.
LEFT ARM/DELTOID MUSCLE TENDERNESS AND SWELLING 4 HOURS POST VACCINATION AND PERSISTENT UNTIL TODAY 11/3/2020
ad cold like symptoms since 10/31/21, and tested positive for covid 11/3/21. nasal congestion, and runny nose.
Headache, paresthesia, anxiety, epigastric pain, chest pain, palpitations for weeks with  resolution in 3 months
ON 8-12-08ON PT C/O S.O.B.FEVER CHILLS AND COUGH CXR:BILATERAL INFLITRATE.ROCEPHIN 1 GRAM,AVELOX 400MG 1 QD #10 DAYS, Z-PAK #1, VALTREX 1 GR TID #30.ON 08-12-08 HOMEHEALTH IV HYDRATION 500ML BOLUS OF N.S. AND 2 GRAM ROCEPHIN IV.8-14-08 INCREASILY S.O.B. STILLC/O CHILLS, AND FEVER.REPEAT CX WORSENING BILATERAL PNEUMONIA/CT SHOWED INFILTRATES WITH EFFUSION. LAB SHOWED BUN OF 74, CRATININE 3.1, HEMOGLOBIN 9.3. HEMATOCRIT 28.2. PATIENT TRANSFERRED TO STANFORD HOSPITAL. 10/27/08-records received for DOS 8/14-8/21/08-DC DX: Shortness of breath. Respiratory distress. Presented with C/O SOB and pain/numbness in legs. Progressive SOB times 2 weeks and RLE swelling began after flight to Europe. Returned 2 weeks prior from foreign travel.
Case number PHEH2014US020652, is an initial spontaneous report from a physician received on 13 OCT 2014. This report refers to a male patient of an unknown age. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on an unknown date. It was reported that during administration some of the vaccine dripped down his arm. No adverse event was reported following this medication error (vaccine under dose).
Pharmacist did not add the diluent to the vaccine and drew up 0.5 ml and administered to patient on 06/19/2021. I found out the mistake 06/22/2021 and called the patient in question and they claimed to not experience any adverse events since receiving the vaccine.
Rash/Hives/Pruritis to head, face, neck, chest, abdomen and back Neck tightening Treated with Benadryl and Dexamethasone. Benadryl x 3 doses(25mg), Dexamethasone X 1 dose(8mg) Neck tightening resolved within an hour, Pruritis/rash, hives lessened within 4hours but continued into the nest day