chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of injection site burning in an unspecified number of patient who received FLUARIX TETRA. On an unknown date, the patients received FLUARIX TETRA at an unknown dose. On an unknown, immediately after receiving FLUARIX TETRA, the patients experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown. The reporter considered the injection site burning to be related to FLUARIX TETRA. Additional details were provided as follows: The age at vaccination for the patients was not reported. The reporter had noticed a high percentage of patients who had received the FLUARIX QUADRIVALENT vaccine via the prefilled syringes for the 2016-2017 season and had experienced local injection site reactions including itching, burning, redness, swelling and hot feeling (refer case US2016132082). The patients concerned in this case had experienced only burning as the vaccine was being administered. The field representative was unable to provide any further details at the time of the call. The field representative was unable to provide any further details at the time of the call. The field representative was unable to provide any further details at the time of the call. The field representative indicated that this practice was a new user of the FLUARIX QUADRIVALENT product and had only been using the product for approximately two weeks before the time of reporting. He was also going to contact Medical Information.
Information has been received from a physician concerning an approximately 20 year old female patient who on an unspecified date, was vaccinated with the second dose of GARDASIL vaccine (yeast). The physician reported that the patient had an unspecified systemic reaction after receiving GARDASIL vaccine. The patient sought unspecified medical attention. Additional information has been requested.
Patient states that four days after receiving vaccine he started to get a rash that started on his arms and then progressed to his chest, back, legs. He stated the rash is itchy. He has tried no new soap, detergent, fabric softner or personal care products and no one else at home has the rash. The rash will calm for a few days but then comes back. Symptoms: SkinRash Treatment: DIPHENHYDRAMINE 50 MG QID, METHYLPREDNISOLONE use as directed per instructi
Pt became limp and was not breathing for about 1 minute. She was very pale and slightly foaming at the mouth. Mother did mouth to mouth, but pt still did not breathe for about 1 minute. Mother called 911. Pt was ok when EMS arrived. Pt was taken to ER by EMS and admitted by MD.
Patient received shot and told us about 2 minutes later that he did not feel good. His eyes rolled back into his head and he lost consciousness. He started convulsing and seizing for about 20 seconds.
About 1 1/2 hour later, I had severe nausea and vomited.  Light headache during the night time, fatigue and was super tire.  2nd day, diarrhea and nausea.  I had chills for 3 days, diarrhea for 2 days.  Light pain that randomly appears throughout the body.  On April 14, Severe bloated stomach started and nausea.  Drinking water and food would be have nausea feeling and threw up.  As of today April 19, 2021, bloated stomach and nausea is getting better.
Large, round, red, itchy, warm-to-touch rash at vaccine site with hard skin underneath with onset 13th day after vaccine. Increased fatigue and headaches a few days prior to onset and severe fatigue, nausea, headache and loss of appetite on day 15 after vaccine.
DTaP-HIB combo given before 15 months of age. No side effects reported.
Information has been received from a health care professional concerning a 25 year old female with no medical history and no allergies who on 21-FEB-2007 was vaccinated with GARDASIl vaccine (lot # 653736/0014U), intramuscularly. There was no concomitant medication. Later that evening she passed out. She hit her head when she fell to the floor. It was reported to be unknown if treatment was required. She called the doctor this morning and was taking the day off from work. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Follow up information was received which stated that the patient had weakness and fatigue at the time of the first intramuscular vaccination in the left deltoid of GARDASIl vaccine (lot # 653736/0014U) on 21-FEB-2007 at 16:45. At 17:30 that same day, post vaccination, the patietn expereinced lightheadedness, dizziness, chest tightening and passed out. No treatment was reported. At the time of the report it was unknown if the patient had recovered. Additional information has been requested.
After 3rd Anthrax injection in Aug. 99, pt.'s left middle finger began aching, then deformity of joints began in middle and little fingers of left hand.Left ankle aches sporadically. As of follow up information received on 06/16/2000 member has retired from the USAF reserves. He will be followed by the veterans administration.
Client received vaccine and began to feel a tingling sensation on his left hand and believed it looked blue. Assessed client.  Vitals all wnl.  no further evaluation needed.  Client released at 1:15pm.
Itchiness; Seemed like a severe bee sting; Very large,swelling; Sore/painful; Normal side effects at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Normal side effects at the injection site), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Seemed like a severe bee sting), VACCINATION SITE SWELLING (Very large,swelling) and VACCINATION SITE PAIN (Sore/painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE REACTION (Normal side effects at the injection site). On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Seemed like a severe bee sting), VACCINATION SITE SWELLING (Very large,swelling) and VACCINATION SITE PAIN (Sore/painful). On 05-Feb-2021, VACCINATION SITE REACTION (Normal side effects at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Seemed like a severe bee sting), VACCINATION SITE SWELLING (Very large,swelling) and VACCINATION SITE PAIN (Sore/painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (he got his third dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A, 046B21A and 004C21A) for COVID-19 vaccination. Concurrent medical conditions included Heart disease, unspecified and Atrial fibrillation. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced ACCIDENTAL OVERDOSE (he got his third dose). On 01-Jul-2021, ACCIDENTAL OVERDOSE (he got his third dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product information, if any, was not provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up Information received on 01-JUL-2021 doesn't  contains any significant Information.
Swollen right arm - upper arm, seen about 24 hours after immunization.  Improved in 48 hours.
was administered to a patient was from the refrigerator and the temperature is 41 degrees F; This is a spontaneous report from a Pfizer sponsored program. A contactable Pharmacist reported for a male patient.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The reporter reported that a Pharmacist called with regards to the stability. She wanted to know if there was any flexibility with the previous information on the website, that the COVID-19 vaccines should be used after reconstitution before 6hrs at room temperature. At the onset of the call, she also mentioned that morning, a patient was administered with a vaccine that was already 1hr and 40 mins expired. After clarification, the caller said that there was no temperature excursion. The Pfizer Covid-19 vaccine that was administered to a patient was from the refrigerator and the temperature is 41 degrees F. Outcome of the events was reported as Unknown.  No follow up attempts are needed. No further information is expected.
4/8/21 @130am: nausea vertigo extreme headache and pressure to forehead and back of head. Fatigue& muscle soreness, chills and hot flashes without fever. 4/22/21@1130 pm: nausea with vomiting, vertigo extreme headache with pressure to forehead and back of head, chills and hot flashes without fever.  4/27/21 today I am still unable to bend head down without vertigo, and headache and pressure to back of head and forehead continue.
pt recvd vax 10:45 10-15 min later, pt appeared to have sz-turned white, not pale; eyes rolled back; slumped or slid out of his desk;started to thrash & shake;mouth opened; eye dilated went on for 1-2 min, then color & pupilnl;had no memory
Woke up morning after with body aching all over, fever and chills. Took Aleve for pain and laid down at approximately 2pm. Slept until 7pm. When I woke up, I felt great, no more pain, chills or fever.
Headache, sweating, 12 red itchy spots on left leg and foot, 8 red itchy spots on right leg and foot, 4 itchy red spots on left forearm, 6 itchy red spots on right arm and shoulder. The spots looked similar to flea bites in size about the size of a notebook hole. Treated with BACTINE Spray and Calamine lotion. The left injection site arm was extremely sore for three days. Sleeping was difficult with the sore arm but extreme tiredness was experienced and slept for 10 hours straight the day after having the shot. Some residual very small scabs remain from the original spots after three days everything seems to be back to normal.
FLU LIKE FEELING (FEVER, CHILLS, BODY ACHE); This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the subject experienced flu like feeling (fever, chills, body ache). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like feeling (fever, chills, body ache) was not reported. This report was non-serious.
has been in contact with his family (wife and child) who tested positive for the coronavirus; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown dates (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had been in contact with his family (wife and child) who tested positive for the coronavirus and would like to know if he should get his second dose of the Covid vaccine. The outcome of the event exposure to COVID-19 was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
covid arm - rash and itchiness around the injection side.  Some mild arm pain.  I have arm pain for a week and the rash and itchiness has been around for at least 4 days.
Pregnant patient received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient received vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy. Concomitant products included FOLIC ACID, IRON, MINERALS NOS, VITAMINS NOS (PRENATE [FOLIC ACID;IRON;MINERALS NOS;VITAMINS NOS]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 08-May-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient received vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2020, Pregnancy test: positive (Positive) Positive.         Patient test included Genetic with normal result . No treatment information was provided.  The patient did not experience any pregnancy related complications or other acute illnesses.
After Moderna booster received on 29Oct 2021, still COVID positive results on 20Jan2022.
presents to ED complaining of shortness of breath, general weakness and fatigue, cough and sore throat for past 3 days. Pt had a positive at home covid test on 11/25/21. He was feeling OK then but has steadily been feeling worse. Today he is losing his breath with any activity. He has occasional cough, which has been dry but is hacking when it occurs
This spontaneous report was received from an other health professional (nurse) refers to unspecified number of patients of unkown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB. No adverse symptoms were reported. The temperature excursion for RECOMBIVAX HB was supported with in-house stability data. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with RECOMBIVAX HB. This case is related to MARRS# 1410USA015443, 1410USA015943 and 1410USA015945. Additional information has been requested.
This is a serious spontaneous case, initially received from other non-health professional (consumer) on 25-Mar-2019, concerning a 05-weeks-old infant male patient. The patient's mother was a 33-year-old, female patient. The patient's mother had 4 previous pregnancies in which two were miscarriages. The patient's mother had no maternal or paternal medical history. The patient's mother last menstrual period (LMP) date was 16-May-2018. The current condition of the patient's mother included hypothyroidism and concomitant medication included levothyroxine. The mother had not used any contraceptives. At approximately 22 weeks of gestation, on 17-Oct-2018, the patient's mother received FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for active immunization against influenza. The patient was exposed to the vaccine via transplacental route (explicitly coded as foetal exposure during pregnancy). The estimated date of delivery (EDD) was reported as 20-Feb-2019. On an unspecified date, the mother delivered a male neonate. On an unspecified date after vaccination, the patient experienced fever, cough and nasal congestion and was diagnosed with an upper respiratory tract infection at 5 weeks. The patient had no other conditions and had not received any treatment/ medication for this infection. The outcome of the event fever was recovered on an unspecified date (reported as lasted for less than 24 hours), the outcome of the events cough, nasal congestion was not recovered, and upper respiratory tract infection was recovering. This case is linked to 201804617 (mother-baby case). Reporter's Comments: A 05-week-old male infant experienced fever, cough and nasal congestion and was diagnosed with an upper respiratory tract infection at 5 weeks, on an unspecified day after receipt of FLUCELVAX QIV vaccine administered to mother at approximately 22 weeks of gestation (explicitly coded as foetal exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event, inactivated nature of the suspect vaccine and infectious aetiology of the reported event, the causal role of suspect vaccine was assessed as not related. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the event 'upper respiratory tract infection' as serious (medically significant).
Got COVID-19 after receiving the Moderna COVID-19 vaccination; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Got COVID-19 after receiving the Moderna COVID-19 vaccination) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced COVID-19 (Got COVID-19 after receiving the Moderna COVID-19 vaccination). At the time of the report, COVID-19 (Got COVID-19 after receiving the Moderna COVID-19 vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that patient had no allergies. No treatment medication were reported.  Company Comment: This is a spontaneous case concerning a 79-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a booster dose of mRNA-1273 vaccine. The dates of vaccination of the previous doses of COVID-19 vaccine was not provided in the case. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 79-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a booster dose of mRNA-1273 vaccine. The dates of vaccination of the previous doses of COVID-19 vaccine was not provided in the case. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I developed a blood clot or deep vein thrombosis in the ulnar vein in the left upper extremity. On set of symptoms NOV2022 with routine bloodwork drawn from upper left extremity of minimal swelling pain and discoloration that continued and increased or worsened. Symptoms confirmed with Doppler imaging DEC2022 treatment was initiated with ELIQUIS and treatment continues at this time.
Head pressure, nausea, metallic taste, dizziness, flushed faced, Epi 0.3 mg given with relief
9:00 PM dizziness, patient felt itchy, puffy rash. Took Benadryl, rash appeared again.
pt recv vax; exp a stomach cramps, general fatigue, a HA, v,d, flu like sx & "was very congested over the phone";was instructed to see MD;RN felt there was a problem w/ the particular lot vax;
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age. On an unknown date the patient was vaccinated with doses of improperly stored (Merck) VARIVAX (unknown lot #s and expiration dates). The vaccine was stored under -8 degree Celsius for 8 hours and 33 minutes. No previous temperature excursion. No adverse effect was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vomiting, diarreah, became unresponsive, convulsive seizure; was put on a ventilator.
Painful; Unable to raise arm that received the injection dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th April 2019, couple of hours after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient reporter for herself. The patient received Shingrix her left arm.    A few hours after injection, she experienced painful and unable to raise arm that received the injection dose. The event was improved over the next few days and had resolved. The patient consented to follow up and provided her doctor's details.
Big red hard spot at injection site about 3 days after shot itches and very swollen still a week later.
Soreness at injection site continues as of 2/20/18. Extreme pain in each shoulder requiring 2 ER visits to Hospital. Swelling of hands, feet, joint pain and stiffness. Inflammation numbers very high. No previous symptoms prior to the shot. Inflammation, pain and stiffness continues.
Pt. irritable pm of 1016-02. Parent administered Tylenol. Thursday (1-17-02) noon, temp 104 degrees F. Pt to Md's office
Information has been received from a licensed practical nurse concerning a 13 year old female with diabetes and no known adverse drug reactions or allergies reported. On 8/30/06, the pt was vaccinated IM with a 0.5ml dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653937/0637F). Concomitant therapy included insulin. On 9/9/06 the pt developed a yeast infection. It was reported that the pt had vaginal itching since receiving HPV It was reported that the pt underwent a vaginal swab which came back positive for yeast. The pt was being treated with Monistat. the pt was treated with the over the counter medication and was not required to follow up with the physician at this time. According to the licensed practical nurse, the physician did not feel that HPV was the cause of the yeast infection and that it was the pts mother who inquired about the event. At the time of this report, the pt had recovered from the yeast infection (date unk). No further information is available.