chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the consumer for her physician. The age at vaccination was not reported. The symptoms were not delineated or explained by the reporter. The reporter denied permission to contact their physician.
9/15/21 pt had a positive COVID test; 9/17/21 pt to ED with COVID pneumonia; had another positive COVID test in ED; respiratory status worsened requiring CPAP; transferred to ICU; given Dexamethasone, Remdesivir, Lovenox, ABX; pt's condition worsened requiring intubation and vasopressors, high ventilation support; renal function worsened; dc'd Remdesivir and biologic agents; transitioned to comfort care; extubated and pt passed away in the hospital
+ Edema, erythema to LD (site of injection) post 24 hours after vaccination with Resp sx. 5/19/07 + purplish hue to site with increased edema extending pass L elbow, mom worried, seen at ER. Tx with Benadryl PO Q PM increasing itching.
SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side effects. This report was non-serious. This case, from the same reporter is linked to 20220200610 and 20220201530.
58 Hours post injection. Mom reports lips swollen, eyes swollen, wheezing. Mom also reports insect bite in hours prior to event, and exposure to perfumed bath product/shampoo.
This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown age and gender. Patient demographics were not provided. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L002419. expiry date-23-JUL-2017 (dose, route and anatomical location were not reported). No adverse effects were reported. Product storage temperature was 18 F, for a time frame of 30 minutes, there were previous administered excursions reported, 6 F for 10 hours and 5 minutes. Additional information has been requested.
Within 2 minutes of vaccine i became very light headed and needed to lay down and was sweating. This is common with me with any vaccine. Within 24 hours severe shortness of breath and severe chest pains. Went to 2 urgent cares. Was prescribed Prednisone and a Inhaler. Both did nothing. Symptoms got worse. went to my primary doctor who ordered a chest X ray which came back good. and a EKG which came back with a slight issue and referred me to a cardiologist next month. Was sent home to recover. Pain and shortness of breath got worse. Within a week after that i got severe headaches and the left side of my head arm and leg began to get numb and tingle sensation  which lasted about 48 hours. About 2 weeks after vaccine i began to improve. Chest pain started to go away and my shortness of breath as well. As of today 4-18-2021 no chest pain, and shortness of breath still comes and goes but nothing compared to weeks before.
Fever chills, body aches, soreness at injection site, migraine, and sore throat.
When RN administered vaccine, the liquid dose came out of connection between needle and syringe  and vaccinator is unsure if client received vaccine dose. Client and RN observed vaccine liquid down on arm.
Redness/sore on 4/20/17, swelling, warm to touch. Now using warm compress 2-3 times a day with TYLENOL and BENADRYL 25 mg every 8 hours. All on Left Deltoid.
Information has been received from a registered nurse concerning a 9 year old male with no allergies or medical conditions who on 17Jul96 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. On 06Jun05, the pt was seen in a doctor's office for multiple varicella lesions on the trunk and head. The pt was treated with diphenhydramine hydrochloride (Benadryl) and calamine. Subsequently, the pt recovered in mid June 2005. No diagnostic lab tests were performed. Additional information is not expected.
Received High Dose FLUZONE at 11:00 am and by 1:00 pm she started vomiting, fever, flu-like symptoms, trouble with balance and loose stools.
Headache, chills, 100.9 fever at its peak, soreness at injection site, mild nausea, hot flashes, nasal congestion, extreme fatigue
Very shortly after shot felt disorientated. I was on my way to another appointment and had to pull over to gather thoughts and try to regain my bearings. I went to my appointment but felt odd and immediately came home. I slept for fourteen hours. When I awoke had a serious headache which I thought to me expected due to the shot. However, headaches have continued to plague me and never did prior to and I have light headiness when I stand from a period of sitting, which has never been an issue before. The dizziness greatly concerns me.
Report completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 12/30/20 pfizer,Lot#EL0142 2nd dose: 01/20/21Pfizer,Lot# EL3247 Diagnosed covid positive:08/09/21 Symptom onset:08/07/21 Exposure:Home Symptoms:fever, cough fatigue,runny nose, muscle aches
injection after 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (injection after 42 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (injection after 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (injection after 42 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported. Consent to follow up was not obtained before the line was disconnected.
Muscle tightness all over body. Sensitive/ hurting skin all over. Heavy and drained of energy. Pain at level 10.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-DEC-2015 at 21:16, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 6.8 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
vaccine administered from a vial punctured more than 18 hours ago; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered from a vial punctured more than 18 hours ago) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medically reported history).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered from a vial punctured more than 18 hours ago). On 11-Mar-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered from a vial punctured more than 18 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment:This report refers to a case of expired vaccine used for mRNA-1273, lot # 027A21A  with no associated AEs; Sender's Comments: This report refers to a case of expired vaccine used for mRNA-1273, lot # 027A21A  with no associated AEs
Information has been received form a medical office concerning a 70 year old female with allergies to PCN and Demerol who on 27OCT2003 was vaccinated in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent. Concomitant medication included Nexium, nonsteroidal anti-inflammatory drug and estrogens. On 29OCT2003, the pt was seen with left upper extremity swelling , warmth and redness, was afebrile and had no infection. She was diagnosed with angioedema. The pt was seen again on 30OCT2003 and 05NOV2003 and had developed paresthesia of the upper arm and the swelling was decreased. It was noted hat an EMG was scheduled for next week if there was no improvement. Treatment included Benadryl and Medrol dose pack. Medical treatment was sought. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with (wistar ra 27-3) M-M-R II (lot#, expiration date, dose and frequency unknown) intramuscularly (inappropriate route of vaccination) for prophylaxis. No adverse symptoms reported.
Had shot at 6:30 pm on 1/24/17. The next morning, my eyes (both) were swollen, red, throbbing and light sensitive headache went to eye doctor 1/25/17 and 1/26/17. Follow up on 1/30
Patient eyes and hands became swollen and red 15-20 minutes after administering the immunizations. Patient given Benadryl .04ml and allergic.
Bruising on my arm and soreness.; Mild headache; Bruising on my arm and soreness.; This is a spontaneous report from a contactable other healthcare professional (patient). A 25-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EN6500), dose 1 via an unspecified route of administration, administered in left arm on 24Feb2021 18:45 (at the age of 25-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. On 25Feb2021 at 07:00, the patient experienced bruising on her arm and soreness and mild headache the day after injection. No Covid prior vaccination nor tested with Covid post vaccination. The patient received no treatment for the events. The patient recovered from the events on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Stated that symptoms started around 1am on 9/10/21 where he woke up with a fever and sweating. He then started having a real bad headache, body aches and fatigue that lasted throughout night and is still experiencing symptoms at this time. Also reported having right arm soreness where injection was given.
Much pain in left deltoid with a "knot" and swelling. States it was also red and warm to touch. (Had shot 10/11/17). States it was very painful and is still very sore today, 10/17/17. And is taking Tylenol .  Denies a knot still being there. No redness or warmth noted at site today. Has not missed work.
EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, and 1808986 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced expired product administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired product administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915852, 20210915731, 20210916228, 20210916312, 20210916455, 20210916553, 20210915748, 20210916658, 20210915719, 20210916910, 20210915661, 20210917226, 20210917160, 20210916465, 20210916697, 20210915646, 20210916808, 20210916715, 20210917163, 20210916768, 20210917515, 20210916965, 20210915623, 20210916300, 20210916584, 20210916811 and 20210918425.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Swelling in mouth, bottom lip, and tongue, sore throat Itching on entire body and head Rash on entire body --looks like sunburn  PCP prescribed-- Prednisone 10mg tab--12 day course on 04/5/21 Betamethasone  valerate 0.1% ointment on 03/25/21  Patient claims to be recovering
Arm so sore that I needed help dressing for two weeks. Now, I just use it with the pain.
Child was vaccinated in our office on 8/14/03. Received call from coroner on 8/15/03, that child had expired this morning. Reported was that grandmother heard child cry went into room and found child unresponsive. No further info available at time of completion of report. Autopsy Report received on 11/07/2003 states COD is SIDS.
Right ear tinnitus(from every now and then to continuous), very dizzy and hard to keep balance when moving, Sleep and tired, low blood pressure
dealt with cancer issues; sick; This is a spontaneous report received from a non-contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Caller got first dose of the covid vaccine and got sick, dealt with cancer issues. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
underneath my underarm on the side in which I was injected with this vaccine it has been swollen an has a not underneath my skin; swollen in my goin area; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (underneath my underarm on the side in which I was injected with this vaccine it has been swollen an has a not underneath my skin) and SWELLING (swollen in my goin area) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (underneath my underarm on the side in which I was injected with this vaccine it has been swollen an has a not underneath my skin) and SWELLING (swollen in my goin area). At the time of the report, LYMPHADENOPATHY (underneath my underarm on the side in which I was injected with this vaccine it has been swollen an has a not underneath my skin) and SWELLING (swollen in my goin area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The Treatment information was not provided.
It was reported that a patient received a Fluzone vaccination, Lot # UO593AA, date not specified. Reportedly, the patient developed a local reaction. Reportedly 14 other people also developed with local reactions after receipt of a Fluzone vaccination. From additional correspondence received on  03/28/01, it was reported that the patient was 57 year old female that received a Fluzone SV'01-'02 vaccination on 10/26/02 and developed a local reaction within two hours after administration. Additional vaccination was given was also provided. This case is linked to reports U2002-00237 and U2002-00238.
erythematous rash with blistering on left arm and hand. Loss of ROM of left wrist.
SHINGLES; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2018, the patient received the 1st dose of Shingrix. On 13th August 2018, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. The patient did not recall if injection was given on the left or right arm. The representative did not ask for batch number and route of administration of Shingrix. The patient experienced Shingles fiare ups had been ongoing and the patient had shingles to date. The patient was seen by an immunologist and his doctor recommended not to get the second dose of the Shingrix. The patient gave consent to be followed up.
Developed 2mm x 6mm white raised area above injection site 10 min after injection (Lt outer arm).
Husband had shot and has them now/Suspected vaccination failure; Husband has them now; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 79-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient's wife. The age vaccination was not reported. The patient got the Shingles vaccine and got the shingles. The reporter did not know, would the vaccine was Shingrix or Zostavax. The reporter inquired that was shingles contagious, as the patient had them now and the reporter's dermatologies said no. The pharmacist said that if the person exposed to the virus might develop chickenpox and the virus spreads through direct contact with fluid from the blisters of the shingles rash, once the shingles blisters have developed crusts, they were no longer contagious. The reporter informed that she heard that some who get Covid vaccine get shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The information regarding consent to follow up was not reported.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium
Within 10 minutes of receiving vaccine patient reported arm feeling tingly and numb which progressed to a squeezing feeling.  Slight shortness of breath.
Patient called clinic next day to report pain at injection site unlike any previous vaccine. Site painful, warm, instructed to warm pack and take acetaminophen. Went to ED but told they could do nothing. Called next day with less pain.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 7/3/21 (EW0176) Pfizer Dose 2 7/24/21 (FA7484) COVID Positive 10/11/21  10/11/21: History is obtained from patient as well as a personal review of records. Patient is a 58-year-old with known history of insulin-dependent diabetes mellitus, hypertension, sleep apnea, tobacco use, pancreatic stricture and other medical problems.  She had multiple episodes of pancreatitis in past.  Has seen Dr.  Pancreatic stents were placed and subsequently removed.  She presents to emergency department with abdominal pain, and other complaints.  She had cough for 1 month.  Has received antibiotics without much relief.  Reports nasal congestion.  Denied fever or chills.  Abdominal pain of 1 day duration.  Located in upper abdomen and radiates to back.  Rated as 5 on a scale of 1-10.  Pain medications help.    It reminded her of previous episodes of pancreatitis.  She had  elevated lipase in emergency department.  CT scan showed  ileus.  Her daughter tested positive for  SARS-CoV-2 last week.  SARS-CoV-2 result pending at the time of my examination.  10/16/21: Patient is a 58-year-old female who presented to the emergency department with some increasing abdominal pain complaints along with a cough.  There had been some nasal congestion with no fever or chills.  Elevated lipase was noted while in the emergency room with a CT scan that showed an ileus.  Patient was treated for abdominal pain secondary to acute on chronic pancreatitis and was initially placed NPO with IV fluids along with as needed pain medications.  In addition to this the patient was also found to have COVID-19 and was treated for this with IV remdesivir.  The patient did slowly improve and did tolerate advancement of her diet.  Patient completed treatment with remdesivir and was briefly on oxygen after she was admitted.  Patient was able to be weaned to room air and tolerated this with normal oxygenation.  On the morning of 10/16/2021 the patient had improved to the point where she was otherwise felt stable for discharge home. The patient's imaging studies, vital signs, laboratory studies, current medications and follow-up plan was all discussed. Patient indicated understanding.
right hip pain; right groin pain; This is a spontaneous report from a contactable nurse (patient). A 56 years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA: Lot number: not reported) via intramuscular route of administration in right arm on 31Dec2021 at 02:00 PM as a single dose for covid-19 immunisation (age at vaccination was 56 years). Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient's medical history includes hypothyroidism. Patient's concomitant medication includes synthroid, clonazempam, trintelliz, vitamin D, amytriptaline for unknown indications on unspecified dates. On 08Jan2021 the patient experienced right groin pain, right hip pain. Right hip pain increased on 11Jan2021. Patient did not receive any other treatment for the events. The outcome of all events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.