chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 27-JUL-2012 the patient was vaccinated with the first dose of GARDASIL (dose and lot# not reported) (nurse did not know if this was GARDASIL or GARDASIL 9. On 17-NOV-2015 the patient was vaccinated with a dose of GARDASIL 9 (dose and lot# not reported) (confirmed not GARDASIL). The patient received GARDASIL 9 outside of the recommended series schedule. No adverse symptoms reported. The patient had not yet received a third dose. This is one of three reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On 17-DEC-2018, the patient was vaccinated with an expired dose of ZOSTAVAX lot # N025701, expiration date 16-DEC-2018 (dose, route and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent lot # N027626, expiration date 20-MAY-2019. No adverse effects were reported.
This case was reported by a physician and described the occurrence of intermittent left hand tingling in a 12-year-old male subject who was vaccinated BOOSTRIX (GlaxoSmithKline). On 14 October 2010, the subject received 1st dose of BOOSTRIX (unknown). On 22 October 2010, 8 days after vaccination with BOOSTRIX, the subject presented to the doctor's office complaining of intermittent left hand tingling and intermittent tingling bilateral in hands and feet that had been going on for three days. The physician reported that the subject has been otherwise a healthy kid. No further information was known at the time of reporting. At the time of reporting, the outcome of the events was unspecified.
Swelling at injection site. Itching in lips. Began 24 hrs after injection on Sunday - patient says they have history of allergies to NSAIDS. Contact Dr on call - advised patient to take BENADRYL. Patient will follow up with primary Dr. Tuesday 9/8/15.
really bad headaches after each dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (really bad headaches after each dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Dec-2012, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (really bad headaches after each dose). At the time of the report, HEADACHE (really bad headaches after each dose) outcome was unknown.            The patient had no concomitant medication.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-417050, MOD-2021-417033 (Patient Link).
Had vaccine at 12:30 pm., then had blood spotting in urine at 4:00 pm. the same day and continuing at this point (same day).  At 66 years old I am menopausal and have been for an extended number of years.  Called to report to my Dr. who had already left for the day.  Because it is Friday I will not be able to contact him until Monday, otherwise I am basically unaffected at this point.
Felt itchy and shaky after vaccine.  Left after 30 min.  She later developed hives and was seen at ED. Per ED notes, approx 1 hour after vaccine, she developed mild erythematous rash over upper chest/ collarbone region. Slightly itchy. She took benadryl PO x 1 with resolution of itching and rash within 1-2 hours. Patient has noted she is needing to clear her throat more often, feeling like it is "a little mucousy".  She does not have a frank cough. She denies SOB, chest pain, difficulty breathing, stridor, wheezing or nasal congestion. She does not feel her mouth, lips, face or tongue are swollen. She has no difficulty swallowing. She denies abdominal pain, vomiting, and diarrhea. Denies myalgias, headaches, chills or fevers at this time.   Discussed can use additional antihistamine as needed for further rash. Does not need epi IM at this time.  Reviewed common side effects for 2nd vaccine to expect in next 24 hours. Reviewed elevated BP and asked to recheck at PCP or next medical visit to monitor for possible hypertension
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 28-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (shingles back in 2017). In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, fever and general body pain. On an unknown date, the outcome of the shivering, fever and general body pain were recovered/resolved. It was unknown if the reporter considered the shivering, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, could be 27 to 28 yrs. The patient 28 year old who was now in healthy condition. Since the patient insurance would not cover the 2nd dose vaccine to patient under 50, so the patient decided to pay for both doses out of pocket. The patient received a dose of SHINGRIX and experienced shivering, fever and body aches. The patient wanted to know how long would SHINGRIX be effective for the patient to prevent a shingles flare up. All side effects subsided within 24 to 48 hours. This case was 1 of the 2 cases, reported by the same reporter for the same patient.
Two weeks after 2nd dose, patient had his annual physical.  PCP, found AFIB (1st time).  Tests listed in #19, and referred to cardiologist.  AFIB contra-indicated Amlodipine was switched out for another BP med, and started on Xarelto.  Possibility of shocking heart into normal rhythm after 6 months if no missed doses of Xarelto.  May have had follow up visits to doctors.  AFIB still evident.  Tolerating Xarelto, new med combo.
Pt was given the Abrysvo (RSV) vaccine 9/6/23 by a pharmacist who was doing an offsite RSV clinic. Pt had no immediate reaction to the vaccine but approximately 20-25 minutes later the patient was found passed out in the hallway. The ambulance was called and pt then became alert and oriented. Per the facility caregiver, pt has a history of atrial fibrillation and congestive heart failure. He was set to have an appt with his provider to follow up on this. Pt has had incidents like this in the past but I wanted to report this since I had given him the vaccine less than 30 minutes prior. Pt was taken to the hospital via ambulance since he was having runs of SVT with a. fib.
Does not itch, feels like sunburn; Oblong pink rash about 4 inches long and 3 inches wide below the injection site; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included positional tachycardia. The patient had a history of allergy to lobster, mussels, latex and garlic. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 13Mar2021 at 13:45 (at the age of 62-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 COVID-19 vaccine. On 03Apr2021 at 21:00, five days after vaccination the patient developed an oblong pink rash about 4 inches long and 3 inches wide below the injection site and she felt like sunburn but it did not itch. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events oblong pink rash about 4 inches long and 3 inches wide below the injection site and does not itch, feels like sunburn was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable physician (reporting for the daughter) via a Pfizer sales representative. A 18-year-old female patient received TRUMENBA (Lot # J29203, Exp date Jun2016, NDC number 100000003540), intramuscular in the left deltoid, on 05Aug2015 at 04:30 pm, at 0.5 ml single. Relevant medical history was not reported. Patient did not have illness at time of vaccination. Concomitant medications included TDAP (Lot # U4998AB), intramuscular in the left deltoid, on 05Aug2015; LEXAPRO tablet, oral, at 20 mg daily, for an unspecified indication and unspecified birth control tablets. The patient previously received first dose of TDAP on an unspecified date. The patient experienced tenderness, swelling, generalized aches on 05Aug2015 later in the evening and vaccination site rash (on left upper arm), patchy areas of raised redness on 07Aug2015. Event course was as follows: the patient initially had swelling, tenderness and generalized aches. Rash didn't show up until 07Aug2015. Rash appeared on left upper arm where injection site was. Rash was patchy areas of raised redness. No discharge. The patient was not admitted to the hospital. Events resolved on 08Aug2015. The reporter considered the reported events as related to TRUMENBA. Follow-up(10Sep2015); New information includes: reporter's details. Follow-up (28Sep2015): New information received from the same contactable physician includes: causality assessment. Follow-up attempts completed. No further information expected.
Pt received first dose of Moderna COVID-19 vaccine on 4/3/21, second dose on 5/1/21. Lot numbers not specified in electronic medical record (EMR). Pt was admitted to hospital 8/21/21 after initial COVID diagnosis via ER on 8/8/21. Pt admitted with intermittent breakthrough fevers as high as 102 degrees F. Persistent nausea, decreased appetite, SOB/wheezing. No vomiting. Pt admitted after substantial SOB on 8/21/21. Admitted to gen med, discharged home 8/23/21.
patient was sick and missed dose appointment; sick; Patient has only received first dose on 23Mar2021, has not received second dose.; This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient was sick and missed dose appointment), PRODUCT DOSE OMISSION ISSUE (Patient has only received first dose on 23Mar2021, has not received second dose.) and ILLNESS (sick) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has only received first dose on 23Mar2021, has not received second dose.). On 20-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient was sick and missed dose appointment) and ILLNESS (sick). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient was sick and missed dose appointment), PRODUCT DOSE OMISSION ISSUE (Patient has only received first dose on 23Mar2021, has not received second dose.) and ILLNESS (sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment medications were not reported  no concomitant medications were reported  for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.
Child started with rash around mouth. It then spread to face and trunk with itching. Child is breathing fine. He then started feeling very sleepy all within 15 minutes. Was taken by paramedics. The mother of the child contacted our office on 12/12/03. She described the event as a "serious allergic reaction" and informed me that EMS had administered a shot of epinephrine. The child was transported to the ER and later released. He is fully recovered and doing fine.
Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and mild malaise, wen to be early and slept all night. Next several days feeling extra tired especially in the evenings. On 1/12 I got up at 05:30 feeling fatigued and super tired, i call out work. I slept for most of the day and called occupational health (OH) and they scheduled a PCR Covid test for the next day 1/13, which came back negative. (1/14) still feeling fatigued, having palpitations and noticed my heart rate increasing significantly with mild exertion such as walking and eating, so I reached out to my PCP, who ordered labs and a second PCR Covid test for 1/15. Labs returned the next day 1/15 with elevated WBC and second Covid test came back negative on 1/16. Felt a bit better on Sunday 1/17, but today 1/18, I am still very tired and my heart continues to increase when I get out of bed, eat, shower or do any simple thing, my heart rate jumps from 64-68 to 115-120s,  called my PCP back and he is seeing me tomorrow morning for an EKG and other tests, and I have been out of work for a week. I take no prescriptions drugs and have no health problems.
Information has been received from a physician concerning a 40 year old female employee with hypothyroidism who was vaccinated with a dose of Varivax. Concomitant therapy included SYNTHROID. On 21-MAR-2006 the patient had a titer performed the result of which was 0.71. It was reported that normal at "their lab" was greater than 0.89. The employee did not recall if she had been vaccinated with Varivax or had the disease in the past. Unspecified medical attention was sought. The patient's outcome was not recovered. There was no product quality complaint involved. Additional information has been requested.
Patient had "sinus headache" at time of immunization and for 3 days before date of immunization. On 8/10/06 - he experienced tenderness at left deltoid injection site. On 8/11/06 patient experienced joint aches, muscle aches, low grade fever (99 degrees when taken on 8/13/06), chills, nausea, malaise and continued sinus headache. He took 600 mg Ibuprofen on 8/13/06 with improvement of all symptoms. All symptoms resolved as of 8-17-06.
Pfizer-BionTech Covid-19 Vaccine EUA  Woke up around 0530 AM, with a rash covering my chest, stomach, groin, scalp, and upper legs.  The rash was very itchy.  Took Benadryl and applied hydro cortisone cream which reduced the rash, but didn't eliminate in upper groin area.  If it doesn't subside, I'll be contacting my primary care.
Mild fatigue; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Mild fatigue) and PAIN IN EXTREMITY (injection arm soreness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (Mild fatigue) and PAIN IN EXTREMITY (injection arm soreness). At the time of the report, FATIGUE (Mild fatigue) and PAIN IN EXTREMITY (injection arm soreness) outcome was unknown. Not Provided          No Concomitant medications were reported. No Treatments were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-049781 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049781:crosslink
Diagnosed with bad sinus infection after returning from  (May 8-15).  Masks were worn at all times (inside and out) except when stationary and eating or drinking.  It was HOT and humid.  I had a lot of trouble breathing.  I was given a rapid COVID test which was negative.  I was given a shot of prednisone and a course of 15 pills orally.  I was also given a 10-day course of antibiotics.  I felt better, but I started having a lot of lung congestion and a bad cough.  I went back in two weeks later, and I was given another COVID test (negative) and a lung x-ray (not pneumonia).  I was told that my immune system was having trouble fighting the infection because of wearing masks for a year and that the cough would have to run it's course.  I still have a cough and I'm coughing up nasty yellow green stuff.  It is getting better slowly.
Patient refers lack of hearing, dizziness and nausea. Patient is pale and sweaty. Vitals are taken 110/60 BP, 99% oxygen, 65 pulse, and Dextrose 52. Glucose tablet is administered and Dextrose is taken with a results of 57. 20ml of syrup and after 5 minutes his Dextrose had a result of 77.
Shot given 7-21-20. 10:00 A.M. - 7-22 - Dinner feeling kinda sick - 34th feeling depressed and sick again. small headache, muscle pain ithing several places. 25th feeling better" still muscle pain - 26th - itching on same arm of shot. 27th still red on same arm - 27th Big whelp,swelled, getting hungry again  28th Noitching - a little red and real hungry -
Patient was asked prior to admin if he ever passes out with vaccines. Patient mother noted that he does get light headed around needles. Head of bed elevated so patient could lean about back in case of anything. Patient slightly anxious. Vaccines administered and advised patient to take a couple minutes prior to leaving. About 4 minutes later, mother updated us that patient was nauseated and felt like he was going to vomit. Patient given cold compress and water.  Patient symptoms relieved and patient left with mother.
Patient received Moderna vaccine 3/3/21 at 3 pm.  Patient reported next morning at 10 am, he had chills and severe weakness.  He also reported a fever of 102.  He had extreme weakness for a couple of days.  For the next week and a half, the patient states he was weak and had a cough.  He also reported sores on his lower lip that extended onto his chin.  He states he felt as bad as he did when he went into the hospital with COVID (December 2020).  The symptoms started resolving after a "couple of weeks."
she had some amount of lesions; lesions; rash; Thought I had poison ivy; Itchy rash all over my body from head to toe, front to back; Woke up in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Thought I had poison ivy), RASH PRURITIC (Itchy rash all over my body from head to toe, front to back), SLEEP DISORDER (Woke up in the middle of the night), ULCER (she had some amount of lesions) and SKIN LESION in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Thyroid atrophy, Type 2 diabetes mellitus and Hypercholesterolemia. Concomitant products included AMLODIPINE and LISINOPRIL for Hypertension, LEVOTHYROXINE for Thyroid atrophy, METFORMIN for Type 2 diabetes mellitus, and VITAMIN B and VITAMIN D for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DERMATITIS CONTACT (Thought I had poison ivy), RASH PRURITIC (Itchy rash all over my body from head to toe, front to back) and SLEEP DISORDER (Woke up in the middle of the night). On an unknown date, the patient experienced ULCER (she had some amount of lesions), SKIN LESION and RASH. On 01-May-2021, RASH PRURITIC (Itchy rash all over my body from head to toe, front to back) and RASH (rash) had resolved. At the time of the report, DERMATITIS CONTACT (Thought I had poison ivy), SLEEP DISORDER (Woke up in the middle of the night), ULCER (she had some amount of lesions) and SKIN LESION had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RASH PRURITIC (Itchy rash all over my body from head to toe, front to back) to be possibly related. No further causality assessments were provided for DERMATITIS CONTACT (Thought I had poison ivy), SLEEP DISORDER (Woke up in the middle of the night), ULCER (she had some amount of lesions), and SKIN LESION (lesions).    Patient washed the area and states she applied disinfectant for relief. The patient developed itchy spots on arms. On day 11 rash was on trunk and extremities. The patient denied SOB or difficulty swallowing and after a few days resolved. The patient was advised to use over the counter cream for pruritus and the therapy is for symptomatic relief.   This case was linked to MOD-2021-097574.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 and does not contain any new information On 08-Jun-2021: follow up received on 08-JUN-2021 Contains patient demographic details was updated. Medical history was added. Dose 1 details updated. Vaccination facility information added. Concomitant medications added. Events was updated.
On the first day of symptoms, experienced pins and needles in right wrist and hand. In the following days, the sensation moved to full right arm and right leg. The symptoms are still persistent at the time of this submission.
Patient presented to the hospital after experiencing chest pain, took ASA for the pain and upon arrival to ER, patient was chest pain free.  Patient tested positive for Covid-19. Heart cath done showing no obstructive coronary artery disease. Cardiologist thought the pain to be demand ischemia from aortic stenosis, covid and hypertension. No specific covid treatment done other than Lovenox, vitamin supplements. Patient was discharged home.
Patient is receiving vaccines in preparation for cochlear surgery.  After vaccination muscle soreness that afternoon.  On 08/05/ at 01:30 began to mow lawn but had to stop and rest because experiencing breathing problems got well after resting.  On 08/06 no problems noted.  On 08/07 also had breathing problems but might have been due to menstrual period was starting.  Mom usually experiences similar problems.  On 08/10 patient again had breathing problems when just started to Mow lawn.  Patient has been performing this type of activity all summer with no problems, only difference this instance is the vaccine.  On 08/10 had an adjustment with the chiropractor.  On 08/17 had another adjustment and complained of breathing problems after appointment, at 11PM had hard time breathing, Benadryl given.  On 08/18 had adjustment session for opening airways before leaving for camp, adjusted front of chest.  On 08/12, 08/17, 08/18 chiropractor mentioned that during the adjustment he found that the joints on left side were tight (same as vax received).  On 08/19 left for camp.  Today 08/24 patient is feeling much better but complains of some breathing discomfort still.