chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 23-MAR-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one on several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
6 patients received the expired doses on 07Jan2022 and 12Jan2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received the expired doses on 07Jan2022 and 12Jan2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received the expired doses on 07Jan2022 and 12Jan2022). In January 2022, EXPIRED PRODUCT ADMINISTERED (6 patients received the expired doses on 07Jan2022 and 12Jan2022) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.   Reporter did not allow further contact
Pt had been feeling unwell (generalized malaise) for the past 10 days.  She suffered a ground level fall while in the shower and was found to have an occluding thrombus of the proximal ICA as well as COVID-19.
Left shoulder and left back and left upper arm area hurt really bad after the shot and it is December 2021 now  and it is still hurting really bad when I try to move my left arm up or turn it.  Even removing or wearing clothes lifting my arm extremely hurt.
The pharmacy received Moderna vaccine (lot number 069H21A, expiration 4/6/22) from the  Department of Health on 12/6/21 at 3:23 PM. The pharmacy miscalculated the beyond use date as 1/6/22, when it should have been 1/5/22 (30 days from the date received). It appears the pharmacy did not account for December having 31 days, which lead to the miscalculation. Patients administered vaccine after 3:23 PM on 1/5/22 received product that was past its beyond use date.
have many allergies; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (have many allergies) in a 78-year-old patient of an unknown 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (have many allergies). At the time of the report, ALLERGY TO VACCINE (have many allergies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment was reported.
given 12/27/20; arm became reddened approximately 3in by 5in area, warm and tender to touch over deltoid are on 1/2/21; on 1/3/21 the reddened area traveled down arm about 3 in; redness gone on 1/4/21
This spontaneous report was received from a medical assessment referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 24-MAY-2017, the patient was inadvertently vaccinated with one pediatric dose of VAQTA (lot # N012324, expiration date: 05-APR-2018) (frequency and route of administration were not provided) instead of one adult dose, for prophylaxis. No adverse effects were reported.
Pt recvd MMR vax; 7 to 10 days post vax pt devel fever 101-103, rash & malaise; Pt subsequently recovered;
fever and chills the evening following the second shot.  Sunday and Monday started experiencing itching on my legs. Monday during the night hives broke out on both of my legs itching uncontrobally.
Similar to reaction # 1 on 02/08/2012. Rotateq was administered, pt was swallowing without problem. Pt began coughing, but not gasping for air as at previous reaction. Nurse stopped administration about halfway through. Lungs were checked and were clear. Pt seemed to be breathing a little faster, but soon calmed down & stopped coughing. Appeared fine. Nurse called to check on her later in afternoon and mom reported no problems and said that she was fine.
c/o numbness in rt arm where recvd inject about 30 mins prior; @ inject site 1 cm area of induration/redness noted; no streaking sl tender; no motor/sensory deficits;
Vaccine administered at 1425, patient did not have any tinnitus at time of vaccine. At 1730 she began to experience bilateral pulsatile tinnitus that has been consistent to this moment. She reports it as high-pitched ringing like turning on an old TV.  Around that same time she began to experience a bilateral throbbing headache at her temples. The headache resolved when she went to sleep. The tinnitus has been persistent.
This  64 year old female received the Pfizer Covid shot on  4/6/21    and went to the ED on 4/20 /21     and was admitted  on4/20/21 with the following diagnoses listed below. I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) I63.9 - Cerebral infarction, unspecified R29.810 - Facial weakness
Client presents to vaccine site to receive additional dose due to immunocompromised one day early.  Client states he would like additional dose early as vaccine site will be closed tomorrow.  Medical consult team approves additional dose for today.  Client is vaccinated with Pfizer additional dose, no adverse symptoms reported in observation period and client is able to leave vaccination site.
My right shoulder needs to be replaced, so i got the shot in my left  shoulder, after 6 hours my shoulder started to hurt to the point that  I couldn't move it. this is 12 days after the shot and my left shoulder is in sever pain, much worse than the shoulder that needs to be replaced! I had  Covid  on 1/1/2021 and i'm thinking i got my shot too soon after having Covid.  should I get my second shot which is due on February 23, 2021??  I'm affraid my second shot may be worse than my first??
After receiving GARDASIL patients went to the lab. Felt lightheaded and starting sweating profusely as well as heart rate fell below 60. Epinephrine 0.3mg IM given as ordered by MD. Patient was transferred to Emergency Dept. for monitoring.
constant dull pain, muscle cramps & spasms in back up to neck-hurts w/movement;late w/menstral cycle-period due 15MAY has not had period yet;denies pregnancy;
Pt developed cellulitis on L deltoid area measuring 5" X 6 1/2". Tender to touch, red and warm. Started on Cephalexin and Benadryl (5/10/06).
pt had a positive COVID test 10/28/22; brought to hospital 11/4/22 with SOB; treated for septic shock, acute hypoxemic, hypercapnic respiratory failure secondary to COVID pneumonia, AFib with RVR; cardiology txmt; BiPAP, bronchodilators, mucolytics, steroids, ABX, Remdesivir; pt's condition worsened; uncontrolled A Fib; DNR with comfort measures only; transitioned to hospice and passed away in the hospital
started seeing things; shaking; A spontaneous report was received from a consumer concerning a 69-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and patient started seeing things and began shaking.  The patient's medical history, as provided by the reporter, included Parkinson's Disease and Dementia.  No concomitant medications were reported.   On 13-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 16-FEB-2021, after receiving mRNA-1273, patient started seeing things and began shaking. Event was considered to be medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   No treatment details were provided.  The events, patient started seeing things and shaking, were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Started with weakness and fatigue that evening. 10/31 cold and low grade fever in the morning. by evening, fever 102.4. 11/01 body aches, nausea, fever 102.6. 11/02- 11/04 nausea, milder body ache, low grade fever, vomiting, fatigue
White part of right eye is all red; achy; fatigued; headache; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), OCULAR HYPERAEMIA (White part of right eye is all red), MYALGIA (achy), FATIGUE (fatigued) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), MYALGIA (achy), FATIGUE (fatigued) and HEADACHE (headache). On 06-Mar-2021, the patient experienced OCULAR HYPERAEMIA (White part of right eye is all red). At the time of the report, PAIN IN EXTREMITY (arm was sore), OCULAR HYPERAEMIA (White part of right eye is all red), MYALGIA (achy), FATIGUE (fatigued) and HEADACHE (headache) outcome was unknown.            Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
11 X 8 cm erythematous area 3 nodule at injection site right deltoid with pruritus and warmth observed 4/9/07. Treated with Elocon cream qd, Zyrtec 10 mg qhs with improvement in 24 hrs.
I had headache, body ache, coughing, fatigue and running nose. These lasted for about 5 or 6 days but the fatigue lasted for about 3 weeks. On Dec 27th, I tested positive for COVID-19.
Large red rash at injection site.  Very hot skin.  Itchy and painful to touch.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The reporter was reporting arm pain that he experienced (for tolerance see case US2018152723) and mentioned that his doctor's wife (patient) also had the injection and that she had arm pain in the injected arm as well. Did not probe for additional information.
Headache; Muscle ache; Chills; Joint pain; injection site pain to left shoulder; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program.  A 67-year-old male patient received first dose of bnt162b2 (BNT162B2, lot number EL8982) , via an unspecified route of administration on 16Jan2021 12:40 at single dose on left arm for covid-19 immunisation. Medical history included COVID-19 from 11Dec2020 to an unspecified date.  There were no concomitant medications.  The patient received his first Covid 19 vaccine on (16Jan2021) at 12:40 and that all the symptoms began at 6:00 that evening. Stated that he recovered from headache one hour ago. Stated that he had a headache with muscle ache, chills, joint pain and injection site pain. Stated that he took Ibuprofen for his headache. The patient underwent lab tests and procedures which included covid test: positive on 11Dec2020, negative on 31Dec2020. The outcome of headache was resolved on 18Jan2021, of muscle ache was not resolved, of other events was resolving.
MUSCLE PAIN AND STIFFNESS IN LEFT SHOULDER, MUSCLE WEAKNESS IN LEFT SHOULDER, MUCH REDUCED RANGE OF MOTION IN SHOULDER MUSCLES, NECK PAIN, AND TINGLING SENSATION ON LEFT SIDE OF FACE. SYMPTOMS INCREASED OVER THE COURSE OF 4 DAYS, GRADUALLY DIMINISHED THEREAFTER. SORENESS PERSISTED OVER ONE WEEK.
Mild fever; Whole body pain; Chills; Headache; Nausea, gagging; Flu like symptoms; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever), PAIN (Whole body pain), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea, gagging) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Milk allergy.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PYREXIA (Mild fever), PAIN (Whole body pain), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea, gagging), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Body aches). At the time of the report, PYREXIA (Mild fever), PAIN (Whole body pain), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea, gagging), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Body aches) outcome was unknown. Not Provided          Patient concomitant medication includes Xyzal and vitamins. Treatment medicines were not reported. Action taken with mRNA-1273 in response to the event was not applicable
Fever 104 F within 24 hours of vaccination.  Also has vomiting, dry cough, headache and body aches.  Treated with 7 day course of Tamiflu
Information has been received from a physician concerning a patient who was vaccinated with Rotateq. It was reported that one to two weeks after the vaccination the patient developed abdominal pain and irritability. Current patient status was not reported. A product quality complaint was not reported. Further information was not available. Additional information has been requested.
Mother states child developed raised rash on torso, arms and legs on 6/08/05.  States," it is itchy."  Child also has a low grade fever. Mother states injection sites "look fine".  Mom states that child complains of "mild soreness at site of DTap and IPV injections.  Mother is giving child Ibuprofen for pain.
PT WAS IN PHARMACY PICKING UP RX FOR HIS WIFE ON 12/31/2019 AND MENTIONED TO ME THAT EVER SINCE HIS FLU SHOT HE HAS BEEN EXPERIENCING STIFFNESS AND MILD PAIN IN LEFT ARM WITH LIMITED MOBILITY.  IT USUALLY RESOLVES BY EVENING BUT REOCCURS WHEN HE WAKES UP IN THE MORNING. PT SAW MD ON 01/02/2019 AND HAS RECEIVED A RX FOR PREDNISONE
Sore throat, cough, congestion since Tuesday after receiving Moderna #1 vaccine; states cough got worse with increased green mucous; no meds today
(L) arm, (L) axillary, (L) facial pain and edema, (L) deltoid - pain and edema. Fever.
pt recv vax 28DEC96 & 15JAN97 a urine test was positive for pregnancy (LMP 25DEC96);medication during pregnancy included prenatal vitamins;lab eval on 17JAN97 revealed IgM 0 & IgG 48 for rubella;1FEB97 pt had spontaneous miscarriage;
Two days after receiving vaccine, client called and told RN she'd just found out she was pregnant. 8 Weeks per OB/Gyn (LMP stated to RN was 2/28/05).
RUA - red, swollen, hot to touch, itching 4.75"x5.25". Mother noticed on Sunday morning after child told her her arm itched. Temp 97 (ax).
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, Rash, Chills, arm soreness. Narrative:
Fever, staring episodes x3 lasting approximately 10 minutes in which baby unresponsive.
Information has been received from a registered nurse (RN) concerning a 16-week-old patient who was vaccinated with the first dose of Rotateq. It was unknown if medical attention was sought. Additional information has been requested.
Sore arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient experienced sore arm after receiving 1st dose of Shingrix. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189737:same reporter US-GLAXOSMITHKLINE-US2020189740:same reporter US-GLAXOSMITHKLINE-US2020189741:same reporter
Information has been received from a nurse practitioner for the pregnancy registry for GARDASIL vaccine concerning a 27 year old female with a history of 5 pregnancies and 4 live births and no pertinent medical history and no allergies who on 28-JAN-2008 was vaccinated with a first dose of GARDASIL vaccine 0.5 ml (lot # 655327/1287U). Other medication used during pregnancy included pre-natal vitamins, ZOFRAN ODT 8mg PRN for nausea (previously reported as vomiting), FERROUS SULFATE 325 mg daily for anemia and MACROBID 100 mg BID for UTI. There were no birth defects and no infant complications in previous pregnancies. The patient became pregnant after vaccination "34 weeks" ago. The date of last menstrual period was 11-FEB-2008. The estimated due date is 17-NOV-2008. The patient sought medical attention seen at the practice. The routine pregnancy work up was performed. On 31-MAR-2008 the ultrasound was performed. On 02-JUN-2008 MSAFF was performed with normal limits. Follow-up information was received from pregnancy questionnaire. On 10-MAR-2008 the routine pregnancy labs were performed within normal limits. On 29-JUL-2008 the glucose test was performed within normal limits. On 29-JUL-2008 the whole blood hematocrit ad blood hemoglobin test were performed with the results of mild anemia. On 14-OCT-2008 the vaginal Streptococcus group B culture test was performed with negative results. On 02-NOV-2008 the patient with 1 spontaneous abortion (incomplete abortion D&C done) delivered a male health baby weighing 7 pounds 6 ounces with apgar score 9/10 at 38 weeks. There was no congenital anomalies or other complication or abnormalities. There was no complication during pregnancy and delivery. Additional information is not expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ALLERGIES; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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 not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on 05-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 in 2021, the patient developed symptoms that the patient put down as allergies. There was an overlap between the symptoms of COVID and seasonal allergies including cough, sore throat, but when the patient experienced temperature, and body aches his partner suggested to do laboratory test. On an unspecified date in 2021, the patient's COVID-19 virus test for which result was positive and patient was diagnosed with suspected covid-19 infection and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and allergies was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210554707-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
The day after vaccine the patient reported to school nurse with rash. School nurse phoned mother of child that she had hives over most of her body, and swollen hands. Currently taking BENADRYL to control symptoms.
Per mother, patient had swelling of eyes, lips, nose, face x 1 day. Resolved spontaneously. Mother brought pictures on phone - difficult to ascertain. No swelling today. Mother insists I make a report.