chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. Concomitant products included atorvastatin calcium (Atorvastatin), methylphenidate hydrochloride (Concerta), methylphenidate hydrochloride (Ritalin), spironolactone and fluoxetine. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site rash and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site rash and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site rash and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left lower forearm.
temperature excursion involving unopened ADACEL PFS with no reported adverse event; Initial information received  on 07-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced temperature excursion involving unopened adacel pfs (pre-filled syringe) with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6984AA via (unknown route and strength) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "temperature excursion involving unopened adacel pfs with no reported adverse event "(product temperature excursion issue) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion involving unopened ADACEL PFS with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion involving unopened adacel pfs with no reported adverse event.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was reported. No concomitant medication was reported. Vial was moved to fridge on 06-Oct-2021. Vaccine was administered past the 30-day from the initial storage at 2 degree Celsius to 8 degree Celsius.
She wants to get the smaller dose for the second one instead of full 30 mcg. She thought its too much and too toxic; she feels weird after getting the first shot; She feels shaky and quavering inside; This is a spontaneous report received from a Pfizer sponsored program via a contactable consumer (patient herself). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch and Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date it was reported as the patient mentioned that she doesn't want to get the full dose of 30 mcg shot because she feels weird after getting the first shot, she feels shaky and quavering inside. She wants to get the smaller dose for the second one instead of full 30 mcg. She thought its too much and too toxic. She is saying that she knows that there is a small risk but every day she is just reading stuff. Its toxic, poison and we need a smaller dose. The vaccines are not only based on people weight they are also based on people age. She is a small person and receiving the same dose as her husband is four times. She wants to know if she can get the second dose and not the full shot of the dose, if not if she can just get one dose of the vaccines since she cannot tolerate the side effects. She is wondering if there is any information on taking partial doses of the COVID vaccine as she does not want full dose. The seriousness of the events was considered as non-serious. The outcome of the events was unknown.   Information on lot/batch number has been requested.
Patient noticed redness and swelling at injection site, which progressed down arm (front) and across chest. Also had flu-like symptoms.
weight loss; has also been nauseous ever since; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (weight loss) and NAUSEA (has also been nauseous ever since) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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, 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 WEIGHT DECREASED (weight loss) and NAUSEA (has also been nauseous ever since). At the time of the report, WEIGHT DECREASED (weight loss) and NAUSEA (has also been nauseous ever since) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Live significant FU appended: patient age, dosing regimen.
Pt had her J and J vaccine on 5/18/21. now hospitalized from home on 6/15 with a few days of chest pain and admitted with sepsis, UTI, dense rll pneumonia and new svt/tachycardia/NSTEMI, syncope, rhabdomyolysis. her hospital course was very protracted due to recurrent tachycarida/svt and she was eventually discharged to rehab on 6/23/21.
Information has been received from a Registered Nurse concerning a 5 year old female patient with no drug reactions or allergies and with no pertinent medical history, who on 11-AUG-2005 and on 13-FEB-2009 was vaccinated with the first and second dose of VARIVAX (Merck) (dose and route not reported, lot #s 650227/1110P and 662184/1398X), respectively. No other co-suspects were reported. No concomitant medications were reported. It was reported that, on 22-JUL-2012, the patient developed rash described as "several, about 10 - pimples, hollow, <1mm to 2mm on trunk. Less of 50 lesions with no fever. It was also reported that the patient did not have history of chicken pox. It was reported that the patient was diagnosed with rash on 23-JUL-2012 by the physician. No laboratory tests were reported. The patient recovered from rash on 27-JUL-2012 (duration: 6 days). Additional information is not expected.
Patient had a new onset seizure, initially focal and then generalized that required midazolam to cease. It lasted approximately 20 minutes. He is now under observation in hospital. He has normal physical exam. No fever. Normal vital signs.
FELT TIRED; FLU-LIKE SYMPTOMS (CHILLS AND HEADACHE); SORE LEFT ARM; BOTH HANDS HURTING AS WELL; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced flu-like symptoms (chills and headache). On 12-APR-2021, the subject experienced sore left arm. On 12-APR-2021, the subject experienced both hands hurting as well. On 13-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (chills and headache), sore left arm, and both hands hurting as well on 13-APR-2021, and felt tired on 14-APR-2021. This report was non-serious.
a dose of PROQUAD that was accidently administered to a 17 year old patient; This spontaneous report was received from a nurse, referring to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant medications were not reported.  On 16-AUG-2022, the patient was accidentally vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, vaccination squeme, anatomical site and route of administration were not reported) Lot No. U039955 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date not reported, but upon internal validation established as 14-JUN-2023 (product administered to patient of inappropriate age).
One AM 10/30/2011 Neck and Headaches, chills, teeth chattering, Bones hurt all over - Jaws sore. Slept most of 10/30/2011. Very weak and bones really ached. Felt better on 10/31/2011 But still weak.  Had 2 dizzy spells on 11/2/2011.
Information has been received from a pharmacist referring to a 68 year old female immunocompetent patient. The patient had no pertinent medical history or drug reactions/allergies. History vaccine included PREVNAR 13 vaccinated on 21-DEC-2015. On 18-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # L022795 with expiration date of 05-NOV-2016, dose, strength and route unknown). There was no concomitant medication. On an unspecified date "over the weekend" after 18-FEB-2016, the patient developed a "red rash" and horrible pain with heat at the injection site of PNEUMOVAX 23. No treatment was given for the events. The patient was recovering from the events. Causality was not provided. Additional information has been requested.
PT GIVEN PEDIATRIC DOSE OF PFIZER, SHOULD HAVE BEEN GIVEN ADULT PFIZER VACCINE
Patient was unable to provide specific timeline on the onset of symptoms on 2/11 but reported adverse event to our office (PCP) approximately 15 hours after receiving injection.   Per ER provider note 2/11/20: "Pt was given the pneumovax vaccine shot yesterday. Since then it was very swollen and painful. She has felt tired all day and has minimal sleep. Pt's daughter was concerned about her and has been afraid to let her sleep. Daughter noticed some redness to the area today. Her pain is on the lateral aspect of the deltoid and has radiation of the pain to the posterior aspect of the shoulder. She tried 1000mg of Tylenol today with minimal relief. On further questioning, pt remembers that the person who gave her the vaccine yesterday couldn't find alcohol wipes. She remembers that she was runnign around looking for them, but couldn't find them. Pt is unsure if the area was cleansed prior to the vaccine. "  After ED evaluation on 2/11/20, patient given prescription for Keflex 500 mg qid x 10 days. While in ED received IV fluids and ketoralac 15 mg.  Patient then returned to ED on 2/13 with this assessment by ED MD:  "Patient was seen by her primary care physician on 2/10 and had an inoculation performed at that time.  Shortly thereafter patient began developing swelling and erythema of her left upper extremity where she got the injection.  She seen in the emergency room on 2/11 and started on antibiotics with Keflex.  She did fatigue since that time but afebrile.  Her symptoms seem to improve, however this evening it began to worsen with increased erythema and worsening swelling of the left upper extremity.  No weakness or numbness.  Has been taking her antibiotics as prescribed.  No fevers at this time.  Reports that the pain is been improved since being on the initial antibiotics."   Patient was prescribed Bactrim DS bid x 10 days for treatment to expand coverage for MRSA.   Patient followed up with PCP Dr. on 2/14/20 for follow up.
PT C/O DIZZINESS. DENIES ANY OTHER PROBLEMS. NO SOB NOTED.  BP 158/98  HR 94 O2 SAT 98%  PT STATES SYMPTOMS ARE RELIEVED @ 10:55 AM AND LEFT THE OBSERVATION SITE @ 11:00 AM.
Pt recv vax on 9/8/98; on 9/9/98 pt exp soreness LA;later in day-edema red patch 3-4" diameter LA, hot,very sore below injection site;tx=Tylenol,Benadryl,ice.On 9/11 pt imp.On 9/18 pt completely recovered.
07/30 9:45 Pt given extra dose of pneumococcal. From last visit it was noted in chart pt had gotten Zoster and Td and needed PNEUMOVAX at next visit. It wasn't until vaccination given that PNEUMOVAX given already at prior visit and not Zoster. Nurse staff attempted to call patient to be made aware of adverse event. 07/30 10:45 Pt here with localized reaction at injection site. Site erythematous. No reports of fever, shortness of breath or chest pain.
pain got better then came back; Pain in left arm/ hurt so bad; saw stars; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm/ hurt so bad), DIZZINESS (saw stars) and PAIN IN EXTREMITY (pain got better then came back) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, ZOLPIDEM TARTRATE (AMBIEN) and CALCIUM for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2020, the patient experienced PAIN IN EXTREMITY (Pain in left arm/ hurt so bad) and DIZZINESS (saw stars). On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (pain got better then came back). On 24-Dec-2020, PAIN IN EXTREMITY (Pain in left arm/ hurt so bad) had resolved. At the time of the report, DIZZINESS (saw stars) had not resolved and PAIN IN EXTREMITY (pain got better then came back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has taken ibuprofen and acetaminophen for pain. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm/ hurt so bad), DIZZINESS (saw stars) and PAIN IN EXTREMITY (pain got better then came back) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, ZOLPIDEM TARTRATE (AMBIEN) and CALCIUM for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2020, the patient experienced PAIN IN EXTREMITY (Pain in left arm/ hurt so bad) and DIZZINESS (saw stars). On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (pain got better then came back). On 24-Dec-2020, PAIN IN EXTREMITY (Pain in left arm/ hurt so bad) had resolved. At the time of the report, DIZZINESS (saw stars) had not resolved and PAIN IN EXTREMITY (pain got better then came back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has taken ibuprofen and acetaminophen for pain.
Pt received FLUZONE HD on 1.11.18. 7 days later pt returned to pharmacy with pain in arm. She said she could hardly lift her arm and certain movements were painful. She had used OTC NSAIDs with no relief.
I received 4 syringes of the dermal filler Vollure over a one month time, as well are Voluma on another occasion.   About a month following, I had a stroke while my face was puffy where the filler was injected.  High blood pressure, slurring of speech, loss of balance, numb cheeck, dullness to teeth and tongue, muscle pains, and tingling in the face has occured intermittenly over the course of several months.
Information has been received from a physician concerning a patient who was vaccinated with a first and second dose of Rotateq on 28-NOV-2006 and 16-JAN-2007, respectively. On the evening of 22-FEB-2007 the patient experienced intussusception. No product quality complaint was involved. The route of administration was recorded as "injection" (further clarification is pending). Upon internal review, the patient's intussusception was considered to be an other important medical event. Additional information has been requested.  4/27/07 Received medical records from hospital which reveals patient experienced vomiting x 3 days prior to admit on 2/21-2/26/07.  Had been on antibiotics since 2/15 for ear infection.  Seen on day of admit at PCP office & sent for testing due to concerns of IS.  Exam also revealed right OM.  On 2/22 had currant jelly stool & was taken to OR on 2/22 where reduction & resection was done w/primary anastomosis.  Had gradual improvement to normal stools & feeding at d/c to home. FINAL DX: ileocolic intussusception involving terminal ileum & extending into left colon, not completely reducible.  Ileocecectomy w/end to end anastomosis.
Upper arm began to swell around day 2-3 then it became black and blue. It's still swollen and aches and pt is going to specialist.
PT WAS ADMINISTERED SMALLPOX VACCINATION. SCABBED AREA SPREAD TO 70% OF RIGHT UPPER ARM. PT STATED THAT CORPSMAN TOLD HIM TO PUT LOTION ON THE AREA. AFTER SEVERAL MONTHS THE PATIENT FINALLY CAME INTO THE CLINIC TO HAVE THE AREA CHECKED. PT WILL LIKELY HAVE PERMANENT SCARRING TO GREATER PORTION OF HIS UPPER ARM.
Information has been received from a physician via a company representative reporting on a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. In approximately 2015 (reported as "2-3 years ago"), the patient received the third dose of GARDASIL 9 as prevention of HPV (strength dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient developed postural orthostatic tachycardia syndrome. The patient had "fatigue, and low blood pressure". The patient sought for medical attention and received treatment for the adverse event. At the reporting time, the patient had recovered from postural orthostatic tachycardia syndrome. The reporter did not assess the causal relationship between the event postural orthostatic tachycardia syndrome and therapy with GARDASIL 9.
Patient reported back to pharmacy and alerted pharmacist that she had experienced an injection site reaction to the vaccination. Patient reported redness and swelling in the immediate area of the vaccine and pain of which both extended down the arm and to the armpit. Patient stated that the reaction stopped after a few days.
warm to touch at injection site; 3-4 inches diameter at the injection site which is red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE ERYTHEMA (3-4 inches diameter at the injection site which is red) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), SEMAGLUTIDE (OZEMPIC), GLIPIZIDE, CALCIUM CITRATE, VITAMIN D3 and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE ERYTHEMA (3-4 inches diameter at the injection site which is red). At the time of the report, VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE ERYTHEMA (3-4 inches diameter at the injection site which is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment Medication included Steroidal cream.
I started feeling some excruciating pain in my neck; it is a little bit swollen; This is a spontaneous report from a contactable consumer (patient).  A 77-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 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 and concomitant medications were not reported.  The patient stated that had first shot on the 16th of the month and was supposed to go back for second shot on the 16th (as reported), it was supposed to go this afternoon. Today (as reported) the patient started feeling some excruciating pain in neck, she had been taking things (as reported)  and now it's changed a little and it's the back of my neck. The patient done heat and ice because it was a little bit swollen, coming from the vaccine 3 weeks after getting vaccine. Outcome of the event neck pain was recovering while outcome of the event neck swelling was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.