chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Poor quality product administered; Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes; No adverse reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes) and NO ADVERSE EVENT (No adverse reaction) in a 60-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes).    No concomitant medication was reported by reporter.  Vial was in refrigerator during temperature excursion. Lot number 060A22A had 2 unpunctured and 1 punctured vial with expiry date 28-Aug-2022, lot number 013B22A had 1 punctured vial with expiry date 22-Nov-2022 which were affected. Vial was moved from freezer to refrigerator on 25-Jul-2022. Unpunctured vials were returned to refrigerator and punctured vials were discarded. during visual inspection before vaccination it was normal. Before this there was no prior temperature excursion.  No treatment medication was reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-627647, US-MODERNATX, INC.-MOD-2022-627771, US-MODERNATX, INC.-MOD-2022-627784, US-MODERNATX, INC.-MOD-2022-627786 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2022: Live follow-up was received and lot number and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627647: US-MODERNATX, INC.-MOD-2022-627771: US-MODERNATX, INC.-MOD-2022-627784: US-MODERNATX, INC.-MOD-2022-627786:
This was the 4th Pfizer Covid vaccine (2nd booster) and was administered on 6/1/22. No issues with prior Pfizer doses on 12/29/20, 1/22/21, or 9/29/21. Since I already had another script for prednisolone 1% and Atropine eye drops, I started treatment prior to seeing ophthalmologist.
The vial was punctured on 26-AUG-2021 at 1:15PM. The dose was given to the patient on 27-AUG-2021 at 11:50AM; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 26-AUG-2021 at 1:15PM. The dose was given to the patient on 27-AUG-2021 at 11:50AM) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 021C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Intellectual disability, Schizophrenia and Vitamin D deficiency.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021 at 11:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021 at 11:50 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 26-AUG-2021 at 1:15PM. The dose was given to the patient on 27-AUG-2021 at 11:50AM). On 27-Aug-2021 at 11:50 AM, EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 26-AUG-2021 at 1:15PM. The dose was given to the patient on 27-AUG-2021 at 11:50AM) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not reported.  Reporter also states that The patient did not report any other adverse reactions after the first or the second dose of Moderna Covid-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up information included patient details, past medical history and vaccine dose details.
Patient received Moderna on 6/15/21 and pt stated 9 days later the arm broke out in a kidney shaped, red rash that covered her arm from shoulder to elbow with the center being right at the injection site. She went to her PCP and was prescribed benadryl and clotrimazole/betamethasone. She said only the benadryl worked and took that around the clock. The clotrimazole/betamethasone  was only used for a day and the pt stated "it did not work." After 3 days of benadryl the rash was less noticable. The doctor still advised the pt getting the second shot.
Pt recv vax on 3/16/98; within 24 hrs pt exp local reaction of red and swelling about 6x11cm.  Three days later (3/19/98) site looks the same. It was reported that a 4-year-old male patient was vaccinated with TRIPEDIA, OPV and was tested with PPD on 16/Mar/1998. Within 24 hours of injection, the patient had a "local reaction, red and swollen about 6x11 (cm). No other reactions other than local. Site about the same today (19/Mar/1998), 3 days later." Follow-up #1 (2/Aug/2002): During internal review of all files, it was deemed necessary to amend the report by updating the Adverse Event date by adding the year 1998
On 7/22/05, was witnessed to have seizure activity (Grand Mal) by friend. Pt was asleep at the time. Duration: approx. 3 minutes. Brought to ER. Postictal, confused, nauseated, headache and temp 97.5. New onset. No history of seizure.
Headache, Myalgia, Fever, NauseaVomiting, c/o chills and injection site sore. Told to follow up with primary care physician if no improvement
No adverse event, patient was given a second dose of Pfizer at the adult dose instead of the smaller dose.
Received Pfizer Covid booster on 11/2/2021. Within 12 hrs was sick. Similar adverse reactions that I experienced with shot 2
Acute ischemic multifocal right-sided anterior circulation stroke. It was determined that admission to Rehabilitation was necessary to allow for safe discharge back to home. Admission within 6 weeks of receiving the COVID vaccine.
Severe allergic reaction occurred 30 hours post booster.  Anaphylaxis, urticaria, nausea, high fever, significant underarm and right breast swelling.
Systemic: High blood pressure and dizziness, did not recover, BP reading of 240/97 by ambulance, awaiting more information. Event may be independent of vaccine, patient has history of highb blood pressure -Severe; symptoms lasted 0 days
Severe headache; Joint pain; Muscle pain; Fever of 103; Severe chills; Weakness; Still dizzy; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 16:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not had allergy to any medications, food, or other products. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) and diazepam (VALIUM); both taken for unknown indication on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Mar2021 at 06:00, the patient experienced severe headache, joint and muscle pain, weakness, fever of about 103 (unknown units) and severe chills for 24 hours. The patient still felt dizzy and weak 2 days later. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the reported events and included treatment with TYLENOL and ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of the events severe headache, joint and muscle pain, fever of about 103 and severe chills were resolving, while that of the event dizzy and weakness were unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
My daughter had an episode while we on vacation where she lost consciousness and was disoriented for a period afterward.  She experienced some twitching before she lost consciousness.  She was brought to the ER, had an EEG, a Cat Scan and all results were normal.
Right leg warm, red, and inflamed.  Temperature 99.9.  Mom states decrease on activity.  Complain of pain.  Diagnosed with cellulitis. Treated with Duricef 500/5 3 cc twice a day.  Area 8 by 6 centimeter.
Event 1: Palpitations, dizziness, heart racing, afib notification on smart Watch  Afib and symptoms started at 12pm, arrived in ER at 1pm, Treated with beta blocker at about 4:30pm, resolved afib and all symptoms within 30 seconds  Event 2: Visible blood in Urine, no treatment
Left deltoid and bicep area tenderness and redness and tissue swelling. Area warm to touch. Treatment with ice to site, Benadryl and Tylenol.
Within 20 minutes of the administration of the vaccine the patient got very nauseated and dizzy but did not vomit. He self treated with Pepto Bismol with effect.  This occurred with each of his vaccinations.
Periods stopped- despite still being on birth control. Even on the ?off? week there is no bleeding. For the last 20 years I?ve taken that medication and always bled that week. But about 3 months after the vaccine I stopped bleeding for that off week, but will sporadically bleed a few days during the month.  Also have an autoimmune disease now. Had lots of symptoms starting in November 2022 and bloodwork in April and again in May of 2023 that confirm an autoimmune disease. Waiting to see a specialist to determine which one I have. Never had a history of that before.
Headache; Fever; Chills; Nausea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Psoriasis. Concomitant products included VITAMINS NOS for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Tiredness). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Tiredness) outcome was unknown. Not Provided          Patient had all the side effects in the first dose also.  Treatment information reported that she did not take any medications for the side effects she received from the second dose, she just stayed in bed and drank ginger ale and ate crackers.
Right thigh swelling several hours after DTAP injection. Occurred at same site as DTAP. Increased swelling in 24-48 hours. Seen by MD on 5/13/06. DTAP given: 5/11/06. Ice given and Augmentin for possible cellulitis/limb swelling.
my left pupil dilated fully for no reason; My left eye vision was blurry; I felt light headed and dizzy; I felt light headed and dizzy; I do frequently get blurry vision and dizzy spells now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 10:00 (Lot number: Ew0178) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: Ew0167, Administration time: 10:00 AM, Vaccine location: Left arm), administration date: 29Apr2021, when the patient was 35 years old, for Covid-19 immunization. The following information was reported: MYDRIASIS (non-serious) with onset 22May2021 08:00, outcome "recovered with sequelae", described as "my left pupil dilated fully for no reason"; VISION BLURRED (non-serious) with onset 22May2021 08:00, outcome "recovered with sequelae", described as "My left eye vision was blurry"; DIZZINESS (non-serious), DIZZINESS (non-serious) all with onset 22May2021 08:00, outcome "recovered with sequelae" and all described as "I felt light headed and dizzy"; DIZZINESS (non-serious) with onset 22May2021 08:00, outcome "recovered with sequelae", described as "I do frequently get blurry vision and dizzy spells now". The events "my left pupil dilated fully for no reason", "my left eye vision was blurry", "i felt light headed and dizzy", "i felt light headed and dizzy" and "i do frequently get blurry vision and dizzy spells now" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of mydriasis, vision blurred, dizziness, dizziness, dizziness.  Additional information: The patient had not other vaccine in 4 weeks and had not other medications in 2 weeks. 2 days after second dose patient left pupil dilated fully for no reason. Patient right remained normal size. Patient left eye vision was blurry and felt light headed and dizzy. It stayed dilated for 4 days, slowly going back down to normal size. Once it went back to normal it has remained that way but she do frequently get blurry vision and dizzy spells now. The adverse event resulted in doctor (other healthcare professional) office (clinic visit). The patient was recovered with lasting effects. Patient had not covid prior vaccination and had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient is an employee who was administered her 3rd Hep B injection. Injection was tolerated well. About 10 minutes after injection she reported feeling very shaky in her.
I have had small, painless red spots pop up on my hands, arms, legs, and upper torso. They are not itchy, but they are not attractive in the least (they resemble shingles at first glance). I went to my dermatologist, and she prescribed me a topical steroid. While the steroid makes the spots shrink a little and fade to a pink color, they do not fully subside, and if I stop putting the steroid on, they immediately go back to their same size and bright color. Also, while I no longer have pain at the injection site, it is still fairly prominent and dark in comparison to other people who had the vaccine around the same time that I did.
Bell's Palsy Diagnosis at Hospital Emergency Dept on 05/06/2007.  07/16/2007 MR received for a vaginal delivery and elective BTL.  Rubella vax given prior to D/C. 07/24/2007MR received for ER visit 5/6/2007 for c/o facial swelling.  Pt c/o lip and tongue swelling, drooling, and left cheek and eyelid numbness which have worsened in the last hour.  Differential DX:  Allergic reaction to anesthesia, meds, and food.  Clinical picture: angioedema. Additional record received for ER visit 5/16/07 for infected episiotomy. PE WNL  except for edema, pain and swelling of R labia.   Since no mention of Bell's Palsy, TC made to MD who reported to reporting pharmacist for clarification.  Pt seen at two hospitals. 8/13/2007 MR received for DOS 5/16-23/2007 for infected episiotomy and R labial majora cellulitis. H&P notes Dx of Bell's Palsy of 5/6/2007 from above ER visit.  On admission 5/16/07 pt still unable to lift L eyebrow. Txd with steroids.
hives on back, side of torso, under breasts, on head and some on face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Oct2021 11:30 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single and administered in arm right, administration date 19Oct2021 (Batch/Lot number: unknown) for covid-19 immunisation. Relevant medical history included: "thryoid disease" (unspecified if ongoing); "known allergies : Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LEVOTHYROXINE. The following information was reported: URTICARIA (non-serious) with onset 22Oct2021 16:00, outcome "recovering", described as "hives on back, side of torso, under breasts, on head and some on face". Therapeutic measures were not taken as a result of urticaria. Prior to vaccination,the patient was not diagnosed with covid 19 and since the vaccination,the patient has not been tested for covid19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (01Dec2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
I have a terrible ringing in my ears that started out every once in a while but as of last month it is daily and frequently throughout the day.
Systemic: see comments-Medium, Additional Details: pt received expired vial of moderna; vial was punctured at 11am on May 30 2021 and the vaccine was given today June 1 2021. the open vial was not disposed of correctly end of day May 30 2021.
This spontaneous report refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on APR-2011. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced inappropriate schedule of drug administration. No treatment information was reported. The outcome of inappropriate schedule of drug administration is unknown. Inappropriate schedule of drug administration is not related to GARDASIL. Nurse called regarding GARDASIL and delay in administering to patient between first and second dose. First dose given 04/2011 and second dose given 10/2012. Nurse asked if the 3 dose series had to be started over. No adverse effect reported. No further information available. Additional information has been requested.
completely paralyzed; ended up blind; Initial information was received on 14-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves a female patient of unknown demographics who was completely paralyzed and ended up blind after being vaccinated with INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer with unknown formulation, strength, dosage, lot number and expiration date via unknown route in unknown administration site as prophylactic vaccination.  It was reported that the patient got the flu shot and 3 days later she was completely paralyzed (Paralysis) and stayed in ICU on an unknown date. It was reported that on an unknown date after unknown latency, the patient ended up blind (Blindness). It is unknown if the patient experienced any additional symptoms/events. These events were assessed as medically significant. The patient was hospitalized for these events on an unknown date.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (completely paralyzed, ended up blind).  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments: Sanofi company comment 23-Jan-2022: This case involves a female patient who was completely paralyzed and ended up blind after being vaccinated with Influenza vaccine. On the basis of the reported information a significant temporal relationship can be established . However, additional information regarding patient medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
A non-serious, spontaneous report of second dose administered 12 days after first dose was received from a nurse concerning a 4-year-old female patient. Medical history and concomitant medications were not reported. On 24-Sep-2010 and 06-Oct-2010, the patient received a dose of FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received in 08-Nov-2010 and incorporated into the narrative: the patient did not have an adverse event.
Sudden onset on tinnitus. Went to bed Saturday night normally. No alcohol or anything unusual (exposure to loud sounds, etc.). Woke up Sunday morning with tinnitus and has never gone away since.
Soreness at injection site, stiffness in shoulder - neck and jaw, sensitivity on left side of face and inside mouth.
1. Loss of taste and smell/Fatigue-- R/o covid. PCR test done. No exposure but her husband has a cough and seems to be getting sick now. Quarantine below.  2. Muscle aches and leg and back pain--  Checking labs like CMP,CK and Mag 3. DM-2 higher risk patient for severe covid. 4. HTN-- BP is stable right now. Mild tachycardia is present and thus a reason for the labs.
Started vomiting, low grade fever, throat swelling and difficulty swallowing started around 8:00pm on 8/6/2018. No vomiting morning of 8/7/2018, continues with complaints of throat swelling/difficulty swallowing. Has taken sips of water. General malaise. Seen by provider at Employee Health Services at 10:00am on 8/7/2018. Monitor s/s, sent home from work today, report to the ED for increase in s/s, shortness of breath.
Per pt: side pain, hip pain, back pain, vaccine site soreness with hard lump.
I started exp. itching and had a break out in hives couple hours after dose 1, got Benadryl. I went to urgent care, gave me prednisone and continue Benadryl. I followed up with my PCP she gave me 10 days of prednisone, Zyrtec and continue Benadryl.