chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (vaccine expired on 1 Apr 2022, Date the vial was initially stored in the refrigerator on 05 Apr 2022) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) 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) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (vaccine expired on 1 Apr 2022, Date the vial was initially stored in the refrigerator on 05 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (vaccine expired on 1 Apr 2022, Date the vial was initially stored in the refrigerator on 05 Apr 2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug information was provided. Reporter reported that the administration of vaccine occurred from 6 Apr 2022 to 9 Apr 2022. Patient had not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 1 Dec 2021. Vial was initially placed in refrigerator on 5 Apr 2022. The product did not undergo any temperature excursion issue. No treatment drug information was reported. This case was linked to MOD-2022-537580, MOD-2022-538672, MOD-2022-538673, MOD-2022-538675, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538689, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538696, MOD-2022-538697, MOD-2022-538698, MOD-2022-538701, MOD-2022-538702, MOD-2022-538698, MOD-2022-538689 (Patient Link).
The patient suffered herpes zoster. As a result of these symptoms, was seen and treated by medical providers and is still under their care.; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date, after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the event was considered to be not recovered. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered to be disabling.
I gave the 1st Pfizer in right arm, patient seemed fine at the time. He was to sit 15 minutes in our sight. A few minutes later after sitting, he fainted. He was conscious, we called 911. Emergency services came. After 30 minutes, patient said he felt fine and wanted to go, and he left
Within 10-15 min of injection, she was walking in the POD, waiting around to leave, but felt dizzy.  Was instructed to sit down. People around her noticed a flushed face, she felt her HR increase ( as a sensation, not measured) she rested and stay seated for about 10 min.  While she was seated, her (she checked her own pulse) noticed it went from 55- 70.
Patient got shot at 10:20am, around 10:30am patient was slumped in chair completely flacid on left side of the body. 911 was called immediately. Patient remained alert and oriented but mouth started to droop and slurred speech started around 10:45am. Ambulance arrived around 10:50, no other issues. Patient was loaded and transported to the ED. Vitals were stable throughout.
Swelling up and down arm, warm to touch, swelling subsiding by time she came in.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 years old female patient who received an expired MENACTRA (frequency once) lot number: U5712AA and expiry date 11-Oct-2018 via intramuscular route in the left deltoid on 29-Oct-2018. The patients past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included FLUARIX QUADRIVALENT for Immunisation. It is an actual medication error case due to expired vaccine used. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Fever of 101, intense body aches, chills, headache, and vomiting that lasted for 6 hours. Triggered dehydration and fatigued...  fever and headache lasted 36 hours
Vaso-vagal response. Nausea, dizzines, flushing/sweating, no loss of consciousness. Pt stabilized, VS stable (95/57; HR 65; RR 16; O2 sat 100%), ambulates appropriately
9/15/2021 Fluzone Qiv Vaccine given in right arm  , 9/18/2021 Discovered Lump in right armpit , 9/23/2021 reported to health Center.   Instructed to Follow up with his personal oncologist due to hx of Lymphoma x2 time , currently in remission.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, dose number, route of administration, injection site, lot number and expiration date were not reported). It was reported that the patient felt weak and did not "feel well" (unspecified on how the patient did not feel well) an unspecified time after receiving an unspecified dose of GARDASIL. According to the reporting physician, the female patient had also developed general malaise and non specific symptoms after receiving GARDASIL on an unknown date. No treatment was given for the adverse events. No laboratory diagnostic studies were performed. The patient's mother sought medical attention for her child by calling the physician (on an unspecified date) to report the events and was told to bring her daughter in for a visit if she really concerned about her. The outcome of the events of feeling weak, not feeling well, developing general malaise and developing non specific symptom after receiving GARDASIL was unknown at the time of the report. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sore throat; 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 OROPHARYNGEAL PAIN (Sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history reported.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.            No concomitant medication provided by the reporter No treatment information reported by the reporter
1/12/2021 @ 2200hrs - Muscle/body aches, injection site tenderness 1/12/2021 @ 2300hrs - Muscle/body aches, chills 1/13/2021 @ 0300hrs - Muscle/body aches, chills, fever of 99.0, general malaise 1/13/2021 @ 0600hrs - Muscle/body aches, chills, tired, no energy, difficult to get out of bed.  Did not go to work. 1/13/2021 @ 1000hrs - Symptoms continued.  Advil 600mg PO taken.  Allowed sleep from 1030-1230hrs. 1/13/2021 @ 1230hrs - Woke up feeling damp as if having had night sweats.  Rested the entire day. 1/14 to 1/15/2021 - Left arm site tenderness with raised hard area at site of injection.  Left armpit raised/swollen, appears as lymphadenopathy.
Patient reported a high fever of 103 degrees F, stingy, intense all-over body pain, and a very bad headache the day following the vaccination. She contacted her doctor and they conculded that her symptoms were due to the vaccination and instructed patient to take over-the-counter pain and fever reducer. However her doctor also said she will still need to get the second dose.
Bell's Palsy event: noticed about 12 hours after the shot that I could not easily spit after brushing teeth. Assymetrical smile. The left side of my face is mildly numb or paralyzed for certain movements.  Also general soreness of the arm and fatigue, but not worried about that.
I got COVID-19 and I have severe headache, sore throat, fatigue, congestion, fever, chills, night sweats, coughing and tightness in chest. Is been a week and it fluctuates. I had a video visit. Recommended me to not take PAXLOVID and prescribed albuterol and benzonatate. They did help with some symptoms.
I began having cold chills in the evening about 6-7 hours after I got my vaccine shot. Got a headache soon after. Woke up the next day with a migraine headache, feeling very woozy and running a fever.  Had to call off work to recover from flu-like symptoms.
Extremely heavy menstrual cycle. Lots of blood loss and clots with painful cramping. Possible hemorrhage.
G51.0 RIGHT FACIAL PALSY 2/16/2022 SEPSIS DUE TO HEMOPHILUS INFLUENZAE
06/03/2022  I had a runny nose and coughing. On 6/4/2022 I tested positive for COVID.  I emailed my PCP on 6/3/2022 that my husband was positive and that if I became positive, what should I do.  He said to call the PA who was on call over the week-end. She prescribed Paxlovid which I started on June 4. I have weird taste from it, but otherwise I am doing fine now, but have been pretty sick.
Was given vaccine around 1:30Pm on 2-11-2021. He and his wife waited in the building for 15 minutes and then left. he denied complaint. (He was waiting to have both Covid shots before he went to cardiologist Re: CAD.) He had an alarm going off in his house, was going to basement to check it out. Police officer heard alarm, came into house, & heard a thud when Doc fell. He was in PEA (Pulseless Electrical Activity) when brought into ER. Given 5 "rounds of Epinephrine with no response.
Patient admitted to the hospital with redness, swelling, and pain on left upper arm two days after receiving Pneumovax at the patients PCP.  Patient was afebrile with a WBC of 11 and was diagnosed with cellulitis.  Patient was started on cefazolin and then was switched to vancomycin after no improvement was seen.  Patient's reaction spread to below the elbow and became more swollen and red after 2 days of antibiotic use.  It was determined that the patient had an extensive reaction to Pneumovax vaccine as opposed to a true infection since it didn't respond to antibiotics.
CLAMMY SKIN , LABORED BREATHING , DRY COUGH,  TREATED WITH BENADRLT . SENT TO ER, PLACED ON DECADRON.
mom took child to MD who reportedly told her that child had good case of both measles & chickenpox;hlth dept nurses saw child & rpeorted that there was 2 kinds of rash of 1 was chickenpox;
Body aches started first. headache, chills. Nausea and dizziness. No temperatures. lasted about 2 and a half days after vaccination
arm is red/pink; arm is sore/stiff; arm feels warm to touch/Under the weather and logey; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red/pink), MYALGIA (arm is sore/stiff) and FEELING HOT (arm feels warm to touch/Under the weather and logey) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MYALGIA (arm is sore/stiff) and FEELING HOT (arm feels warm to touch/Under the weather and logey). On 31-Mar-2021, the patient experienced ERYTHEMA (arm is red/pink). At the time of the report, ERYTHEMA (arm is red/pink), MYALGIA (arm is sore/stiff) and FEELING HOT (arm feels warm to touch/Under the weather and logey) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
A nurse reported the occurrence of aphasia in a 3 year old female who was vaccinated with hepatitis A vaccine inactivated for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. In October 2002, the subject received her first injection of Havrix. In the last few weeks, the subject had a pronounced change in her speech regarding the speed and fluency of her speech. She is not mute, but clearly gets frustrated when she tries to form words and now stammers. Results of computed tomography and magnetic resonance imaging were interpreted as normal. As of 11/15/02 the event persisted. The aphasia in this report is considered medically serious.
Weakness, low grade fever, body aches, and headache. Regular Tylenol. Not effective.
Patient reports that since getting second Moderna covid 19 shot she feels terrible, she is experiencing various muscle pains and headaches. Additionally, her menses which was always consistently 28 cycles with 5 days of bleeding is now completely dysregulated. The cycle is now variable in length with bleeding ranging from 9-20 days with darker than usual blood and a lot more clotting. For this the patient is receiving acupuncture therapy in our clinic as according to her reports none of her allopathic doctors even believe that she is having a reaction to the vaccine and only offer pain medications that give her anxiety and stomach pain. Today is her second acupuncture treatment. The first yielded relief for only two hours and the pain returned quickly after.
Swelling (R) arm, tenderness w/ nausea, vomiting and diarrhea.
Patient stated that the next morning after receiving her Pfizer vaccine, she started to get really hot. Patient stated that she was very dizzy, over the weekend she had chills. Sunday she felt fine. But Monday, she started to feel dizzy again then everything started to go black. Patient stated that an ambulance took her to hospital. Blood tests and CT scan was taken. Patient was given meds to help with Adverse Event, and she stated that she's been lightheaded ever since she was at the hospital. Patient has not recovered from Adverse Events.
This spontaneous report was received from a medical assistant via company representative and refers to a female patient in her forties of unknown exact age. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient "in her 40's (years old)" was vaccinated with a dose of GARDASIL (dose, route of administration, lot#, expiration date and indication were not reported). Concomitant therapy was not provided. No adverse effect was reported. Additional information has been requested.
I missed 2 periods right after getting my second shot.; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received second dose of BNT162B2(Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date of Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The concomitant medication includes oral birth control for over a decade started on an unspecified date. The patient wanted to report that I missed 2 periods right after getting my second shot. My periods returned normally the 3rd month after my vaccine. I have read that there is no evidence of correlation there, but I know other women who have experienced this. my hope is for you to catalog my experience and investigate it if appropriate. The outcome of the event was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
While I didn't believe my allergic reaction to be severe, so did not call my doctor, I thought it important to report this for your system records.  On May 7, 2018, I received the Pneumococcal Pcv13 Conj injection and had no adverse reactions.  On February 26, 2020, I received the Pneumococcal PPSV23 injection; however, the injection equipment failed (broke apart) during the injection and sprayed all over.  Therefore, it was unknown how much of the injection I actually received (again, I had no side effects).  My doctor stated she was going to check into whether or not I should have the injection redone.  At an appointment on August 10, 2020, she decided that I should receive another injection just to be on the safe
Elevated blood sugars - as high as 305 within first 24 hours and 420 on 2nd day. Added short acting insulin Humalog on sliding scale to daily meds. Testing blood sugars more often until vaccine clears my system.
Pt. said she was unable to lift her arm or move it to her back, had limited range of motion for 2 days. As of 12/7/20 AM when I spoke with patient, she still had pain/limited range of motion to want to follow through with her provider's appointment at 12/7/20 11am.
Blood clots, pulmonary embolisms (4), hospitalized 5 days so far with likely a few more days to go barring any more set backs
Patient was due to receive Meningococcal and a Meningococcal B. However, he was accidentally given two doses of the Meningococcal vaccine and no doses of Meningococcal B. The mistake was not realized until afterwards.
Dermatographia - Persistent skin reactivity, hives, rash, itch. Treatment - Generic allergy medication antihistamine 2/day.
Pericarditis, out on steroids and antibiotics, was bed ridden for 7 days.
Left upper arm, left shoulder, left neck pain;  Rash on left upper arm; Chest pain; Shortness of Breath
This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). On 14-NOV-2016 the patient was vaccinated with unspecified doses of expired VARIVAX (lot # K018960, expiry date: 15-OCT-2016) and M-M-R II injection (lot # K020188, expiry date: 22-OCT-2016) (dose, frequency and route were not reported) for prophylaxis (expired product administered). It was not reported that, the sterile diluent (MERCK STERILE DILUENT) used to reconstitute vaccine was expired. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Albumin status for M-M-R II is recombinant human albumin (rHA).
horribly sick; Initial information regarding an unsolicited valid non-serious case received on 12-Dec-2020 from a consumer (patient) via social media.  This case involved a patient of unknown demographics who had horribly sick (Illness), while patient received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported It may not contain an active virus, but it contained something that made patient horribly sick, two years in a row (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was reported as Unknown for reported event.  There will be no information available on batch number for this case.
Patient developed dizziness that began 2 hours after Pfizer vaccine on 07/24/2021. She reports a significant spinning sensation lasting 30 minutes to 2 hours at a time that occurred off and on for a week. She would not recover completely after each episode. She felt off balance between episodes. Denies otologic symptoms. She reports a "heavy" sensation in her eyes/facial pressure. Denies headache before or after. Denies photophobia/phonophobia. Denies history of migraines. Denies illness prior to onset. Denies difficulty in dim light. Denies difficulty stepping down off a sidewalk. Denies correlation with barometric pressure changes. Denies motion sensitivity.    She has history of imbalance in the past and had evaluation in 2012. She was diagnosed with a Meniere's variant and started on dyazide. She is still taking dyazide.
Patient called today to report injection site reaaction.  She reports a red 2 inch raised area (circle) at the site of injection, she does not complain of any pain or itching.  She found this when putting on her deoderant today.  She said it feels a little hard.  Patient was referred to doctor for evaluation.
No additional AE reported.; Improperly stored doses of RECOMBIVAX HB and VARIVAX were administered to the patient.; This spontaneous report has been received from a pharmacist referring a patient of unknown age and gender. The patient's concurrent conditions, medical history,drugs reactions or allergies and concomitant medications not reported.    On 05-AUG-2022, the patient was vaccinated with improperly stored doses of hepatitis B vaccine (recombinant)thimerosal-free (RECOMBIVAX HB) intramuscular injection, vial, lot number U008328 with expiration date: 16-DEC-2022 and with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous Injection, lot number U028164 with expiration date: 09-SEP-2023, both of them administered for prophylaxis (strengths,doses, frequencies, routes of administration and anatomical sites of application were not provided) (product storage error).  The hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) had temperature excursion between 48.79 F for 2 hours and 43 minutes and 22.87 F for 3 hours and 36 minutes. Also, varicella virus vaccine live (oka/merck) (VARIVAX) had temperature excursion between 33.13 F for 14 hours and 55 minutes. It was reported that there were no previous temperature excursions. No additional adverse event reported.