chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the shots. Still got shingles/Suspected vaccination failure; Got the shots. Still got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. Despite of receiving shots, the patient experienced shingles, but was it not the bad case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No further information would be available.
Narrative:  Patient received second Moderna 4/26/2021 vaccination. He had no prior LEFT shoulder pain or complaints. He was hospitalized following a UTI and thought to have had a cerebellar stroke due to ataxia; however, MRI was negative. Patient had EMGs done, multiple confounding factors than can ben found in his outside medical records from Hospital in agency system from 7/21/2021 including lumbar radiculopathy, neuropathy, h/o of severe ETOH dependence. However, recent MRI dated 12/13/2021 for worsening LEFT shoulder pain concerning for rare disorder, Parsonage Turner Syndrome, affecting that joint. Patient states that LEFT shoulder pain significantly worsened from a 4/10 to 8-9/10 pain in about 14-21 days after the 11/10/2021 for Moderna 3rd dose, requesting an MRI for the shoulder as well as seeing an orthopedic surgeon who recommended the MRI (but whose specialty was not shoulders). The MRI findings and the time frame are why an ADE is suspected. Furthermore, MRI of the brain confirmed no cause for the ataxia (i.e. no cerebellar stroke) from his June/July 2021 MRI to eval for his ataxia. A consult for neurology f/u is pending. EMGs of UE and LE were done in June/July 2021 at hospital. Also significant is that patient's rehab has improved faster than expected by KT/PT. This lends to a possible vaccine reaction; although, a constellation of other contributing factors remain. Alos potentially related is that Patient had obstructive uropathy during this period. It is uncertain whether this may also be part of this, but he had been urinating better prior to his hospitalization on or about June 11,2021 and while he was treated for prostatitis, one would have expected him to have been at baseline more rapidly with treatment. This is resolving finally in these last two month.
7 vesicles arose at site of injection on L qaud. Still there today.. now more red.
Swollen lymph nodes 1.5 weeks Headache  Fatigue  Flu like symptoms  Abnormal liver and kidney blood work
Two days after administration, patient developed a 8-10 cm wheel on his arm and experienced pain. Parents administered Benadryl, and it was gone by the next day.
Shot was administered at 14:58 on 1/22/21 to left deltoid area.  He reports that the injection was 1 finger breadth below the acromion process.  Reports shoulder pain to Left shoulder since the evening of injection.  Right after injection, the area felt hot but not painful; this lasted a few hrs then subsided.  Woke about 1:00 AM on 1/23/21 with very significant shoulder pain.  Also experienced body aches, on 1/23/21; no other side effects noted.   Has been on Ibuprofen 800 mg q 8 hrs since that time.  ROM is intact when on full dose ibuprofen but movement is restricted by pain when not on full dose ibuprofen.    BPMHx except asthma; no other current meds except prn albuterol; Was on prednisone 1.5 months ago for asthma exacerbation.  No allergies.
Received 1st and only Moderna vaccine at Pharmacy, May 14th, 2021 at 8:45 am.  Administered in left arm.  As vaccine traveled through blood stream, felt burning and pain on inside of both arms and wrists, and then slowly spreading to the insides of both legs.  Getting up from the sitting position, felt like my legs were weighted down especially behind the knees. Pain and burning in arms and legs increased over a period of several weeks and cramping in both legs started.  Began having troubles walking due to pain.  Became very tired rapidly after doing any physical activity. On 7/20/2021, visited primary care physician, Dr (Internal Medicine) about condition getting worse.  Comprehensive blood test done several days later at Lab.  Approximately 1 week later followed up with Dr. Blood test normal, and doctor stated that condition sounded like neuropathy and didn't think it was caused by vaccine.  Perscribed Gabapenen (300mg).  Over several more weeks Pain, burning and cramping increased to become severe.  Spent 3 1/2 weeks in bed only getting up for toilet and eating.  Could not sleep. Made office visit in August 2021 (don't remember exact date) to see Dr. (Oncologist/blood disorders). She referred me to Imaging to check for blood clots in the legs.  Approximately two days later Ultrasound performed on inside of both legs.  Dr.'s office confirmed results from Ultrasound by phone as all clear. On 9/4/2021 appointment with Urgent Care, by, PA-C exam conclusion; Myalgia, Unspecified. Referred to new primary care physician Dr., MD. Exam conclusion: Polyneuropathy, Unspecified.  Referred to neurologist. Appointment with Dr. (arthritis, Internal medicine) on 9/14/2021.  Blood screening for autoimmune disease performed 9/29/2021 at Lab.  Follow up visit with Dr. Results from blood test: Neuropathy.  Try Gabapenten for pain. Return vist to primary care physician Dr. on 12/2/2021. Exam conclusion: Neuropathy.  Prescribed Gabapenten 100mg for pain.  Asked if I wanted a referral for Clinic. Declined. Pain and burning in arms and legs continue one year later with very slight improvement.  Little relief with Gabapenten.  Mobility very limited.  Walking for short periods.  Cannot drive.  Can only put pressure on wrists for short periods of time.  Occassional cramping in legs.
Headache; injection site pain; This is a spontaneous report from a non-contactable consumer. A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 19Feb2021 12:30 as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose on 29Jan2021, 12:30 PM of BNT162B2 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was Unknown if there were any allergies reported. Patient was not covid prior vaccination. Patient did not tested covid post vaccination. It was unknown if there is any other medical history. The patient experienced headache, and injection site pain on 19Feb2021 14:30. The outcome if event was recovered.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
I had a sore throat that was mild. I didn't have a fever but felt overly sluggish. We had been traveling so I took a COVID-19 test and it was positive. I got Paxlovid and was on it for the duration 5 day dosage. I've had a lot of fatigue after having COVID-19 and excessive sweating.
PATIENT COMPLAINED OF PAIN, ERYTHEMA, AND SWELLING IN THE RIGHT ARM. ADMINISTERED 2 VACCINES 1 IN SAME ARM ABOUT 5 INCHES APART.
Patient reports lip numbness roughly one week after receiving this vaccination.  She does not have any other numbness/tingling in other body parts on the day of report.
Patient has history of immunocompromised.  Discussed vaccination with provider prior to vaccination. Client vaccinated with Covid 19 vaccine at 9:50 AM and advised to wait 30 minutes.  At 10:00 am client c/o feeling light headed and dizzy.  Client appeared pale.  C/o scratchy throat.  BP 110/70, Pulse 78, regular, RR 18.  Client laying on cot.  10:05 client given Benadryl 25 mg po.  10:10 client c/o chest redness.  Denies breathing difficulty or numbness or tingling.  Throat feels "funny", not scratchy.  10:15 am BP 130/80, Pulse 86, regular, RR 20.  10:20 am Throat no longer feels "funny or scratchy.  10:25 client sitting in wheelchair.  10:30 BP 148/86, Pulse 86, regular.  10:45 BP 130/78, Pulse 88, regular.  11:00 client states she is feeling ok with no more allergic symptoms.  Client went home for day.  Phone call to client at 1:00 pm.  Left message.  Text from client at 3:12 that she is no longer experiencing any symptoms, except exhaustion.
No adverse event; 35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant medications was reporter.  Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022. It was reported that the patient had received 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose.  It was unknown if patient experienced any symptoms after getting the vaccine.  No treatment medications was reporter.
Patient had allergic reaction when Prevnar was administered; This is a spontaneous report from a non-contactable consumer based on the information received by Pfizer from Merck & Co., Inc. (Case number: 01394376). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient had allergic reaction when prevnar was administered on an unspecified date with outcome of unknown.    No follow up attempts are possible. No further information is expected.
Mother wanted child checked. Child has small lump under the skin on her left leg. Received IM immunizations 9/10/04. No redness or fever, no pain, moves both extremities equally.
Experienced vaccinator, was vaccinating the patient and during the deployment of the syringe, the needle separated from the syringe.  Some of the vaccine was administered prior to the separation and some of the vaccine had dripped out of the syringe.  It is unclear how much of the vaccine the patient received as the syringe had been completely deployed at the time of separation.  The patient was informed of the incident and instructed to follow up with his PCP.
09/11/22 presents to ED for "altered mental status". PMHx of "HTN, DM"
She had her vaccine, felt shaky afterwards, really tired, fatigued, nausea, then got a really bad headache that started out small and got worse and worse.  The site was red where she got the injection, like a gooseegg, big red bump.  She did not have this with any of the other shots that she received.  She went to the car after the vaccine, and her caregiver drove her and they were driving home and she knew that she was going to pass out as she was that dizzy and shaky.  She had to take her coat off even though it is cold, had to put her head in her lap so that if she fainted she wouldn't fall.  She started to get a headache.  They decided that she should go to the ER because it would be easier to get her seen  immediately by a doctor.  She was having a hard time standing due to the dizziness, so they went to the ER to be seen.  If they went back to her apartment then they would have to call EMS and that would be a problem.    While she was in the ER her headache got worse.  They did a CAT scan of her brain and a lot of tests that were pretty much normal. Her BP was really low, got medicine for the nausea and Tylenol for the headache.  She was there for 3 hours and was feeling much better, was able to sit up and got off the gurney and got into a wheelchair.  It was difficult for her to get on the bed when she first went in the ER, but when she left she had no problem at all, and her BP stabilized at 124/77, her temp was normal for her 97.5, and her pulse was 74, oxygen saturation 95%, so she was feeling better, although she felt much better later on in the evening.    She went to Hospital ER.  On discharge they told her to drink water and to rest.  She did do these things and she feeling much better today.  The diagnosis was near syncope.
Client waited 30 minutes post vaccination due to previous medication reaction concern. She was standing and became dizzy, diahporetic. She returned to a seat and continue to feel ill, stating that she was feeling weak and not herself. She asked if we were able to  take her vitals. Her BP was found to be low as well as heart rate. Employee was taken to the emergency department on site
within the first 24hrs I experienced soreness and swollen armpits and inflammation in my joints (hands, wrists, hips, knees, ankles etc.) That subsided along with injection site soreness and general fatigue. Almost exactly 10 days later, I experienced severe hives, swollen hands and feet, bloating, and tightness in my throat and chest. I was seen in the ER and prescribed allergy medication and a steroid. It has been 2 months and I can only go a day or two without allergy medication before hives reappear, hands swell and bloating returns. I have gained over 15lbs in the last 2 months with no other lifestyle or diet changes. Exercise and previously enjoyed physical activities have become difficult (harder to breathe/hr raises higher sooner, loss of endurance, low energy, etc.) and I get headaches easily.
Information was received from a claims administrator for a pharmacy concerning a female who was vaccinated with ZOSTAVAX. On 29-MAR-2014, she sustained an allergic reaction. No further information was provided. Additional information has been requested.
leukocytoclastic vasculitis; This is spontaneous report from a consumer (Patient) reporting for herself. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiry date: May2021), first dose via an intramuscular route of administration, in Arm Right, on 14Feb2021, 10:30, as a single dose for COVID-19 immunization. The patient did not administered her second dose yet. Medical history of patient included high blood Pressure, Arthritis, Uterus removal surgery, Appendix removal surgery. Concomitant medication included Levothyroxine 75 mcg for thyroid, Losartan 100 mg and Metoprolol 25mg for high blood pressure. Patient did not receive other vaccine in four weeks of vaccination.  It was reported that the patient experienced IGA vasculitis on 14Feb2021, at 22:00 hours and the patient was hospitalized for 11 days and the events requires the patient to visit emergency room, physician's office, also experienced small red dots on right ankle. The patient was at hospital and was getting treated by two doctors and after 5 days the doctors of the hospital were unable to treat the patient. The patient was transported via ambulance to medical center, the patient was treated by a team of doctors and specialists. She was discharged on 01Mar2021 and the rashes appears to stop spreading and no new ones has shown. The old rashes turned to bruises and the are clearing up slowly. The patient followed up with her rheumatologist after the discharger and the rheumatologist now tapering down the prednisone dosage. At the discharge were 80 mg per day and currently is at 60 mg per day, patient must drop 10 mg every 4 days until it comes reaches 20 mg. She has an appointment to visit her rheumatologist on 15Apr2021. The biopsy result from 01Mar2021 is leukocytoclastic (allergic) vasculitis. The biopsy result is IGA vasculitis. The doctors are not sure what has caused the rashes (AI) on the patient. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
receiving Daptacel with short expiration dates (4 months out upon receipt); Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked with AER# 2019SA172658 and 2019SA172657  This case involves unknown age and gender of patient who received expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] lot C5190AA (expiration dates (4 months out upon receipt) in an unknown route on 25-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was an actual medication error case due to expired vaccine used.  It was not reported whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
States that arm was numb then slowly resolved, but then the following day patient developed red spots/patches (some up to 5 inches long) along her shoulder on the left side (side of injection).
Janssen COVID-19 Vaccine  10 Hours after injection, fatigue started.  About 11 hours after, chills and full body pain.  Headache. 18 Hours after, less fatigue and soreness.  Chills gone. 40 Hours after, all side effects gone.
Vaccination after freezing; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Vaccination after freezing). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 19-JUL-2023 The reporter reported that a patient received a dose of Menveo after being exposed at freezing conditions, which led to incorrect storage of vaccine. The reporter consented to follow up.
Have been diagnosed with Bell's Palsy due to a facial paralysis; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 23Apr2021 11:00 (Lot Number: EW0171) as 2ND DOSE, SINGLE for covid-19 immunisation. No known allergies and other medical history. The patient concomitant drugs were not reported. The patient previously received first dose of BNT162B2 on 02Apr2021 12:00 am in left arm (lot number: ep7534). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had been diagnosed with Bells Palsy due to a facial paralysis on 04May2021 12:00 AM. Unknown if it was related to the vaccine or the cause. The adverse event result in emergency room/department or urgent care. Currently taking prescribed medication for event. The outcome of event was recovering.
The baby is very fussy, has a temperature and is not eating. Not active and seems anxious.
expired vaccine administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to a patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to a patient). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Roughly 24 hours after injection, I experienced confusion. I had an appointment with a client, I'm a Mental Health case manager. The appointment was at 4:00pm.  I left at 3:45 to go pick her up.  Around 4:30pm I knew that I was lost and had no idea where I was at. I finally came across a main highway that took me to my targeted location. I went into a store to ask the clerk directions. I've lived in town for over 46 years, yet I had no idea where I was at. Very scary.
Client described electric pain in her arm which traveled up her arm to her neck and head, feeling like a migraine for a moment and then disappearing.  Her vision blurred; she felt dizzy; she had a hard time hearing herself, although she could hear me fine; and she felt faint.  We had her sit back down and got her some water, checking on her every 5 minutes or so.  She was still dizzy, but not as faint.  She also reported a cold sweat.  We got her some orange juice and continued checking on her.  She called her husband to come and get her.  She was able to get up and walk out of her own accord with her husband.  We will follow up with her tonight to see how she is doing.
Per pt: Beginning the next day Left arm began to swell from upper arm to elbow over the next 4-5 days a big lump developed on her elbow. Cold compresses applied to reduce swelling. Gone after one week.
Chills, numbness in legs, weakness in legs, pain at injection site, inability to walk.