chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach pain; Chills.; Fever; Diarrhoea; Continuing to have rashes; Itchy skin; Ongoing headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 18Apr2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included estradiol (ESTRADIOL) patch taken for an unknown indication from an unspecified date. The patient previously 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 28Mar2021 at 01:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19Apr2021 at 04:45, the patient experienced chills, fever, stomach pain, diarrhea for 3 days. On 19Apr2021 at 04:45, the patient also experienced rashes which continued at the time of reporting, itchy skin and an ongoing headache with no relief. The events resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included therapeutic massage and acupuncture. The clinical outcome of the events chills, fever, stomach pain and diarrhea were resolved on 22Apr2021. The clinical outcome of the events rashes, itchy skin and headache were not resolved at the time of report.  No follow-up attempts are needed; information about lot number cannot be obtained.
Patient had anaphylactic reaction to flu vaccine. Pt. was vomiting, had facial swelling tightened airway.
Bell's Palsy diagnose 2/5/2021 and treated with Prednisone and antiviral.  Has history of Bell's palsy in the past.  She started with right sided facial droop and was choking with swallowing.
Patient received first dose of Moderna COVID vaccine on 01/19/2020. He did not receive his second Moderna dose four weeks later as scheduled. He returned to the vaccination clinic on 05/28/2021 and indicated on his pre-vaccination checklist that he had never received a COVID vaccine before. He was vaccinated on 05/28/2021 with the above noted Janssen vaccine dose. When this administration error was discovered, the patient was contacted by phone. He could not recall the circumstances of his vaccination and was not aware that he had received a mixed dose series. He was informed of the error and his questions about it were answered.
On 1/22/21 when I woke up my left arm were paralyzed for a few seconds.  I went back to sleep for a few minutes and again the left arm became paralyzed for a few seconds then I got feeling back.
Developed Inflammatory Diarrhea with 24 hours of vaccine. No fever. Now has chronic Diarrhea for 8 weeks.  8/24/09 Medical records received DOS 5/26/09 to 7/29/09 Assessment: Diarrhea. Presents with green mucousy stools, Diarrhea, "small flecks of 'blood' in stool". Some discomfort before BM. Dropped on growth chart from 90th percentile to 74th percentile. Runny nose and cough. Placed on milk free diet.
elevated temp 99.2-99.9F, sore throat, fatigue, and cough, Sinus congestion, body aches
03/17/22 presents to ED for "Eye edema severe". PMHx of "lupus"
flushing on my arms, face, neck and chest; Warm to touch and very red; Warm to touch and very red; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EY0584, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Jul2021 at 12:00 hours as dose 1, single (at the age of 57-years-old) for covid-19 immunisation.  Medical history included high blood pressure (BP) from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medication(s) within 2 weeks of vaccination included levothyroxine; benazepril and omeprazole (all taken for an unspecified indication, start and stop date were not reported). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. On 08Jul2021 at 13:00 hours, on day 6 after my vaccination, patient experienced flushing on her arms, face, neck and chest, warm to touch and very red. Patient received no treatment for the events. All events were reported as non-serious by the reporter. The outcome of all the events was recovered on Jul2021  Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a 62-year-old male patient who received ENGERIX B (batch number ET5TE, expiry date unknown) for prophylaxis. Previously administered products included LIPITOR, Shingles vaccine (received shingles live vaccine in 2017), ENGERIX B (1st dose received on an unknown date without any symptoms), ENGERIX B (2nd dose received on an unknown date without any symptoms) and SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, for tolerance refer case US2018130314). On 11th July 2018, the patient received the 3rd dose of ENGERIX B. On 13th July 2018, 2 days after receiving ENGERIX B, the patient experienced lower extremities weakness of, leg pain, burning leg and unable to walk. On 14th July 2018, the patient experienced rectal bleeding (serious criteria GSK medically significant). On 15th July 2018, the patient experienced epistaxis. In July 2018, the patient experienced weakness and pain localized. On 19th July 2018, the patient experienced back pain, abdominal pain and burning in abdomen. On 18th July 2018, the outcome of the rectal bleeding was recovered/resolved. On an unknown date, the outcome of the epistaxis was recovered/resolved and the outcome of the lower extremities weakness of, leg pain, burning leg and unable to walk were recovering/resolving and the outcome of the weakness, pain localized, back pain, abdominal pain and burning in abdomen were unknown. It was unknown if the reporter considered the rectal bleeding, epistaxis, lower extremities weakness of, leg pain, burning leg, unable to walk, weakness, pain localized, back pain, abdominal pain and burning in abdomen to be related to ENERIX B. Additional details were reported as follows: The patient experienced nosebleed. Starting on 13th July 2018, the patient's his legs were weak and painful (no cramping) but burning at the top of patient's legs and in his hips after walking half a block. It was on the sides of his legs and to stop walking. The patient's rectal bleeding started on 14th July 2018 and peaked on 16th July 2018. These symptoms reached their peak on 14th July 2018 and 15th July 2018. The patient was asked if these symptoms are resolved completely for which the patient stated, he felt a tinge but it had moved to his waist, upper back, trunk which he would feel if he tried to bend over. The patient also said he woke up on 19th July 2018 with these symptoms in his back and abdomen. The patient stated he had not reported his symptoms to his physician office but he had reported them to the pharmacy and they provided him with the lot number.
Second dose not yet given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th September 2020, batch number 3XR3X, expiry date 12th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
This case was reported by a other health professional via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced fever, fatigue and shivering. On an unknown date, the outcome of the fever, fatigue and shivering were unknown. It was unknown if the reporter considered the fever, fatigue and shivering to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the physician assistant (PA). The age at vaccination was not reported.
An employee received the seasonal INFLUENZA vacc and noticed hives 2 days later. The hives were still apparent about a week later. She had a similar reaction a few years ago but it was much worse at that time. She also reacted to contact lens solution years ago. Both contain preservative and she was going to discuss it with her primary doctor.
Systemic: Fainting / Unresponsive-Medium, Additional Details: bp 159/75 hr51
o 2-Apr-21, developed fever, chills, nausea, and diarrhea which he was managing at home. o 5-Apr-21  performed a PCR swab at Hospital and received positive results on 6-Apr-21. o 8-Apr-21  developed difficulty breathing and notified his Mgmt. who called for an ambulance. He was transported to  Hospital and later to Hospital. o SOB on exertion. Receiving vitamins, P and antibiotics. O2 via face mask. Stable condition was the report provided to his wife from Hospital. o 14-Apr-21 condition deteriorated and he was intubated and placed on the ventilator o 15-Apr-21  was transferred to Hospital
3"x2" red swelling at injection site. mild itchiness. mild warm, this occurred 8 days after injection
She got her vaccine, it was sore.  The next day it became real warm, and the redness started out about 1" in diameter, and progressively throughout the week it grew to the size of a baseball.  Then at times it is warm, and other times it almost looks black and blue and now 2 weeks out it's very noticeable.  She went to her doctor last Monday, 8/8/22, that he did not know what was going on and he prescribed antibiotics thinking it was an infection and also suggested taking Allegra D for a week to see if it was a reaction and also to apply Cortisone cream topically.   It has not improved much, it is still still the same size but not hot to touch anymore.
Focal segmental glomerulosclerosis; recurrence of FSGS; This is a literature report for the following literature source(s):   The authors report a case of a 21-year-old male with a history of focal segmental glomerulosclerosis (FSGS) who underwent deceased donor KT at 13 years of age complicated by early disease recurrence requiring 6 months of plasmapheresis and rituximab therapy. He was then stable for the following 8 years, with serum creatinine 0.8 mg/dL and serum albumin 4.8 g/dL until 1 month after completion of mRNA COVID-19 two vaccination series when he presented with edema, nephrotic-range proteinuria (urine protein/creatinine ratio (UPCR)?>?6.21 mg/mg with?>?2500 mg/dL of protein), albumin of 1.7 g/dL, and peak sCr of 1.3 mg/dL. Kidney biopsy showed diffuse foot process effacement, concerning for recurrence of FSGS. He was treated with methylprednisolone, plasmapheresis, and rituximab (two 375 mg/m2 doses). His nephrotic syndrome resolved after 4 weeks of plasmapheresis. Now 10 months after recurrence, he remains in remission of nephrotic syndrome with a normal UPCR (0.18 mg/mg), sCr (0.66 mg/dL) and serum albumin (4.3 g/dL) on mycophenolate mofetil, tacrolimus (goal trough 4-6), and prednisone 5 mg daily. While there are isolated reports of new onset or recurrence of proteinuric kidney disease after mRNA COVID-19 vaccine, to their knowledge, this is the first report of FSGS recurrence in a kidney transplant recipient after COVID-19 vaccination. The pathogenesis of COVID-19 vaccine-related glomerular pathology remains poorly understood; though T-cells are hypothesized to play a prominent role given the rapid disease presentation in relationship to vaccine receipt. Although causality is not proven, the temporal relationship of this case strongly suggests an association between vaccination and disease recurrence. While the risk-benefit ratio of COVID-19 vaccination for kidney transplant recipients remains favorable and vaccination is encouraged by national clinical guidelines, close monitoring for disease recurrence after vaccination in kidney transplant patients at risk is warranted.; Sender's Comments: This 21-year-old male had a history of focal segmental glomerulosclerosis (FSGS) and underwent deceased donor kidney transplant (KT) at 13 years of age complicated by early disease recurrence requiring 6 months of plasmapheresis and rituximab therapy.  There are many factors which may have impacted the recurrence of FSGS.  Considering temporal relationship, a possible contribution role of COVID-19 vaccination to the recurrence of FSGS cannot be excluded in this case.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
26 days after dose 1 received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) (batch number DP95H, expiry date 15th April 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th September 2020, the patient received the 2nd dose of Shingrix. On 28th September 2020, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was reported. The patient received 1st dose of Shingrix on 2nd September 2020. The pharmacist reported that, the patient received 2nd dose early than the recommended time interval, which led to shortening of vaccination schedule. The reporter asked, if the patient needed 2nd dose of Shingrix. The health care professional declined to provided further details from patient, only gender reported. No other details of patient and vaccine available. The reporter consented to follow up.
The case were received on 21 March 2014 at the agency. Initial misuse report received from a healthcare professional on 23 August 2013. A patient had received PENTACEL and IPOL on the same visit instead of DAPTACEL. No adverse event was reported. List of documents held by sender: none.
second dose within 24 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 24 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis of scalp (He's being treated for Scalp psoriasis with prednisone and Clobetasol for 10 days now). Concomitant products included PREDNISONE for Psoriasis, CLOBETASOL PROPIONATE (CLOBETASOL [CLOBETASOL PROPIONATE]) for Psoriasis of scalp.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 24 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 24 days) outcome was unknown.            No treatment medications were reported.
Patient received updated booster on 03/11 instead of second dose; The second dose given incorrectly but was expired, refrigerated for more than 30 days; Vaccine was expired and refrigerated for more than 30 days; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received updated booster on 03/11 instead of second dose), EXPIRED PRODUCT ADMINISTERED (The second dose given incorrectly but was expired, refrigerated for more than 30 days), PRODUCT STORAGE ERROR (Vaccine was expired and refrigerated for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received updated booster on 03/11 instead of second dose), EXPIRED PRODUCT ADMINISTERED (The second dose given incorrectly but was expired, refrigerated for more than 30 days), PRODUCT STORAGE ERROR (Vaccine was expired and refrigerated for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received updated booster on 03/11 instead of second dose), EXPIRED PRODUCT ADMINISTERED (The second dose given incorrectly but was expired, refrigerated for more than 30 days), PRODUCT STORAGE ERROR (Vaccine was expired and refrigerated for more than 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient received updated booster on 03/11 instead of second dose), EXPIRED PRODUCT ADMINISTERED (The second dose given incorrectly but was expired, refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was expired and refrigerated for more than 30 days).    It was reported that patient received the first vaccine on 02-Aug.  No concomitant information was reported. No treatment information was provided.
The day of the vaccination I started getting headaches and body aches. I was very tired and got chills. And it was pretty bad for 48 hrs. Then I started feeling better. Then not the day after but the following Monday I got a really bad migraine headache. The Wednesday following that I got a floater in my left eye. I have muscle aches in my back and I'm nauseous, and I'm still tired. Last Wed I saw the Dr. and she said if the headache doesn't go away as of yesterday I should call her and I did. Now I have a follow up appointment with her next week. I also saw an eye Dr. for the floater in my left eye.
Deltoid area was painful after injection but not unusually severe. The area has continued to be intermittently painful on movement since the injection 3 1/2 weeks ago.
5/25/22 at 3:30am first witnessed seizure, fever 106 -> parents took private vehicle to Emergency room.  4:00am patient received Tylenol in ER and still lethargic and discharged home.  5:00am patient home.  Motrin given 7:00am, 7:15am second seizure witnessed. 7:45 ambulance arrived and transported patient back to the emergency room.  Patient had another seizure in route to the hospital witnessed by parent.  Patient had fever 104.6 in ER and lethargic.  Patient sent by private vehicle to hospital for an EEG.  Then patient returned back and was observed overnight at ER.  5/26/2022 a rash appeared all over patients abdomen, face, partial down legs.  5/27/2022 another doctor appointment and no fever present.  5/30-31/2022 Rash started to resolve.  Referred to Pediatric neurologist.  Another EEG was preformed.
The second she injected the vaccine I got a sting metal taste in my mouth.  This is day number 2 and I still have the metal taste.
Client received the 1st dose of COVID vaccine by Pfizer lot #EW0161 and expiration 4/14/2021 at 10:58AM. At 11:30AM client reported to EMT that she felt shaky and anxious.  Nurse responded and found client sitting upright and talking to EMT.  Client has a history of high blood pressure and diabetes and had COVID during Christmas. Client is taking Lisinopril and bulsgar.  Client reports no history of anxiety.  Provided client with water and repeated sets of vitals.  Client alert and oriented x 4. At 11:30 am the first set of vitals were taken: Blood pressure: 120/70, Pulse: 88, Oxygen 95%. At 11:40 am vital signs were: Oxygen 96%, pulse86 and blood pressure: 115/70. Client reports she had a tightness in her chest at 11am but states it rapidly went away.  client reports no headache or chest pain at this time. Client reports she has constant dizziness and blurred vision due to her diabetes. Client reports she sees her provider every three months. Provide client with emergency precautions. At 11:49am last set of vitals taken blood pressure: 115/70, oxygen: 95%, pulse:88 and client reports symptoms resolved and does not want to wait. At 11:50am client left facility with a steady gait.
Multiple palpitations all day every day since  about 2 days after receiving second dose, making appt with cardiac dr.
On 9-3-22, 8 days post vaccine started with hives  that covered entire body. Sore throat. Woke next day with some swelling of lips and hives worse. Went to ER. Was prescibed a prednisone mouth rinse and discharded. Follow up with Dr. family doctor on 9-6-22. Had some general achiness and he prescrided a Medrol pak. I didnt started the Medrol right away was going to see how I was doing. The hives and mouth sores improved over the next week. On 9-11-22 I woke with severe muscle and joint pain, even the bottoms of my feet. I started the Medrol pak around 9-15-22 when the symptoms were not improving. The syptoms improved until about 1 week after finishing the Medol pak. The muscle/joint pain started to worsen. I saw Dr. again on 10/6/22 and he prescribed Prednisoone 10mg that I took 3 daily for 3 days then to 2 daily and now taking 10mg daily. My symptoms have improved since this last dosing of steroids. I have my normal joint achiness currently.
Fever over 100 after 7 hours on day 1, 104.1 on day 2 - in bed for 19 hours, chills. Day 3 much better, fever back to just over 100. Day 4 - mostly fine, with occasional chills that come and go, temperature of 99. Day 5 still some chills, especially in the few hours after waking. No fever.
Patient was vaccinated on 1/12/21 and 2/9/21, so was fully vaccinated when testing positive for COVID-19 on 10/6/21.