chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu vaccination administered on 11-7-2016. On 11-13-2016, woke up at 3:00 AM and described "left leg on fire". Gradually progressed over next two days to both legs and hands. Could no longer walk. Was hospitalized for approx 11 days, treated for GBS. Now in rehab hospital.
Expired vaccine administered.  Expiration time is usually 12 hrs for moderna, the vaccine was administered 24 hrs later. No signs and symptoms reported by patient. Waiting  for moderna for the farther notice on what to do next.
patient received the first dose / on 06-Jan-2020 and has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 6th January 2020).   On 6th January 2020, 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 reported 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.
Nausea/vomiting, malaise, fever  (101.6 degrees F), flu-like symptoms, headache. On quarters for 24 hours.  Rx:  Tylenol
This spontaneous report as received from an approximately 73 years old male patient with high blood pressure and cholesterol. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Concomitant medications included Lisinopril, Clonidine, Hydrochlorothiazide and Simvastatin (manufacturer unknown). In 2010, months after the ZOSTAVAX injection was given he stated perhaps 2009 or 2010, he noticed both sides of his face starting to feel a painful burning sensation and spots by left eye, lower left ear that was very sensitive to the touch which has not subsided and was still experiencing. The patient sought unspecified medical attention. The patient received prescribed gaspentin 600mg three times a day. Additional information has been requested.
Pain/swelling at injection site lasting more than 5 days, nausea, chest tightness, light headedness, severe joint pain, and headaches.
Adverse Reaction Notes 1050 Dizziness, blurred vision. BP 138/99, HR 78, Sats 98%,Resp 20 1st vaccine, reports Cardiac Hx. 1054 C/O chest pressure, denies pain frequent PVC on monitor 12 lead EKG done. Rescue called. BP 128/100, HR 89, Sats 97% Resp 18. 1100 C/O SOB Sats 97%, O2 two liters via NC placed. 1106 denies chest pain, chest pressure continues . Rescue arrived . BP 133/99,HR 89, Resp 18. 11:09 left with rescue
I had itching at the site and then a large circular hive covering most of my upper left arm. I took Zertec 10 mg. I applied ice for 20 min which did provide some relief of the pain at the site but the swelling persisted. Saturday and I took Zertec 10mg twice to control the itching. The area did reduce in size but redness and swelling persisted until today (Monday).
vaccine caused Trigeminal Neuralgia; vaccine caused Bells Palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: vaccine caused Trigeminal Neuralgia) (serious criteria GSK medically significant) and trigeminal neuralgia (Verbatim: vaccine caused Bells Palsy). The outcome of the bell's palsy and trigeminal neuralgia were not reported.   The reporter considered the bell's palsy and trigeminal neuralgia to be related to Shingles vaccine.     The company considered the bell's palsy and trigeminal neuralgia to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-JUL-2023 The case was received from the consumer interactive digital media. The reporter stated that vaccine caused Trigeminal Neuralgia and Bells Palsy The follow-up could not be possible as no contact details were available.
Post vax, the pt experienced excessive and uncontrollable crying and fussiness starting 24 hours post vax and lasting 7 days.
Information has been received from a registered nurse concerning a 12 year old female patient who was vaccinated with varicella virus vaccine live. Subsequently, the patient "came down with chickenpox". On 09JUN2003 "she began feeling tired and had a low grade fever and started breaking out on 10JUN2003. The patient reportedly had 50 to 75 lesions. The doctor told the mother to give diphenhydramine HCl (benadryl), acetaminophen (tylenol) and oatmeal bath. On 11JUN2003, the patient was reportedly "beginning to recovery." It was also reported that this child was exposed to other children with chickenpox. At the time of this report one other patient was reported to have a similar experience. Additional information has been requested.
Shaking/jerking of hands & feet, slumped forward in chair, unresponsive 5-10 seconds.
Information has been received from a healthcare worker (Certified Medical Assistant) referring to a patient of unknown age and gender. On 27-JAN-2015 the patient was vaccinated with a dose of GARDASIL which was post non-supported excursion (lot # K005083, expire date, 04-NOV-2016, dose and route were not reported). No adverse effects were noted. This is one of several cases reported by the same reporter. Additional information has been requested.
Developed DVT in left leg from groin to ankle. Diagnosed on 01/29/2021. Pain, swelling, and difficulty walking lead to emergency room visit, admission to hospital for 2 days.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in left arm, on 05Jan2021 at 13:30, at a single dose, for COVID-19 immunization. The patient's medical history included diabetes, arthritis, vitamin D, bones, gums, eye, joint pain lubrication, hair and nail growth and strength, control sugar, atrial fibrillation (Afib), heart, supplement, cholesterol, liver clean, and gastro problem. The patient's concomitant medications included apixaban (ELIQUIS) for Afib from 2019 (a year and three-fourths), metoprolol for heart from 2019 (a year and three-fourths), metformin hydrochloride (METFORMIN ER) for diabetes, berberine to control sugar, biotin from 2011 (for 10 years) for hair and nail growth and strength, Silybum marianum (MILK THISTLE) to make liver clean (two or three years), hyaluronic acid for joint pain lubrication, niacinamide for diabetes, chondroitin sulfate/ glucosamine sulfate (GLUCOSAMINE CHONDROITIN) for bones, Monascus purpureus (RED YEAST RICE) for cholesterol, colecalciferol (VITAMIN D3; UPC Number: 3373900373, Lot Number: 3162111, and Expiration Date: Jun2024) for vitamin D, probiotics for gastro problem, betacarotene for eye, ubidecarenone (COENZYME Q10) for gums, calcium/ magnesium (CALCIUM MAGNESIUM) for bones, and unspecified multivitamins as supplement and OSTEOPHASE for arthritis; all were ongoing. The patient her first dose of COVID-19 vaccine dose on 05Jan2021. The patient had experienced diarrhea ever since 09Jan2021 and is still continuing until today. The patient experienced a sudden onset of diarrhea and it has continued on and off since then; it is persisting or worse. She has seen a gastroenterologist, but they don't have any answers, sent stool cultures in Jan2021 but no results yet. The patient was asking if this is a documented adverse event. The patient is scheduled on 26Jan2021 for the second dose. With this experience, the patient was asking what to do with the second dose- if she should get the second shot. The patient had not recovered from the event.
No adverse event; vaccines administered past the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date.).    This is case is for Patient 1 of 13 patients.  No concomitant medications were reported.   It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna COVID-19 Vaccine with Lot number: 060H21A was received on 27-Dec-2020 with expiration date as 28-Mar-2022 but the Date of administration was 11-Apr-2022 with doses of 13.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728249, US-MODERNATX, INC.-MOD-2023-728254, US-MODERNATX, INC.-MOD-2023-728251, US-MODERNATX, INC.-MOD-2023-728256, US-MODERNATX, INC.-MOD-2023-728260, US-MODERNATX, INC.-MOD-2023-728264, US-MODERNATX, INC.-MOD-2023-728266, US-MODERNATX, INC.-MOD-2023-728268, US-MODERNATX, INC.-MOD-2023-728269, US-MODERNATX, INC.-MOD-2023-728273, US-MODERNATX, INC.-MOD-2023-728280, US-MODERNATX, INC.-MOD-2023-728275 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow up received with no significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728251:Patient no 02 US-MODERNATX, INC.-MOD-2023-728254:Master Case(Patient 1) US-MODERNATX, INC.-MOD-2023-728249:Master Case(Patient 1) US-MODERNATX, INC.-MOD-2023-728256:Master Case(Patient 1) US-MODERNATX, INC.-MOD-2023-728266:(13 patient Out of 13) US-MODERNATX, INC.-MOD-2023-728269:3rd patient Out of 13 US-MODERNATX, INC.-MOD-2023-728260:(11 patient Out of 13) US-MODERNATX, INC.-MOD-2023-728264:(12 patient Out of 13) US-MODERNATX, INC.-MOD-2023-728268:( 5 patient Out of 13) US-MODERNATX, INC.-MOD-2023-728273:(6 patient Out of 13) US-MODERNATX, INC.-MOD-2023-728280:( 7 patient Out of 13) US-MODERNATX, INC.-MOD-2023-728275:4th Patient Out of 13
Developed hives, would flare up in different parts of his body. Took low dose of antihistamine and it seemed to help temporarily. Prescribed prednisone. Went to a dermatologist, was prescribed Allegra 180mg, Zyrtec 40mg, Pepcid 20mg, Benadryl. With medications the hives are getting a little better but still flare up daily.
Patient received vaccine fine.  I told mom to have all her children sit, and 3-4 minutes later she came to me and said one of her sons were passing out.  She brought him to sit, and we gave him wet paper towels and ice packs.  Then Dad brought this patient around because he was light headed too.  We gave him the wet paper towels and ice packs too.  He passed in and out of consciensness.  Dad was working with him and kept wiping his face and kept him upright.  Finally after several minutes he was responding and staying awake.  They sat for several minutes more until they both felt ready to go.
Was hospitalized on 3/29/04 for RSV Bronchiolitis. Was still in hospital when event occurred. Event not due to vaccines. Discharge summary on 04/28/04 states: fever, RSV, Bronchoplumonary dysplysia.
Patient brought to the ED on 11/8 for evaluation of confusion. Patient lives independently, and for the past 3 days her son has noticed that she has been confused. Patient was brough in by EMS, and on arrival to the scene she was notably hypoxic to 75-85%. She continued to have hypoxia in the ED and required supplemental oxygen. Patient had a COVID-19 PCR test done in the ED which resulted positive. Ultimately, she was admitted 11/8 with acute hypoxic/hypercapnic respiratory failure, suspected COVID-19 pneumonia with superimposed pneumonia, and chronic COPD with possible acute exacerbation, among other diagnoses. Patient was transitioned to comfort cares, and passed away on 11/11.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 08-MAR-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. An adult male patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history ad concomitant medications were not reported. The patient experienced decreased sleep a few weeks after vaccination on an unspecified date with outcome of unknown.
hurting feeling throughout the body; shaking; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PAIN (hurting feeling throughout the body) and TREMOR (shaking) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced PAIN (hurting feeling throughout the body) and TREMOR (shaking). At the time of the report, CHILLS (chills) had resolved and PAIN (hurting feeling throughout the body) and TREMOR (shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This spontaneous report as received from a healthcare worker refers to a multiple unspecified number of patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) (dose and route of administration were unknown) either lot # M041085 with expiration date of 31-JAN-2018 or lot number  M044220 with expiration date of 03-JAN-2018 for prophylaxis, which were stored  from  -14 Celsius degrees (°C) to -10°C (-12.1 °C) for 30 minutes. The healthcare worker was unsure if sterile diluent (strength, dose, route of administration, lot number and expiration date were unkonwn) used to reconstitute the ZOSTAVAX was properly stored. The temperature excursions were detected by a data logger. There were no previous temperature excursions. No adverse effects were reported.
On 1/4/21 patient had itching to both hands(possibly from dry skin). On 1/6 patient stated her left hand swelled at around 1:00pm, then her first two fingers on her right hand swelled and first two fingers on her left hand were numb for approximately 45 minutes. Patient was seen by her primary care provider, no treatments have been done at this time. Dr. thought patient was having a systemic response when she woke up this morning  (1/7/21) with no swelling or any other problems.
Patient with incidental COVID detected test prior to admission to behavioral health unit.  No symptoms during stay.  Admission for behavioral health needs.
Fatigue, body aches, headaches, hot flashes (no fever), chills, decreased concentration, heart rate spikes, mild nausea, malaise. Effects lasted through the evening of vaccination date and the following two days.
Information has been received from a certified nurse midwife concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergies who in April 2008, was vaccinated IM with the first dose of GARDASIL (Lot# not reported). In November 2009, the patient was vaccinated IM with the second dose of GARDASIL (Lot# not reported) and on 23-SEP-2010, the patient was vaccinated IM with the third dose of GARDASIL (Lot# not reported). There was not concomitant medication. It was reported that on 18-AUG-2008, the patient had an abnormal pap smear. There was not treatment provided. At the time of the report, the patient's outcome was unknown. The patient sought medical attention. Additional information has been requested.
2 wks after injection patient noted warts lesion on external genitalia- 6 mos persisted. She was seen today and has 1 cm. condyloma.
100 employees had been enrolled in Hep B immun program & as of 4MAR91 approx 1/2 had completed or shortly would complete their vax; 19 had completed titer screening & of those, 8 had titers below 10;
Information has been received from a radiology technician concerning a female who on 29DEC2003 splashed (also described as "sprayed") varicella virus vaccine live into her right eye. It was noted that the eye was red. Treatment included eye irrigation at an eye wash station x 20 minutes. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.
elevated BP reading w/o dx of htn. 171/125 and 160/125 w/assd headache and dizziness.
This spontaneous report was received from a healthcare worker refers to a 17 unspecified patients of unknown demography. On an unknown date, the 17 unspecified patients received improperly stored (Oka/Merck) VARIVAX (dose, route and frequency were not reported) exposed up to 6F for a total of 5 day period which started on 13-MAR-2014. No adverse effect reported. No further information was provided. Additional information was provided. Additional information has been requested.
Pt had arm pain after injection. Called office on 11/1/2010 c/o continuing severe Lt arm pain from shoulder down to wrist. Decreased range of motion, pain wakes her up at night. Pt seen for visit, advised Ibuprofen and heating pad. Called again 11/15/10 with continuing pain but refused appt as there was no redness, swelling and pt unable to come in for another appt. Pt given pain medication of Ultram. Pt called again today still reporting continuing arm pain,which is persistant and interferes with sleep, daily activities. Declines appt. as nothing external to see or evaluate per pt. We have now ordered physical therapy to see if they can recommend some treatment or ultrasound to deep muscle and see if effective. Pt testing of strength on 11/1/10 visit was normal.
5/08 Given ZOSTAVAX -> 9/08 Had shingles abd. mod- severe, self limited.
Started unusually heavy period at least two weeks early two days after 1st dose. Not a big deal but I've read that I should report it.
Rash and nodule on the spine. Severe pain and muscle spasm with accompanying reduced ability to stand upright.
Information has been received from a physician concerning a female who on 29-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot #660685/0619X). On approximately 29-OCT-2008 the patient developed edema and could not raised her arm. The patient's edema and could not raise her arm persisted. The physician stated he was given a "bad batch" of PNEUMOVAX vaccine. A lot check has been requested. This is one of several reports from the same physician. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information has been requested.
Patient felt light headed and passed out which led to falling down on the ground 2-3 minutes after receiving the first dose of the Moderna vaccine. Patient with supported to the ground until EMT showed up and assessed the reaction. The patient felt okay minutes later and refused to go to the hospital with the EMTs.
Patient developed abrupt onset frontal headache with abdominal pain, nausea and vomiting occurring approximately 20 or so hours following receipt of the 2nd dose of the Pfizer Covid19 vaccine series.  Patient did not have any adverse reaction to the first dose.  He presented to our clinic (same location where he received the vaccine) for evaluation and treatment.  I examined him and gave him 8 mg of oral ondansetron for his nausea and vomiting which seemed to improve this and permitted him to tolerate drinking sips of water and eventually taking 400 mg of ibuprofen for the headache.  He was discharge home from the clinic having improved from initial presentation with these interventions.
The patient informed me right after she got the vaccine that she felt cold and tingly like after anesthesia.  She also reported a metallic taste in her mouth.  She was given water and observed for 30 minutes.  I called and left a message for her on 1-12 to see how she was doing.