chrisvoncsefalvay/vaers-outcomes huggingface dataset:
post herpetic neuralgia on right abdomen; pain; Product supply issue; This case was reported by a physician via call center representative and described the occurrence of post herpetic neuralgia in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 14 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced post herpetic neuralgia, pain and product supply issue. In November 2018, the outcome of the post herpetic neuralgia and pain were recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the post herpetic neuralgia and pain to be related to Shingrix.  Additional details were provided as follows: The patient is a retired neurologist. The patient reported that about 2 to 3 weeks after injection, he developed what felt like a post herpetic neuralgia on his right abdomen, about 2 inches from the mid-line. The reporter stated that wearing a t shirt or any shirt was annoying and that the pain resolved sometime in November 2018. The patient reported that due to his travel as well as unavailability of product, has yet to get the second dose and was outside the 6 month window.
expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment: The reporter from a pediatric office reported an expired dose of Kinrix was administered to a patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The reporter from a pediatric office reported an expired dose of Kinrix was administered to a patient, which led to expired vaccine used.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with VARIVAX (strength, dose and route of administration were not reported) lot # M019643, expiration date 20-APR-2018, and lot# M038857, expiration date 14-SEP-2018, for prophylaxis. The vaccine was exposed to 6 degree fahrenheit to 14 degree fahrenheit for 300 hours. There was no previous temperature excursion.Digital data logger was involved. No adverse effects were reported. There was no product quality complaint(PQC) involved.
cardiac arrest on the evening of 5AUG92; ?SIDS-no cause found; 7AUG92 pt probably brain dead; 7AUG92 pt died @ hsop;
Moderna vaccine leaked little while administration; Moderna vaccine leaked little while administration; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Moderna vaccine leaked little while administration) and DEVICE CONNECTION ISSUE (Moderna vaccine leaked little while administration) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced UNDERDOSE (Moderna vaccine leaked little while administration) and DEVICE CONNECTION ISSUE (Moderna vaccine leaked little while administration). At the time of the report, UNDERDOSE (Moderna vaccine leaked little while administration) and DEVICE CONNECTION ISSUE (Moderna vaccine leaked little while administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
My arms were swollen, I was light-headed and I had a rash on my left bicep.
COVID Moderna #1 given 1/13/21, lot #025L20A; COVID Moderna #2 given 2/10/21, lot #030L20A; pt had a positive COVID test on 11/9/21; pt presented to the Hospital 1/14/22 with altered mental status, O2 sats 51% on 2L O2; placed on BiPAP; pt had a DNR/DNI but family overturned that and pt was intubated in ED; pneumonia, UTI, AHRF; pt given ABX; admitted to inpatient hospice where he was extubated on 1/16/22 and he passed away on 1/19/22; death certificate and medical records sent to info@vaers.org per VAERS request
Patient presented with poor feeding, irritability, vomiting fever, weakness, decreased urine output that started 24-34 hours following administration of the vaccines. He was diagnosed with transverse myelitis by MRI and clinical findings and admitted to the pediatric intensive care unit at  Hospital.
This spontaneous report as received from the patient's mother via a company representative and refers to a currently 20-year-old male patient. The patient's concurrent condition included Down's syndrome. The patient's medical history and concomitant therapies were not reported. In approximately 2005, at the age of about 7-year-old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, lot number, expiration date were not provided) for prophylaxis. He was vaccinated. Other suspect therapies included sterile diluent (manufacturer unknown). On unknown day in approximately 2005, reported as day after receiving the vaccine, the patient became non-verbal and he remained that way ever since. The patient sought medical attention. The relatedness between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and sterile diluent (manufacturer unknown) was not reported.
Sudden intense acid reflux, started on 6/26/2021 and continued with no relief, also experiencing trouble swallowing. Saw a doctor on 7/1/21 and was told to take Omeprazole daily for 2 months and to check back in September.
no adverse event; Expired vaccine used; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  On 22-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T031825 (rHA), expiration date 16-MAR-2022 (expired product administered) for prophylaxis (dose, route and anatomical location were not reported). No adverse events reported.
patient was given an expired menvo injection patients mother was notified and I let her know he would be fine and that he has to come back in to get revaccinated, mother was fine when I spoke to her
Joint pain, severe headache, shortness of breath, 104.9 fever, nausea, discomfort in upper right lung  I had the same reaction after the first shot on March 14. They started about 22 hours after the first shot. However, after the second shot, I started having the adverse reactions within an hour of the shot.
Pt came in to be seen for hives wide spread over body with swelling, pt received vaccine else where.
Noted swollen lymph nodes (L) side of neck 10/23/12. Noted swollen lymph nodes (L) side of neck increased in size 10/24/12 at 1530. Sent to see PCP. He thought probably some sort of reaction vs infection secondary to shot. Placed on abx and ZYRTEC.
In the early morning of the day after 2nd dose, woke up with shaking and chills. Shaking lasted 30 seconds, chills lasted rest of morning. Then had body ache and fever of 100.2 during the day.
sore injection site arm after second Moderna Covid-19 dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm after second Moderna Covid-19 dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm after second Moderna Covid-19 dose). At the time of the report, VACCINATION SITE PAIN (sore injection site arm after second Moderna Covid-19 dose) outcome was unknown.            It was reported that the patient received a flu shot and asked the nurse if she had the Moderna booster dose. The patient received his third full dose of the Moderna Covid-19 vaccine on 29-Sep-2021 with lot number 021C21A.  Concomitant medications were not reported. No treatment information was reported.   This case was linked to MOD-2021-354302, MOD-2021-354331 (Patient Link).
Pt received varicella dose #2 on 8/10/08.  Pt developed chicken pox lesions on 8/30/08.  Pt's 2 brothers (ages 11 and 6) developed chicken pox lesions on the same day.  Both brothers had been immunized for varicella.  I realize this is rare and wanted to document.  All boys are doing fine.  Please follow up with us on this matter.  Is there someone else this should be reported to?
Patient received vaccination and was asked to remain in the pharmacy waiting area for approximately 15 minutes following administration. After about 10 to 15 minutes, patient approached pharmacist complaining of throat tightness, chest tightness, and headache. Patient was advised to be seated in the waiting area. A second pharmacist as well as the store manager waited with the patient while the Immunizing pharmacist called 9-1-1. An epinephrine pen along with aspirin tablets were made available in case the symptoms worsened, but were not administered. Paramedics arrived on the scene within 10 minutes of contacting 9-1-1. Paramedics evaluated the patient in the pharmacy waiting area and then escorted patient to their on-site ambulance for further tests/evaluation. Patient was not transported off of store property by the paramedics. Patient was able to return home of his own accord. Immunizing pharmacist called patient to follow-up on 1/18/20. Patient reported that the throat and chest tightness had both been resolved/gone away within 30 minutes from the start of those symptoms. Patient reported that the headache he experienced did not resolve until 1 to 2 days after vaccination occurred. Patient reported that he did not seek further examination or follow-up with a physician, emergency, or urgent care following vaccination episode and that he currently felt that he had returned to his "normal" health.
high fever; nausea; weakness; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (reporter's husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, on 11Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included Addison's disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Mar2021 (after the 1st dose), the patient experienced high fever, nausea and weakness. Outcome of all events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingly sensations that radiates from the upper lip to the skin between her nose and mouth and up to the tip of her nose), FATIGUE (extremely tired) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018A21 and 01ZA21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced FATIGUE (extremely tired) and HEADACHE (headache). On 31-Mar-2021, the patient experienced PARAESTHESIA (tingly sensations that radiates from the upper lip to the skin between her nose and mouth and up to the tip of her nose). On 01-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, PARAESTHESIA (tingly sensations that radiates from the upper lip to the skin between her nose and mouth and up to the tip of her nose) and FATIGUE (extremely tired) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
About 5 minutes after receiving the Moderna COVID-19 vaccine, patient reported feeling light-headed; as staff approached, pt. was sitting down and fainted in a chair in the lobby.  No fall or physical harm occurred as the patient was sitting. He regained consciousness within 10-15 seconds, and reported feeling nauseated. Pt. supervised by pharmacy staff, and offered water and crackers as tolerated. Pt. able to leave after resting for about 30 minutes.
Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection site)
Patient developed nausea, dizziness, while sitting in observation at approximately11:02am. Placed legs on chair, cool compress on neck. Vitals:  Baseline (11:04am) BP 129/92, pulse 71,  F/U (11:11am) BP 135/98, pulse 71, (11:20) pulse 70 Patient's symptoms resolved and was able to stand on her own at 11:24am without nausea/dizziness..  Was accompanied by her mother, a nurse, who took her home.
I started to develop a headache and extreme fatigue about 4 hours after getting the shot. By 6pm I started getting severe chills and body aches. About 2 hours later the chills were alternating with fever and I could barely stand because I felt so weak from the muscle aches. I was in so much physical pain I didn't sleep at all that night. The fever lasted until late afternoon the next day (about 24 hrs total), and the body aches lasted until late afternoon the day after that (about 48 hrs total).
Left arm with flu vaccine started as big red warm, swollen reaction. Right arm with Menactra started small and then next day became large swollen reaction. Pt returned to clinic day 3 post vaccine with 3" well demarcated red raised, itchy warm and tender on both site. Ice, Benadryl and return if no improvement.
Information has been received from a physician concerning a 7 year or old female patient who on unspecified dates was vaccinated with two doses of VARIVAX (Merck). Two months ago (approximately 18-MAR-2010), the patient experienced a case of chickenpox. No lot numbers were provided. The patient sought unspecified medical attention and was treated with unspecified therapy. At the time of the report, the patient recovered. Additional information has been requested.
mom of pt gave APAP p/vax states pt became febrile t104, had jerking motion, was pale & cold;taken to ER;mom reports no test done in ER p/pt taken back home had jerking & fever 5AM on 5SEP96 & 9:00 on 5SEP96;pt fine now;
I noticed flat red marks on the front and back of my torso. They were mildly itchy in certain places. They were there a couple of weeks. When I saw the Dermatologist on December 15, 2022, she took two skin biopsy samples. She took one sample from the belly button area and one sample from my side. The dermatologist was leaning towards a virus. She prescribed triamcinolone. I use it twice a day. The rash is already quite a bit better.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/09/21 2nd dose02/06/21 Diagnosed covid positive:09/08/21 Symptom onset:09/01/21 Exposure: Symptoms:cough, fatigue,loss of smell/taste,sore throat,runny nose,HA.
Patient stated that 3 days after vaccination she woke up in the middle of the night with sudden development of hives. Patient states no change in lifestyle, food, or detergents. Patient states reaction lasted throughout the night and went away by the afternoon.
Vasovagal syncope, 1 week later extremely swollen lymph nodes and unusual fatigue for approx. 2 weeks.
Pt called this date, 1/26/21 with concerns that one week later after her covid vaccination was placed that she is still experiencing warmth, tenderness and swelling to the injection site of the L deltoid. Pt also indicated that she has been having intermittent itching throughout her body and feels generalized fatigue.  Pt was directed that should her symptoms worse, or should she feel her current symptoms warrant  a visit to her PMD, ER or Urgent care, that she should present to one for further evaluation. Pt denies the need for that intervention at this time and wants to apply warm compresses and give it a few more days.  Pt will keep this clinic updated regarding any further reactions or worsening events.
Tingling in the arm and high blood pressure of 170/86.  Paramedics assessed pt. once symptoms subsided pt. was released to leave.  Tent 14.
Dose 1 of Shingrix back in 2018; 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 2018).   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 to this report. The  pharmacist reported that till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination. The reporter stated that it had been a long period of time they did not know if to administer 2nd shot or restart the series. The pharmacist not completely sure to provide Follow Up when agent asked.  No data from patient was provided, only gender but this information was not certain as per HCP statement.  No more information was reported. The VAERS details were provided for 1st dose. The reporter did not consented to follow-up.
2 minutes after receiving vaccine, local area of arm became very red and uncomfortably itchy.  She got agitated, and then had severe stomach pain.  Became pale and very subdued.  Monitored vitals, as still in doctors office, offered water and cookies once she started to feel a little better, after 20 minutes, rash fading and feeling better.  Color returned.  Day later, rash developed and very itchy on proximal arm same side as shot.  Faded relatively soon.  Released from doctors office once she was stable and back to normal.
Menactra was given to a patient at an earlier interval than it should have been with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via regulatory agency (Reference number- 00752061) and transmitted to Sanofi on 02-Sep-2021.  This case involves a 13 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] at an earlier interval than it should have been (inappropriate schedule of product administration).  The patient's past vaccination(s) included MENACTRA primary dose injection on 23-AUG-2019.  The patient's medical history, past medical treatment(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  On 02-Sep-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Injection, lot U6921AA and expiry date was not reported) via intramuscular route in the left deltoid for prophylactic vaccination (inappropriate schedule of product administration).  It was a case of actual medication error due to inappropriate schedule of vaccine administered (latency: same day).  It was reported "patient received primary MENACTRA injection on 23AUG2019; clinic did not have the documentation of the primary shot and administered second primary shot today, 02SEP2021."  "Asked if there were any side effects to be concerned about."  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 the guidelines. 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.
Within 15 to 20 minutes of receiving vaccine got severe headache. Within 2 hours felt tired and sleepy. Within one day had sweats alternating with cold chills and fever of 99.5 degrees F. Within 3 days my INR level increased from normal range of 2.0 to 3.0. INR became 4.7 and began easily bleeding. Went to ER on Sunday April 18, 2021 due to severe headache and numbness & tingling in right arm and leg.
About an hour post shot my lips and neck started to swell. I took Benadryl at home and we watched my symptoms. For the next 3 days my right hand (shot arm) was swollen and itchy-treated that with Benadryl as well which worked fine.
02/24/2023 I started off with a headache and congestion with runny nose and fatigue. After testing for Covid-19 I was positive for Covid-19. I reached out to my doctor and was prescribed PAXLOVID. Symptoms lasted a whole month.
On July 31st I started coughing and had a scratchy throat. Next day I felt worse, was very tired, had a headache, and cough got worse. The symptoms continued so on Monday Aug 2 got tested for COVID-19 and it was negative on Aug 4th. Aug 5th my husband started feeling bad, so we went to urgent care, and we got tested and were both positive. The other office called me back and said they read the wrong date and, I was positive. I was told to drink plenty of fluid and rest. I was prescribed a steroid step down, and another that I can't remember what it is, also a step down, I ended up with covid lounge-red sore, blistered, hurt to eat, or drink, loss of taste and smell-it would come and go and still does. Joint pain also. Symptoms lasted about 2-3 weeks.  After first dose I noticed my hair didn't seem right. I mentioned it to my hairdresser, and she said noticed it was thinning a lot soon as I walked in. She stated she had quite a few clients telling her this same thing.  the hair loss that is continuing.
pt to ED with increasing SOB, cough, fever, chills; home sats on RA were in the 70s; placed on O2 supplementation; Acute on chronic HRF secondary to COVID pneumonia; treated with dexamethasone, and remdesivir; condition deteriorated; encephalopathy; DNR; with worsening condition, pt was changed to comfort measures; pt died in the hospital
I started itching all over my body.  I have had enough allergic reactions to know I was having one.  I took a Benadryl and went to bed.  I was still having some itching the next morning.