chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administrated with an expired dose / on June 24 2021 / vaccine expired on June 14 2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 24th June 2021, unknown after receiving Pediarix and Pediarix 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 details were provided as follows:  The age at vaccination was not reported.  The patient was administrated with an expired dose of Pediarix, which led to expired vaccine used. No adverse event was reported. The reporter consent to follow up.
5-19-12 Warm to touch - started to redden in area of inj. 5-20-12 Reddened, warm, itchy, - felt like sunburn. 5-21-12 Same as above but felt like a really bad sunburn slightly swollen. No treatment.
Instant swelling egg shape lump on arm slowly went down throughout the day, patient didn't feel sick or arm hurt any more. Check with pt following day pt fine.
On 03/06/2021, about 3 days after the vaccine I had a rash on my lower neck and it lasted for about 5 day to a week,  and it was very, very itchy. After the 2nd Dose of Moderna, Lot # 038A21A, on my left arm, 04/30/202 the rash appeared about a month after the vaccine. It also lasted about 5 to 7 days, and it was very, very itchy. HCF called me to see how I was doing and they asked me to postpone my booster. I had never had this rash before. After the 3rd Dose, on 11/12/2021, the rash appeared again on 12/09/2021, but the rash was a lot less and the rash only lasted about 3 days and it was also very itchy. I was given some topical cream to put on it.
swelling in my elbow, like tendonitis, red and painful. It is not related to the vaccine. I get this tendonitis sometimes; swelling in my elbow, like tendonitis, red and painful. It is not related to the vaccine. I get this tendonitis sometimes; swelling in my elbow, like tendonitis, red and painful. It is not related to the vaccine. I get this tendonitis sometimes; This is a spontaneous report from contactable consumer (Patient) via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced swelling in her elbow was not related to the Pfizer vaccine she received. Also experienced swelling in my elbow, like tendonitis, red and painful. It is not related to the vaccine. I get this tendonitis sometimes." She is due for her 2nd Pfizer vaccine dose on 23Mar2021. The outcome of event was unknown.  Information on product lot/batch is requested.
This case was reported by a nurse and described the occurrence of vaccine underdose in a 19-year-old female patient who received HAVRIX 720 (batch number 3J9AM, expiry date unknown). On an unknown date, the patient received the 2nd dose of HAVRIX 720. On an unknown date, an unknown time after receiving HAVRIX 720, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. Additional information: an adult patient was inadvertently given a 720 dose of HAVRIX as her 2nd booster dose.
Towards the end of August, my three-year-old had a fever followed by cough and runny nose. We did a COVID-19 test. She had COVID-19. We kept her in quarantine and about a week later, my husband also developed fever and other respiratory symptoms and four or five days after that I developed symptoms. Other child got symptoms after that.  My husband and I were both vaccinated and both kids weren't. I was tested twice and was negative and then was positive around 9/13. I had fever, body aches, cough and sore throat. Diarrhea, also. Really, really bad headache. I could breathe fine and didn't need any serious treatment. I had Advil/Sinus Med and cold medicine.  My symptoms lasted about a week. Did a telehealth visit but it wasn't really a doctor appointment. Just to get the testing done.
I woke up the next morning with a head splitting that went down to my next. I had a fever, dry heaves, diarrhea, and bed body aches. This was followed with over all weakness. There was also a strange taste in my mouth. This went on till the next day. My fever broke around 11 a.m. on Saturday. I could not drive to get to an Urgent Care. I have yet to contact my Doctor but I did call the nurse line. They gave me this website. I still have body aches but not like the previous days, and light headedness. But I couldn't eat for two days.
2 hours after HIGH-DOSE flu shot, pt experienced drop in BP from 125/75 -> 90/50. Chills, uncontrollable shaking. Almost passed out, very lethargic and several hours.
arm became swollen immediately; shortness of breath/Runs out of breath right away; chest pain; Pain on left side of the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm became swollen immediately), DYSPNEA (shortness of breath/Runs out of breath right away), CHEST PAIN (chest pain) and MYALGIA (Pain on left side of the body) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LINACLOTIDE (LINZESS) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm became swollen immediately), DYSPNEA (shortness of breath/Runs out of breath right away), CHEST PAIN (chest pain) and MYALGIA (Pain on left side of the body). On 07-May-2021, PERIPHERAL SWELLING (arm became swollen immediately) had resolved. At the time of the report, DYSPNEA (shortness of breath/Runs out of breath right away), CHEST PAIN (chest pain) and MYALGIA (Pain on left side of the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient took Tylenol and an Inhaler(name not provided) as advised by her doctor, to relieve the symptoms.
diarrhea; Sore arm; high fevers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (high fevers) and DIARRHOEA (diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020M20A) for an unknown indication.     The patient's past medical history included No adverse event (No medical history.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (high fevers). On 06-Apr-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (high fevers) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided          No concomitant medications were given No treatment information was provided    Reporter did not allow further contact
Minor muscle pain and low fever in AM switched to joint pain, muscle pain, weakness, sweats and high fever (hallucinations) in PM. Hives and redness at injection sites occurred 10/14 (still exists).
After reeiving immunizations patient walked down hallway, fainted collapsed, hitting door. Responded right away. BS 102, BP 99/50, P 50. Stated he was dizzy and discomfort back of head. Patient had not eaten that morning. Patient was examined by doctor and was given water and Gatorade. Patient rested a while and walked out under parental supervision. Pt returned 4/2/14 c/o HA.
BlurredVision, Dizziness, Headache & Myalgia Narrative:
fever, chills 16 hours post injection, mildly febrile 24 hours later
Patient received vaccine 17Feb21. Within 24hrs pt developed radiating pain from shoulder to neck that has lasted since today, 22Feb. Of note pt recently had back surgery on 30Nov20 which she states is contributing to her pain.
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 10:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 10:39 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.28 years.  Concomitant products were not provided.  On 11-Feb-2021, the vaccines were moved to fridge.   On 17-Feb-2021, five vials were moved to clinic. On the same day at 09 AM, the vials underwent temperature excursion with temperature 22 degrees Fahrenheit . The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 13-Mar-2021. Total doses administered were 62.    It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Herpes Zoster- Information has been received from a health care professional concerning a 22 month old female patient who on 07 Jul 1999 was vaccinated in the left arm with one dose of varicella virus vaccine live (25580/1538E-invalid).  There were  no concomitant medications, known allergieis or past medial history.  The patient did not have a post vaccination rash within 42 days of the vaccination.  On 05 May 2000 the patient presented to a physician's office with what was said to appear like shingles.  The rash was located on C4, C5, C6 and all the median nerves on the right arm, involving the entire shoulder.  The patient was reportedly fussy.  The registered nurse quantified the patient's pain as 7 on a scale of 1-10 (worst) and descrived the herpes zoster as pretty had.  It was noted that the patient was afebrile and was treated with diphenhydramine hydrochloride (Bendadryl) and acyclovir po and has recovered.  Follow up information reported that preliminary results of pcr analysis from columbis university are vzv positive.  Follow up information reported that the final results of the PCR analysis obtained on 08 May 2000 from Columbia University were VZV + and Oka VZV was identified on PCR analysis.
Information has been received from a physician concerning a male who was vaccinated with a dose of varicella-zoster virus vaccine live (Merck) on an unspecified date. Subsequently two weeks post-vaccination the patient developed a rash that looked like an "outbreak of shingles". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2005. Additional information from the physician indicated that the patient recovered on 16-NOV-2006. No other information was provided.
Local reaction developed day after on LA. Edema and erythema  x 2 days. Seen on 10/25 3 cm reddened area. Shot given 10/22.
Vertigo; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Vertigo) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-214599 (Patient Link).
numb; tingling; hasn't slept; feeling light headed; whole body feeling cold; being sore; nausea; headache; feel like she has to vomit; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numb), PARAESTHESIA (tingling), INSOMNIA (hasn't slept), DIZZINESS (feeling light headed) and FEELING COLD (whole body feeling cold) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced HYPOAESTHESIA (numb), PARAESTHESIA (tingling), INSOMNIA (hasn't slept), DIZZINESS (feeling light headed), FEELING COLD (whole body feeling cold), MYALGIA (being sore), NAUSEA (nausea), HEADACHE (headache), NAUSEA (feel like she has to vomit), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PEPPERMINT [MENTHA X PIPERITA] at an unspecified dose and frequency. On 15-Jul-2021, PARAESTHESIA (tingling) had resolved. At the time of the report, HYPOAESTHESIA (numb) had not resolved and INSOMNIA (hasn't slept), DIZZINESS (feeling light headed), FEELING COLD (whole body feeling cold), MYALGIA (being sore), NAUSEA (nausea), HEADACHE (headache), NAUSEA (feel like she has to vomit), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient also experienced being sore. No concomitant medication was provided by reporter. Patient also had water to stay hydrated and advised to take rest at home after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow-up received and does not contain any new information.
Client began jerking motions after receiving HPV vaccinations. Began to fall forward, caught client and laid flat on floor with feet elevated. Client was clammy to touch. Was responsive. shortly after laying down, began to dry heave, so laid client on side. Did not vomit though. Very pale and clammy, but responsive and oriented.
Eight days after  given the first Moderna  shot my arm began to itch and a large red, sore, and swollen area began to spread down my left arm. The area was about three inches wide and four inches long. I treated it  with ice packs off and on . The ice helped the itch. having Gl
73 year old female patient with PMH of AFib s/p ablation, HTN, HLD, GERD presents with left sided low back and hip pain since 12/24. Denies injury or trauma. Described as a stabbing pain in the left low back and groin with shooting pain down the leg with standing and sometimes sitting. Pain radiates down to the foot with associated tingling and numbness. Went to her chiropractic three times recently without relief. Rates pain 9/10 in severity when standing, minimal while lying down. She saw pain management last week and received oral prednisone. She has another appointment coming up with pain management on 1/22. Incidentally found to be Covid-19 positibe in the ER. No respiratory complaints.
Feels "itching" in her body. No distress/SOB. Able to swallow. No visual symptoms of allergic reaction. Pt A&O. Symptoms resolving. Diphenhydramine 50 mg PO administered. Pt observed for 45 mins. All sxs resolved
Pressure behind right eye; Right eye swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of sensation of pressure in eye in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 2nd dose of Shingrix. On 06-MAR-2023, 3 days after receiving Shingrix, the patient experienced sensation of pressure in eye (Verbatim: Pressure behind right eye) and eye swelling (Verbatim: Right eye swelling). The outcome of the sensation of pressure in eye and eye swelling were not resolved.   It was unknown if the reporter considered the sensation of pressure in eye and eye swelling to be related to Shingrix.     It was unknown if the company considered the sensation of pressure in eye and eye swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAR-2023 The reporter was the patient who received his second dose of Shingrix and stated that he experienced pressure behind his right eye and swelling of his right eye.  Symptoms had not resolved, and he had been going to an ophthalmologist. The reporter did not consent to follow up.
Tinnitus in right ear only, lasting from ~2:30 AM until mid-morning.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and drug reactions or allergies was reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot number L001325 and expiry date: 13-JAN-2017, (dose, route of administration and injection site were not provided). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information has been received on 03-AUG-2015 informing that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received on 05-AUG-2015 from the reporting certified medical assistant via telephone call. The Certified Medical Assistant reported that she would have to research the request made for patients identifiers, lot number, expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-month-old patient of unknown gender. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot number was confirmed as L001325 with an expiry date of 13-JAN-2017. This is one of the several reports received from the same reporter. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
The patient experienced dizziness and lightheadedness about 2-4 minutes post-vaccination. Determined patient may have experienced a vasovagal episode.
Developed cellulitis like reaction (right arm), 4 inches long along medial aspect of right arm.
I found my daughter in bed unresponsive and struggling to breathe at around 245 am. She (along with her siblings received both flu and Pfizer Covid; they have been getting flu since 6 months of age, the only COVID vaccines they have received was Moderna, she received Pfizer at the pediatrician). My husband called 911. I laid my daughter on the floor in our living room on her side. She had a pulse but was going in and out of consciousness. I gave a few rescue breathes and sternal rubs to help arouse her. She started to wake up more as the ambulance arrived. Once we arrived to the hospital, she was more awake, but weak with standing and speech was still slightly slurred. She also had a fever once we arrived. We stayed in the hospital for a few hours until she was back to normal. She received blood work and an egg upon arrival. The diagnosed her with transient alternation of awareness with suspicion of seizure (no prior or past history of seizures).
I was given the Pfizer vaccine as my first dose. 25 days later I returned to the same Doctor's office for my second dose. Later to find out,  I was given the Moderna for the second dose, rather than the Pfizer. About 12 hours later, I  had the chills so badly, I was shaking uncontrollably.  I had a fever of 102.  Pounding headache, I was nautious, achey, and so weak, I could not lift my 3 month old baby. Symptoms lasted about 60 hours. About 72 hours later, my heart began to race and pound hard. This lasted about 4 or 5 days. Unsure if the heart racing was related, I went to urgent care, who did an EKG and found nothing wrong. Labeled it as anxiety. I. Aware fever, etc are considered a normal immune response to the vaccine. However, I am reporting  die to my unique situation, which is I was given the wrong vaccine to complete my series.