chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient administered moderna covid vaccine while temperature excursion was ongoing; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
Information has been received from a nurse practitioner (NP) concerning a 22-week-old female with no medical history who on 13-NOV-2006 and 20-JAN-2007 was vaccinated PO with the first and second doses, respectively, of Rotateq (Lot #654247/0600F). There was no illness at the time of vaccination. The NP reported that on 05-MAR-2007, the patient had one episode of liquid dark brown stool with a small amount of bright red blood. Unspecified medical attention was sought. On that same day, the patient was also noted to have cramping and increased crying. On 06-MAR-2007, an abdominal ultrasound was negative for sonographic signs of intussusception. A diagnosis of bloody diarrhea was made. On 06-MAR-2006, the patient recovered. Upon internal review, bloody diarrhea was determined to be an other important medical event. Additional information has been requested.
Severe shoulder pain and loss of motion. Loss of motion 50% for day 1-7 and still painful and 10-20% loss of motion 18 days later.  Loss of sleep for the first 2 weeks after the injection. Brain fog has been very bad since the day after the injection. I sometimes forget what I'm doing, can't focus at work, and I find myself struggling while doing a task that takes more than just a few moments. I have to force myself to pay attention and my attention keeps getting pulled away from whatever task I am doing.
Four days post vax, the pt recovered from the upper respiratory infection. Ten days post-onset, the pt recovered from the upper respiratory infection. Follow up information from a RN reported that the symptoms turned out to be upper respiratory tract infection, not a reaction to vax.
Patient received a high dose flu shot FLUAD and returned before the 4 week interim asking for a PNEUMOVAX 23 5 days later. She requested it to be given in the same arm. The day following her arm became red, swollen, hot, and tender only from the pneumonia shot down to just below the elbow. Ultrasound at the doctor's office revealed a blood clot. Unsure of length. Patient recovered.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, a dose of of PROQUAD (strength, lot# and expiration date were not reported) was reconstituted for a patient instead M-M-R II (strength, lot# and expiration date were not provided). The reporter stated that this product confusion was due to insufficient knowledge of the staff and confirmed that the patient was not administered and incorrect product and did not missed the scheduled vaccination of the correct product M-M-R II. Additional information is not expected as the reporter did not consent for follow up attempts.
Dtap was to be given,  instead Dtap +IPV given and dose of Polio also given
Information has been received from a consumer concerning her approx. 4 year old daughter with no past medical history and no known drug allergies who was vaccinated with measles virus vaccine live. Approx. 7 to 10 days, post vax, the girl experienced an acute asthma attack. It was reported that she now has acute attacks periodically. Her current therapy includes albuterol via nebulizer and prednisone. A trigger to the attacks has not been determined. The mother indicated that they recently moved, have a new pediatrician and that she is unsure of the exact dates of the incident. Upon internal review, acute asthma attack was determined to be an "Other Important Medical Event". Additional information has been requested.
Received pfizer vaccine on 6/24/21 and 7/15/21. Presented to ER on 1/27/22. She was admitted to the hospital 1-27-22.  She has multiple medical issues but was brought in because she  fell at the nursing home and was complaining of being dizzy and weak.  She is  morbidly obese, she has chronic leg wounds, and she has severe diabetes  mellitus.  She resides in an assisted living facility.  She was brought in  because of change in mental status.  She had fallen and hit her left abdominal  wall in the bathroom, resulting in a large hematoma.  She tested positive for  COVID on 1/27/22.  She has had 2 doses of the COVID vaccine but has not had a booster  shot yet. She has not been hypoxic since coming to the emergency department. Received cefepime, fluconazole, doxycycline and remdesivir. She did require 2L NC at one point. Hypoxic respiratory failure.  Contributions from heart failure, ? Pneumonia, sleep apnea.  Was in the ICU yesterday.  Extensive conversation with her daughter regarding goal of care and decision was made to make patient comfort care.  She has been transferred to the floor.  She is on 2 L of supplemental oxygen for comfort only.  Patient passed away on 2/9/22
Nausea and diarrhea. Got hives from head to toe and had to go to the ER.
fully vaccinated, tested positive for Covid with symptoms; fully vaccinated, tested positive for Covid with symptoms; This is a spontaneous report from a contactable physician (patient's husband). A female patient of an unspecified age received BNT162B2 (COMIRNATY), as dose 2, single (Batch/Lot number was not reported), and as dose 1, single (Batch/Lot number was not reported), via an unspecified route of administration on unspecified dates for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated and tested positive for COVID with symptoms lasting for more than a week on an unspecified date. Outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
severe pain rt upper arm-started right p/vax given & got worse p/1wk;unable to lift objects in reach w/rt arm
I had 2 COVID-19 vaccines and now I have noise in my head. It is horrible. I was thinking that it will go away but it does not.
I experienced extreme chills and a severely sore throat after the 2nd dosage of the vaccine. During a tele-visit with my doctor advised that I take a COVID test because my throat was sore as a precaution since the Delta Variant was spreading so quickly. The test came back negative.
was intended to receive Gardasil however the HCP accidentally gave trumenba; no side effects at this time; This spontaneous report was received from a other health professional via other company Pfizer and refers to a 36-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was intended to receive quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection ( dose, anatomical location, lot #, expiry date, and route of administration were not provided) for prophylaxis, however the healthcare professional (HCP) accidentally gave her meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA), (dose, anatomical location, formulation, lot #, expiry date, and route of administration were not provided) (Wrong product administered). The HCP reported no side effects at this time from the patient (No adverse event).
Information has been received from a registered nurse referring to unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with VARIVAX (lot # L042266 with expiration date: 27-OCT-2017, lot# L043624 with expiration date: 03-NOV-2017; lot# L049534 with expiration date: 08-DEC-2017, dose was unknown) which were improperly stored (42.3 Fahrenheit (F) for 2 hours 15 minutes). No adverse events were reported. Previous temperature was not excursion. This is one of several reports received from the same reporter. Additional information has been requested.
About 2 weeks later when I came home from work, I checked my blood pressure and it was high at around 180 /120. I laid down for a little bit to see if it will go down. I rechecked it, and it didn't go down. I also had a nose bleed. I called the triage line, and the nurse told me to go to the ER. When I went to ER they gave me a dose of nifedipine. That brought my blood pressure down to a normal range. When I followed up with my doctor she continued that medication up until I had a reaction to the nifedipine.  My doctor then took me off of the nifedipine and tried me on another blood pressure medication. Then the other blood pressure medicine was making my blood pressure drop too low. Now I am only on the lisinopril. In August 2021 I had a weekend of a lot of swelling in my lower extremities. I was told that I have heart failure and pulmonary hypertension. Now I am under the care of a cardiologist. I was prescribed Lasix. I started losing weight so then I stopped taking the Lasix because I haven't needed to use it anymore.
Administration error, no adverse event. Client received additional bivalent booster dose inadvertently, 8 weeks after last bivalent booster dose. Last bivalent booster dose was 11/8/22, inadvertent bivalent booster dose was given 1/4/2023
5-6 days after, my stomach felt pressure, like  something pushing in. On the night of the 6th day, I wasn't interested in eating, the pressure/discomfort feeling was increasing and I was uncomfortable all over and unable to get to sleep. Around 2 or 3 am, I had an episode of violent vomiting, which did not serve to make me feel any better. From that point on, for the next 24 hours, I continued to feel sick, extremely tired, and ached all over. I couldn't get comfortable, didn't feel like eating or even drinking, and had no energy, even to not being able to sit up and watch TV. As the 7th day continued, I threw up mid-day, was able to sip my way through 2 glasses (water, tea), and eat a few crackers. I felt very dizzy when I walked. I checked my temperature twice and didn't seem to be running a fever, which surprised me. I didn't take any pain relievers, as I felt I would just throw them up. By evening, however, I was able to take 2 ibuprofen, take a hot shower, and slept pretty well that night. By the 8th day, the aches were pretty much gone and I was able to eat soft foods and get rehydrated. I felt a little weak, still tired, and wobbly, but was clearly over the worst of it. By the 9th day, I was back to normal.
pt recv vax 27FEB96 & 27FEB96 pt exp mania & was unable to concentrate;pt recovered by 28FEB96;no further details were provided;
Had redness and swelling with warmth the following day. Possibly a  histamine reaction from the shingrix which is fairly common. Patient is allergic to benadryl so I suggested taking another anti-histamine (they had allegra) and try to ice it. Patient said it was sore but that is common with both vaccinations.
Patient received Moderna COVID vaccine on 4/7/21 and 5/12/21 at another facility. On 7/18/21, COVID PCR test was positive and patient was admitted to our facility  on 7/24/21 for COVID-19 pneumonia. Patient received dexamethasone starting 7/24  for 10 day therapy and tocilizumab was given on 7/28. Patient was transferred to CCU on 7/28/21 for ARDS and currently still in CCU. Patient immunocompromised due to ocrelizumab use for multiple sclerosis.
The pt developed dizziness, fever of 100.1 deg F, shaky, and elevated blood pressure. Taken to ER and given Tylenol. Blood and urine tested. No bacterial infections. Pt's symptoms resolved.
Pt called 4/28/09 after sx has resolved. Stated that 12 hr after Td-had arm soreness, faint pain in knees, felt like fever, enlarged lymph node under (L) axilla, and (L) clavicular lymph node enlarged (size of pen). No trouble breathing. Felt like fever and achy all over sx 12 hr after shot -> 72 hr. Pt stated there is nothing to see when asked her to come in.
10/16/02 injection site edema and warm to touch, pruritis and erythema. On 10/17, patient called office and instructed to use cold compresses 20 minutes on/20 minutes off and NSAID analgesic. Call office 10/18 if no improvement. Patient called office 10/18/02, instructed to return to office. Injection site edema, erythema, pruritis with induration about 10cm. Center firm and warm to palpitation. Instructed to apply head 20 minutes on/20 minutes off.
Sore throat; Hoarseness that has not lifted after a couple of days; This non-serious case was reported by a consumer and described the occurrence of sore throat in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included back pain. Concomitant products included tramadol.   On 11-JUL-2023, the patient received Shingrix. On 18-JUL-2023, 7 days after receiving Shingrix, the patient experienced sore throat (Verbatim: Sore throat) and hoarseness (Verbatim: Hoarseness that has not lifted after a couple of days). The outcome of the sore throat and hoarseness were not resolved.   It was unknown if the reporter considered the sore throat and hoarseness to be related to Shingrix.     It was unknown if the company considered the sore throat and hoarseness to be related to Shingrix.   Additional Information: GSK Receipt date: 18-JUL-2023 A reporter reported about her self after shingrix vaccination experienced Sore throat and Hoarseness that had not lifted after a couple of days and she wanted to see the ingredients and the website will not show them. The reporter was did not consent to follow up.
Patient received monovalent COVID vaccine as a booster when direction states only bivalent vaccine can be given as booster. No adverse reactions occurred.
dministration of one dose of an improperly stored vaccine; No adverse effects; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and drug reactions or allergies was not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R024023 with an expiration date in 22-AUG-2020), (strength, dose, route and frequency were not provided),  for prophylaxis, that underwent a temperature excursion of 17 degrees Celsius during a time frame of 50 minutes. No previous temperature excursion was reported and the digital data logger was involved. The sterile diluent used to reconstituted the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) was properly stored. No adverse effects were reported.
This spontaneous report was received from a Physician Assistant refers to a patient of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with three doses of MMR II (dose, route and lot# were not reported). No adverse experience was reported. No product quality complaint was involved. Additional information has been requested.
Patient fainted approx 1 minute after administration of GARDASIL vaccine. Shaking a little bit.
Site: Pain at Injection Site-Severe, Additional Details: Patient states that she has been experiencing severe pain at the site of injection since the day of administration. She is unable to lift her arm. After doctor visits and tests, her physicians have determined that she has bursitis related to the injection and needs to have a procedure done. The pharmacist that administered the vaccine was informed.
In addition to fever, headache, muscle aches and chills. I had Generalized body rash, severe abdominal cramping, nausea, fatigue, abdominal pain worse with food and drink ingestion, 8 pound weight loss in 10 days
This spontaneous report was received from a consumer regarding herself. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, frequency and lot# were unknown) and an unspecified "flu" vaccine two nights ago for immunization. On an unknown date, soon after her arm from her elbow to the top of her shoulder became red and swollen and was still very painful (peripheral swelling, pain, erythema and joint swelling). She contacted her primary physician and he prescribed "BENADRYL". No further specifics or symptoms were provided. No further AE information was provided. The outcome of peripheral swelling, pain, erythema and joint swelling were not recovered. The causality assessment was not provided. No PQC was found for the case.
This spontaneous report was received from a healthcare worker and refers to a 31 year old female patient. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 02-NOV-2015, the 31 year old patient was inadvertently vaccinated with a dose of PROQUAD (Merck) (strength, dose, route of administration, lot #, albumin status and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
Unusual discomfort when receiving injection.  Shot was administered by RN who was standing while I was standing and seemed to be too high up on the deltoid.  Felt like it "hit bone" or something.  Sore immediately, then within one week could not sleep on left shoulder.  Progressed to adhesive capsulitis that required 2 depot steroid injections, a interscalene block, and manipulation under general anesthesia followed by one month of CPM therapy.
Pt states as soon as she got home she was doubled over in abdominal pain.  She said she was in severe GI distress for several hours. After this she felt pain all over that was a stabbing pins and needles type of pain that lasted for the evening. She also had severe pain at the injection site for 2 weeks that has resolved. She reported this to the pharmacist today 12/20 and I told her I would report the AE.
Dizziness, lightheadedness, sweating   Interventions: Observation Water vs  patient left in stable condition @ 1310 AxOx4 speaking in full complete sentences with no neurological deficits noted and able to ambulate with strong steady gait
Swelling; Itchiness; Arm was warm to touch; soreness; Redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness), ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (Itchiness) and FEELING HOT (Arm was warm to touch) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 immunisation.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (soreness) and ERYTHEMA (Redness). On 06-Feb-2021, the patient experienced SWELLING (Swelling), PRURITUS (Itchiness) and FEELING HOT (Arm was warm to touch). The patient was treated with CORTISONE at an unspecified dose and frequency. On 29-Jan-2021, PAIN (soreness) and ERYTHEMA (Redness) had resolved. At the time of the report, SWELLING (Swelling), PRURITUS (Itchiness) and FEELING HOT (Arm was warm to touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
On approximately 10/19/2000, the patient had strep throat. On approximately 11/14/2000, the patient developed very mild chicken pox with approximately 20-30 lesions and no other symptoms. A titer for the serum varicella virus antibody test was not drawn. Unspecified medical attention was sought.  Additionally, it was reported that the patient had 2 brothers who also developed chicken pox. The patient's mother, who had no previous confirmed case of chicken pox, was vaccinated on 07/10/1995. At the time of this report the mother had not developed any lesions or other symptoms. Additional information has been requested.
Within 24 developed high fever and slight erythema, edema at site a immunication. Rx'd with BENADRYL/Ibuprofen.
Am has a little bit of redness; Arm only bothers her when she lies on that side with a little soreness; Vaccination site Discoloration; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Am has a little bit of redness), VACCINATION SITE PAIN (Arm only bothers her when she lies on that side with a little soreness) and VACCINATION SITE DISCOLOURATION (Vaccination site Discoloration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Am has a little bit of redness), VACCINATION SITE PAIN (Arm only bothers her when she lies on that side with a little soreness) and VACCINATION SITE DISCOLOURATION (Vaccination site Discoloration). At the time of the report, VACCINATION SITE ERYTHEMA (Am has a little bit of redness), VACCINATION SITE PAIN (Arm only bothers her when she lies on that side with a little soreness) and VACCINATION SITE DISCOLOURATION (Vaccination site Discoloration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.