chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels throat tightness, feels liek her throat has mucous and she has to clear her throat. Client is able to sip water with no difficulty. Client able to ambulate. BP 136/82; HR 102; RR 18. at time of onset. Denies lightheadedness or chest tightness. No stridor per auscultation.
Initial misuse report received from a healthcare professional on 14 November 2013. On unspecified date FLUZONE ID was administered to an 11 year old patient. Wrong vaccine was administered. No adverse event was reported. List of documents held by sender: none.
pt recv vax & began breathing w/grunt;02 saturation was measured & found to be fine;pt became agitated & devel a fever of 101.8;hosp & was improving @ the date of this report;
Pt states she feels achy. Both shoulders and neck within 6 hrs and persists at 2 pm today. Achy neck and shoulders resolved in 2 days.
I don't know which name to choose since your list showed 2 pneumonia vaccines. I know this was my 2nd pneumonia vaccine. No reaction at all at the site. But left arm started hurting several hours later. Then a couple of hours after that it was excruciating pain to the point where I could not use my left arm. Then I seemed the suddenly get fever: chills, teeth chattering. Fever varied from 99.5 to 100.8 over the next 36 hours or so. My arm hurt like hell for about the same amount of time. It still hurts but is partially useable now.
RN here this AM for flu vaccination.  Approximately 2 hrs later (12 noon), pt developed persistent coughing, no wheezy, dyspnea, truritis, mucose swelling.  Irritated throat but no tightness complaints.
Rash all over his body; rash which is red patchy tiny blistery things; rash which is red patchy tiny blistery things; pain of the rash and blisters; Itching; Shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899) solution for injection, via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient experienced shoulder pain on 22Jan2021; itching started on 23Jan2021; rash all over his body which has worsened, rash which was red patchy tiny blistery things on 24Jan2021. Patient further reported that he had a rash over his entire body. It started as an itch on his legs which developed into more itching which turned into a rash which was red patchy tiny blistery things. Now it was on his arms, back, belly, neck, and legs. He had shoulder pain and it was hurting the day after he got the vaccine on Friday 22Jan2021. Rash started on Sunday 24Jan2021, it was like a chicken pox type rash. It was like red dots that become sensitive and look slightly blistered. Shoulder pain: this was nothing compared to the pain of the rash and blisters (24Jan2021). He had taken off the bandage and was sore. He was not even sure if he was still sore or not because he was only paying attention to everything else. It was overwhelming. Treatment: He called his doctors and they said that he should use Calamine lotion as a temporary soother for itch and rashes. They also told him to take Benadryl and his doctor prescribed Prednisone. Outcome of the event shoulder pain was unknown while the other events was not recovered.  No follow-up activities are needed. No further information is expected.
Pt recvd vax & exp fever of 38.9, diarrhea, scaling erythematous rash, oral candidiasis & an enlarged liver 98cm); lab results revealed elevated alkaline phosphatase, gamma-glutamyl transferase, aspartate aminitransferase;
Pt experienced cough while laying flat. Has had this off and on since october. No cough while sitting up. Pt is experiencing tiredness and achiness.  Pt is increasing water intake and took ibuprofen for his achiness
During the evening of the day that the vaccine was given, patient had pain in right flank.  Pain lessened the next day.  That second night at about 3:00 AM, she was awakened by severe pain in the same area.  The next day, she went to her physician.  By that time, she had a rash in the right flank area.  Her physician diagnosed shingles and  prescribed Valtrex.   The Valtrex , along with ice, subdued her pain. and after 2 weeks, her symptoms resolved.
chill; feel nausea; arm sore; high fever; headache; lying in the bed the whole day; body really sore; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (high fever), HEADACHE (headache), ASTHENIA (lying in the bed the whole day), ARTHRALGIA (body really sore) and NAUSEA (feel nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products PARACETAMOL (TYLENOL) for an unknown indication and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENYLIN 1 COLD AND FLU) for an unknown indication.    Concomitant products included Steroid hormones for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENYLIN 1 COLD AND FLU) (unknown route) at an unspecified dose. On 17-Jan-2021, the patient experienced PYREXIA (high fever), HEADACHE (headache), ASTHENIA (lying in the bed the whole day) and ARTHRALGIA (body really sore). On 18-Jan-2021, the patient experienced NAUSEA (feel nausea) and PAIN IN EXTREMITY (arm sore). On an unknown date, the patient experienced CHILLS (chill). At the time of the report, PYREXIA (high fever), HEADACHE (headache), ASTHENIA (lying in the bed the whole day), ARTHRALGIA (body really sore) and NAUSEA (feel nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. It was reported that vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Patient received first dose of Moderna covid-19 vaccine during a vaccination clinic. When patient returned for second dose on 4/28/21, she reported experiencing pain around her shoulder and collarbone area (which was noted on her consent form). She has subsequently reported that she believes the injection was administered too high in her arm, causing pain which lead her to seek physical therapy and has also consulted with a neurology specialist. Follow-up call attempts to obtain additional information have been unsuccessful.
Initial report was received from a consumer, who was also the patient, on 19 March 2012. A 64-year-old male patient had received a dose one injection in the left deltoid of ADACEL, sanofi pasteur Ltd. (lot number and route not reported) on 08 March 2011. In November of 2011, the patient developed a cough and by January of 2012 the cough became violent. The patient was treated with doxycycline for 10 days and the violent cough persisted. The patient saw a pulmonologist in March of 2012 and had a nasal swab that was negative. The patient was told her had "pertussis as all other diagnoses were ruled out." The patient also had pulmonary function test (PFTs). The patient's cough continued. The cough had lessened and continued to produce mucus. The patient had no illness at the time of vaccination. The patient had an allergy to amoxicillin and a medical history of celiac disease, thrombocytopenia, increased liver function test (LFT) and hypertension (HTN). The patient's outcome was not recovered. Documents held by sender: None.
Patient received the 1st COVID vaccine (Pfizer, lot # EW0185 use by 06/24/21 at 0845) at 1446. At 1503, the clients boyfriend told PM that his girlfriend said she felt like she was about to faint. PM ran to patient at 1503 who was sitting upright and blankly staring in front of her. RN assessed the client who was alert and oriented to person and place for 90 seconds, but would go in and out of responding to questions during the 90 seconds. No loss of muscle tone was present. The client was unable to visually track an object during the 90 seconds of blank staring. RN instructed another RN to call 911 at 1504. Client was placed on a yoga mat in a supine position on the ground by EMT and PM. The client's legs were elevated by being placed on a chair. The client was diaphoretic and clammy. The client was alert and oriented x 4 at 1505. Radial pulse was bounding bilaterally. Vital signs taken at 1506, HR- 60, BP- 158/106, RR-12, oxygen saturation at 98%. The patient denied any drug allergies, any chronic medical conditions, or currently taking any medications. Client continued to be diaphoretic and clammy. Client did not hit her head during the incident and denied any shortness of breath, chest pain, or difficulty breathing. Vital signs taken at 1507, BP- 170/122, HR- 81, RR-14, oxygen saturation at 98%. The clients legs were immediately placed from being in an elevated position to a supine position. The client was speaking in full sentences and was alert and oriented x4. Vital signs taken at 1508, BP- 146/98, HR-86, RR-14, oxygen saturation at 98%. Client remained mildly diaphoretic and clammy. The fire department assumed care at 1510 when they arrived on site. Fire Department Personnel advised the client to be transported to a hospital, client declined transport to the hospital and signed AMA paperwork. Client stated, "My boyfriend will drive me to Emergency Room." The Fire Department and EMS left the site at 1532. RN educated the client about the importance of going to the emergency room immediately and to follow-up with her primary care provider. The client left the site at 1536, the client's boyfriend pulled the vehicle in the parking area and the client ambulated with an even and steady gait to the car.
A report was received from a health care professional on 2/16/04 concerning a 3.5 year old male vaccinee who inadvertently received Fluvirin on 10/10/03 and 11/10/03. On 10/10/03 and 11/10/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
Red spot; Itchy; weak and tired; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchy all over, feels weak and tired, Red spot on belly.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17-FEB-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 300042698) via Intramuscular route for prophylaxis of COVID-19 infection.   On 21 FEB 2021, 5days after the vaccination the patient experienced the event(s) events itchy all over, feels weak and tired, Red spot on belly.  Treatment details for the events are not Included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), itchy all over, feels weak and tired, Red spot on belly  was unknown.
patient had a vasovagal event, became diaphoretic, pale, lethargic/minimally responsive
Earlier today, a Moderna patient at 3213 experienced a 15-30 second seizure after receiving his 1st Moderna vaccine. Shortly after sitting down for his 15-minute post immunization observation period, patient X began seizing resulting in him falling to the ground from a seated position to his left side and seizing for about 15-20 seconds. Patient was positioned in a left lateral recumbent position. Code white was called and EMT arrived on site within 10 minutes.   Patient's immunization questionnaire did NOT have any contraindications that would warrant he should not receive the vaccine. Patient reported no allergies to medications/past immunizations/foods and reported no seizure and/or neurological condition.   Once recovered and at baseline, patient reported having a light breakfast this morning and also having a needle phobia that may have played a role in his adverse response.   Shortly after recovering, patient was coherent and aware of person, place, and time. He remained weak and fatigue and BP readings from EMT indicated hypotension. EKG was normal.   Patient's mother happened to be waiting outside in the car. One of my associates was able to call her in and we updated here on the event.   EMT recommended, and patient agreed, to be taken to the hospital for further examination.
Menstrual cycle began early and has lasted more than 2 weeks which is unusual compared to 1 week menses usually experienced
underwent temperature excursion started on 21Feb2023. They were to be used within 24 hours but administered to; Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion started on 21Feb2023. They were to be used within 24 hours but administered to), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion started on 21Feb2023. They were to be used within 24 hours but administered to), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion started on 21Feb2023. They were to be used within 24 hours but administered to), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (underwent temperature excursion started on 21Feb2023. They were to be used within 24 hours but administered to) and PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023).    No concomitant medication were reported.  It was reported that Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023. They were to be used within 24 hours but administered to 24 patients on unknown dates. Vaccine administration dates and patient information were unknown.  Excursion Timeframe, on 21-Feb-2023, Max 8.60C for 10 hours and 57 minutes, on 22-Feb-2023 Max 8.5 C for 24 hours, on 23-Feb-2023 Max 8.5 C min 7.4 C for 17 hours and 56 minutes. No treatment information was provided by the reporter. This case was reported for patient 10 out of 24.   This case was linked to US-MODERNATX, INC.-MOD-2023-713467 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713467:Patient 1 out of 24 Patients
developed COVID after vaccine, sx onset 4/21/21, hospitalized 4/24-4/27, treated with remdesivir and steroids, improved, then readmitted 5/2/21 with respiratory failure, required ICU admission 5/21/21, intubated, PEA arrest, passed away 5/24/21.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # was not reported). The reporter reported that the patient developed an injection site reaction "a few days" after receiving ZOSTAVAX. The reporter stated "the patient had a circle about 1.5 inches around the injection site that felt hot". The patient sought unspecified medical attention. The outcome of the adverse events was unknown. Additional information is not expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via Social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after receiving vaccine the patient experienced sick coded as suspected clinical vaccination failure, and suspected covid-19 infection and tested positive for Covid-19. The reporter stated that "it's sad! I'm not Vaxed my family is. my daughter got covid a month ago then my husband tested positive 2 days later he gave the test to me I tested positive I had no symptoms they both got sick. we've been at home for 16 days now and I feel great except I'm going crazy, tomorrow I'm going grocery shopping so stay away". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Quality complaint: 90000217267. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220230287.  Additional information received from Complaint Vigilance department on 24-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was amended: Case validity changed from invalid to valid.; Sender's Comments: V1: Additional information received is regarding product quality complaint investigation result and Case validity changed from invalid to valid. The follow up information received does not alter the assessment of prior company causality of previously reported event. : 20220230241-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Within one hour of vaccination skin became flushed, developing into rash with hives over torso, arms and face.  Then developed sore throat with hoarsness which lasted approximately four hours.  Treated with benadryl.
This spontaneous report was received from a nurse and refers to a two unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unspecified dates, the patients were administered an improperly stored doses of VARIVAX injection (lot # M040138 with expiration date at 28-SEP-2018; doses, routes of administration and anatomical locations were not reported), for prophylaxis. On an unknown date, the administered doses of vaccine were exposed to a temperature of 6 degrees Fahrenheit (F) for 4 minutes. There was also reported a previous temperature excursion including exposure to a temperature of 12 degrees Fahrenheit (F) for 3 minutes (date unspecified). Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004566:
Same day as vax, the pt experienced tiredness and irritability, refused to use his legs, he was up all that night "screaming" and holding his legs out straight, injection site was red with slight swelling. Tylenol given once during the night. The next day, the child remains irritable. Was seen by PCP. No signs of ear infection or URI, no fever. Child has improved by 1/6/01.
pt recv vax 16APR97 & 1/2hr p/vax pt devel hives on lips, tongue & inside mouth;went to MD spontaneously resolved 1/2hr p/vax;
Patient is a 69-year-old vaccinated(COVID) gentleman with past medical history significant for partial seizures, prostate cancer in remission (status post RT) who presented to the emergency department on 11/24/2021 for evaluation of symptoms of sore throat, productive cough, diarrhea since 11/17/2021. In the emergency department was noted to have desaturations to the 88% requiring 2 L via nasal cannula. his COVID screen was positive and imaging showed bilateral airspace disease. COVID-19 pneumonia was suspected, patient started on IV Decadron and admitted to internal medicine for continued care.  Post admission patient's pro callus noted to be elevated. Patient was started on super added antibio
pt devel infect mononucleosis 3MAR94;elevated SGOT throughout illness, cont to have elevated tests;referred to gastroenterologist;dx primary sclerosing cholangitis;had liver transplant;
Patient experienced fainting, describing loss of peripheral vision before experiencing syncope. Patient did not injure himself during the episode as his father was present and nearby; he was able to hold the patient. Symptoms quickly resolved with patient describing quick recovery within a matter of minutes as EMS arrived.
10 days ago I developed the virus; 10 days ago I developed the virus; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he had the first Pfizer COVID vaccine dose and he was scheduled to get the 2nd dose on 25Jan2021. He reported that 10 days ago (12Jan2021) he developed the virus. The patient asked if he should wait longer to get his 2nd dose. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.