chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 48.24 No concomitant medications were reported. On 15-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 06-Apr-2021 and beyond use date was 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
reaction came back; hot and covering a sizable area; very itchy; swelling; very red; large local reaction; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE REACTION (large local reaction), SYMPTOM RECURRENCE (reaction came back), VACCINATION SITE WARMTH (hot and covering a sizable area), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE SWELLING (swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergies to some medications.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE REACTION (large local reaction). On 21-Jan-2021, the patient experienced SYMPTOM RECURRENCE (reaction came back), VACCINATION SITE WARMTH (hot and covering a sizable area), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (very red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at an unspecified dose and frequency. On 23-Jan-2021, SYMPTOM RECURRENCE (reaction came back), VACCINATION SITE WARMTH (hot and covering a sizable area), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (very red) had resolved. At the time of the report, VACCINATION SITE REACTION (large local reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
About 5-10 minutes after Pfizer vaccine was administered, she reported heart pounding, muscle spasms, blurred vision, and feeling light-headed and body pain. While in the wheelchair, patient had a witnessed syncopal episode that lasted about 45 seconds. EMS was called and patient taken to Medical Center for further evaluation.
Fever t103.5 ax, pale, could not comfort for 2 hrs straight; 1/2in red lump @ the site of the inject;
The night of the shot I got a headache, body aches, throwing up, chills, fever, felt dizzy,  my whole arm was really swollen,  red and hurt. Fast forward to 1-6-2021 I have had a headache ever since and started getting a reaction at the injection site which consist of being swollen, red, a large knot under the red area, the area is really warm and sensitive to touch. I also have pain going up the left side of my neck and down my armpit/lymphatic system.
1st dose of fluzone 3 days after shot onset of pruritis for 1 hour, lethargy and fever 100-103 for 2 days.  2nd dose onset 4 days later similar onset and fever but also needed meds for cough and congestion.  Follow up on 01/12/04: "Mom would like you to call.  PT was seen on friday screaming for 1/2 hour and then went limp.  Had temp then after 24 hrs was fine.  Then other 2 bros/sist got it and now another bro has it.  She would like to talk to you for just a minute.  Called mom.  3rd child now about to come down with same syndrome - 24 hour fever and fussiness. Doubt from imm."
receiving an extra dose of DTAP in dose 3 of PENTACEL at 9 months no adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 9 months old female patient who received an extra dose of dtap in dose 3 of pentacel no adverse event after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (VERO)] and diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 06-Jun-2022, the patient received 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (With unknown strength, lot number, expiration and at unknown administration site) via intramuscular route for immunization.  On 17-Jan-2023, the patient received a dose 3 of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (With unknown strength, route, lot number, expiration and at unknown administration site) for immunization. Before this dose, patient also received doses  of same vaccine on 29-Aug-2022 and17-Oct-2023 respectively.  On 17-Jan-2023 the patient received an extra dose of dtap in dose 3 of pentacel at 9 months no adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Fever chills headache, tiredness, nausea and that night I coulnt sleep, my arm was just unbearable. Then the next day I had a red rash like sunburn by my bikini line and the n up my back and arms. By yesterday my are was unbearable this morning there is not as much redness everywhere
First dose given at 17 years of age; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given at 17 years of age) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given at 17 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given at 17 years of age) had resolved. 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.   No concomitant medications were reported. No treatment medications were provided.
One minute after he got the shot, he did not feel ok, he was shaking, sweating and dropped his phone. The pharmacist was next to him, we called 911 immediately. They came like 10 minutes after, but by this time, he was ok, they checked his blood pressure , it was 115/75. He was completely alert, and  did not want to go with them. we asked him to stay at the pharmacy till he feels completely fine. we called him at 7 pm to follow up, he said he is ok.
Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer or other non healthcare professional. This case was cross-referenced with the case 2018SA206137 (same reporter). This case involves a 75 years old female patient who experienced the site looked lumpy (injection site), she states the pain went away after 3 days, swole up, she started getting a weird tingling sensation toward her hips and buttocks, decrease in appetitie, headache, she is having weird crazy dreams ("nightmares"),while she received vaccine IMOVAX RABIES. Patient's medical history included had a scratch wound from raccoon about 3 years ago on an unknown date. On 03-Jul-2018, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported in the right thigh. On 05-Jul-2018 she also received a dose  dose of the same vaccine  with an unknown batch number in the left thigh. On an unknown date, the patient developed a non-serious the site looked lumpy (injection site) (injection site mass)  following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious she states the pain went away after 3 days (pain)  following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious swole up (swelling) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious she started getting a weird tingling sensation toward her hips and buttocks (paraesthesia) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious decrease in appetitie (decreased appetite) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious headache following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious she is having weird crazy dreams ("nightmares") (nightmare)  following the administration of RABIES (HDC) VACCINE. Patient required emergency department or doctor visit. (Other relevant tests included No lab data was reported..) Final diagnosis was she was having weird crazy dreams ("nightmares"), headache, decrease in appetitie, she started getting a weird tingling sensation toward her hips and buttocks, swole up, she states the pain went away after 3 days and the site looked lumpy (injection site). Bandaid was covered with so much blood where usually there would be just a couple of dots. The patient outcome is reported as Unknown for the site looked lumpy (injection site), as Unknown for she states the pain went away after 3 days, as Unknown for swole up, as Unknown for she started getting a weird tingling sensation toward her hips and buttocks, as Unknown for decrease in appetitie, as Unknown for headache, as Unknown for she is having weird crazy dreams ("nightmares"). List of documents held by the sender: None.
DIARRHEA; REALLY BLOATED/STOMACH DISTENSION; BODY ACHES WORSENING FROM  PREVIOUS LEVEL; ABDOMINAL PAIN; RASH ON THE FRONT OF THE RIGHT SHIN / RASH THAT GOES AROUND THE LEFT  SHIN; POSSIBLE WORSENING OF PREVIOUS  HEADACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included degenerative disc disorder, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included golimumab for rheumatoid arthritis. On 21-MAY-2021, the subject experienced diarrhea. On 21-MAY-2021, the subject experienced really bloated/stomach distension. On 21-MAY-2021, the subject experienced body aches worsening from previous level. On 21-MAY-2021, the subject experienced abdominal pain. On 21-MAY-2021, the subject experienced rash on the front of the right shin / rash that goes around the left shin. On 21-MAY-2021, the subject experienced possible worsening of previous headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, really bloated/stomach distension, body aches worsening from previous level, possible worsening of previous headaches, rash on the front of the right shin / rash that goes around the left shin, and abdominal pain. This report was non-serious.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  OBSTRUCTIVE SLEEP APNEA  5/30/2022 -- RECURRENCE OF SAME SYMPTOMS
Began to develop ?tickle in throat? 8 minutes after injection, no rash, no respiratory distress, VS stable. Observed for 30 minutes and then released.  Symptoms resolved with Benadryl.      25 mg of Benadryl
Initial unsolicited report received from a nurse on 26 September 2016. This case involves a male patient (age not reported) who was vaccinated with a 0.5 ml dose of FLUZONE (batch number: UI658AA, expiry date, dose, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unpecified date, following the vaccination, patient experienced neck pain and vomited three times. Lab data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Projectile vomiting, followed by 2 days of diarrhea and flu symptoms. Slight fever popped on day 2
Sore throat, extremely sore arm (first day could barely lift arm), 102 degree temp one time only spike but 101 consistently till morning of next day before returning to normal plus body body aches and sinus drainage.  Morning of day 3 (today, 12/5/2019), arm remains sore but has improved, no fever, ongoing sinus drainage and fatigue. Since injection 3 days  ago unable to perform duties as pilot.
Vaccination reaction with pain, swelling to left thigh. 110 mm X 86 mm area with erythmatous, edema, and tender.
Injection site pain; Headache; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  additional information: experiencing headache, nausea and injection site pain the day after receiving a Pfizer Covid vaccine booster.   the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
At 0200 on 06/04/22, total body aches, headache, fatigue, nausea, loss of appetite, and fever of 101.9.  Sts 06/05/22, temp 99.2.  Today, 06/06/22 feels better. Less fatigue and able to get up and perform daily activities.
MMR given 8/11/06. Report of reaction to hospital on 8/14/06. Area on left upper arm presented with erythema measuring 6x7cm, minimal tenderness, flat with minimal induration. Axillary nodes, nontender, no other red streaks noted.
Patient said his arm was red after the shot on 9/14/21. He pulled up his sleeve and the redness appeared to be mild if there at all. Let patient know I am a pharmacist and not a physician, so I didn't feel comfortable diagnosing his arm if the patient was concerned about it. (I did not see anything unusual, but again I am not a physician. It looked like his shirt was just a little tight as he could not pull it up very far... but this also meant I could not see the area very well)none  Recommended patient follow-up with his dr. Called 9/17/21 to see if patient had followed-up and he had not.
My son was scheduled for Sports Physical and was found to have abnormal levels of the Liver Function Test,  Potassium, Certamen and Blood Platelets after receiving his booster vaccine.
07/03/2022 She had a cough and a low fever, 99.3. She tested positive for COVID with at home test. The next day her fever went up to a little bit, around 99.7.  She had a sore throat and the cough still. The next day, she began to feel better. She had a little bit of a cough, but no sore throat or fever.  For two weeks, she had nose bleeds. We called her pediatrician for her nose bleed.  He said to put petroleum jelly in her nostrils.  Her cough lingered for several months. She has had nose bleeds off and on since, maybe once or twice a month. We took her to the doctor for her cough in the middle of September. The doctor did not prescribe anything but said to give her children?s Zyrtec. That seems to have helped. The cough has now gone away.
Covid Arm.  One week after first shot I developed a swollen upper arm with redness and rash. Itchy, throbbing and uncomfortable. About 3-4 inches in circumferance.
Progressively increasing rash characterized with redness and swelling approximately the size of a baseball on patient's left thigh.
Left thigh positive erythema, warm about 4cm, non-tender and no drainage.
Light headed, stomach ache, swelling, redness and warm/hot at site, mild flu like symptoms, aching all over and fatigue with sleeping all day.
Water blister at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 3FJ59, expiry date 27th November 2021) for prophylaxis.   On 22nd September 2019, the patient received the 1st dose of Shingrix. On 22nd September 2019, couple of hours after receiving Shingrix, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was not recovered/not resolved.   It was unknown if the reporter considered the injection site blisters to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be between 70 or 71 years. The reporter stated that, the patient developed a water blister at site of injection a couple hours after vaccination. The event was ongoing.
Found Menveo powder without the diluent; gave a patient only the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 18-Jul-2022 Reporter's comment: The nurse reported that one of the clinics found a Menveo powder without the diluent. They thought they gave a patient only the diluent and the powder were still in the box but they were still researching.  The reporter stated that they narrowed it down to being 1 of the last 5 patients who may had received only the diluent. The reporter wants to know there be any side effects/harm in giving all patients another dose. The lot or expiration date was not available and no patient details to share. The reporter consented to follow up. Additional Supportive Information: The patients received Menveo vaccines without the powder portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
MOM NOTED SHE HAD FEVER AND LATER WITH INCREASED SWELLING TO RT ARM WHERE VACCINE WAS AND IT GOTBIGGER -
Patient complained of itching, redness and swelling at the injection site and was more concerned with the itching. I recommended benadryl every 6 hours and to ice it down. I informed her to keep an eye on the rash area and to make sure it did not get any bigger. She agreed and was going to put a circled mark around it to see if would get larger. She would let us know of outcome and see the doctor or urgent care if it did not improve.
Quarter sized warm area at inj site, afebrile 1-17-17. 1-17-17 at 8:00P area increased to Lacrosse ball sized C/O itchiness.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 21st August 2018 11:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and arm discomfort. In August 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the arm discomfort was unknown. It was unknown if the reporter considered the injection site pain and arm discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to any one. The patient received SHINGRIX in the left arm. The reporter had a consumer (patient) that reported experiencing soreness at the injection site after receiving the SHINGRIX vaccine that lasted for two days. Over the last two days by the time of reporting, the patient reported that his left arm felt different. The reporter was unable to provide any additional details.