chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 1:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 1:21 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 18.57.  It was reported that unknown number of patients were 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 time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 24-May-2021, Excursion time was 08 AM and 09 AM, temperature was 35 at both the times, total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 18-May-2021, vial was moved to clinic on 24-May-2021. 03 vials were sent to clinic. Vaccine BUD date was 17-Jun-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
This spontaneous report was received from a consumer (friend of the patient), refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial, (lot #, expiry date, dose, frequency and route of administration not reported). On an unknown date, the patient experienced rash. The outcome of rash was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information obtained for adverse event. Additional information has been requested.
As described by the patient:  As they were putting the vaccine, the area got really warm, and the arm began to feel inflated. Then I began to feel the liquid moving through my arm, elbow, and wrist. My wrist started hurting. I told the nurse, who told me to keep moving the arm.   As time passed (15 minutes), the warm feeling flowed to my should and left side of my back.  Another 15 min passed, and it moved down my left leg and knee, which started to hurt.    Then got neck got warm and stiff, and I felt the warm feeling got to the left side of my brain. 15 minutes passed left side of the face got warm. And then it headed to my lips and then tongue. Lips got numb, and tongue got numb. 5 minutes pass and my tongue and
Patient had an instance of low blood sugar, glucose was 59 on 08/28/2022 at 8:53pm.  She states she has never had low blood sugar before.  Ate grapes and her blood glucose went up to 83 at 9:02pm.  She has had no further instances of low sugar since.  Patient also reports being fatigued and having flu-like symptoms on saturday 08/27/2022 and sunday 08/28/2022.
The day after I received both my first and second shot, I was resting and when I got up out of bed I took about a half of dozen steps and my legs gave out and I ended up on my butt on the floor. It took me a few to gather my self then I craw back to my bed and there I stayed for the next 4 hours.
Bells palsy- Severe headache, tingling of left side of face, trouble closing left eye progressed to left face palsy.
Patient woke up the following am with red spots to face, which spread throughout the day, including developing a blister on his lip. The second am following vaccines, woke up with a 101 degree temp.
Chest pain, shortness of breath, and itchiness. Took one Benadryl tablet and symptoms did not return thereafter.
Initial report received on 26 March 2009 from a consumer, who is the patient. A 35 year old female patient, whose medical history included allergies to gluten, penicillin, sulfa drugs, dye in pyridium, DEMOROL, FLOMAX and TOPAMAX, received four doses of IMOVAX (lot number not reported) starting on 08 March 2009. Concomitant medications included NEURONTIN, DARVOCET and ULTRACAL. Within 12 hours of receiving each dose of the vaccine, the patient experienced the same reaction which consisted of a stomach ache, diarrhea, fatigue, weakness, cramps in legs, and headaches which lasted several days. According to the patient, the reaction after each rabies vaccine was similar to the reaction she has if she has gluten. The patient's outcome was reported as unknown.
Approximately at 5:40 PM My son started to scratch his right arm and his left leg. When I looked at him he had hives where he was scratching. No medication was provided. Pictures were taken.
No red no edema 9/24/12 rec'd Flu shot 9/24/12 Lt deltoid IM. Went to Hosp ER 9/28/12 c/o Lt shoulder, arm pain radiating to upper back and midsternal and decreased ROM. DX: cellulitis. Antibx and pain meds 10/09/12 ran out of Ibuprofen. Came to clinic got refill. Appt 10/16/12 with clinic PCP - improved but not 100%. X-rays RF Ibuprofen.
Pt developed swelling at injection site and hives over entire body day of vax. Pt was taken to ER on 8/16/01 because of difficulty breathing.
The pain was on and off and the same happened after the booster dose; The pain was on and off and the same happened after the booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003536.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "Heart disease" (unspecified if ongoing), notes: He had a history of heart disease in his family. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 immunization, reaction(s): "It was reported that after the 1st dose his arm hurt and he was tired.", "It was reported that after the 1st dose his arm hurt and he was tired."; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "enlarged lymph node", "developed a decent amount of pain under his left arm". The following information was reported: PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "The pain was on and off and the same happened after the booster dose".  Additional information: Adverse Event Information: On 16Sep2022, it was reported that a patient started treatment on Feb2021 with Pfizer BioNTech COVID-19 Vaccine of two doses for unspecified indication. It was reported that after the 1st dose his arm hurt and he was tired. After the 2nd dose, he developed a decent amount of pain under his left arm. He went to his doctor who said he had an enlarged lymph node. The pain was on and off and the same happened after the booster dose. It was concerning and he wanted to avoid it. He had a history of heart disease in his family. His doctor said getting the Novavax vaccine is a good idea.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Itching began at injection site 2 days after shot. Patient reported to pharmacy 3-5-17 and asked if she could use Calamine lotion or, and suggested BENADRYL. No fever, no redness at site. Localized itching only.
Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat. Then I began to have difficulty swallowing my saliva. And then the lump inside my throat started to feel larger and larger. By this time Dr  had already injected me with Epipen and the pharmacist injected me with Solumedrol and I still felt as if I was having difficulty breathing and then I was taken to  ER and I really can't remember too much after that. I was very groggy and then I was discharged from  ED about 9:30 pm.
The patient fainted about 5 minutes after receiving the shot. She was out for about 30-45 seconds and was feeling fine afterwards. Had a snack and juice to drink. She was monitored for about 30 minutes and was fine when she left with her friend.
I am on Warfarin daily and prior to my first Moderna vaccine, my INR was 2.2.  It jumped to 3.4, 3.8, then 3.9 and I have not changed anything in my diet, nor have I changed any medication routine.  I have heard about blood clots, but was wondering if there is an interaction with warfarin or similar meds.  I have no symptoms other than bruising more easily.
Hours and up to 2 or 3 weeks after receiving first dose, patient experienced itching all over the body, tongue and lip swelling, left arm tingling, sharp stabbing pains in the chest and a metallic taste in the mouth. All symptoms subsided over the 3 weeks with exception of the metallic taste in the mouth.
MA visiting from clinic. MA gave 4 yr. vaccinations to pt. Another MA found boc if Hib to have one bottle of Hib powder but no diluent. MA last MA known to give Hib. Site Mgr. questioned MA about reconstitution of Hib. MA stated used diluent on fridge door (Sterile water for MMR/Varicella) to reconstitute Hib. MA stated she did not know there was diluent in the same box as the Hib powder. Recontituted incorrectly. Notified Health dept. informed needs to be regiven. Parent notified of error 8/16/13. Vaccine reconstitued correctly and given to the pt.
Pt recvd 1st dose of Hep B vax in APR92 & on 8MAY92 recvd 2nd dose; 2 1/2 wks  p/2nd dose devel arthralgias, joint pain, lymphadenopathy & malaise; lab eval pos for rheumatoid factor & borderline elevated ANA titer;
per phone report, mother stated infants eyes began swelling about 3 hrs after vaccines administered. Saw pediatrician next day. Infant had developed a fever and rash. Pediatrician told mother infant had an allergic reaction to vaccine.
After vaccination, pt. complained of wanting to vomit.  He went into the bathroom with a parent and nearly passed out. He was evaluated by the staff.  Pt. never lost consciousness.  He did not fall.  He was hot and sweaty.  His shirt and undershirt were removed. He was given sips of Coca cola to drink and a candy cane to suck on. Within the next 10 minutes or so he resumed his normal self and was able to leave the building with his parents.  He regained full function.
ARM SWELLING, REDNESS, TENDERNESS, UNABLE TO MOVE WITHOUT PAIN
GI Bleed Anticoagulant adverse reaction, initial encounter ALTERED MENTAL STATUS EXTREMITY WEAKNESS Angiodysplasia of colon with hemorrhage
Pain in legs, hips and especially knees that had been replaced. Weakness. Had to have many tests. Still weak and painful to this day.
Vomit x 5 days. Dizziness x 2 weeks since vaccine. Pt was rechecked 3-9-10 - Dizziness may be s/p hypertension. Pt will f/u with PCP. No acute findings at present.
Initial health care professional report received on 02 Nov 2010: This patient was vaccinate4d with MENVEO (batch number: 100001) 0.5 ml intramuscularly on 01 Nov 2010. The patient was vaccinated with only the Men CWY component of the MENVEO instead of being reconstituted with lyophilized Men A component. No adverse event was reported following this administration error.
Platelets were down to something like 70 and my neutrophils were 400. This last time my platelets were 123 And my neutrophils were 1200; Platelets were down to something like 70 and my neutrophils were 400. This last time my platelets were 123 And my neutrophils were 1200; This is a spontaneous report received from Pfizer. This contactable consumer (patient) reported to pharmacy about herself that:  A 66-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on Feb2021 (age at vaccination was 66 years) as dose 2, single for COVID-19 immunization and palbociclib (IBRANCE, Batch/Lot number: unknown, Expiration date: 30Jun2022), oral from an unspecified date, at 100 mg oral daily (Daily for 21 days) for breast cancer. Patient medical history of allergies: acetaminophen, codeine, enoxaparin, hydrocodone, lovenox, oxycodone. Concomitant medication(s) included calcium carbonate (CALCIUM CARBONATE), docusate sodium (COLACE), lorazepam (LORAZEPAM), eszopiclone (LUNESTA), omeprazole (OMEPRAZOLE), ondansetron (ONDANSETRON), oxycodone hcl (OXYCODONE HCL),levothyroxinesodium(SYNTHROID),hydrochlorothiazide,valsartan(VALSARTAN/HIDROCLOROTIAZIDA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on Jan2021 as dose 1, single for COVID-19 immunization. The patient received COVID shot in Jan and February and my blood work went kinda wonky afterwards, so skip a month. Platelets were down to something like 70 and neutrophils were 400. Last platelets were 123 and neutrophils were 12000. Patient haven't had any problems for 4 years the only thing different was patient got COVID shot. Patient started back on Ibrance on 23April2021 after being off for 5 weeks per pt. The patient underwent lab tests and procedures which included neutrophil count decreased which showed 400 result and platelet count decreased which showed 70 results on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Memory lapse, difficulty with memory recall; Confused; Blood clots; Cerebral Ischemic Attack; Brain Fog; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall), CONFUSIONAL STATE (Confused), THROMBOSIS (Blood clots) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart valve operation. Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confused) (seriousness criterion hospitalization), THROMBOSIS (Blood clots) (seriousness criterion hospitalization) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) (seriousness criterion hospitalization). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (Brain Fog) and HEADACHE (Headache). The patient was hospitalized from 10-Apr-2021 to 12-Apr-2021 due to CONFUSIONAL STATE, MEMORY IMPAIRMENT, THROMBOSIS and TRANSIENT ISCHAEMIC ATTACK. At the time of the report, MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall), FEELING ABNORMAL (Brain Fog) and HEADACHE (Headache) had not resolved and CONFUSIONAL STATE (Confused), THROMBOSIS (Blood clots) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Computerised tomogram: abnormal (abnormal) revealed blood clots. On 10-Apr-2021, International normalised ratio: low (Low) Low. On 10-Apr-2021, Magnetic resonance imaging: abnormal (abnormal) revealed blood clots. On 15-Apr-2021, International normalised ratio: low (Low) Low.         It was reported that the patient still has difficulty with memory recall, brain fog, headache, and still having trouble with low INR. The patient did not have any side effects after the first dose. Treatment for the events included Levonox injections and Coumadin (increased dose).  Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Headache is consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Headache is consistent with the product known safety profile.
myocarditis with elevated troponins, findings on cardiac MRI. No treatment required, self-resolved. Admitted for close monitoring
Received Covid-19 Booster of Moderna on 11/30. On 12/10 I had hives all over my body and they appear whenever I scratch. I am on week 6 and I have not had any relief.
Pain starting from the back of the left pelvis moving slowly to the right. Severe headache. Pain when walking, getting in and out of the car, getting in and out of bed. Last for 7 days. Taken Tylenol for 7 days Call doctor for advise only. Doctor did not recommend the 2nd dose.
Weird like metal taste in her mouth; Felt a little itchy; Rash from head to toe which spread out as well in the private area; Body ache; Headache; Vomiting profusely of previously ingested food (in her case just water and gatorade) for about 5-6x; Nausea; Neck pain; Swelling of the right arm which felt like she was hit by a baseball bat; Feels so hot like searing hot; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Weird like metal taste in her mouth), NECK PAIN (Neck pain), SWELLING (Swelling of the right arm which felt like she was hit by a baseball bat), FEELING HOT (Feels so hot like searing hot) and PRURITUS (Felt a little itchy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression, Fruit allergy (Allergic to Kiwi), Fruit allergy (Allergic to Mango) and Iodine allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and TOPIRAMATE for Antidepressant therapy.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NECK PAIN (Neck pain), SWELLING (Swelling of the right arm which felt like she was hit by a baseball bat), FEELING HOT (Feels so hot like searing hot), RASH (Rash from head to toe which spread out as well in the private area), MYALGIA (Body ache), HEADACHE (Headache), VOMITING (Vomiting profusely of previously ingested food (in her case just water and gatorade) for about 5-6x) and NAUSEA (Nausea). On 25-Apr-2021, the patient experienced DYSGEUSIA (Weird like metal taste in her mouth) and PRURITUS (Felt a little itchy). The patient was treated with IBUPROFEN on 24-Apr-2021 at a dose of 1 dosage form; PARACETAMOL (TYLENOL) on 24-Apr-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 24-Apr-2021, NAUSEA (Nausea) had resolved. At the time of the report, DYSGEUSIA (Weird like metal taste in her mouth), NECK PAIN (Neck pain), SWELLING (Swelling of the right arm which felt like she was hit by a baseball bat), FEELING HOT (Feels so hot like searing hot), PRURITUS (Felt a little itchy), RASH (Rash from head to toe which spread out as well in the private area), MYALGIA (Body ache), HEADACHE (Headache) and VOMITING (Vomiting profusely of previously ingested food (in her case just water and gatorade) for about 5-6x) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-JAN-2013, a healthcare provider administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.