chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Teeth were hurting; Earache; Diarrhea; Very sleepy; Very tired; Really big increase in appetite; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Teeth were hurting), EAR PAIN (Earache), DIARRHOEA (Diarrhea), INCREASED APPETITE (Really big increase in appetite) and SOMNOLENCE (Very sleepy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Obesity and Arthritis. Concomitant products included RISPERIDONE, METFORMIN, COLECALCIFEROL (VITAMIN D3), LORATADINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), ATORVASTATIN and LEVOTHYROXINE for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced INCREASED APPETITE (Really big increase in appetite). On 27-May-2021, the patient experienced SOMNOLENCE (Very sleepy) and FATIGUE (Very tired). On an unknown date, the patient experienced TOOTHACHE (Teeth were hurting), EAR PAIN (Earache) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; BENZOCAINE (ORAJEL) at an unspecified dose and frequency and CAFFEINE at an unspecified dose and frequency. At the time of the report, TOOTHACHE (Teeth were hurting), EAR PAIN (Earache), DIARRHOEA (Diarrhea), INCREASED APPETITE (Really big increase in appetite), SOMNOLENCE (Very sleepy) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About an hour after the vaccine, the patient noticed a really big increase in her appetite, she was really hungry and ate a lot. The next day, she felt very tired and sleepy and slept all day and all night. Last night, teeth were hurting and  had an earache.
Presented to ED w/weakness & SOB; admitted for COVID-19 pna; tx w/steroids, remdesivir, Vit-C, zinc. & O2; dc to home w/O2.
13 days after injection, woke up with red blotchy, spread out rash at injection site/across upper arm. Very slightly raised. Lightly warm to touch. No pain. Only slightly itchy if touched. There was NO redness, rash, pain or itchiness anytime PRIOR to this.
Diagnosed with strep throat 3/20/23 at Urgent Care. and required antibiotic treatment started 3/20. Symptoms of sore throat and vomiting started Friday 3/19.
Fatigue; Nausea; Jump in blood pressure; Pain in chest; Headache; This is a spontaneous report from a contactable consumer (Patient) reporting for himself.  A 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Jan2021 (age at the time of vaccination was 85-year-old) as dose 1, 0.3 ML single for COVID-19 immunization. Medical history included thyroid cancer from an unknown date and unknown if ongoing (diagnosed with thyroid cancer, in remission, paraganglioma, which he says is a benign tumor in the artery, it is maybe something that effects the vaccine. he doesn't know, hypertension and left bundle branch block), paraganglion neoplasm from an unknown date and unknown if ongoing, bundle branch block left from an unknown date and unknown if ongoing (only problem is the left bundle branch block, which is something his cardiologist told him, and that is concerning the most). The patient's concomitant medications were not reported. It was reported that on 27Jan2021 the patient underwent his first inoculation with Pfizer COVID vaccine, and developed constant fatigue, nausea, jump in blood pressure and pain in chest on an unspecified date in 2021. The blood pressure and pain in chest resolved in 3 days, left only fatigue, headache, and nausea, no chest pain anymore, his blood pressure was back to normal with medications. The symptoms lasted for three days, the patient asked should he follow up with the second inoculation. The patient underwent lab tests and procedures which included blood pressure measurement: jump in blood pressure on an unspecified date in 2021. There was no medical information request. Therapeutic measures included medications which were taken as a result of jump in blood pressure and was back to normal. Outcome of the event fatigue, nausea and headache was reported as Unknown, outcome of the event jump in blood pressure was reported as recovered on an unspecified date in 2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
25 X 19 flare hive Wheezing, itching, respiratory reaction problem breathing, delayed respiratory reaction. Given Hydroxyzine and 2 weeks later prednisone.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Infection / Cellulitis (diagnosed by MD)-
12JAN97 @ 2AM pt woke up w/fever 100;dx ear infect by phone & ordered cofactor;14JAN97 5PM pt woke up from nap felt warm;mom held pt & eyes rolled back;started shaking all over;mom called 911;t105;taken to ER;
Pt describes itchy throat immediately after vaccination, rec'd po benadryl. Pt reports 5 mins after Benadryl, she felt dizzy. Pt woke the next morning with blurry vision in both eyes and vertigo. Pt was advised by pcp clinic to seek immediate medical care, pt did not. Pt reports her symptoms resolved by 72 hours post vaccination.
Patient fainted after receiving vaccine/ Pt was monitored in observation chair for 15 minutes, blood pressure, and heart taken within normal limits/ Patient  stated he wasnt concerned because this happens to him everytime
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "BP" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal, start date: 05Sep2018, stop date: 21Nov2022. Past drug history included: Minacycline, reaction(s): "Known allergies: Minacycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events and the suspect drug BNT162B2 cannot be excluded.
Breast cyst; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CYST (Breast cyst) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's past medical history included Breast cancer in 2012 and Mastectomy bilateral (She had both breast removed.) in 2012.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In March 2022, the patient experienced BREAST CYST (Breast cyst). At the time of the report, BREAST CYST (Breast cyst) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623371 (Patient Link).
pt presented to ED after a fall @ home; c/o generalized weakness, SOB x 1wk; dyspneic; recent metastatic renal cell carcinoma; treated with O2 supplementation, antibiotics, steroids, vitamin supplements; pt's condition declined in spite of therapy; comfort care measures; pt died in the hospital
Day after vaccines pt had an episode characterized by rocking his head back and forth from side to side motion and jerking of the arms or legs. Pt had eyes closed at the time. No more activity until 11/24/03. Electrolytes. Electoencephalogram.
severe pain and swelling of my left arm inlcuding fever body pain nausea ect,
This 12-year old's first dose of the Pfizer was deemed invalid due to storage error and repeated 13 days later.  About 14 hours after revax he had a seizure in the middle of the night, which he reported to his mother the next morning.  He also had fever that next day lasting about 24 hours.  His mother reasoned his seizure was due to fever since his last seizure was 150 days ago and he had been well-controlled on 2 meds.  She presented today for 2nd vaccination, (technically 3rd dose of Pfizer) expressing concerns about another seizure.  She was advised to consult his neurologist,  for guidance and was advised vaccine will be available if/when she and the doctor deem it safe to give.
Mar2021 noticed some short term memory loss, got worse in Apr2021. Did not have memory issues before taking the shot.; Mar2021 noticed some short term memory loss, got worse in Apr2021. Did not have memory issues before taking the shot.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EN6201) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Other Medical History: Diabetes; "High blood pressure" (unspecified if ongoing), notes: Other Medical History: High blood pressure; "High cholesterol" (unspecified if ongoing), notes: Other Medical History: High cholesterol; "reflux" (unspecified if ongoing), notes: Other Medical History: reflux. Concomitant medication(s) included: SERTRALINE; LISINOPRIL; ATORVASTATIN; METFORMIN. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer, Lot number=EL9262, Administration date=21Jan2021, Dose number=1, Vaccine location=Left arm), administration date: 21Jan2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: AMNESIA (non-serious) with onset 15Mar2021, outcome "not recovered", CONDITION AGGRAVATED (non-serious) with onset Apr2021, outcome "not recovered" and all described as "Mar2021 noticed some short term memory loss, got worse in Apr2021. Did not have memory issues before taking the shot.". The event "mar2021 noticed some short term memory loss, got worse in apr2021. did not have memory issues before taking the shot." and "mar2021 noticed some short term memory loss, got worse in apr2021. did not have memory issues before taking the shot." was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of amnesia, condition aggravated.  Additional information: Psych eval; dementia meds; depression meds used for the treatment of the event. Patient did not had any Known allergies. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not had with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a 4 year old female patient. On 21-JUL-2014 at 6:00 PM the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX lot # J012773 with expiry date 09-OCT-2015, subcutaneous in the left arm. On the same day at 6:00 PM, the concomitant therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) DTap, poliovirus vaccine inactivated (unspecified) (IPV) and M-M-R II, VARIVAX was improperly stored. No adverse symptoms reported. Thi sis one of four reports received from the same reporter. Additional information is not expected.
Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a two years old patient who received a 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (Batch number: UJ045AA, expiration date: 30-Jun-2019, route: intramuscular and site of administration: left deltoid) on 08-Nov-2018. The patient's medical history was not reported. The subject did not receive any other vaccine. It was an actual medication error due to overdose (0.5 ml dose was given to a child who is two years old). It was unknown whether the patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
blurry; eyes were just dry; spin; dizziness; vomiting; sweaty; clammy; nausea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious) with onset 2021, outcome "unknown", described as "blurry"; DRY EYE (non-serious) with onset 2021, outcome "unknown", described as "eyes were just dry"; VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "spin"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "vomiting"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "unknown", described as "sweaty"; COLD SWEAT (non-serious) with onset 2021, outcome "unknown", described as "clammy"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information: Caller got the first dose of the Pfizer COVID-19 vaccine last Friday (02Mar2021). She was doing fine until Tuesday night (30Mar2021). While she was watching TV, her vision started to get blurry and she started to get dizzy but not fully dizzy. She tried to close her eyes because maybe her eyes were just dry but the dizzy sensation just keeps getting worse and worse. She describes the sensation as the spin when you have drunk too much alcohol. Even when she close her eyes, she still has dizziness. She also started vomiting pretty bad and se got sweaty and clammy. When she got better, she started to feel the symptoms again. She said she never ran a fever. She has nausea and a very slight headache in the eyes the next morning and at night. She was told that this reaction couldn't be from the vaccine since 24-72 hours has passed. Her HCP referred her to Pfizer. She wanted to know if the onset could be later than 72 hours. Consumer reported that It was for herself and she knew what the side effects were. She just wanted to know if side effects could occur after 72 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
10cm X 8cm redness & swelling around site of immunization left and lateral thigh
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  PARTIAL EPILEPSY, INTRACTABLE EPILEPSY, UNSPECIFIED ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE
The day after the vaccination, 10/16/2021, I had joint pain and muscle pain that lasted for 36 hours. My shoulder hurt during that time frame, but it was just achy. Until about day 10 after the injection, I had pain in my left shoulder that continued to increase. On 11/01/2021 I called Dr. the office returned my call on 11/02/2021- I had a telehealth interview with the nurse and they called in 2 prescriptions: prednisone 20 mg od, tizanidine 4 mg, 3 a day, 1 every 8 hours. CB 11/06/2021 my condition had not improved it got worse. I went into the doctor's office Dr. He examined me and asked a lot of questions and prescribed another medication at that time- Gabapentin 100 mg, 3 times a day. He wanted me to CB 11/08/2021, I was not getting worse, but I still was having the pain, very painful. And he increased the Gabapentin 300 mg 3x day, and prednisone he increased to 40 mg od. I am supposed to call this afternoon, 11/10/2021 to Dr. office to do possible blood work and CAT scans if I was not improving. Today, 11/10/2021, is the best day I have had with the issue. I do feel like I am starting to feel better. I am improving, but I am still experiencing the pain and spasms. The symptoms have improved since the doctor increased the medication.
Day 1 within 4 hours intense burning in arm at site of shot lasting for 3 days. Day 2 to current time(day 6)  swelling of hands and feet.  Day 2 to current time (day 6) burning / itching / small red spots on face and behind ears that eventually dried up and peeled . Peaked at day 3.  Still very irritated and raw but intense itching has subsided. Day 5 extreme fatigue and minor headache preventing me from working.
Headache, fever, pain on my shoulders and knees, dizziness during the day. Feeling symptoms of Migraine.
I had a fever, heavy congestion, muscle aches, headaches, and body aches. I just felt really exhausted and just thought it was travel lag from my flight the day before. On 07/21/2022, I went to a pharmacy to get a COVID-19 PCR test done because my symptoms continued to get worse. The doctor said because of the current medications I was on, I wasn't a good candidate for the PAXLOVID prescription. They told me to go home and treat my symptoms with medication like cough suppressant and TYLENOL. Over the days, my cough eventually suppressed as well as my body aches and slight fever. As of now, I feel pretty recovered with residual cough.
Information has been received from a physician concerning a 19 year old male who on an unknown date was vaccinated with MMR II HAS (route, site, dose and lot number not reported). On 08-NOV-2009 the patient experienced mumps. The outcome for mumps was not reported. Patient was exposed to a sibling who was exposed to mumps. "Lab results on 15-Oct-2009: "IgM 0.46 and IgG 3.31. The outcome of the patient was not reported at this time. Follow up information has been received concerning the 19 year old male patient who on an unknown date was vaccinated with MMR II HSA (route, site, dose and lot number not reported). On 11-NOV-2009, the patient experienced mumps (he was diagnosed on 12-NOV-2009), he was afebrile and had L parotitis. On 12-NOV-2009, a first blood work was performed with IgM negative, IgG was 1.2 and serum amylase tests was 39. At the time of this report the patient's outcome was unknown. No further information is available.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe flu like symptoms for 2 days. The reporter agreed to be contacted by GlaxoSmithKline. This case has been linked with case US2018GSK188963, reported by the same reporter.
Temperature to 105 degrees F 7 days after vaccine given 10/30/02. Patient had trouble walking and seemed delirious to the parents. Antipyretics were given. No further treatment was needed.
Narrative: Patient received Janssen vaccine on 04/09/2021; upon follow-up call with nurse, patient reported fatigue as only symptom. There was no reported  time frame and patient did not report treating symptom with any medications.
I received my vaccine on the 25th at 8:50 a.m.  At 4:00 a.m. on the 26th, I woke up with a pain in my chest that wasn't too bad, and a slight headache. I got up and went to the bathroom and took my temperature. It was 101.9. I went back to bed and the pain in my chest felt like a spasm at the base of my esophagus. It would come and go and I thought it might be indigestion or something but it coincided with when my temperature started. I had woken up a few times before 4:00 and felt chilled but had taken my temp  and I didn't have any. Over the course of the next few hours, the pain got more and more intense to the point my husband felt we should go to the emergency room. When it would be in my chest area, it was excruciating. It would alternate between the center of my chest and then would be in the center of my back between my shoulder blades. I took five or six Tums over this period of time. I took two Tylenol at around 5:30 a.m.  The episodes lasted several minutes, would ease a little and then start up again. My temp started to come down around 6:00 but was still 100.1.  The pain in my chest felt like a spasm type pain, but when it would go to my back, that was a fairly constant pain. I finally agreed to go to the emergency room and my husband helped me get dressed. This was about 6:30 a.m.  Shortly after that, the episodes started spreading out to where they weren't as long or frequent. About 7:45 a.m. they had eased up completely, and I took my temp again at that time, and it was completely normal. We did not end up going to the emergency room.  The pain did not come back for the rest of the day.
After his first shot he had slight headaches. The day after his shot, 5/26, he felt fine so he played  basketball. The next couple of days he continued to doing normal workouts and played basketball, he was never warned by health professionals not to. Within a week of getting the first shot, he would do normal cardio workouts that he had been doing prior to getting the shot, but during the workouts he noticed his heart having almost painful palpitations that he had never noticed before. Now even the slightest increase in his heart rate results in palpitations during normal activity and he has to stop all activity until the palpitations stop.
Patient had 1st dose on 6/15/2021. Both she and father verified with the pharmacist that she was 12 years old. the pharmacist asked several times how old she was and she verified 12 years old.  Today, they came back for 2nd dose and put the DOB as 7/27/2009 on the form. I asked how old she was and she said 11 years old. I told her she can get her second dose after 7/27/2021 when she turns 12 years old. When they got home, I called her father again to verify if he has her birth certificate or passport. He said he has her passport. Her DOB is 7/27/2009.
temp of 103.4, fatigue, weakness - given Tylenol, ice packs Confusion, hypoxia,