chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Awoke at 1130 pm. Felt like my face was laying on metal mesh. Next I developed tingling and sharp electrical sensations along my entire body. This was painful. I proceeded to rub my arms and legs together to decrease the sensation.Then my muscles began to contract as if I was having a seizure but my brain was untouched.  I recall thinking that "this can't be a seizure" but the contractions and jerking were strong enough to make my body jump and my neck thrust forward.  Each of these phases lasted about 5 minutes. Next came an intense coldness throughout my body. I managed to get up and put on warm clothing.  My temp was 100.9 at that time.  I took tylenol 500mg and advil 200mg.  I then wrapped myself in fleece and tucked my body into the fold of the couch in order to try to wait until the temp decreased.  I fell asleep for 1.5 hours and awakened with a headache, muscle aches and tingling in my lower legs and feet.  This resolved over 12 hours.  My temp declined to normal this 9am.  I remain extremely tired.
Lack of drug effect; Lack of drug effect; Localized itching; Unexpected therapeutic benefit; This is a solicited study report from the marketing program received from a contactable consumer (patient).   A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; risankizumab (SKYRIZI), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for Moderate to severe chronic plaque psoriasis.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced localized itching, unexpected therapeutic benefit, lack of drug effect on an unspecified date with outcome of not recovered. On unknown dates, the patient experienced itchiness in head, back and buttocks, unexpected benefit/had no joint pain or swelling since starting SKYRIZI and lack of effect. COVID-19 vaccine was also considered suspect. The patient got Covid vaccine and experienced itchiness for about a week or two. He started experiencing itchiness in head, back, and buttocks less than 12 weeks after doing Skyrizi injection. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine. Primary reporter did not have the lot number information, because the packaging was discarded. The action taken in response to the events for risankizumab was unknown.  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the events of itchiness in head, back and buttocks, unexpected benefit/had no joint pain or swelling since starting SKYRIZI and lack of effect with SKYRIZI(RISANKIZUMAB) was a reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Suspected COVID-19, Pruritus and Therapeutic response unexpected cannot be completely excluded.
2nd dose pfizer vaccine was given to patient on 07/07/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window.
Estimate Date of delivery - May 19, 2022. I had a fever, body aches, Vomiting my arm was sore, lymph nodes was swollen. I had all the symptoms except diarrhea.
COVID Positive>14 days post vaccine Narrative: COVID Positive>14 days post vaccine
after shot i was ok .two days after severe pain in right leg nausea  for the last 3 days  leg has been hurting very bad can barely walk or drive today feels slightly better.  but the pain was  very intense and still not totally gone
62 y/o, male, presents with (L) arm pain, redness, and chest wall redness/itchiness since he received recombinant zoster vaccine. Denies shortness of breath or throat swelling. No fever, chills. NO any new exposures. Rash and urticarial pruritus. Famotidine 1 tab BID, Diphenhydramine 1 tab QID, epinephrine 0.3 mg once.
The patient experienced a full body arthritic reaction with joint aches in the knees and shoulders most prominent.
This spontaneous report was received from healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored PEDVAXHIB which were exposed to 1.0 C for 5 hours, (Dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reprots received from the same reporter. Additional information has been requested.
My right shoulder (near vaccination site) started hurting the next day and still does 4 days later. Last night, I broke out in a bilateral upper extremity and back rash. I saw my MD who prescribed corticosteroid cream and an antihistamine. Rash is improving now.
Several minutes after receiving 2nd vaccination, pt. reported bilat. arm itchiness. Pt. was being observed in clinic waiting room for 15 min. wait time per protocol when symptoms began. Pt. denied any other symptoms,  no redness or hives noted, no injection site symptoms noted. Pt. denied staff call emergency contact, pt. denied desire for eval in ED. Pt. requests to go home stating that he lives 5 min. from hospital. Staff discussed Benadryl admin. with pt. Pt. agrees to take Benadryl 25 mg PO. Med admin. and then pt. left clinic. Pt. instructed to go straight home and explained that medication can cause drowsiness. Pt. verb. understanding. Nurse contacted pt. approx. 10 min. after leaving facility to check on safety. Pt. reported being home and safe, continues to experience itchiness to arms bilat., mild headache. Instruced pt. to call 9-1-1 if experiencing any chest discomfort, difficulty breathing, swelling of mouth/throat, any other major concerns that deviate from baseline, pt. verb. understanding.
Water in left eye; Legs are weak; Headache; Went blind for 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Went blind for 6 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental prosthesis placement (Dental work done on top teeth in the past year- 4 teeth removed and plate put in.). Previously administered products included for an unreported indication: TYLENOL. Concurrent medical conditions included Cough (He's always coughed since last 40 years, stopped smoking. Cough has changed since last year.) and Poor vision (Patient already have poor vision.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (Went blind for 6 hours) (seriousness criterion medically significant), LACRIMATION INCREASED (Water in left eye), MUSCULAR WEAKNESS (Legs are weak) and HEADACHE (Headache). At the time of the report, BLINDNESS (Went blind for 6 hours) and HEADACHE (Headache) had resolved and LACRIMATION INCREASED (Water in left eye) and MUSCULAR WEAKNESS (Legs are weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal normal (normal) normal.         Patient has been using CPAP  machine for at least 5 years.  Cough was sound different than what he used to.  Treatment information is not provided.  Concomitant medication were not reported.  The patient took Tylenol extra strength because he had a headache last week. He cough's but he was always coughed for 40 years, stopped smoking. Ocrevus identified as suspect as patient was on routine therapy.  Company comment: This case concerns a male of unknown age with no relevant medical history who experienced serious unexpected event of  blindness on unknown date lasting six hours after the second dose of the Moderna Covid 19 vaccine..Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a male of unknown age with no relevant medical history who experienced serious unexpected event of  blindness on unknown date lasting six hours after the second dose of the Moderna Covid 19 vaccine..Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Patient reports he received injection around 12:30pm on 9/14/21 then went home and felt dizzy. He states he checked his blood pressure and it was 70/40. He states he believes that he may have passed out for a few minutes. Patient states symptoms resolved later that day with no treatment. No ongoing concerns or symptoms.
From history and physical on 12/28/21: Patient is a 67 y.o. morbidly obese female with 2L dependent COPD, DHF, chronic PE's on Xarelto, HTN, OSA qhs BiPap presented to a HCF ED with 3 days escalating dyspnea sx's associated with N/V/D.   Patient says she initially lost her sense of taste and smell approximately 3 weeks ago, causing a poor appetite and some unintended weight loss.  Patient did not think this was Covid since she has had both Pfizer vaccines and her booster.   12/23/2021 patient was around church members and family celebrating preholidays.  On 1224 and 1225 she started to have abdominal cramping, flatulence, and then proceeded to have emesis and diarrhea for 24 to 48 hours.  On 1225 and 1226 her shortness of breath symptoms started, patient was DOE and begin turning up her home oxygen to help with her symptoms.  Her dyspnea has gotten more severe, now with intolerable orthopnea associated with bronchospasmatic cough.   ED evaluation significant for (+)Covid PCR, CTA of the chest with right upper lobe hazy infiltrate consistent with pneumonia, urinalysis consistent with UTI.  Patient was satting in the mid nineties on her baseline 2 L while resting in the emergency department
the vial was initially stored in the refrigerator on 02-MAR-2023 and administered on 27-Apr-2023; No adverse event; HCP explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 02-MAR-2023 and administered on 27-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an 85-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     Patient had no relevant medical history and allergy.  It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 02-MAR-2023 and administered on 27-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 02-MAR-2023 and administered on 27-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 02-MAR-2023 and administered on 27-Apr-2023).    No concomitant medications were provided. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 02-Mar-2023. The vial did not undergo any temperature excursions. No Adverse events were reported.  No treatment medication was provided.
pt recv vax 4OCT95 & AUG97 pt devel a breakthrough of varicella all over body 45-50;
Administration Error - Dose was given beyond 6 hour mark.  Vial punctured 01/03/22  9am;  On 1/4/22 a dose was drawn from this vial and administered to the patient mentioned in report.
people /got the shot and/ got /shingles\ Suspected Vaccination failure; got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients got Shingles shot and several weeks later got the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Patient experiencing arm pain near injection site. Dull ache all the time exacerbated by movement. Started immediately after the vaccine. Patient has made an appointment to see his MD.
I felt some fatigue just little tired; I have allergies too and I battle with allergies all the time; Feeling a little under the weather; runny nose; Feeling a little under the weather; runny nose; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (Pfizer/BioNTech Covid-19 vaccine, lot/ batch number EL1284) on 30Dec2020 at a single dose for Covid-19 immunization. The patient had no medical history and had no concomitant medications. The patient got her vaccine on 30Dec2020 in the morning and she had not experienced any type of severe side effects from the Covid vaccine and only felt some fatigue just little tired. But she started feeling a little under the weather and runny nose on 03Jan2021. The patient also reported that she had allergies too and battled with allergies all the time (clarification required). The patient had no treatment received for the events. The patient had no fever. The events little under the weather and runny nose resolved on 03Jan2021 and outcome of other events was unknown. The patient would like to ask whether the events were related to the vaccine as it was happening a few days later.
Subsequent to receiving vax, the pt began to experienced unspecified symptoms. The reporting neurologist made a diagnosis of bilateral peripheral neuropathy of the feet. As of 03/27/2001 the event is ongoing.
The morning after my dose 5 I woke up with fever, headache, muscle aches. The two weeks I felt terrible and was in bed and down for two weeks. My fever ranged from 100.5-103.1. I was pretty sick and felt terrible the whole time. I did contact my doctor and there was nothing they could do for me so I had to just wait it out. As of today once and while I will get a high fever and will be gone in a day. I have never had this issue before.
heart palpitation; Just a little tired; This is a spontaneous report received from a contactable consumer (patient herself). An unspecified aged female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Mar2021 for COVID-19 immunization and experienced with fever, achy, allergic reaction, face swelling and hives. Lad data includes patient went to her family doctor and had an EKG, which didn't show any palpitations on an unspecified date. She received her second dose on 05Apr2021. She felt great on Monday and yesterday, just a little tired. However, last night (06Apr2021) at about 10:30 she started getting heart palpitations. She felt like her heart is dancing in her chest. She called the Health Department this morning. Stated they have heard of that as a Pfizer side effect. She stated that they heard the palpitation. She was put on a 3 day Holter monitor and the doctor never heard of this as a COVID vaccine side effect. She has not had heart issues before. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reported throat irritation, which started a few minutes after receiving vaccine.  Symptoms improved at 15 minutes.  Had similar reaction with flu vaccine.  14:00 Patient called.  Reported he took diphenhydramine.  Throat irritation decreased.  Reports headache.
Pt states she did not have a reaction on the date of the vaccine. On wednesday she notices a rash on her arm at the injection site ranging 4-5 inches long and 3 inches wide. she states it was warm to touch and slightly itching sometimes. She states it has gotten better since Wednesday but the site is still red. I told pt to try taking some benadryl to help the rash. If she continues to see the rash she needs to get checked out by a doctor.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, vaccination site, route unspecified). The reporter stated that, the patient had experienced rash after ZOSTAVAX vaccination. The outcome of rash was unknown. The reporter was interested in Varicella Zoster Virus (VZV) analysis by polymerase chain reaction (PCR) and wanted to send viral isolates. Product quality complaint (PQC) was not involved. Causality assessment was not provided. No further information was provided. Additional information has been requested.
Patient reported rash at injection site, with fever and redness. He said it is hurting anymore. I informed him to try a cold compress and some oral antihistamines
The patient had gone shopping in the store after receiving the Moderna Covid-19 vaccine and then returned to the pharmacy after about 10 minutes saying she wasn't feeling well. She reported feeling hot, that her lips were tingling, and stating she just felt weird. I had her sit in the immunization booth so I could tend to her without and audience. I gave her 10 ml of Benadryl because she mentioned her lips were tingling. I broke one of the instant icepacks for her and had her place it on the back of her neck and put her head between her knees. She reported feeling that her face felt hot, so I broke two more icepacks and had her sit up right and place the ice packs on the front of her neck. I stayed with her in the booth and talked to her until she felt better. I set the timer on my phone for 15 minutes. After 10 minutes she said she was feeling better and wanted to move to the waiting area. She was fine after the full 15 minutes and left our store. I estimate she remained in the store for approximately 30 minutes after receiving the vaccine.
Patient received high dose flu shot on 10/20/18 at 2:43pm and states that she started experiencing a severe cough during that nighttime on the same day. As a result patient took a dose of ZYRTEC that night and the next night which help alleviate the cough. Patient states she still has minor cough as of 10/23/18. Patient has gotton flu shot in the past with no reaction.
More pain than normal starting on day 1. 1 Week later patient developed cellulitis, a 3/4 inch wheal and an abscess with white pus like discharge. Within 3 weeks after vaccination the site was scabbed over. Almost a month later the site has healed. No treatment sought.
pt recvd vax on 23SEP93 & on 24SEP had chills, achiness, poss fever on sat 25SEP became SOB, diarrhea, nausea; 27SEP c/o numbness in lt leg;
pt recvd vax 29DEC92 & on 2JAN93 c/o dyspnea, general malaise, & achiness; examined by MD on 3JAN93 & 11JAN93; t98.0; dx poss adverse reaction to Heptavax versus poss viral illness; will obtain hep B surface antibody titer prior to inject ;
slight heart palpitations like quivering which went on for 18 hours; This is a spontaneous report from a contactable healthcare professional (patient). A 72-year-old male patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: 5/31 EL 3249 (as reported), unknown expiration), via an unspecified route of administration in right arm on 13Jan2021 at 14:00 (02:00 PM) at a single dose for COVID-19 immunization in a hospital.  Medical history included known allergies to shellfish.  Concomitant medications included enalapril, metformin, insulin, and clopidogrel. Four hours later that evening of 13Jan2021 at 06:30 PM (18:30), the patient experienced slight heart palpitations like quivering which went on for 18 hours. He went to a hospital for 3 hours EKG, chest x-ray, and some two blood tests, all of which came back normal (Jan2021). He had no issues like this before or since. The event resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient did not receive treatment for the event.  The patient recovered from the event in Jan2021.
An undiluated dose of 0.2 ml dose of pfizer maroon cap was given to this child. A call was placed to the parents at 6:21 pm. The parents report the child feels warm but has not taken a physical temperature. She has received 1 dose of tylenol. Doctor (attached as a contact to this form) recommended ibuprofen and tylenol be given and fluids and increased.
11-24-21 (next day) cough,  chills,  body aches; 11-25-21, Chills and cough; 11-26-21 felt a little better; 11-27-21, evening, significant decline in health, used rescue inhaler (seldom uses normally), O sats dropped to 84; 11-28-21, went to local  Urgent Care and had negative flu/COVID, prescribed Zpak and prednisone and steroid shot, continued decline, went to a second Hospital at 11pm; 11-29-21 4:30am sent home from ER with AirDuo, returned to same hospital in the evening because he felt as though he was continuing to decline and did not get admitted but sent home.  As of 12-7-21,  resting heartrate varies between 100-120, still coughing, still shortness of breath, exhausted but slowly improving