chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am the coordinator for the facility. She started to have problems after the first dose of the vaccine. There was also a lot of fatigue and feeling poorly. Her condition got worse after the second dose of the vaccine and she saw her doctor. It was discovered that she was in the final stage of Lung cancer. She had two treatments of radiation and then it was advised that she receive Hospice Care. She passed away shortly after that.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication were reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among 100 patients who were administered an invalid dose of  Moderna COVID-19 bivalent  booster.  It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Got the flu; Diarrhea; Running temperature; Freezing cold; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Got the flu), DIARRHOEA (Diarrhea), PYREXIA (Running temperature), NASOPHARYNGITIS (Freezing cold) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA (Got the flu), DIARRHOEA (Diarrhea), PYREXIA (Running temperature), NASOPHARYNGITIS (Freezing cold) and FATIGUE (Fatigue). At the time of the report, INFLUENZA (Got the flu), DIARRHOEA (Diarrhea), PYREXIA (Running temperature), NASOPHARYNGITIS (Freezing cold) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No treatment information was provided.    Reporter did not allow further contact
p/ pt recv vax approx 1yr later lab evaluation revealed varicella zoster AB IGG non-immune
Monday 3/29/2021 at 9:00 am received the second Moderna vaccine.   After 5:00pm, pain started at the injection location followed by body chills. Tuesday & Wednesday 3/30-31/2021:  Arm pain, body chills, and joint pains. Thursday 4/1/2021: light arm pain, on and off body chills, joint pains, and fatigue. The second shot?s symptoms were less severe  than the first shot.
This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 07-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Breakthrough case admission after 5 vaccines Pfizer 2/2/21 Lot# EM9810;  PFizer 2/23/21 Lot# EN6202;  Pfizer 9/24/21 Lot# 301358A;  Pfizer 4/3/22 Lot# FK9894;  Pfizer 9/17/22 Lot# GH970
This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L038917, expiration date 20-FEB-2018 and lot # M009378 expiration date 23-APR-2018 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperatures and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Additional information has been requested.
Low platelet count; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLATELET COUNT DECREASED (medically significant) with onset 2021, outcome "not recovered", described as "Low platelet count". The patient underwent the following laboratory tests and procedures: platelet count: (2021) low; (2021) 15; (2021) 40, notes: now he is up to 40 but it is supposed to be 150,000. Therapeutic measures were taken as a result of platelet count decreased. Clinical course is as follows: The patient had the Pfizer covid vaccine and had the reaction of a low platelet count and it is 7-8 months and he still has the low platelet count; it was reported that they tried different things to try to boost the platelet count, the reporter has no names of things they tried to boost the platelet count and no dosages, medication names, lot numbers or further information to provide other than she knows he had some kind of drip where he had to go once per week for four weeks and that ended 3-4 weeks ago and the lowest point of his platelets was 15 and now he is up to 40 but it is supposed to be 150,000. The reporter has no lots, expiry dates or NDC numbers to provide for the patient's Pfizer Covid Vaccine.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
"Allergic reaction" to pertussis vaccine as an infant. Mom advised child received first DPT, Hib and OPV on 6/4/1992 with no remembered adverse events. She had premedicated with infant TYLENOL. He received his second set vaccinations on 8/6/1992 (DPT, Hib and OPV). Mom advised he began crying and continued crying for about 6 hours with swelling and redness to top of vaccinated thigh and would not use this leg (unsure which leg). Mom could console child with TYLENOL and/or holding and rocking. She denied any rash, difficulty breathing, seizures or any anaphylactic like reactions. Child slept normally that evening, not crying, and was his "normal self" using his leg the next morning. The vaccine site redness/swelling resolved within 1-2 days. Mom advised he was seen by his pediatrician who told her he had had an "allergic reaction" to pertussis portion of DTP vaccine". On 10/1/1992 he received his 6 month vaccinations which included DTP and Hib vaccine. Mom advised child had similar reaction, site redness, swelling, limited use of leg, and crying. Crying resolved in < 6 hours with comfort measures. Site redness and swelling resolved within 1-2 days. He has received all other recommended vaccinations, including receipt DPT at 16 months and then DT at age 4, without reactions being pre-medicated with TYLENOL before all infant vaccinations.
Rash over entire body with a burning and itching sensation. No know allergies to any food products and I was not taking any medications.
Had a sore throat on 6/30/22, took a Home COVID-19 test on 07/01/2022 and it was positive. Went to Urgent Care. Because I have problems with my Kidneys, they did a Kidney Function test and a Metabolic Panel. Everything looked ok so they gave me a Prescription for Paxlovid. Started feeling a lot better after 24 hours. Took another Home COVID-19 test 6 days later and it was negative.
Tested positive for covid 19; Tested positive for covid 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 27 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test (2021) positive. Patient received COVID 19 vaccination on an unspecified date in May/Jun2021. She had headache, sore throat, chills, cough, muscle aches2, and was tested positive for COVID 19. It was reported that, event took place after use of product.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Fever of 100.4 first noted at 8AM 3-19, continuing to stay stable through the day.  Fever of 100.3 noted at 5PM, 3-19 Vomiting starting roughly 5 hrs after vaccine was given, continuing into 3-19, turned into low level nausea through rest of day Severe chills starting around 3AM, ending around 7AM Migraine starting around 6AM, lowering into regular headache by 1PM Body aches starting from roughly 6AM until 3PM
Swelling in area of injection, redness spreading around area of injection, warm to the touch.
PATIENT HAD VACCINE 9/13/2018 AND REPORTS THAT ON 9/19/218 SHE STARTED TO BREAK OUT IN A RASH AND RED BLISTERS ON HER LEFT SIDE OF HER NECK. THIS WAS THE SAME SIDE THAT SHE RECIEVED HER VACCINE IN.
On 10/23 I noticed two bumps red raised bumps on my lower back. One 10/24 the rash has now spread from two bumps to now four and are now itchy. On 10/26 the rash has spread from the lower back up towards the middle of my back and middle of my chest  and bilateral flanks. The rash became extremely itchy and more pronounced. I applied OTC hydrocortisone cream and took OTC Benadryl. The rash lasted for about a little over a week and started to subside however on 11/1/21 the rash returned  and I then scheduled an appointment with my primary care physician .
I was 30 Weeks pregnant when I got the H1N1 vaccine and 2 weeks later I went to the ER because I did not feel my baby moving. They told me my baby had died!!!
Pediatric dose of Hep B given to adult on 7/6/09, followed by adult dose given on 7/9/09. No adverse s/s.
felt sensation of heaviness in extremities & swelling of tongue during the noc following inj;noticed rash on neck the next day lasting 2 days 23MAy & 24MAY;very tired x 3 days;
Large lump/swelling at injection site still persists and has not decreased as of day 5
Information has been received from a nurse via Pfizer (manufacturer control number# 2017001485) referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route and lot number not provided) for prophylaxis. On an unknown date, the patient experienced severe bursitis after PNEUMOVAX 23. The outcome of bursitis was unknown. The causality between the event and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Pt reported that approx 12 hrs following vaccine, her lips and nails turned "blue". She reports "intense" body aches, chills and difficulty breathing. She also reports headache. She denied and swelling of lips or throat. She did not seek treatment. She took OTC excedrin migraine and states symptoms lasted 3 days
I started having aches and I had a low grade fever that evening. And I had fatigue as well. Those symptoms carried into the next couple of days. The body aches resolved between six and eight weeks. The fever lasted over 2 months - it was consistently between 99 and 100 and could get as high as 101 - it just never went away. The fatigue has been ongoing. I was not allowed to come back on campus of the hospital until the 1st week of April - almost three months.  (Back on the 18th, I lost my sense of taste and smell and that is when  I went in and got tested for COVID test - and on 19th it came back positive.)  I went back to the Urgent Care on the 29th because I had respiratory problems. My breathing started getting better about a week or so after that. From time to time, I still have a little breathing difficulty but it still improving.
Pt over the age of 12 was inadvertently administered a 1st dose vaccination of Pfizer\BioNTech (age 5-11).  No adverse effects were noted after the vaccination, no treatment was rendered.  Pt's grandmother was notified about the event.
ACUTE NON ST ELEVATION MI DEMAND ISCHEMIA  5/4/2022 -- RECURRENCE OF SAME SYMPTOMS
Tender to touch; Soreness in Arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA (Tender to touch) and MYALGIA (Soreness in Arm) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERAESTHESIA (Tender to touch) and MYALGIA (Soreness in Arm). The patient was treated with PARACETAMOL (TYLENOL) for Tenderness, at an unspecified dose and frequency. At the time of the report, HYPERAESTHESIA (Tender to touch) and MYALGIA (Soreness in Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
My arm was sore after receiving the injection. Soreness improved after a few days.   Soreness returned after eight days. Accompanied by redness, swelling/firmness, and itching. Redness had spread on the ninth day after receiving the injection. Improved over several days. No noticeable swelling or redness 12 days after injections.
inflated in the pectoral area; pain in his joints, pains in his knees and shoulder; swelling in the lymph nodes; swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 (Lot number: FH8028) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: FF2587, Anatomical location: Arm Left ), administration date: 26Oct2021, when the patient was 42 years old, for Covid-19 Immunization, reaction(s): "inflated in the pectoral area", "Discomfort". The following information was reported: LUNG HYPERINFLATION (non-serious), outcome "unknown", described as "inflated in the pectoral area"; ARTHRALGIA (non-serious) with onset 17Nov2021, outcome "unknown", described as "pain in his joints, pains in his knees and shoulder"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "unknown", described as "swelling in the lymph nodes"; SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "swelling".  Additional info: Patient took the first dosage on the 26Oct2021 and he got inflated in the pectoral area and had discomfort and it was disturbing him. He had taken the second dosage on 16Nov2021 and the same thing happened again and was inflated in the pectoral area. It was pectoral or breast plate below the left arm. It started the next day after the first dose. It happened again after the second dose and it was ongoing and it was stronger. The symptoms are much more than the first time on the left side. . It had been more than 72 hours since he got the shot and had the swelling. It had not gone. He was a really healthy man. He doesn't do drugs or drink. He had a good diet and was healthy. He had no underlying conditions. This happening was worse with the second dose. That area was still swelling. Vaccination Facility Type: health department of withheld. No prior Vaccinations within 4 weeks. He did not have flu vaccine or any other vaccines.   No follow-up attempts are possible. No further information is expected.
Pt afebrile but with AOM and Otitis Externa and superficial cellulitis on foot. Rocephin x1 + vaccines or below. Keflex ordered but not started. 20-24 hrs later mom noticed rapidly increasing swelling and erythema warmth at upper arm, under rash. 1hr later swelling, induration, erythema and tender further to to ante and now arm to elbow. Given Benadryl, Keflex continued admitted. Benadryl alone (Keflex too but developed problem on Rocephin 5hrs later the induration had decrease, still warm and red, hard, but burdens has not extended further. The following morning on Benadryl (+ Keflex) there was complete resolution and the pt was discharged. Medical record recieved 08/17/05 states allergic reaction.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 1 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 1 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information was received on 14-JUL-2017 from a nurse who reported that multiple unspecified patients were administered improperly stored VARIVAX (lot#/expiration unknown) reconstituted with properly stored sterile diluent (lot#/expiration unknown) on multiple unspecified dates. Temperature was 15 degrees F to 46 degrees F for a time frame of less than 72 hours. Previous temperature excursion was unknown by reporter. Call was because of a "data logger". No adverse effects reported. No further information provided. Additional information has been requested.
Pfizer BionCOVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer BionNTech Vaccine on 03/05/2021 and 04/02/2021. Patient presented to ED on 8/4/21 for shortness of breath. Patient reported progressive worsening of shortness of breath which  started 3 days prior. EMS found pt to have O2 sats at 70% RA and temp of 104F. Patient tested positive for COVID-19 infection in the emergency room.  Patient had a chest x-ray done in the emergency room which revealed bilateral infiltrates consistent with COVID pneumonia versus pulmonary edema. Patient's requirement for oxygen started to increase.  He was on high-flow oxygen.  He also has thrombocytopenia. Required pressor support. Treated with Rocephin for UTI for Klebsiella. Pt also recieved decadron and remdesivir during stay. Patient had severe bradycardia and had a external pacemaker placed on 8/11/2021. Patient was then intubated for airway support.  He also developed some acute kidney injury with the history of CKD.   Patient condition slowly worsened requiring pressors.  His leukocytosis increased. Patient went on to need dialysis and additional measures and family opted for comfort care. Patient expired on 8/21/21
By the 1st night following the shot, I was running 100 temp, with a cough, by the 2nd day I had as high as 102.2 temp with running nose, and bad cough   By the first night I had the smell of cigarette smoke that I could not get away from.  No one smokes at our house or near our house.  I even stepped out the door to see if anyone was smoking off of our back porch.  By the second day, it was so bad that I kept near our air purifier to inhale because it felt like the cigarette smoke was keeping me from getting oxygen, even though it read at 98 %.  But this is the 7th and I am feeling much better.  I went to my primary care Dr. on the day following the shot and he did feel like I was having an adverse effect of the shot but also maybe having a sinus infection so he gave me Cephalexin 500 mg antibiotic. I have not had any fever since April 3rd, 2021.  I feel like I may have recovered from the adverse reaction but still have a sign of the sinus infection.
Mother brought patient in on 07/03/2003 to have PPD check and mentioned that the patient's arm was warm, swollen and red, so I checked it.  Patient seemed to be doing ok.
6-13-11 Client came in to clinic states" I started to notice hives to my left and right arm near injection site with itching."
Patient admitted to hospital with cellulitis on 10/2/17, condition worsened, abscess to Right deltoid found via CT scan; patient is currently hospitalized.
welt that peaked on 4/27/23, significant vomiting that began on 4/28/23
15 Dec 2010; 3rd Anthrax received; rash on chest. Seen in ER on 18 Dec 2010, given prednisone & BENADRYL.