chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 63 year old female patient with no drug allergies. No pertinent medical history and concurrent conditions were reported. In approximately 2014, reported as "a month ago or longer"  the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route of administration and lot # not reported). No concomitant medication was reported. On an unknown date in 2014, the patient experienced warm, raised rash around the injection site shortly after vaccination. On an unknown date in 2014, reported as "within a couple of days" the rash went away but the patient developed a shingle near the injection site. On an unknown date in 2014, reported as "within a couple of days", the shingle went away again and the patient developed another shingle (unspecified date in 2014). Within one week of the vaccination (unspecified date in 2014), the patient recovered from all symptoms including warm raised rash around the injection site and shingle near the injection site. No treatment was given to the patient. No lab diagnostics studies were performed. Relatedness between warm, raised rash around the injection site and shingle and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Client states that she initially had swelling, redness, and soreness at the site; swelling decreased after days or weeks- she is unsure; soreness continued; when client presses on "site", it hurts; does not hurt when client moves arm; client sleeps on her left side and states that her arm is sore while sleeping on it.
Pinpoint rash started on trunk (front and back) developed into full measles-type rash covering entire body. Also, pt had cold-like symptoms (congestion and coughing) with fever started on 2/10/15, and R ear infection dx'd 2/20/15, started on amoxicillin 2/20/15 x 10 days BID. Rash and cold-type symptoms almost resolved on this date (3/2/15).
Although this is not a significant adverse reaction, it seems important that state and CDC advise families that COVID-19 Pfizer vaccine in youth can cause abnormal blood sugars including lows. We did have two days of unusual lows which required we treat with standard 15-15 method.  Given that we utilize a CGM, we were able to constantly monitor but I would have been concerned for families that do not have this technology. After noting lows, I contacted multiple peers whom also have T1D children whom have had similar experiences. I clearly believe the benefit outweighs the risk and will have my son complete the series of vaccines but do believe it is important that families are notified to monitor blood glucose levels more frequently post vaccine.
Feels like the blood is rushing back into her arm when in a certain position and tingling sensation.
1st dose on 21Apr2021and 2nd dose on 28Apr2021; Rheumatoid arthritis flare up; Pain in arm; Foot pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4220480-00.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single and intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "Cold symptoms", start date: Mar2021 (not ongoing), notes: In Mar2021, the patient experienced COLD SYMPTOMS. On an unknown date, COLD SYMPTOMS resolved. The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "not recovered", described as "Rheumatoid arthritis flare up"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Apr2021, outcome "unknown", described as "1st dose on 21Apr2021and 2nd dose on 28Apr2021"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Pain in arm"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Foot pain". The action taken for adalimumab was dosage not changed. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter considered "rheumatoid arthritis flare up", "pain in arm" and "foot pain" not related to bnt162b2. The reporter's causality for the event(s) of Rheumatoid arthritis flare up with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of Left Foot pain was not provided. Causality as per reporter between bnt162b2 (Pfizer Biontech COVID-19 vaccine (TOZINAMERAN)) for event Inappropriate schedule of product administration was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events rheumatoid arthritis flare up, pain in arm, foot pain cannot be totally excluded. The case will be reassessed when additional information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sz on 12DEC87; 2nd sz on 25DEC; 3rd on 26DEC87. Episodes were similar - sudden onset characterized by limb & truncal stiffening with eyes directed upward lasting seconds. Afebrile. tx Phenobarital. sz free sinc DEC87. exam normal.
Patient developed extensive superficial thrombophlebitis of left leg  within 36 hours of receiving the vaccine with no other provocative factor
The patient has had no adverse side effects at this time.; Medical Assistant called stating that a dose of PEDVAX HIB was drawn out of the vial into a plastic syringe and accidentally reconstituted with ROTARIX instead of the recommended ROTARIX diluent.; Given to a 5 month old patient orally instead of intramuscularly today.; This spontaneous report was received from a medical assistant regarding a 5-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-AUG-2022, the patient was accidentally vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter x 1 dose, lot #U029145, expiration date: 30-MAR-2024, (strength was not provided) as prophylaxis, which was used as diluent of rotavirus vaccine live oral 1v (ROTARIX), 1 milliliter x dose, expiration date: 29-JUN-2023 (strength, formulation, lot #, and indication were not provided), instead of the recommended diluent (Product preparation error) and it was given to the patient orally instead of intramuscularly (Incorrect route of product administration). At the time of reporting, the patient had no adverse side effects. The reporter stated that they were able to get in touch with poison control who stated there should be no issues or adverse side effects with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) taken orally an they could vaccinate the patient via the appropriate route.
Red and swollen at injection site for 4 days. Injection site was itchy for 2 days.
Patient received 2 dose series of Pfizer Vaccine from Hospital previously. Patient came in and received Janssen Vaccine at Pharmacy.
SORE THROAT; COUGHING UP BROWN MUCUS INITIALLY WHICH IS NOW GREENISH WHITE; RIGHT SIDED EARACHE; FATIGUE; SICK TO STOMACH/NAUSEA; PAIN AT INJECTION SITE; EDEMA; CHILLS; TEMPERATURE ELEVATED; BAD HEADACHE; SWELLING UNDER THE ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 175 pounds, and height was 68 inches. The patient's past medical history included covid-19 infection, and concurrent conditions included high cholestrol, gerd, latex allergy, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient has no history of drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for gerd, and atorvastatin calcium for high cholestrol. On FEB-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On JUN-2021, the subject experienced swelling under the arm. On 04-JUN-2021, the subject experienced chills. On 04-JUN-2021, the subject experienced temperature elevated. On 04-JUN-2021, the subject experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 05-JUN-2021, the subject experienced edema. On 05-JUN-2021, the subject experienced fatigue. On 05-JUN-2021, the subject experienced sick to stomach/nausea. On 05-JUN-2021, the subject experienced pain at injection site. On 06-JUN-2021, the subject experienced coughing up brown mucus initially which is now greenish white. On 06-JUN-2021, the subject experienced right sided earache. On 06-JUN-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick to stomach/nausea on 07-JUN-2021, was recovering from bad headache, chills, edema, right sided earache, and pain at injection site, had not recovered from temperature elevated, fatigue, coughing up brown mucus initially which is now greenish white, and sore throat, and the outcome of swelling under the arm was not reported. This report was non-serious.
Shots given 03/31/2005. Pt came to office on 04/04/05 with fever, not eating, and coughing. Arrived again to office on 04/06/05 with swollen lymph node in the groin area.
6/20/21 Diarhea at 4 am.    6/11/21 Diarhea at 6 am.  6/12/21 Severe Diarhea, nausea, headache, extremely tired beginning  at 6am. This lasted till 6/13/21 .
MIGRAINE; This spontaneous report received from a patient concerned a 45 year old  female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker and drug allergy to hydrocodone/acetaminophen and metronidazole.  On 02-JAN-2022, the patient experienced symptoms like bad headache, cough, congestion, feeling cold and hot, pain, fatigue and loss of apatite which is a suspected clinical vaccine failure and suspected covid-19 infection (dose number in series was 1) when previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 1820095 and expiry: 02-OCT-2021) dose was not reported, (dose number in series was 1), administered 1 in total on 28-May-2021 to the right arm for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835 and expiry: UNKNOWN) dose was not reported, (dose number in series was 2) administered 1 in total on 21-DEC-2021 to the left arm  for prophylactic vaccination. No concomitant medications were reported.  On 02-JAN-2022, the patient experienced migraine (dose number in series was 2). Patient visited urgent care and took a rapid test. Patient was told to quarantine for 10 days. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine was not reported. This report was non-serious. This case, involving the same patient is linked to 20220107394 (booster series 1 case).
Information has been received from a company representative concerning an 18 month old female who was vaccinated with a dose of VARIVAX. The company representative reported she read in the newspaper that in July 2003, the patient developed an adverse reaction to the immunization (not further specified). As a result of the adverse reaction, the patient has had numerous surgeries. At the time of this report, the outcome was unknown. Upon internal review, adverse reaction requiring numerous surgeries was considered to be an other important medical event (OMIC). Follow up on 03/22/04 states: "Follow up information was received from a newspaper article and registered nurse. The RN reported that she spoke with the pt's grandmother who indicated that her granddaughter had been vaccinated with a dose of varicella virus vaccine live in July 2003.  One day after being vaccinated the pt became ill with temperature and vomiting. Subsequently, the pt underwent a bowel resection and temporary colostomy. It was noted in the newspaper article that the pt was recovering from several surgeries. It was also noted that the pt's physician related the pt's events to vaccination with varicella virus vaccine live. Upon internal review, bowel disorder requiring a bowel resection and temporary colostomy was considered to be an other important medical event. Additional information has been requested."
weakness; Cant sleep; Discomfort; aches every place [like he has been in a fight ]; Headache; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ARTHRALGIA (Joint pain), ASTHENIA (weakness), CHILLS (Chills) and INSOMNIA (Cant sleep) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills), INSOMNIA (Cant sleep), DISCOMFORT (Discomfort) and PAIN IN EXTREMITY (aches every place [like he has been in a fight]). On an unknown date, the patient experienced ASTHENIA (weakness). At the time of the report, HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills), INSOMNIA (Cant sleep), DISCOMFORT (Discomfort) and PAIN IN EXTREMITY (aches every place [like he has been in a fight]) outcome was unknown.            concomitant medications are not provided. No treatment information was provided.   Reporter did not allow further contact
H1N1 vaccination given 12/11/09. He had 20 minute seizure on 12/12/09, admitted to PICU. He has history of Cerebral Palsy but no known history of seizure disorder. No fever and extensive infectious workup including lumbar puncture negative.
COVID Vaccine Breakthrough CAse  Moderna Dose 1  11/15/21 (033F21A) COVID Positive 11/30/21  12/1/21: Patient has dementia.  He also has myasthenia gravis and hypothyroidism.Not a very reliable historian.   He reportedly tested positive for  SARS-CoV-2 10 days ago. Having cough with yellowish expectoration.  Family think that he may have aspirated in a.m.  Family noticed increased work of breathing in last 1 day.      He had temperature of 100.3° F in emergency department.  Was hypoxic and was requiring up to 5 L of oxygen in emergency department.   Had elevated lactic acid level.  CRP was 16.25.  His D-dimer was very very high at 35.2.  CT pulmonary angiogram showed bilateral pulmonary emboli.  12/10/21: 85-year-old male patient with a history of severe dementia, myasthenia gravis and hypothyroidism was admitted the hospital with complaints of cough.  The patient was diagnosed with COVID-19 infection obtained side to admission to the hospital on 12/2/2021.  Patient was noted to have some shortness of breath and elevated body temperature is 100.3° F. He was also hypoxic requiring 5 L of oxygen in the emergency room on admission.  CT of the chest showed evidence of bilateral PE E the patient was admitted for further care.  Acute hypoxic respiratory failure the the  -secondary due to COVID-19 and pneumonia  -patient maintained on oxygen  -patient completed treatment with steroids, remdesivir and antibiotics treating COVID-19 infection   Bilateral PE with right lower extremity superficial thrombus  -patient nt on ay medications as he is discharged home on no medication  -Pt under palliative care at home now and then hospice care eventually after d/c to home per the son   Dysphagia  -patient followed by dietitian, recommend puree diet with honey thickened fluids, continue   Severe dementia  -patient son is the power of attorney   Catheter associated trauma, off antibiotics at the time of discharge.   Discussed the patient's case with care coordination again this morning.  The son, power of attorney wishes for the patient to be transferred home.  Patient will have a 24 hour attendant/nurse at home.  Outpatient palliative care to follow the patient at home.  The son will consider hospice at a later point after the patient is discharged home. All questions answered.  12/13/21: Patient deceased
Pain at injection site, upper left arm Fever, chills, slight headache, and loss of taste and appetite Joint pain throughout body, exhaustion.
The evening of 04/09/2021, I was going to the  bathroom like every hour to hour 1/2. It got to the point were I was keeping track, because it was ridiculous how many times I was going to the bathroom. Normally, i get up like 2 times a night, but this was ridiculous.  On 04/10/2021- I went to the Urgent Care tested me for UTI- it was negative. I emailed my doctor that  I had gone to the bathroom like 14 times in 24 hours when I was tracking my bathroom visits from 04/15-04/16/2021. I was at a lost, when the UTI test was negative.  I went to a bladder doctor to see if there was some type of issue and they switched my medication to solifenacin succinate 10 mg, I was on that for 6 weeks, it did not help. On   09/18 I was put on myrbetriq 50 mg, for 6 weeks. After that they did bladder scan--nothing showed up. I stopped taking all meds. This went on from 04/2021 through the end of the year.  11/18/2021- Urology Center I had a  uro- dynamic  test- they really did not find anything significant. Since that time I had taken no meds and it pretty much went back to normal, not like it was before, but it's better and I'm just living with it.
9/22: 2 mm localized erythema (DTaP) site. 9/23/04: pt brought back in 11cm horizontal 10 cm vertical erythema to left deltoid DTaP injection site. (DTaP only)
hardness; Feeling of warmth; redness; chills; feverish; arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (hardness), FEELING HOT (Feeling of warmth), ERYTHEMA (redness), CHILLS (chills) and PYREXIA (feverish) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included ATORVASTATIN and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced INDURATION (hardness), FEELING HOT (Feeling of warmth), ERYTHEMA (redness), CHILLS (chills), PYREXIA (feverish) and MYALGIA (arm was very sore). At the time of the report, INDURATION (hardness), FEELING HOT (Feeling of warmth), ERYTHEMA (redness), CHILLS (chills), PYREXIA (feverish) and MYALGIA (arm was very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Redness on face. Redness at injection site spreading down arm. Patient was to call Dr back to be seen.
Patient is a teacher and age 44. Patient received vaccination and was recommended to wait 15 minutes after injection to ensure no reaction. After 10 minutes, patient began with urticaria on arms and back. Patient was given 25mg of liquid benedryl at 4:25pm. Symptoms subsided within 5-10 minutes of benedryl.
On 07/12/2021 I noticed I had joint pain in my right hip. It hurts to put pressure on my leg. On the same day I went to my doctor she gave me pain meds. I still have pain but its slowly getting better. I will be seeing an orthopedic next week.
7/21/21 PMHx of Afib (on Eliquis), dementia, HTN, Stroke, CKD, presented for planned access for dialysis future.
Headache, Myalgia, Angina, RUNNY NOSE, FATIGUE Narrative:  Other Relevant History:
Bleeding due to dialysis catheter placement. ED visit within 6 weeks of receiving the COVID vaccine.
no additional adverse events reported; dose of improperly stored GARDASIL 9 was administered to a patient; This spontaneous report has been received from a vaccine coordinator referring to a 12-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 09-AUG-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliters (ml) once (route of administration, vaccine scheme and anatomical site of vaccination were not reported; lot number T030749 has been verified to be valid, expiration date was reported as 09-AUG-2021 but upon internal verification was established as 16-MAR-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of 35.3 degrees Fahrenheit (F) during a time frame of 195 hours and 38 minutes (product storage error). There was no previous temperature excursion, and no additional adverse events were reported (no adverse event).
pt recv vax 21JUN95 & 7MAR97 pt devel chickenpox;it was also reported that another pt (WAES 97030702) devel chickenpox p/receiving varicella vax SC on 21JUN95;
Started having abdominal pains on the evening of April 30th. They progressively got worse and worsened when eating certain foods. Saw PCP on May 6th. Initial thoughts of IBS, Gastritis or Gallbladder.  Started Prilosec on 5/7/21. Abdominal pain has persisted, varying in intensity level, since April 30th.