chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US026589, is a spontaneous report initially received from health care professional (medical assistant) on 16 Dec 2015. This report refers to a 66 year old male patient. Past vaccination history included FLUVIRIN was tolerated in the past. Concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515301) at a dose of 0.5 ml intramuscularly on 14 Dec 2015 at 13:30 hours. It was reported that given FLUVIRIN was stored above temperature range. No adverse event reported following this administration error. Follow up information received from health care professional (medical assistant) on 23 Feb 2016: Updated patient's date of birth and batch number, added vaccination history, time and site of vaccination and seriousness.
I had a sore arm after the vaccine. I tested positive for COVID-19 08/01/2022. I had low grade fever, productive cough, body aches, lower back pain, throat was very sore and very tired. I got in touch with a clinic and they prescribed PAXLOVID. I felt much better. I also took MUCINEX, TYLENOL and ADVIL to help with my symptoms.
Her arm was swollen all the way down to elbow.  It is really sore and she had very back headache and joint pain
7/29/2021: presented to HCF via EMS for Fever. Per patients' son she has been febrile over the last 24 hours as high as 102.5. She did receive the Johnson & Johnson Vaccine about 1 month ago. On arrival to ED pt's temperature is 103.4, blood pressure 219/88. Chest x ray showed cardiomegaly with CHF.  Pt tests positive for COVID 7/29/21. Transferred to another HCF for care same day.  7/31/2021: Pt dc to home, then 8/11/2021: Per patient, since getting home from her recent discharge on 07/31/21 pt has been having persistent cough and congestion. Pt was treated for COVID-19. Her PCP has prescribed her medication to avoid visiting the ED, however pt has had worsening fatigue as she reportedly sleeps all day and has been nonproductive. 8/16/2021: Patient still hospitalized at the time of this report submission.
PHARMACIST DID NOT DILUTE WITH THE DILUENT BEFORE WITH DRAWING THE 0.2ML DOSE FOR INJECTION. ON 8/1/22, PATIENT'S AUNT WAS CONTACTED AND PER AUNT, PATIENT HAD CONGESTION ONLY DURING THE NIGHT WHICH WAS CLEARED UP THE NEXT DAY.  AUNT WAS ADVISED TO MONITOR PATIENT AND IF ANY CHANGE TO LET THE PHARMACY KNOW.
Soreness at the injection site which worsened between day 1 and 2; Headache; Exhausted/ some tiredness; Nauseated for 3 days; Diarrhea for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea for 3 days), VACCINATION SITE PAIN (Soreness at the injection site which worsened between day 1 and 2), NAUSEA (Nauseated for 3 days), HEADACHE (Headache) and FATIGUE (Exhausted/ some tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN for Arthritis.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHEA (Diarrhea for 3 days), VACCINATION SITE PAIN (Soreness at the injection site which worsened between day 1 and 2), NAUSEA (Nauseated for 3 days), HEADACHE (Headache) and FATIGUE (Exhausted/ some tiredness). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. At the time of the report, DIARRHEA (Diarrhea for 3 days) and NAUSEA (Nauseated for 3 days) had resolved and VACCINATION SITE PAIN (Soreness at the injection site which worsened between day 1 and 2), HEADACHE (Headache) and FATIGUE (Exhausted/ some tiredness) outcome was unknown.            The events occurred after the first dose of the vaccination. Treatment included ibuprofen for the soreness arm.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-056391 (Patient Link).
Immun adm @ 10AM on 22MAY91; Seen in ER; Developed generalized redness & facial edema; Also dyspnea when seen in ER; Mom states ER MD said pt allergic to HIB should not receive it again;
Presented from SNF w/ hypotension,weakness, fatigue, difficulty ambulating, n/v X 1. Covid +, Tx for dehydration
My child had to get a booster because we did not get the H1N1 shot last year.  He received one shot on 9/7 and the second on 10/12.  After each time he has had excessive amt of unusual blinking with his eyes. It started to taper off until I got his booster and I noticed it again.  Child is still having the issue.
Pt informed pharmacy via email to provider on 08/4/2021 of the following: Wed 8/4/2021 9:24 AM I recently got my moderna vaccine at from you and had a really bad allergic reaction to it after leaving the hospital. My throat got swollen and itchy and it became really hard to breathe. After I took a Benadryl at home the symptoms subsided slightly. For this reason I am not comfortable getting the second dose of moderna. I am wondering what type of  you can put on my vaccination card to wave the second dose? Please let me know what you think.  Thank you, The provider called the patient on 08/04/2021 at 1:05 pm. Patient stated that after the dose was administered in her left arm, confirmed she waited 30 minutes with her friend Redcap record ID: 556); pt was indicated for 30 min wait period due to hx penicillin allergy (anaphylaxis). Today, patient confirms that PCN is her only known allergy.  Per pt, no ADR experienced during 30 min wait period. Pt reports that she first felt sxs of allergic reaction on her car ride home (lives 15 mins away from pharmacy). Reports left arm and hand became "hot and itchy", followed by throat feeling swollen and tight. States she was "wheezing" but denies loss of consciousness. Arrived home after her 15 min drive, and took 2 tablets of "regular dose" Benadryl (patient unable to confirm dose via phone today. Per pt, symptoms began resolving, with full resolution by 2 hrs. Patient did NOT report symptoms to any healthcare provider until today. She has not experienced any further ADR after initial resolution at 2 hrs.   Patient was informed that she experienced an immediate type severe allergic reaction and that further immunization with Moderna or any other COVID-19 vaccine is contraindicated at this time. Patient understands she should not be receiving her second dose. Patient school requires completion of immunization, and patient will be submitting a medical waiver signed.  Discussed and emphasized with the patient that the symptoms she was experiencing are considered urgent, and must be assessed by a provider immediately. Patient understands that any future incidence of allergic type reactions resembling this one are extremely urgent. She confirms understanding and agrees to call providers/go to urgent care or ER ASAP if ever experiencing severe allergic reactions again.
My arm starting itching right afterwards. It swelled up with a small bump to start out with and was hot. Within an hour or so the redness was about 3 inches in diameter. By the next morning (10/25/13) the swelling had spread, the bump had spread and the heat was severe. My arm was hard to move, it still itched and hurt. I took 600 mg Ibuprofen and Benadryl and put ice on it. When I woke up this morning (10/26/13) the swelling has spread to about 6 inches in diameter, the redness is about the same, and the heat coming from it feels like a bad fever. It hurts to move my arm or carry anything with my right arm. I took pictures, and continued to take Ibuprofen and Benadryl and ice it. Considering going to doctor if it is not better or if it gets worse by tomorrow.
18-year-old female with history of frequent strep throat, ear infections presents to the emergency Department with complaints of one day of generalized body aches, sore throat, cough, mild shortness of breath. Patient states symptoms started yesterday and gradually worsened today. Patient vital signs showed tachycardia on initial presentation.  Patient was monitored on pulse oximetry during emergency department stay with no desaturations. Recommend patient use ibuprofen for body aches and possible fevers. Patient provided pulse oximeter for home and instructions on how to use. Recommendation quarantine.  Discharged to home.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-OCT-2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a health care provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
There is nonocclusive thrombus in the proximal left femoral vein. There is occlusive thrombus from the mid femur vein to the popliteal and calf veins; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 26Mar2021 at 12:00 PM (at age of 58 years old, Lot Number: ER8733) as a single dose for covid-19 immunization. Medical history included hypertension from an unknown date. Concomitant medications included amlodipine, zolpidem, lisinopril. The patient previous took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 05Mar2021 at 01:00 PM (at age of 58 years old, Lot Number: EN6206) as a single dose for covid-19 immunization. It was reported the patient the left common femoral and great saphenous veins are patent. There was nonocclusive thrombus in the proximal left femoral vein. There was occlusive thrombus from the mid femur vein to the popliteal and calf veins on 22Apr2021 12:00. The patient was hospitalized for 3 days, it was life threatening illness. Treatment received IV heparin. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on 29Apr2021. The outcome of event was not recovered.
This case was reported by a nurse via out of hour services and described the occurrence of chickenpox in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (in past). On an unknown date, the patient received SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced chickenpox, malaise, chills, erythromacular rash, fever and vesicular rash. On an unknown date, the outcome of the chickenpox, malaise, chills, erythromacular rash, fever and vesicular rash were unknown. It was unknown if the reporter considered the chickenpox, malaise, chills, erythromacular rash, fever and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. According to the message left in after hours voice mail, the nurse who was the reporter stated that 1 day post vaccination with SHINGRIX, the patient experienced malaise, fever and chills. On 2 day post vaccination with SHINGRIX, the patient experienced vesicular erythematosus macular rash potentially similar to chicken pox. No further details were left in the after hours voice mail.
Routine immunizations given at 3:42 PM on 11/18/04. Child went home and within 2 hours began to get fussy and did not take his bottle well. Mother put him to bed and around 8:00 PM the apnea alarm went off. CPR was unsuccessful and he was pronounced dead in the ER at 9:57 PM.  Autopsy report received and complete.
Patient claimed she experience rash and itching after be immunized.  Patient reported the adverse event on 11/11/2015.
I noted that I felt bad physically and took a nap. That same day January 04, 2022, I could not breathe out of my nose. Felt extremely unfocused and very tired. Rough feeling in my throat, hurt to cough, dry. Nausea. Day after January 5, 2022, felt very poor, itchy, went to bed early. January 7- having poor bowel movements (diarrhea). January 8- very phlegmy, low appetite but I was hungrier, and took a nap. Over the course of the days, about the same symptoms.
C/O of L arm and shoulder pain, radiating to chest approximately 5 hrs s/p receiving a Pneumovax in left deltoid. Pt treated in ER with analgesics.
In September of 2022, no changes in my medications have been done. I was given an EKG and the doctors did not give me any definite diagnosis. I had some shortness of breath, I had some problems with my knees, and I also had received a different vaccination as well nothing to do with COVID-19.  My symptoms have not really improved and unfortunately it is very sudden when it comes on and then it will go away.
i TOOK A QUADRIVALENT FLU SHOT ON 10/14/19. TWO WEEKS LATER i NOTICED AWORM LIKE THING ON MY UPPER LEFT ARM. AFTER A MONTH AND A HALF THIS ORGANISM WENT INSIDE MY BODY AND CAUSED MY LEUKOCYTE TO MASS PROLIFERATION. THIS LED TO A DIAGNOSIS OF LYMPHOCYTE DISORDER AND CLL.
This spontaneous report as received from a registered nurse refers to 14 patients of unknown age and gender. On an unknown date, 14 patients were vaccinated with VARIVAX (Merck) (Lot number, expiry date, route and dose were not reported) that was exposed to unknown temperatures greater than 8 Fahrenheit (F) for an unknown period of time. Nurse was unable to provide any specific temperature excursion details, administration dates and lot number and expiration dates for the VARIVAX (Merck) in question. No adverse symptoms reported. Additional information has been requested.
Resident Provider pended Bexsero vaccine for this patient, although it is not recommended for his age group. LVN prepared and gave the medication. Another LVN recognized the error and informed Nurse Manager and the Attending Provider. Nurse Manager contacted the CDC for guidance and was told that "the dose can be ignored unless contraindicated for this patient - Bexsero is approved for individuals 10 to 25 years old, however the recommended age for receipt is 16-18 years as adolescents need protection during those ages of increased risk. The dose should be repeated at 16 and the series completed using recommended timing intervals." The Nurse Manger notified the Resident Physician and the Attending Provider. The Attending Provider contacted the patient/family to notify them about the vaccine error.
Fatigue-within 30 minutes after shots Loss of Appetite- 1 hr after shots and lasted thru next day Sore Legs- about an hour after shots Unusually fussy- about 90 minutes after shots Fever of 102F- began at 10AM next day
I started to have a heavy feeling in my right arm. On the fourth day it became worse, and my arm was really stiff and heavy. I was taking Advil and it didn?t help much. I went to the doctor on the sixth day. The NP thought it was a pinched nerve because it was my whole arm from the neck down. On the tenth day it started to affect my other arm which was the side that I got the shot in. I had no strength in my arms and my husband had to help me dress. It was almost two weeks after the shot I went back to the doctor. I was prescribed Meloxicam and an Arthritis cream and it did not help. Blood work did not show any definitive problem. Gabapentin and Advil did help a little. Three weeks after the shot the pain started to move to my legs as well. for one week. The pain is not as bad but now it is in my arms all the way into my neck and shoulders. It has been seven weeks since the shot and now the pain is still in my right arm and into my neck and shoulder blade. I still have good range of motion right now.
Pt stated she felt lightheaded after 3rd immunization "GARDASIL". Then she fainted for approx 4-6 seconds. Treatment included cool washcloth to forehead, crackers, water. Pt. stated no food since breakfast. Accompanied by mom. Waited 20 min. Advised ER if further complication.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she the physician tried last 2 Shingles shot serious years back to see if it would minimize how often the breakout. Unfortunately, it was just fed the virus. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
I brought my son to a psychiatrist doctor for medication for his: repetive movements, loss of memory/can't remember, hyperactivity, loss of concentration, social withdrawal, bed wetting, compulsive disorder, ODD, ADHD that only started 5 years ago. He was fine before vaccinations.
Soreness at the shot site; nauseated; Tired; Knot in her chest; Trigerred her migraine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST WALL MASS (Knot in her chest), MIGRAINE (Trigerred her migraine), VACCINATION SITE PAIN (Soreness at the shot site), NAUSEA (nauseated) and FATIGUE (Tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MIGRAINE (Trigerred her migraine). On 19-Mar-2021, the patient experienced CHEST WALL MASS (Knot in her chest). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the shot site), NAUSEA (nauseated) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, MIGRAINE (Trigerred her migraine) had resolved. At the time of the report, CHEST WALL MASS (Knot in her chest), VACCINATION SITE PAIN (Soreness at the shot site), NAUSEA (nauseated) and FATIGUE (Tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-Jun-2021, patient reported feeling better, events outcome updated from unknown to recovering.
Information has been received from a nurse for the Merck pregnancy registry for GARDASIL concerning a 16 year old female smoker with attention deficit/hyperactivity disorder and a history of a functional murmur and febrile seizure as a child who on 25-APR-2007 was vaccinated intramuscularly with the first dose of GARDASIL (655205/1426F). On 28-JUN-2007, the patient received the second dose intramuscularly of GARDASIL (657868/0523U). Following the second dose, the patient was confirmed to be pregnant by ultrasound with a conception date of 12-JUL-2007. Concomitant therapy included prenatal vitamins. The patient had been taking SEROQUEL, METADATE, and TOPAMAX for ADHD but had stopped medications prior to conception. Gestation on 28-SEP-2007 was 11 weeks and 1 day. The patient sought unspecified medical attention. Additional information received from telephone call (09-JUN-2008): The physician reported that the patient delivered a healthy, normal male baby on 21-APR-2008 at 40 weeks gestation. Apgar scores were 8 at 1 minutes and 9 at 5 minutes. Birthweight was 8 pounds, 5 ounces, length 20 3/4 inches, head circumference was 14 1/4 inches and he was blood type O positive. On 29-APR-2008 the baby was seen for a one week well child visit. The baby is a healthy appearing infant, well nourished, bottle feeding and alert. Weight is within normal range for stated age. No known drug allergies. On 02-JUN-2008 the baby was seen for congestion, crying for no reason, vomiting yellow x 2, coughing and fever for a few days. Acute otitis media was suspected and the parents were instructed to take the baby to the emergency room for a septic work up and he was admitted to the hospital. On 24-JUN-2008 the baby was seen for a 2 month well child visit. The parents had no concerns. The baby's ear, nose and throat exam was normal. Additional information is not expected. All medical records are available upon request.
soreness in the arm; headache just for a little while; little unsettling in the stomach; tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 25Feb2021 at 14:30 (at the age of 63-years) as dose 1, single for covid-19 immunization at other facility. The patient medical history was not reported. The patient had known allergies to antibiotics. The patient's concomitant medications received in two weeks included amlodipine besilate (NORVASC) for unknown indication, start and stop date was not reported. The patient had not received any other vaccine within 4 weeks prior to vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 25Feb2021 at 21:00, the patient experienced soreness in the arm, headache just for a little while, little unsettling in the stomach and tiredness. The patient reported that, soreness in the arm, after I got home had a headache just for a little while, little unsettling in the stomach and tiredness. The patient had not received any treatment for the events. The outcome of all the events were unknown.   Follow-up attempts completed. No further information expected.