chrisvoncsefalvay/vaers-outcomes huggingface dataset:
that one of the nurses went to give a patient the Pentacel vaccine and didn't realize she had to mix with ActHIB portion of it, no adverse event; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse. Follow-up was done on 27-Aug-2019.  This case involves a patient of unknown demography for whom it was reported that one of the nurses went to give a patient the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and did not realize she had to mix with acthib portion of it (lot number, exp date, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to product preparation issue.   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested  Documents held by sender: none.
Pt developed induration, tenderness and swelling on left deltoid region at site of injection.
VACCINE ADMINISTERED 11/10/2011.  WARM REDDENED TENDER AREA DEVELOPED AT INJECTION SITE THE EVENING OF 11/10/2011.  ABDOMINAL PAIN THE FOLLOWING DAY DESCRIBED BY PT AS A PINCHING, ACHING HURT IN HER STOMACH.  ITCHY RASH ON HER BACK DEVELOPED 11/13/2011.  PHYSICIAN VISIT 11/15/2011 - DX SHINGLES.  TREATED WITH ORAL ANTIVIRAL AND PAIN MEDICATION.  AS OF 12/01/2011 IT IS RESOLVING BUT SHE STILL HAS SOME LINGERING ABDOMINAL PAIN.  PHARMACY WAS INFORMED ON 11/30/2011 BY PT. I WAS NOT HERE BUT GAVE HER A CALL THE MORNING OF 12/01/2011 AND PROCEEDED TO GET THE INFORMATION ABOVE.  MERCK NOTIFIED ON 12/01/2011.
Information has been received from a physician concerning a female child with no pertinent medical history or allergies, who was vaccinated 3 times with RECOMBIVAX HB and did not seroconvert. Unspecified medical attention was sought. No product quality complaint was involved. This patient also had adverse experiences after therapy with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine (Wistar RA 27/3) (manufacturer unknown) (WAES # 0703USA00615). Additional information has been requested.
pt states had erythema, swelling @ site of inj devel fever 102 day of inj;slept soundly husband had to shake pt to wake pt up;arm locked up on the following inj;felt lethargic intermittently x2wk;did not report until 2nd inj;
Pain and swelling of the left knee, so much so that she could not bend the knee and it was painful to walk. She was seen by her orthopedic specialist on 11/04/2009. Lab work was done and wnl per patient.
pt recvd vax & exp extreme fussiness & was crying for 1 1/2 days; legs were swollen & blue;
Right arm, warm to hot at site of vaccine, red with splotchy welts (1/2 of upper arm) pt c/o pain at site.
1. Increased heart rate 2. Chest Pain 3. Headache  Onset 2.5 hours post vaccine administration
Pt preemie received SYNAGIS 12/16/11 in NICU. Pt developed RSV, was admitted to PICU, intubated for 14 days, and finally discharged after 18 days.
Menstrual periods following the vaccine have been more intense: higher volume of blood lost, more painful cramping, increased breast tenderness and swelling, increased duration of period by roughly 2 days.
Severe Diarrhea, vomiting, nausea, Severe weakness, Chills.  Put on Ondansetron, the BRAT diet, and Pedialyte.  Vomiting lasted 2 days, Nausea lasted 5 days, Diarrhea lasted off and on for 14 days, weakness lessened by lasted for 12 days, chills lasted for 14 days
Two days after visit presented with local swelling at site of vaccine. No loss of function. (L) deltoid.
Systemic: Vomiting-Mild, Additional Details: After telling the patient to take a seat in waiting area, patient vomited about 10 minutes later. Father claimed she had hot dogs earlier. It's hard to say if it's food-related or vaccine-related or a combination of both. She vomited a lot but she seemed recovered. She went home with her father. I counseled her father on fluid replenishment and seeking additional care for his daughter if necessary.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
No problems when vaccine was given, did say she didn't like looking at needles and closed her eyes.  After the injection, she left the consultation room to meet up with her mother.  Witnesses saw her losing her coordination/balance, bump into a display, fall onto her shoulder then bump her head.
Fever of 101+ degrees F, chills, aches, shaking, decreased range of motion of left arm; 6/20/10 left shoulder began to swell and is still swollen and sore to touch; fever broke 6/20/10.
Extreme stiffness of whole skeleton system. This would occur after I was at rest whether sitting, or laying for 15 minutes or more. the stiffness increased the longer I was still.
She got the vaccine, at first things were fine, she got it around noon.  She was there with her father who drove her back home.  She was on her phone on the internet, started to get agitated, had a low grade fever, started feeling itching in her eyes, her head, hair, legs and everywhere.  She has never experienced anything like that before.  She did have some type of allergic reaction to sugar.  The low grade fever was 36.7 c on Tuesday, 36.8 on Wednesday.  She does get chills when she gets a fever.  She started taking Benadryl which did help in the beginning, but then with continued use it stopped working.  The itching lasted for about a week and would get worse in the evenings.  On Thursday was the first day that she did not wake up itchy, but by 6-7 PM she felt very itchy.  She did not call her doctor for this reaction, just treated with Benadryl.   She feels that she has pretty much recovered from it.  She said it felts like bugs were crawling all over her body, but no rash.
A really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (A really bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (A really bad headache). At the time of the report, HEADACHE (A really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient took no treatment for events.
Pt recvd 2-1cc injections of Recombivax 12DEC90 & 14JAN91; 13JUN91 recvd Engerix-B; Pt "did not develop immunity";
Body ache; Feeling very disorented; Dizzyness; Cough; Diarrhea; Itching on face and neck; Feeling very sick to my stomach; Feeling nausuated; Low grade fever; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body ache), FEELING ABNORMAL (Feeling very disorented), DIZZINESS (Dizzyness), COUGH (Cough) and DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus, Sjogren's, Rheumatoid arthritis and Osteoporosis. Concomitant products included PREDNISONE, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and VITAMIN D3 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (Body ache), FEELING ABNORMAL (Feeling very disorented), DIZZINESS (Dizzyness), COUGH (Cough), DIARRHOEA (Diarrhea), PRURITUS (Itching on face and neck), MALAISE (Feeling very sick to my stomach), NAUSEA (Feeling nausuated) and PYREXIA (Low grade fever). 13-Mar-2021, the patient experienced HEADACHE (Headache). On 27-Mar-2021, PAIN (Body ache), FEELING ABNORMAL (Feeling very disorented), DIZZINESS (Dizzyness), COUGH (Cough), DIARRHOEA (Diarrhea), PRURITUS (Itching on face and neck), MALAISE (Feeling very sick to my stomach), NAUSEA (Feeling nausuated), PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.
Patient was taken to ER on stretcher several days following vaccine administration. Patient reported feeling "in her body" (conscious) but unable to move arms or legs. Patient's PCP believes event could have been related to flu shot administration.
Heaviness in chest; tight throat; numb and tingly lips; metallic taste. Metallic taste lasted thru next day.
2 patients received their dose of SHINGRIX from the same reconstituted vial Unsure if patients received partial doses; Wrong technique in drug usage process; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 5yr3p, expiry date 17th June 2024) for prophylaxis.   On 13th February 2023, the patient received the 1st dose of Shingrix. On 13th February 2023, unknown after receiving Shingrix, the patient experienced underdose and wrong technique in drug usage process. On an unknown date, the outcome of the underdose and wrong technique in drug usage process were unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter who stated that patient received their dose of Shingrix from the same reconstituted vial.  She stated that she was unsure if one patient got a full dose and the other received no dose or if both patient received partial doses. The reporter reported about a patient who potentially received Shingrix underdose. The reporter consented to follow up. Additional Supportive Information: The reporter reported about a patient who potentially received Shingrix underdose, which led to underdose and wrong technique in drug usage process. This was 2 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026659:Same reporter
Patient received Janssen Covid vaccine at Weis pharmacy on 5/7/21.  After receiving the vaccination, patient disclosed that she had previously received the first dose of the Pfizer vaccine through her employer on 1/21/21 and had an allergic reaction (hives) within the hour of taking it.  She was refused the second dose of Pfizer due to her allergic reaction that she experienced.  Since the information was not disclosed until after completion of administration of the Janssan vaccine, the patient has now received 2 different vaccines for Covid.
Woke up in the middle of the night with severe chills and 102 degree fever.  Muscle aches in legs started at about 8 a.m. on 9/12.  Fever ended at 5-6 pm on 9/12. Muscle aches lasted until mid day on 9/13.  All symptoms were gone by evening of 9/13. Took OTC Tylenol for the fever and muscle pain.
Pt started with redness and swelling in left arm around the site of injection, 24 hours, post vax. Seen in office at 48 hours, post vax, when mom came in and child had erythema, swelling, tenderness and warmth in all upper arm around shot site. Cellulitis evident and started on Augmentin 400mg bid X 10 days.
Information has been received from a licensed practical nurse concerning a 4 year old white female with an allergy to ciprofloxacin hydrochloride (Ciloxan) opthamologic drops who on 07Jun2000 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. The pt had a minor papular dermatitis diaper rash that was unresponsive at the time of vaccination. Neither the pt nor her brother had any adverse events following previous vaccinations. On 22Oct2003 the pt's mother brought the pt into the physician's office to have her right ear rechecked and stated that the pt had a rash on her arms and legs. The pt was taking amoxicillin (+) clavulanate potassium (Augmentin). It was reported that the pt was exposed to chickenpox (also reported as varicella) at preschool in the last month. The physician diagnosed the rash most likely appears to be some type of varicella variant with less than 20 lesions. It was also reported that the pt had developed breakthrough chickenpox rash with approximately 20 pox on her arms and legs. On 27Oct2003 the pt recovered. No product quality complaint was involved. No further information is expected.
2nd pfizer covid vaccine....Fever the morning after that lasted only about 8 hours (and came down w/ tylenol, but after 2 rounds of that, it never returned). Hives on the feet and ankles appeared the night after (about 36 hours after) and persist now that we are 48 hours out.  Raised skin, redness and slight yellowing of the skin w/ the hives.  Somewhat itchy hives.  Administered Benadryl orally every 4 hours and topical hydrocortisone cream.  It is still there, but not an emergency or causing problems.  We will monitor and call the Dr. in the morning if it persists.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L043704, expiration date 04-NOV-2017) (dose and route were not reported) for prophylaxis. Concomitant therapy included sterile diluent. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA005606: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009438: US-009507513-1709USA009435:
DIARRHOEA; FATIGUE; LEFT ARM PAIN; STOMACH ACHE; ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced diarrhoea. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021, the subject experienced left arm pain. On 12-MAR-2021, the subject experienced stomach ache. On 12-MAR-2021, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhoea, aches, fatigue, left arm pain, and stomach ache. This report was non-serious.
I received my vaccine at 10:39 a.m.  About 8:30 p.m. I started to feel arm soreness at the site of injection.  About an hour later (9:45 pm) I started to feel numbness around my mouth.  When I got up the next morning (today) within one hour the numbness returned all around my mouth and lips.
patient has blood clot while urinate, dripping urination, blood urine, pain while urine.   md gave cipro to treat,  urine clear a little, but still has blood, no clot, md will continue monitor
On approximately 12/11/19 patient developed "scratch marks" and bleeding, scab spots on one side of his face (cheek area) and the other side of face "cheek area" looked like finger scratches.  On 12/12/19 the patient's face looked swollen.  The left eye was swollen and inflammed, but not itchy or tearing and no discharge.  Patient said vision was not impaired.  Patient did not scratch his face.  Patient said face was not itchy. Patient at no time had a fever or shortness of breath.  No eye pain.  No other part of the patient's body was affected.   This description is per patient's wife after consulting with husband.  This was per a phone conversation.
Patient reports rash at site of injection which developed about 6-7 days following administration. No treatment sought by patient, merely monitoring per conversation on 12/18/18.
Pt recv vax on 10/9/98; on same day pt exp swelling, redness, soreness, heat of Rt arm; 10/13/98 pt imp
This spontaneous prospective pregnancy report was received from a registered nurse and refers to a 15 year old female patient with unspecified illness. There was no pertinent medical history and drug reaction/allergy. On 21-APR-2015, the patient was vaccinated with the second dose of GARDASIL (dose 0.5 ml, intramuscularly, lot # K007264, expiry date: 02-MAR-2017 while the patient was in the office for an "ill visit". Concomitant therapies included CLARITIN, trazodone hydrochloride (manufacturer unknown) and ZOLOFT. After receiving the GARDASIL on 21-APR-2015, a urine pregnancy test was performed twice and it was determined the patient was pregnant. Serum pregnancy test confirmed the pregnancy. Last menstrual period (LMP) was 24-MAR-2015, date of conception: 07-APR-2015 and estimated (EDD): 29-DEC-2015. It was reported that no treatment was given for adverse events. The patient's outcome was not reported. Additional information has been requested.
A report from a literature article concerns a 4 month old male infant. The author stated that the patient's mother received H1N1 vaccine at 37 weeks of pregnancy. At 4 months of age, the infant was hospitalized for 1 day with a diagnosis of respiratory syncytial virus bronchiolitis and acute otitis media. The outcome of the respiratory syncytial virus bronchiolitis and acute otitis media was unknown. Assessment of the serious criteria for the report was as follows: Hospitalised.
No adverse event; Patient received vaccine after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     It was unknown if the patient had allergies to medications, food and other products. It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if the patient had acute and chronic illnesses at the time of vaccination.     On 22-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions.  Treatment information was not provided by the reporter.
10 days after vaccine I had unexplained itchy rash over entire body. I still have this rash I have not changed any soaps shampoos laundry detergent ect I went to urgent care on 2/3/22 was given script for Triamcinolone cream  also taking daytime antihistamine and Benadryl at bedtime the night of 2/2/22 also experienced  right upper chest pain  with swallowing discomfort, which had now resolved.  Itchy rash continues
Received the Moderna Vaccine at the Clinic at 3:27 pm on 3/24/2021.  Client noticed an instant metallic taste in her mouth with tingling after injection but didn't really think to report it.  She was home at 4:10 and started to experience burning and swelling in her mouth and throat.  She took 25 mgs of Benadryl at home.  Symptoms did not improve and seemed to be getting worse so she called 911 and was transported to Medical Center for treatment.  Reproted getting more benadryl and epinephrine in her IV followed by a steroid.
Patient was administered the Pfizer Bivalent instead of the Pfizer Monovalent; patient was notified; patient was advised to contact PCP; facility Pharmacist made aware.
Mother stated today at 4 month well baby exam that 2 mos ago at the 2 month well baby exam after his shots she came out with hives.
patient developed hives, she started benadryl. Did not seek medical treatment until 12/16/09 at our office.