chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 year-old girl received ADACEL on 02-Aug-2021 and accidently received another dose on 02-Sep-2021/ no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (MI) (Reference number- 00850312) and transmitted to Sanofi on 09-Nov-2021.  This case involves a seven-year-old female patient who vaccinated with a 0.5 mL (once) dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6964AA) via intramuscular route in the left thigh on 02-Aug-2021 and accidentally received another 0.5 mL (once) dose of the same vaccine (lot U6900AA) via intramuscular route in the left thigh on 02-Sep-2021 (expiry date not reported for both doses) for prophylactic vaccination (extra dose administered).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to extra dose administered (latency was on same day as per second dose).  It was reported "Nurse states they had an error with administration of ADACEL to a patient. They administered a dose on 02Aug2021, and then accidentally gave the same patient another dose on 02Sep2021. Nurse is looking for information on possible adverse effects and what to inform the patient."  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
I had slight soreness at the injection site for several days after the injection, and the soreness went away. Almost two months later, the injection site has become sore and sensitive again with no other known reason for this particular spot in my arm to have pain.
Chills; Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headaches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headaches). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown.            No relevant concomitant medications reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
c/o tingling starting 1 hour ago on left side of her face. She received a Pfizer COVID 19 vaccine, was watched for 15 minutes, went home in stable condition. Later noted a tingling sensation in her left side of the face and throat, she denies any other weakness, no difficulty speaking or walking.
This spontaneous report was received from a nurse refers to 3 unspecified patients of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On unspecified dates, these patient were vaccinated with an improperly stored dose (Oka/Merck) VARIVAX (from either lot # K008819, expiry date: 19-JUN-2016 or lot # L011085, expiry date: 01-APR-2017). Reporting nurse stated that the mentioned vaccine was out of range for a total time frame of 198 hours and maximum temperature reached was 0 degree Celsius. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Had an MMR and flu vaccinations on 3-15-17, developed oral herpes sore on lip.  Had rubeola titer 4-24-17 and still did not show immunity so received second MMR on 4-28-17.  5 days after vaccination developed a mealy, angry raised red rash that burns to upper chest and neck area.
The day after my second shot I got a fever and felt run down through that day, that evening I developed diarrhea which lasted until the following day. All of this I expected from what I had heard that some people have after the second shot. But what I didn't expect was from then until now which has been approximately 6 weeks I am cramped and my lower abdomen everyday and I'm also experiencing atrial fibrillation almost constantly which I've never done before. All my episodes with a fib in the past were due to times when I had been very nauseous or very cramped and would go into a fib which lasted 10 12 hours but for the last 12 years I've been on atenolol for that and it has kept me from experiencing those problems. But since the second shot I'm experiencing atrial fibrillation like I said every day with the cramping which I've never had before to that extent. I'm reporting this because something isn't quite right and if this is a coincidence it's a pretty good one. Thank you for reading this and if I can be of any further help please feel free to contact me through my email.
I had pain in the joints of my hands. My fingers started to bend. It felt like arthritis. The main ones that have become crooked thumb, index, middle. I had no arthritis in my hands before vaccination. I was also very ill after it.
Patient was given a pneumovax vaccine today at her visit. She noticed slight irritation this morning, and it has progressed. Now she has a round swollen area about the size of a tennis ball, redness/warmth and 2 hives have appeared on the red area. Patient states she did take 2 tylenol 500mg to see if that would help and has been icing it off and on. Patient is wondering what to do. She has never had a reaction like this previously with any vaccination.
Headache Chills, Fatigue, Injection site pain Narrative:  Other Relevant History:
06/25/2022 I had a runny nose, coughing and a fever of 101. The symptoms only lasted for one to two days.  I tested with a home COVID test on 6/26/2022 which was positive.  I tested again with a different brand, and it was also positive. I went to the doctor on 6/28/2022 and had a COVID PCR test and it was positive. I was prescribed Paxlovid for 5 days.   The Paxlovid is very bitter and lasted throughout the course of the medication. After the last dose, the taste had gone away. I tested again on 7/3/2022 and it was negative.  I tested again yesterday, and it was also negative.  I have recovered.
Fever 101; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101) 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 COVID-19.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (Fever 101). At the time of the report, PYREXIA (Fever 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Pyrexia: 101 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 044B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2022 at 10:48 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 01-Mar-2022 at 10:48 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  They want to know whether they need to revaccinate these patients. The vaccines were initially placed in the refrigerator on 19Jan2022. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Live follow-up received includes reporter and suspect start date updated.
Multiple myeloma; The patient was administered an additional dose of PEDVAX HlB; The patient was administered an additional dose of PEDVAX HlB; The patient was administered another dose of PEDVAX HlB; This spontaneous report was received from a nurse concerning a 52 year old female patient. The patient's concurrent conditions included family history neoplasm of the gastrointestinal tract, mood disorder, high cholesterol, gastrooesophageal reflux disease (GERD), sleep apnea and hypothyroidism. The patient's drug reactions/allergies included morphine. The patient's concomitant medications included multiple unspecified medications. On unknown dates (many years ago), the patient "may" have been administered doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) as prophylaxis (formulations, strength, dose, routes of administration, lot numbers and expiration dates were not reported).    On an unspecified date (also reported as 15-JUL-2019, conflicting information), she developed multiple myeloma (plasma cell myeloma). The reporter could not confirm if the multiple myeloma occurred prior to of after receiving the first doses of the suspect vaccine (number of doses unspecified).   On 09-MAY-2018, the patient had a stem cell transplant as treatment for multiple myeloma also reported as no treatment was given for the event, conflicting information.  On 17-APR-2019, another dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was administered, intramuscular, lot # R021083, expiration date 13-JUN-2021 as update vaccinations post stem cell transplant (extra dose administered, product administered to patient of inappropriate age) (dose and strength were not reported). On 17-JUN-2019, the patient had the following test performed: complete blood count (CBC), comprehensive Metabolic Panel (CMP) and immunoglobulin, and the results showed potassium, albumin, red blood cells, hemoglobin and hematocrit (HNH) and  immunoglobulin M (IGM) were low. On 11-JUL-2019 , she received an additional dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) intramuscular, lot # R027329, expiration date 12-JUL-2021 as update vaccinations post stem cell transplant (extra dose administered, product administered to patient of inappropriate age) (dose and strength were not reported). The patient sought for medical attention and followed closely with the surgeon.  At the time of the report, the patient had not recovered from plasma cell myeloma. The causal relationship between the event and therapy with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was not reported. Upon internal review the event plasma cell myeloma was determined to be medically significant.
Information has been received from a physician via a company representative referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 28-MAY-2015 the patient was vaccinated with the first dose of ZOSTAVAX (dose, lot #, route and application site were not reported). On 28-MAY-2015 the patient was inadvertently administered a second dose of ZOSTAVAX (dose, lot #, route and application site were not reported). No adverse effects reported. Additional information is not expected because the physician did not wish to be contacted.
Patient received ADACEL vaccine on 12/19/2022; she said the next day she started getting redness, swelling, and itchiness at the injected site. She started applying Neosporin and it seems to help; today 12/26/2022 she said the swelling is going down  but there is still some  itchiness; recommended benadryl pill but she said she does not want to get sleepy, so I recommended second option  as  claritin tablets
made her arm sore; symptoms of covid -19/tested positive for covid-19; I believe the Pfizer vaccine got me and my 12 year old daughter sick.; This is a spontaneous report from a contactable consumer reported for herself and her daughter, this case is for herself. A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Aug2021 14:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at age of 41 years old. Medical history was none. Concomitant medication included semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported. The patient reported that that prior to her first covid Pfizer shot on 26Aug2021, she had a negative covid test. Prior to vaccination, the patient was not diagnosed with COVID-19. The shot made her arm sore on 06Sep2021 at 12: 00, and on 06Sep2021 she started to get symptoms of covid -19. She tested positive for covid-19 on 09Sep2021. She believed the Pfizer vaccine got her and her 12 years old daughter sick. The events were serious per life threatening and required physician office visit. No treatment received for the events. The patient underwent lab tests and procedures which included Covid 19 test (Nasal Swab): negative on 17Sep2021. The outcome of the events was resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
two of her patients are breakthrough cases; two of her patients are breakthrough cases; these two are in critical conditions and they had to be put on ventilator.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for an unknown patient (one of 2 patients). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history included Blood pressure and diabetes mellitus. The concomitant medications for patient were not reported. It was reported that the caller mentioned his daughter (Physician) working in ICU and she told the caller that "two of her patients are breakthrough cases" where they had conditions such as blood pressure and diabetes, and "these two are in critical conditions and they had to be put on ventilator". The caller declined to complete a report on these 2 patients and stated he did not know any information. His daughter told him as she was working in the ICU unit. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Moderna shot 1  3/12/2021. Moderna shot 2 4/9/21.   Patient started on 5/10/2021 with hematuria.  CT scan abdomen 5/18/2021   Showing hyper attenuating mass within urinary bladder, suspicious for neoplasm; new mildly enlarged right pelvic sidewall lymph node (these findings were not present on CT in 2019).  cystoscopy 6/16/2021: Muscle invasive high-grade urothelial carcinoma. Referred to Urology at Medical Center.   Subsequently required bilateral nephrostomy tubes.  Radical cystectomy, pelvic lymph node dissection, ileal conduit on 11/5/2021.  Concern for disease progression on CT urogram 12/15/2021.
Contracted Covid again after being vaccinated. I had a sore throat, hoarse voice, chest cough, bad fatigue and a strong headache. I then was taking PAXLOVID and it cleared for 5 days then rebounded. Everything came back, a bit milder but I was tested again and came back positive for Covid. So I was prescribed another round of PAXLOVID.
Vaccine given on 4/1/2021 two days before patient turning 18 years old. Moderna representative stated would be considered off label use for anyone 16-17 years and okay to administer second dose after 28 days from first dose since patient is now 18 years for this case.
Pt received vaccine on 12/11/15. 12/12/15 mom reported swelling of (L) thigh and (L) upper eyelid w/temp of 101 degrees F. 12/13/15 decrease PO intake, fussy, temp on/off. 12/14/15 diarrhea, runny nose, cough.
Running nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running nose) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced RHINORRHOEA (Running nose). At the time of the report, RHINORRHOEA (Running nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
This spontaneous report as received from a 61 years old female consumer with rheumatoid illness and no drug reactions/allergies refers to herself. On 02-OCT-2013 (3 weeks ago) the patient was vaccinated with a "standard" dose of ZOSTAVAX (lot #, expiration date unspecified), subcutaneously. No Concomitant Medication was reported. She stated during the first week after vaccination she developed an injection site reaction where she had swelling in her arm and around the injection site was red and itchy. She stated that the injection site reaction lasted for 1 full week. She then stated that 3 days after her injection site reaction had ceased she developed intense warming and flushing in her face that then spread to her arms and upper chest. She then stated that she began experiencing discomfort from her right earlobe to her jawbone. She had been to an oral surgeon to assess the discomfort in her jaw area and an (ear, nose, and throat) ENT as well, both providers had ruled out the discomfort due to some type of infection. She would continue to seek medical attention for these events. She also explained that she was seen at her local emergency room (ER) facility who prescribed a 4mg daily of MEDROL which she had taken for 3 days at this time and, she explained, had helped to treat the flushing and warmth symptoms. No Lab Diagnostics Studies Performed. The events outcome except for injection site reaction was reported as not recovered. Additional information has been requested.
Pt with sig pain to her left upper arm at the site of injection of Tdap 20-25cm in length pain, erythema, warmth. No systemic sx. Rx-BACTRIM.
PENTACEL and PEDVAXHIB given on same visit, no s/s of adverse reaction after given injections, pt monitored after injections given.
lt leg turned red from approx 1" above knee to & including lt foot; onset sudden 30 mins p/redness appeared, blue streaks appeared anterior & lateral lt leg; mild swelling lt foot; to ER 4PM 30JUL94; small amt redness lt foot 1AUG;
Severe nausea, chills, vomiting, diarrhea, low grade fever, severe lower backache, headache.
Involuntary full body tremor that lasted until 03/25/2022. Tremor was spontaneous and was not correlated to any specific stimuli; occurred multiple times per day.
On 2/18/09 at about 9:30PM, his eyes rolled back and jerked some, call squad and taken to Hosp and then to Children's, temo 102.9. Questioned seizures,but never diagnosied  3/4/09 MR received for DOS 2/19-20/2009 with D/C DX:  Shuddering movements recurrently with fever. Pt presented to local hospital after episode of staring with shaking/shivering type movements. Some L arm tremors and shaking while in EMS and ER. W/U (-), pt transferred to higher level of care for eval.  PE WNL except for erythematous lesion on L leg. Neuro consult ? Complex febrile seizures. No further w/u at this time.
This spontaneous report as received from a registered nurse refers to a female patient of approximately 46 years old at the time of reporting. On an unknown date the patient was vaccinated with M-M-R II. On an unknown date the patient experienced IgM drawn for Rubeola was higher than normal, at 1.29. The patient showed no signs of infection. The IgG for Rubeola was equivocal at 0.98. One month later the Rubeola IgG titer was negative while the mumps and rubella remained within normal limits. No treatment was provided. The outcome of IgM drawn for Rubeola was higher than normal, at 1.29 was reported as not recovered/not resolved. Additional information has been requested.
Swelling, redness, sore arm (unable to raise above shoulder), headaches, shivering, fatigue.
R arm increased swelling/tender touch & itching after received MCV4 & varicella.