chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old female patient who in the spring of 2009 was vaccinated with a second 0.5 ml IM dose of GARDASIL (Lot No. not reported). Subsequently the patient started to develop migraines every three weeks. The physician stated that the patient's migraines "go away but then they recur every 3 weeks". The patient sought medical attention by an office visit. No laboratory or diagnostic studies were performed. Additional information has been requested.
Awoke with an itchy, raised, little red dots rash all over his body. Pain upper right leg where vaccine was administered. Mother reports she administered Tylenol and Benadryl, and child has been sleeping ever since. States he acts normal otherwise, but plans to take him to Dr if she can get him an appointment.
Rec'd 6mo vaccinations 10/17/17 at 6mo WCE in office. Mom reports 10/18/17, S/S noticed this AM= 100 degree temp and Lt. thigh swollen and tender. Seen 10/18/17 mid-AM for eval. Dx as vaccine reaction. Tx with ice packs, TYLENOL and monitoring.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 17-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 1032 hours, the highest recorded temperature was 59.9 F (15.5 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effect were reported. This is one of several cases received from the same reporter. Additional information has been requested.
4 days after I was administered the H1N1 flu shot (I can't say the actual date and time of the shot - I know it was October 2009), I started having muscle spasms in my left shoulder where I had the shot. Then a few days later I started having muscle spasms in other parts of my body. Those eventually went away, but then I started having pain in my left shoulder. I have a hard time raising my arm and I was finally sent to a orthopedist last week and then on to have physical therapy. The doctor says it sounds like tendinitis. But, the therapist says it doesn't appear to be that and that my neck muscles are also involved.
First dose admistered after vial has been stored for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose admistered after vial has been stored for more than 12 hours) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose admistered after vial has been stored for more than 12 hours). On 21-May-2021, EXPIRED PRODUCT ADMINISTERED (First dose admistered after vial has been stored for more than 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
ERYTHEMA, LOSS OF LIMB USE, RED LINE FROM INJECTION SITE TOWARDS ELBOW
Menstrual cycle has been very abnormal. First spotting, then intense cramps, bloating fatigue, second shot very heavy bleeding that has been ongoing for 3 weeks
sore throat, mild cramps & diarrhea;progressed to head cold & rattling chest, stopped up nose, production cough-yellow sputum;didn't take temp;states that upper resp sx are inc in severity to date 19NOV97;
Red circle, a little larger than a quarter at the injection site.  Hard to the touch, compared to surrounding tissue. Itchy.  No treatment.
Black spot on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Black spot on the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE DISCOLOURATION (Black spot on the injection site). At the time of the report, INJECTION SITE DISCOLOURATION (Black spot on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported. No treatment drug was reported.
Pt received the Moderna series, after having had the J&J 3/9/2021.  Pt received her 1st dose 8/6/21, 2nd dose 9/7/21.  Both given.
1x7cm L induration with min erythema,1x9 cm W and some central bruising (bluish coloration). Tender to palpation, full range of motion of arm.
Developed pallor/lethargy/hives/"stomach ache"  Given Benadryl and epinephrine, transported by ambulance to ER.  watched for 4 hours and sent home without symptoms
82-year-old male who presents after getting dizzy and weak just prior to arrival.  Patient was receiving his first dose of COVID.  Pt's blood pressure was checked and was found to be 78 systolic.  On arrival patient's BP was 91.  Patient states that when he gets up he can still dizzy however while in bed patient currently asymptomatic this time.  According to the patient's failure member he has been dizzy and increasingly dizzy over the past few days.
Pt given immunization on 5/23/07. Pt. states noticed sl. redness at site on 5/25/07. Came to office on 5/29/07. Area about 6 cm in diameter, sl. tender not painful
hair fall; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair fall) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) at an unspecified dose. On 16-Apr-2021, the patient experienced ALOPECIA (hair fall). At the time of the report, ALOPECIA (hair fall) outcome was unknown. Not Provided
Information has been received from a Licensed Practical Nurse referring to a 10 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 25-FEB-2014, the patient was vaccinated with a booster dose of PEDVAXHIB (lot # reported as j011964 with expiration date 19-JUN-2016; dose and route were not reported) at 10 months of age (inappropriate schedule of drug administration). No adverse reactions were reported. There was no product quality complaint. Additional information has been requested.
Toothache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "Toothache".  Additional information: Patient was calling about the Pfizer Covid Vaccine. She woke up and it feels like she was getting a tooth ache, she was going to get her second vaccine today in 2 hours and wants to know if that is okay.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, Rash that lasted several days. After the shots delayed speech, less playing as well.
Admnister 6 yr-11yr moderna as a booster to a completed pfizer  primary series to age 6 yr. Mom stated patient was very tired, sore arm, "glassy eyed," and had some diarrhea.
Stroke; Missed or late 2nd dose; A spontaneous report was received from a consumer concerning, a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke and missed or late 2nd dose.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 03 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  The patient missed the second dose which was scheduled on 05 Mar 2021 as she was hospitalized for a stroke.  No Laboratory investigations were provided. No Treatment information provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, missed or late second dose was considered resolved on 05 Mar 2021. The outcome of the event stroke was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
pt recv vax 5MA97 & 3wk later devel jaundice on 21MAR97;jaundice resolved & pt feeling more comfortable;pt liver function studies are essentially nl @ the present time;
Information has been received from a physician concerning a female (between ages of 14-17) who on unspecified dates was vaccinated with the first and second dose of GARDASIL (lot# not reported). "Within a day or two after vaccine was given", the patient experienced migraines. Physician treated the patient in the emergency room however it was unknown if the patient was hospitalized. The patient was reported to have recovered within the day of the migraine beginning. Additional information has been requested.
Also had 1 dose (of  2) of Shingrix 50mcg injected into muscle of left arm at same event.  Suspect symptoms are from flu shot, given anecdotes from other local recipients of the high dose senior flu shot.  I was sick for 3 days with chills, tolerable soreness at injection sites, low grade fever (99-100), post nasal drip, dizzying headache leading to nausea and one vomiting event.  Was the worst reaction to a vaccine to date.
Nodule at site of administration, abscess? 5-7-18, AUGMENTIN 500 mg/125 mg, BID x 10 days 6-4-18 Sent to Dr, infectious disease who thought possibly reaction to aluminum adjuvant.
cried screamed 11AM-7PM consistently x/to feed; alternate nl-high pitched cry one projectile vomit 430AM next AM 5mins p/feed;
gasping episodes-2 occurred between 2:30-3PM on day of vax;no eye rolling or abn limb movement;also had gasping episode-late in afternoon of 29JAN97;
Moderna COVID-19 Vaccine EUA Ten days after vaccination the injection site became tender.  The eleventh day my left arm at the injection site became red and my arm was swollen and tender to the touch.
Could taste vaccine immediately. Mouth and throat are raw and sore. Bottom lip is very red and swollen. Difficulty swallowing and have no taste buds. Arm is sore but minor issue compared to mouth and throat
About 5 minutes after administration, patient began to feel faint and lightheaded.  We helped her to an exam table to lay down , gave water.  She rested for about 15 minutes until she felt better, then went home
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 22-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot # R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis. The sterile diluent (MERCK) (lot # and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
8 days after the vaccine the injection site began to get warm, red, itchy, and swell again. I also had hives sprinkled around the upper arm near the injection site. The hives spread across my upper chest and back and on my right upper arm as well. after 4 days the symptoms began to fade. Still waiting to see the outcome.
pt recv vax 6JAN94 & a few days later exp hot flashes, tired feeling, achiness, h/a, backache, pain in neck, itching in upper trunk, blurred vision on occasion & tingling in the arm & fingers; SMA-24, thyroid function & CBC were nl;
Injection site became red 1/2 way down to elbow and by the end of the day, the redness and swelling was down to the elbow. Swelling was 2x normal size. Axilla was sore. Pt had chills but did not take temp. Difficulty sleeping. Had to call in sick the next day. Used TYLENOL, ice/heat for recup.
PATIENT SAYS SHE BECAME ITCHY 3 DAYS LATER AND CONTINUES TO FEEL ITCHY. SHE HAS TAKEN BENADRYL TO HELP CONTROL. FACE AFFECTED AS WELL.
No adverse Event; patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD).    No relevant concomitant medications were reported.  No treatment information was provided.
Fever, muscle aches and extreme fatigue. Bed rest the next day. Fever and muscle aches subsided in about 24 hours, fatigue persisted for four days getting progressively less each day.
I did not have a reaction to the vaccine. On 10/28/2022, I began not feeling well with a dry cough. On 10/30/2022, I was not feeling well and decided to take a COVID-19 test and it was positive. I contacted my doctor and was given the prescription PAXLOVID. I tested negative on 11/07/2022. I rebound and tested positive on 11/11/2022 and tested negative again on 11/13/2022.
She had pained in her sinus in the right side; after receiving the Spikevax her nose started running; This spontaneous case was reported by a nurse and describes the occurrence of SINUS PAIN (She had pained in her sinus in the right side) and RHINORRHOEA (after receiving the Spikevax her nose started running) in an 86-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.    Co-suspect product included non-company product RSV VACCINE for an unknown indication.    Patient did not report any medical history or condition.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced SINUS PAIN (She had pained in her sinus in the right side) and RHINORRHOEA (after receiving the Spikevax her nose started running). On 02-Oct-2023, SINUS PAIN (She had pained in her sinus in the right side) and RHINORRHOEA (after receiving the Spikevax her nose started running) had resolved.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  On 03-Feb-2021, the patient received first dose and the lot number was 010M20A.  On 03-Mar-2021, the patient received second dose and the lot number was 003A21A.  On 25-Oct-2021, the patient received third dose and the lot number was 004F21A.  On 30-Mar-2022, the patient received fourth dose and the lot number was 002M21A. On 24-Sep-2022, the patient received fifth dose and the lot number was AS7145B.  The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient recently got the RSV and the Spikevax together. She never got the Pfizer vaccine. Patient got 6 doses, and she did not have any reaction. However, 10 days after receiving the Spikevax her nose started running. She had pained in her sinus in the right side. Then the next day everything was gone. She stated she was not sure if it was a side effect or if she should report it.   Treatment medication use information was not provided by reporter.
received BNT162B2 via trans mammary by mother; This is a spontaneous report from a contactable other HCP reported for herself and baby. This is the baby report. A patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0182), via trans mammary rout of administration in left arm on 05May2021 at 13:30 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. No other vaccine in four weeks. Other medications in two weeks were prenatal vitamins (breastfeeding). No COVID prior vaccination. No COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101068267 Same reporter/vaccine, Diffferent patient/event, Mother case
Patient received the third dose of Pfizer at around 4:10pm and she was a little nervous she said she hated needles she jumped after I injected the needle and said that went straight into the muscle I felt that. About 5 minutes later she stated she didn't feel well and she felt tightness in her throat. I immediately got an epi-pen and asked the patient if she's able to breathe and she was. Then I called 911 and waited for the paramedics to arrive while still monitoring the patient for anaphylaxis.  After a few minutes the patient stated she felt better and the tightness was subsiding. The paramedics checked her out and she declined to go to ER.
Patient states that he has a headache and " isnt feeling well". Patient was assessed by RN, vitals are : BP 117/71, HR 72, Spo2 98 %. Patient is oriented X3. Patient appears to be pale. Patient was given oranges and crackers. RN stayed with patient and reassessed within 5 minutes, patient states the he feels much better. Patient stayed an extra 30 minutes and RN continued to monitor.
per the patient: unusual pain, redness and swelling at injection site. Patient advised to follow up with the Dr or urgent care if pain continues to be unusual
Heart palpitations, extreme fatigue, intermittent pain in chest, shortness of breath - on and off for 3 weeks
pt recvd vax & the pain travelled up neck to head; had pain for several (3) days p/including soreness of the lt arm, neck, shoulder, sniffles, diarrhea & generally all over lousy weekend dragging self around until Monday 17OCT94;
This spontaneous report was received from a licensed practical nurse concerning an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored GARDASIL (lot number, expiry date, dose and route unspecified) which were exposed to 30 degrees Fahrenheit (F) on 19-APR-2013. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Suspected vaccination failure; had / a shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix).   Co-suspect products included Herpes zoster (Shingrix).   The patient's past medical history included shingles.   On 21st January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after her second dose of Shingrix she had an outbreak in the same exact location of a shingles outbreak she had experienced before her first dose of Shingrix. The shingles were clearing up at the time of reporting. The reporter did not consent to follow up. This case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
red patches on her skin that fade out at times and then appear again; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red patches on her skin that fade out at times and then appear again) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol, Allergy and Arthritis. Concomitant products included Nasal inhaler for Allergy, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Arthritis and.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced RASH (red patches on her skin that fade out at times and then appear again). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Arthritis and , at an unspecified dose and frequency. At the time of the report, RASH (red patches on her skin that fade out at times and then appear again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever started 4 days after the injection and has persisted now until today 4/10/2021, and mild HA and fatigue.
Chills, shaking to the point of convulsions, feelings of shocks through hips, back and legs.
Child had flu vaccine on 12/16/11 from there about a week after vacc child began with diarrhea myalgia, also had vomiting, fever, on 12/26/11 seen in clinic with abnormal gait. Ptosis of (L) eye & c/o headache sent to hospital ER on 12/26/11 from there dx with Guillain-Barre from EMG rec IVIG.