chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Abnormal faeces; Breast feeding; Eczema; Faeces discolored; Flatulence; Infant irritability; Infrequent bowel movements; Mucous stool; Pruritus; Skin laceration; Diarrhea; Sleep disorder; Injection site swelling; Injection site erythema; Pyrexia; Viral test negative; Stool analysis normal; Giardia test negative; This case was retrieve during the Reporting System monitoring on 12-JAN-2023.. The original narrative from the sender is the following:  Red swelling at site of left thigh injection (8/19/22 @ 6:15PM. Went away after a few hours).  Fever (8/19/22 @ 6:15PM. Administered 2.5mL Infant Tylenol. Went away after 12 hours. Awake every hour or so that night. Very fussy).  Eczema (Had not seen any signs of Eczema prior to 8/19/22 vaccines. On 8/24/22, I started noticing patches on both cheeks, all over belly, inside/outside elbows, outside legs/thighs, ankles. Seemed to be itchy. Was cutting cheeks & ankles by scratching a lot. Pediatrician said that it may be why he doesn't sleep as well now).  (Prior to 9/14/22 Sick visit: Used AVEENO Baby eczema therapy nighttime balm immediately after baths and throughout the day. Tried using Vaseline 100% pure petroleum jelly after baths and throughout the day. Tried using Lanolin Nipple Cream on areas during the day. It did not get worse, but nothing really helped).  (9/27/22 Applied light amounts of IC HYDROCORTISONE 2.5% Cream on cheeks & ankles (bad areas). This helped, but has not cured. The eczema will come back within a day if I don't apply the cream).  Chronic Diarrhea (Exclusively breastfed. My diet had not changed at all. I tried to cut back on soft cheeses and add more leafy greens, but did not change my son's diarrhea problem. No vomiting. He has continued to have a good appetite. Eats about 30oz of breast milk over 5-6 feedings in a 24 hour period).  (Prior to 8/19/22 vaccines: Small bowel movements 2-3 times a day. Bright mustard yellow, seedy, sweet smelling. Regularly slept through the night between 8:30/9PM-5:30/6AM).  (8/20/22-Present: Large blowout bowel movements once a day or once every 2-3 days. Dark yellow, bright yellow, or greenish, slimy, mucus, foam, or watery/runny. Smells bad, sour, rotten. Has more smelly gas. Regularly wakes up throughout the night and has to be fed between 2:30-4AM to get back to sleep).  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events Abnormal faeces, Breast feeding, Eczema, Faeces discoloured, Flatulence, Infant irritability, Infrequent bowel movements, Mucous stools, Pruritus, Skin laceration, Diarrhoea, Sleep disorder, Injection site swelling, Injection site erythema, and Pyrexia.  The causa relationship between Vaxelis and Viral test negative, Stool analysis normal, and Giardia test negative was assessed as not applicable, due to the nature of these events.  No further information is expected
This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from a consumer, a relative of a male patient who received a dose on an unspecified date along with a dose of Prevnar also administered on an unspecified date. The patient was reported as being mildly autistic. Relevant medical history was not provided. Indication for Hib-Titer Vaccine was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Additional suspect vaccine included Prevnar. Concomitant medications were not reported. On unspecified dates, the patient received a dose of Hib-Titer and a dose of Prevnar. On 6/13/06, the patient was reported as being mildly autistic. The onset date of the event was not reported. The patient's outcome is unknown. No additional information was available at the time of this report.
Patient was misidentified; Order was written for another patient (4 month old) due to a language barrier. Patient was not identified per procotcol and immunization were given in error. Mother was informed by Dr.
Patient received on 11/11/2009 for H1N1 oral hepatitis A-broke out in hives 11/12/2009 no Hx of egg allergy.
Acute kidney injury; CHF (congestive heart failure); COVID-19 virus infection; Chronic hepatitis C without hepatic coma; Edema leg; Essential hypertension
Patient got shot, immediately said she didn't feel good, put her head in her hands and passed out with her head on the table. She was unconscious for about 10 seconds then came to.  She was drenched in sweat and now chilled.  We called EMS to check her out and she was fine.  Also stated she had not eaten all day and was very nervous about the shot.  She went grocery shopping once done with EMS.
Had a more severe reaction / in terms of flu symptoms; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included sinus headache (occurs generally this times of the year). Previously administered products included Flu vaccine with an associated reaction of influenza (received on an unknown date refer case US2021AMR016788).   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   The reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient got the Shingles vaccine this fall and had more severe reaction with it in term of flu symptoms. The patient think the Shingles vaccine was Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR016788:Same reporter.
Patient had cardiac symptoms the same night after taking the shot (10/21/10). He ended up at his cardiologist and was put in the hospital. On the special cardiac machines/equipment - he was having cardiac events for 5 days - he ended up w/ MRI and Myocarditis.
Back of arm has egg size knot that is red and warm to touch. (Still present) fever of 99.9 for 2 days broke with TYLENOL.
Experienced a low hum tinnitus in both ears in the middle of the night.  It stayed throughout the night.
when was getting ready for bed, noticed a dime red spot, like a sunburn; low grade fever. , shivery, knew it wasn't high; shivery; pain at the injection site; felt pretty lousy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (when was getting ready for bed, noticed a dime red spot, like a sunburn), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (felt pretty lousy), PYREXIA (low grade fever. , shivery, knew it wasn't high) and CHILLS (shivery) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included TRAZODONE, LAMOTRIGINE, VENLAFAXINE and VITAMINS NOS for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site), FATIGUE (felt pretty lousy) and CHILLS (shivery). On an unknown date, the patient experienced RASH MACULAR (when was getting ready for bed, noticed a dime red spot, like a sunburn) and PYREXIA (low grade fever. , shivery, knew it wasn't high). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (when was getting ready for bed, noticed a dime red spot, like a sunburn), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (felt pretty lousy), PYREXIA (low grade fever. , shivery, knew it wasn't high) and CHILLS (shivery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Second dose given 7 days early (due 8/17/2021). No adverse symptoms reported at this time (8/11/2021)
Information has been received from a registered nurse concerning a 22-month old female who on 04-May-2003 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (lot #644724/0074N). The nurse indicated that the patient developed a breakthrough case of chickenpox. On 29-Aug-2003 the patient began to experience a maculopapular rash and ran a low grade fever. The patient presented to the office on 02-Sep-2003 and most of the lesions were scabbed over. The child had a total of about 40 lesion. Unspecified medical attention was sought. It was noted that a prescription drug was not required and that the event abated. A product quality complaint was not involved. Follow-up was received from the registered nurse which indicated that no further information was available. No further information is expected.
Starting 06/02/2003, developed red spots.  Then next AM 06/03/2003, several more spots.
The Dtap and MenQuadFi were administered first.  Immediately after administering the third vaccine (HPV) vaccine, pt. c/o feeling lightheaded and then fainted.  RN lowered her to a laying position and elevated her legs.  Patient opened her eyes right away and stated that she felt very warm.  Patient remained laying down for 10 minutes and then slowly sat up after reporting feeling better.  Pt. sat for an additional 5 minutes without dizziness or complaint.  Pt. was able to stand and walk out of the office unassisted.
Tested positive; This is a spontaneous report received from contactable consumer. A 66-years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch EN6198 and expiry date: Unknown) via an unspecified route of administration on 08Mar2021 for covid-19 immunisation. Relevant medical history and concurrent conditions included Pre-diabetic and Blood pressure high from unknown date and ongoing is unknown. Concomitant medication included proprietary medicinal product name: Unspecified medication for Blood pressure. On 15Mar2021 patient tested positive for covid after taking the first shot of the Covid19 vaccine. Reporter wanted to know whether the next dose cane be taken or not as per scheduled date which was on the 28 of March. The events outcome was unknown.   Follow up letter has been generated information on batch/lot number was available.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Information about the patients' relevant medical history and concomitant medications was not reported. In April 2015 (reported for all products as since 01-APR-2015), the patients were administered improperly stored VAQTA (route, dose, lot# and expiration date were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event was reported. There was a vaccine administration error. The patient intended to receive Janssen; however, Pfizer was administered.
8APR c/o soreness rt shoulder/rt neck during eve; 9APR inc discomfort all day; to ER 9APR 330PM; rt shoulder/rt side neck skin pink/red (no hives); tender to the touch & c/o pain w/movement;
around 6PM pt recvd vax; pt was shivering & exp resp difficulty; parent called 911 emergency; fever inc to 102 R over 10 mins period; EMT who responded told parent pt appeared to be having sz; pt was taken to hosp;
acute appendicitis; This is a spontaneous report from a non-contactable consumer (patient herself). A 62-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the right arm, on 15Mar2021 16:00, at a single dose, for covid-19 immunization. The patient has no medical history. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 22Feb2021 in the right arm for covid-19 immunization at the age of 62-years-old. The vaccine was received at the hospital. The patient did not receive other vaccines within four weeks. The patient has no Covid prior vaccination. The patient incurred acute appendicitis on 16Mar2021 12:30 PM, 20 hours after second dose. There were no indications of difficulty prior. This resulted in surgical removal of appendix. The adverse event resulted in emergency room/department or urgent care visit and, hospitalization for 2 days (from Mar2021 to Mar2021). The patient was recovering from the adverse event at the time of the report. The patient had a Covid-test via nasal swab on 18Mar2021 with results of negative.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
Information has been received from a health professional concerning a male in the 3rd grade who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was unknown. The patient was not hospitalized. There was no product quality complaint involved. Additional information has been requested.
Myalgia, Swelling in right upper arm where injection administered. Swollen and painful to touch, Fatigue and chills Narrative:
Severe and rapid onset of two chronic conditions, sciatica pain in glutes and upper legs.  As well at the same time a rather severe onset of GERD symptoms. Next day all day bad symptoms,  3rd day much improved,  4th day both almost all gone.  Prior history of COVID-19 event for myself in March 2020.
Unilateral swelling and soreness of eyelid; Soreness of eyelid; Maternal exposure during pregnancy, second trimester; This is a spontaneous report from a non-contactable consumer. A 25-year-old pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left deltoid on 2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date as prior to the vaccination, the patient was diagnosed with COVID-19. The patient's gestational period is reported as 22 weeks. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01Oct2021, after 5 hours of vaccination, the patient experienced unilateral swelling and soreness of eyelid. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events unilateral swelling and soreness of eyelid was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
onset gen persistent myalgias 3 days p/vax 29OCT; pain inc w/activity;no weakness or numbness;no muscle tenderness;nl CPK;
Redness on arm; Left arm irritation; Chills; Fatigue; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix. On 20th August 2019, less than a day after receiving Shingrix, the patient experienced fatigue and chills. On 21st August 2019, the patient experienced erythema of extremities and skin irritation. The patient was treated with methotrexate. On an unknown date, the outcome of the erythema of extremities and skin irritation were not recovered/not resolved and the outcome of the fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, skin irritation, fatigue and chills to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient experienced redness fatigue, chills, and arm irritation following dose of Shingrix. The reporter consented to follow up. The health care professional describes redness as redness covering the upper arm and stopping at the elbow. The redness began the day after receiving the vaccine and has not improved since it began.  The health care professional describes fatigue as the patient taking a three hour nap. The chills and fatigue began after the vaccine, on the same day, but has since resolved.  The health care professional could not provide complete address of the pharmacy that administered the dose. The health care professional notes the patient takes methotrexate.
On February 4th, 2021 patient died suddenly while skiing. About 2 PM, there was no accident, he was found laying down in the snow and the first to find him gave him CPR - ski patrol came quickly and shocked him three times. But none of these brought him back. He was already gone.
Cascade and Marching of symptoms including but not limited to itching of skin diffuse rash and scalp, Proprioception difficulties, fall, severe progression of numbness and tingling of feet, hands, face and nose, Loss of LE reflexes, weakness, Increase BP and heart rate, feet and hands felt as if walking on or holding glass of cactus , Pain in shoulders and down legs at times.  Difficulty walking  with wide based gait, off balance and dizzy at times and could not tandem walk.
Nosebleed night of vaccine and continue daily, averaging 3 times a day or more
Begin to have burning of tongue within 20 min after vaccine, progressed to swelling of lips & eyelids with flushing chest up. Stable BP. Pulse oximetry 94%, given EPI x2 & DEPO MEDROL with improvement, admitted to hospital.
Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 2:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 2:52 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   An age of patient was reported as 60.44 for dose administered on 28-Apr-2021.  No concomitant medications were reported. It was reported that for the vial Batch number of 007C21A, it was moved to fridge on 19-Apr-2021 that underwent temperature excursion on 28-Apr-2021 with temperature 33 degrees Fahrenheit at 09 AM. The product was moved to clinic on 28-Apr-2021 and beyond use date for the vial was reported as 19-May-2021.  The vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. The vials were only punctured right before administration. The vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received BOOSTRIX (batch number 7ZZ3Z, expiry date 30th November 2019). Previously administered products included dTPa vaccine (The patient had received an unknown brand of dTPa 18 years earlier.). On 10th March 2018 14:38, the patient received BOOSTRIX (intramuscular) .5 ml. In March 2018, less than a month after receiving BOOSTRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. The reporter considered the pain in arm to be related to BOOSTRIX. Additional details were provided as follows: The patient experienced no significant adverse events at the time of 1st dose. BOOSTRIX (and Tdap in general) was indicated as 1 dose per lifetime. In March 2018, less than a month after vaccination with BOOSTRIX, the patient experienced pain in the left arm that radiates down the arm since receiving the BOOSTRIX vaccine. The reporter was unable to provide additional details. MI spoke with health care professional after transfer.
Headaches; Fever; Intermittent sweating; Chills; Body aches; This is a spontaneous report from a non-contactable consumer (patient). This report was received via a sales representative. A male patient of an unspecified age (Age: 53; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Mar2021 10:00 as DOSE 2, SINGLE for covid-19 immunization. Patient medical history included high blood pressure and type 2 diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, SINGLE for covid-19 immunization. On 18Mar2021 02:00, the patient experienced headaches, fever, intermittent sweating, chills and body aches. It was reported that the events took place after use of the product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2 hours after received H1N1 vaccine right upper arm, tingly feeling felt down to right fingertips. Pain upper right arm - applied ice with some relief. Over next few days. Symptoms subsided but did not entirely go away. Pain in bicep & lower deltoid where injection given continues some days worse than others. Tingling went away 2 days later. Went to MD for another reason & mentioned pain and referred to the agency to report.  12/15/09 PCP medical records received. Service date 11/16/09. Assessment: Essential hypertension. Patient reports for DMV physical. Had developed some soreness of right shoulder after immunization injection. At present no swelling, redness, tenderness.
Child ran a fever (not taken) on the evening of 2/21/01. No fever, as of 2/22/01; right leg with 2 areas edematous and red. On 2/23/01, had slight edema that remained on left leg; no redness or warmth and was afebrile.
Stroke. Lost of use of left side. Still in hospital doing therapy.  Only 12 after booster shot stroke happened.