chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymph node tenderness; This case was reported by a consumer via interactive digital media and described the occurrence of lymph node tenderness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lymph node tenderness. On an unknown date, the outcome of the lymph node tenderness was unknown.   It was unknown if the reporter considered the lymph node tenderness to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter asked if lymph node tenderness was a side of Shingrix vaccine. Additional supportive information: Follow-up would not possible as no contact details were available.
Early menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 28Mar2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown; Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced early menstrual cycle. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of early menstrual cycle was resolving at the time of this report.  No follow-up attempts are possible, information about batch number cannot be obtained.
Patient has Pervasive Developmental Disorder.  He was given Flu Mist on 10/20/08 and proceeded to have 3 days of listless behaviour and confusion.  He was improved by the third day.
Headache, Myalgia, FATIGUE, INJECTION SITE SWOLLEN/PAIN, BACK PAIN NEAR INJECTION SITE Narrative:
Super heavy period/bleeding through an overnight pad every 2-3 hours; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153), via an unspecified route of administration, administered in arm left on 08Apr2021 14:45 (at the age of 40-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient medical history included low progesterone and low thyroid both from an unknown date. The patient did not had covid-19 prior vaccination. The patient's concomitant medications were not reported. On 10Apr2021, the patient had super heavy period. She was bleeding through an overnight pad every 2-3 hours. They were supposed to last between 10-12 hours. This lasted for almost 2 days, unfortunately if was during the weekend or she would have sought medical help from her doctor. The patient did not received any treatment for the reported event. Not covid-19 tested post vaccination. The outcome of the event was recovered on 12Apr2021.
"Nausea, headache, lightheadedness, dizziness, paleness, myalgias, lethergy and joint aches. (As of report on 10/23/09)I still have no energy and my joints still ache. Something I did not have before receiving the injection. These symptoms were almost immediate...
Patient received AVA #1 on 17 Dec 03 noticed an intense burn for 5 min that radiated down hand immediately following the vaccination.  Noticed slight redness and swelling at the injection site.  Mid Jan 04 noticed stiffness and soreness of hips, knees and shoulders that would require taking 10 steps just to straighten up from a sitting position.  Initially thought it was due to deployment and poor quality beds.  Patient reported problems keeping up with people walking at a normal gain, nothing drastic, just trailing 10-15 steps behind others in her unit.  Noticed that stiffness was worse in the morning and after periods of inactivity.  Stated began feeling like the day after completing a road march and whole body was fatigued.  Noted some days were better than others, muscles felt sore, but joints bothered more.  Initially hips were most bothersome.  Pain described as a deep pain, #4 scale 1-10 with 10 being worse, with varying degrees of intensity but always present.  Tylenol and physical therapy would help a little but noticed no relief with ibuprofen.  Did initially have problems with foot pain but that is not as bothersome now, however no longer walking as did in the past.  Reports occasional stiffness of hands and mild muscle discomfort.  Describes this discomfort as a fatigue more so than a ache.  Notices that always tired, and unable to attribute this fatigue with activity.  Noticed that there is an increase in the aching when it is cold.  Has had rheumatologic evaluation and to date no diagnosis has been determined.
After 2 hours notices    redness on my forehead, and within 5 days blisters and redness on the right side of the face and eyes. Red blister and a black clusters.
Site reaction of redness, hot, swollen and painful. After 3 days improvement seen but still red and hot feeling
Scrotum, stomach, legs, back, buttock, head 50 lesions.
nausea; diarrhea; fatigued; sharp pain in small area of upper left back; headaches; A spontaneous report was received from a healthcare professional concerning a 55-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headaches, nausea, diarrhea, fatigued, sharp pain in small area of upper left back.  The patient's medical history was not provided. Concomitant medications reported were Vitamin B for drug use for unknown indication.  On 5 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the event(s) headaches. On 6 Mar 2021, the patient experienced the event(s) nausea, diarrhea, fatigued, sharp pain in small area of upper left back.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headaches, nausea, diarrhea, fatigued, sharp pain in small area of upper left back was unknown.
swelling and itching at the injection site; swelling and itching at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (swelling and itching at the injection site) and VACCINATION SITE SWELLING (swelling and itching at the injection site) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (swelling and itching at the injection site) and VACCINATION SITE SWELLING (swelling and itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (swelling and itching at the injection site) and VACCINATION SITE SWELLING (swelling and itching at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported by the reporter. Treatment details was not reported by the reporter.
PAINFUL AND ITCHING BLISTERS ON BOTH HANDS; SPOTS ON LEGS ANKLES ARMS STOMACH WAIST AREA CHEST BACK UP TOWARD THE NECK; ITCHY SPOT; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: blister. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-AUG-2021, the patient experienced spots on legs ankles arms stomach waist area chest back up toward the neck. On 22-AUG-2021, the patient experienced itchy spot. On 23-AUG-2021, the patient experienced painful and itching blisters on both hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spots on legs ankles arms stomach waist area chest back up toward the neck, and itchy spot, and the outcome of painful and itching blisters on both hands was not reported. This report was non-serious.
Fever 104.9 3 hours after administration treated with Motrin, Tylenol. Patient recovered well - diagnosed with viral pharyngitis during his hospitalization. 05/15/07-records received for DOS 4/17-4/20/07-DC DX: Fever, resolved. Acute pharyngitis. Left otorrhea. Three hours after vaccines developed fevers between 104 and 105 and became lethargic.   One day three of hospitalization noted to have pharyngitis appears to be viral. Clogged left myringotomy tube and discharge.
Irregular heart beat, flu like symptoms, irregular sleep cycle, imbalance. breaking out in hives after consuming foods and drinks commonly consumed with no symptoms.
The pt experienced morbilliform rash to trunk, face, extremities. 12 days post vax.
Pain in chest lasted about six months. My primary sent me in for calcium tests on my heart, followed by stress tests. Ultimately, I had an angiogram. Cardiologist did not recommend a stent or stents, told me to go home and take over the counter anti-inflammatory drugs. Fatigue. Constant and debilitating. I could not work a full day. Lasted 6 months. I'm normally full of energy. Diarrhea. Lasted 6 months. Chronic. Three episodes a day, lead to dehydration.
Red left arm; Sore left arm; Left arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm got sore), ERYTHEMA (Red left arm) and PAIN IN EXTREMITY (Sore left arm) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left arm got sore). On 25-Mar-2021, the patient experienced ERYTHEMA (Red left arm) and PAIN IN EXTREMITY (Sore left arm). On 18-Mar-2021, PAIN IN EXTREMITY (Left arm got sore) had resolved. At the time of the report, ERYTHEMA (Red left arm) and PAIN IN EXTREMITY (Sore left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Concomitant medications were not provided. The treatment information was not provided.
TEMPERATURE EXCURSION INVOLVING VARIVAX; This spontaneous report has been received from a registered nurse concerning  a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.        On 28-JUL-2020, the vaccine varicella virus vaccine live (oka/merck)(VARIVAX)  experienced intermittent temperature excursion.  On 03-AUG-2020, the patient was vaccinated with  a dose of  the aforementioned varicella virus vaccine live (oka/merck)(VARIVAX) Lot # S032357, expiration date 14-OCT-2021, .5 milliliter for prophylaxis (frequency and patient route of administration was not provided). Lot # was also reported as T002843 with expiration date 23-JAN-2022. The storage temperature reported was between -14°C to -10°C, being the maximum temperature at -9..5 °C for a period of 38 hours and 30 minutes.          There was digital data logger involved and  no previous temperature excursion was reported.
Pt recvd 3 doses of Engerix-B 12DEC90, 31JAN91, 19JUN91 & 3OCT91 lab tests indicated did not convert; recvd a booster dose of Engerix-B on 31OCT91; 3DEC91 lab tests indicated pt did not convert; recvd a 2nd booster of Engerix-B 10DEC91;
The vaccine can only guarantee a milder case/ I've had it twice/ suspected vaccination failure; I've had it twice; This case was reported by a consumer  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immunocompromised.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The reporter stated that the vaccine can only guarantee a milder case and not prevent it.  The reporter stated if they are immune compromised, they still could get shingles. The patient had shingles twice the first was brutal the second a little easier. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Health problems; This is a spontaneous case, initial and follow up versions, received on 03-Jul-2019 (both versions being processed together), concerning a patient of unspecified age (reported as sixties) and gender.  On an unspecified date, the patient was administered INN Flu Vaccine Pandemic (reported as swine flu vaccine) [influenza virus vaccine monovalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication.  On an unspecified date after vaccination, the patient developed unspecified health problems (ill-defined disorder). It was reported that the patient was in 60s and ended up dying. It was unknown, whether autopsy was performed.  The reporter assessed the case as serious (death).; Reporter's Comments: A patient of unspecified age (reported as sixties) and gender developed unspecified health problems (ill-defined disorder), on an unknown day after administration of INN Flu Vaccine. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported event, vaccination details, concurrent medical conditions, autopsy report and investigations to provide alternate aetiologies. Hence the causal role of suspect vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Health problems
Rash started on my shoulder.  Has since spread up and down both arms. So itchy I can?t sleep the last 2 week. Have been prescribed prednisone hydrooxyzine. Ointments to apply. Nothing has helped the rash or the itch. Now being sent to dermatology. Never anything like this before. No new products/no new food only new thing is the vaccine in that time frame to cause this much constant chaos.
Symptoms: Fever >100 up to 103.4 degrees over the course of 7 days, beginning 3 hours post immunization. Screaming and crying began ~ 3 hours post immunization and continued in 1-4 hour incriments over the course of 7 days.  Lethargic & Listless demeanor > 5 days.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 9-weeks-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 23-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
ZOSTAVAX vaccine given in error, no adverse reactions. ZOSTAVAX given inadvertently instead of VARIVAX. Next day patient had rash at injection site and fever (101F).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 29-SEP-2014, the patient was vaccinated with an expired opened dose of PNEUMOVAX23 lot # J009827, expiry date: 10-AUG-2014 (dose and route were not reported). The pharmacist also stated that from 10-AUG-2014 through 10-SEP-2014, the opened vial of PNEUMOVAX23 was previously exposed to 70F. No adverse symptoms reported. This is one of three cases from the same reporter. Additional information has been requested.
On the first dose given 5/24/21, I had itching at the site of the injection 2 days after the injection and lasting  for 3 days. On the second dose given 6/21/2021, the reaction was more severe similar to my allergic reaction to sulfa. There was itching almost immediately and all over my body as if ants were crawling under my skin. This includes in my scalp as well as under the soles of my feet. Although skin rash did NOT erupt, it felt as if it could have had I not taken Benadryl. The Benadryl was taken around noon on 6/21/2021 within the hour of the injection. When I awakened around 1700hrs, there was still some itching under the skin at the site and throughout my body so I took another Benadryl. The itching at the site continued over the next  5 days; however, it was not so severe to continue taking the Benadryl.
Per pt report: approx. 4 hours after inoculation she began experiencing a headache that has not yet subsided.  Headache is not relieved by analgesics.  Has sought care from PCP and was referred to neurologist for follow up.
Moderate fatigue, mild nausea, mild headache, mild cough, significant body aches, chills, fever 99.6, sweats, difficulty taking a deep breath due to body aches, soreness and tenderness at injection site.
This spontaneous report was received from a medical assistant, concerning a 78 year-old female patient, allergic to SEPTRA. Her concurrent conditions included celiac disease. There were no historical conditions reported and the patient's concomitant therapies included unspecified vitamins. On 04-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection (dose, frequency and route were not reported) lot # M039060 with expiration date of 22-MAY-2018, for prophylaxis. On 05-MAY-2017, the patient developed cellulitis and experienced redness. The patient sought medical attention and treatment was given for the adverse event; no laboratory diagnostics studies were performed. At the time of the report, she had not recovered from the cellulitis. The causality between the adverse event and PNEUMOVAX23 was unknown. Upon internal review, cellulitis was considered to be medically significant. Additional information has been requested.
Two days post vax pt developed erythematous macular eruption over his arms, legs and trunk. Pt was treated with Celestone 2cc IM, Claritin 10mg daily for two days. Pt stated rash was gone within two days.
48 hrs after vaccination, child broke out in a rash, described as hives in ER. Initially on face and upper body and back. 48 hrs later on my exam it is on legs, arms, shoulder, hands and feet, macular papular and not pruritic.
scratchy sensation at the base of her throat, the kind that makes one cough; Tightness in the neck; felt something "funny" in her neck like it was tight; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (felt something "funny" in her neck like it was tight), THROAT IRRITATION (scratchy sensation at the base of her throat, the kind that makes one cough) and MUSCLE TIGHTNESS (Tightness in the neck) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 immunisation.     Concurrent medical conditions included Autoimmune disorder (Unspecified autoimmune disorder), Drug allergy (Unspecified antibiotics) and Contrast media allergy.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced MUSCLE TIGHTNESS (felt something "funny" in her neck like it was tight). On 19-Feb-2021, the patient experienced THROAT IRRITATION (scratchy sensation at the base of her throat, the kind that makes one cough) and MUSCLE TIGHTNESS (Tightness in the neck). On 16-Feb-2021, MUSCLE TIGHTNESS (felt something "funny" in her neck like it was tight) had resolved. On 19-Feb-2021, THROAT IRRITATION (scratchy sensation at the base of her throat, the kind that makes one cough) and MUSCLE TIGHTNESS (Tightness in the neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has taken Benadryl for 3 days for scratchy sensation at the base of the throat.
On 12JUL2018, a report of autoinoculation was received from Study. Subject is a 34 year old male who was vaccinated with ACAM2000 (lot VV03-013-B) on 03JUL2018 at 12:15 hr. He reported no medical history. On 10JUL2018, the subject was seen by staff for day 7 site check and subject explained that after his gym workout on 09JUL2018, he took Band Aid off and removed top layer of skin approximately one half inch below vaccination site on left upper arm. The staff gave further site care instruction to prevent autoinoculation. On 12JUL2018, the subject came to the site early for day 12 site check (subject leaving town). On site check, subject had noted autoinoculation on open wound that was reported on 10JUL2018, day 7 site check. Both vaccination site and transfer site were in pustule stage. Subject was provided further site care instructions and site care kit. (Care kit contains 12 Band Aids and waterproof Band Aids. Subject was also given 4x4 gauze pads). As 16JUL2018, the lesions were in scabbing stage. Due to the size of the lesion, the Principal Investigator considers this as a case of autoinoculation. The case was reported as a mild and not serious adverse event that was related to the administration of ACAM2000. Company Medical Assessment: The Company agrees with the Investigator's assessment. The case was upgraded to serious and to be submitted as 15-day alert report to comply with the FDA post-marketing commitment.
DATE OF BIRTH WRITTEN ON CONSENT FORM COMPLETED BY PERSON INDENTIFYING AS MOTHER. DATABASE INDICATES DOB DIFFERENTLY. CHILD TOO YOUNG FOR VACCINE IN 5/2021.  DATABASE INDICATED THAT CHILD RECEIVED SECOND DOSE AT PHARMACY ON 6/10/2021.