chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy all over; Redness; Itching at the site of the injection; Fatigue/Feeling tired; Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face; Muscle pain at the site of the injection/It was very sore; did feel the chills as the temperature had gone up a bit; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy all over), ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the site of the injection), FATIGUE (Fatigue/Feeling tired) and RASH (Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 030H21B, 044B21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Stays away from Ibuprofen but in past got a red rash from ibuprofen in past).   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy all over), ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the site of the injection), FATIGUE (Fatigue/Feeling tired), RASH (Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face), VACCINATION SITE PAIN (Muscle pain at the site of the injection/It was very sore) and PYREXIA (did feel the chills as the temperature had gone up a bit). At the time of the report, PRURITUS (Itchy all over), VACCINATION SITE PRURITUS (Itching at the site of the injection), FATIGUE (Fatigue/Feeling tired), RASH (Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face), VACCINATION SITE PAIN (Muscle pain at the site of the injection/It was very sore) and PYREXIA (did feel the chills as the temperature had gone up a bit) outcome was unknown and ERYTHEMA (Redness) was resolving.            No concomitant medication reported.  No treatment medication was reported only reported that patient rested, drinking water, eating minimal.
pt recvd vax & devel swelling, redness & tenderness @ inj site;
Per triage RN: Positive for widespread hive; widespread itching or facial swelling and no other serious symptoms and no serious allergic reaction in the past.
(L) arm - at injection site 2 cm wide x 1.5 long. Red and swollen.
Severe chills began 10 hours after injection -- 9:30 PM. Extremely violent shivering began 10 PM and continued until midnight. Slept dressed in two long-sleeved layers under 4 layers of bedding. Fever of 101 upon awakening in the morning (after awakening every hour all night long). Very achy muscles, back of neck especially, lower back pain, and pounding headache. Fever came down to 98.7 after a dose of 1300 mg TYLENOL in the morning. Reduced activity for three days following this event. NOTE: I had no reaction to the first dose given 2 months prior. Perhaps if I had waited 4-6 months to receive the second dose.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 08-JUL-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # L003188 (also reported as "l003188" and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion was 552 hours and the lowest recorded temperature reported was 27 Fahrenheit (F) (-2.777777778 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Headache, Nausea, Vomiting starting 4-9-2021, until 4-14-2021 when I went to ER. Found to be Hypertensive, 190/ 90, and Hyponatremic, Critical Lab Value 120. Sent via ambulance on 4-14-2021 to. Placed on step-down MICU  until 4-16-2021. Sent home on Sodium Tablets 2/day, and Amlodipine Besylate 10mg/day
Patient has pain that started 1 week after vaccine, pain in deltoid- when reported to doctor had been 3 weeks, harder to lift things, painful. pain radiates from deltoid towards shoulder and down into forearm
Approx 6 hrs after getting 2nd dose, developed near syncopal episode.  Become diaphoretic, heart palpitations, light headed,  short of breath.   Was placed in a room, had tachycardia with heart rate  in the 140's, eventually subsided to normal range over the next 4 hrs.  Tuesday had flu like symptoms, headache, body aches, chills, fatigue.  Then at night had severe headache ontop of head,  to even touch which lasted a few moments and subsided leaving generalized headache.  Flu like symptoms persisted through Wed.
This spontaneous report as received from a pharmacist (who also heard of the case through another unspecified pharmacist within her workplace) via a company representative refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 injection route (lot and dose not reported). At the same arm was administered concomitant influenza virus vaccine (manufacturer unknown) (lot, dose, route and indication not reported). Concomitant medication was not reported. On an unknown date, the patient experienced pronounced injection site reaction with redness, soreness and swelling. Therapy with PNEUMOVAX23 was discontinued and not reintroduced. Action taken regarding therapy with influenza virus vaccine (manufacturer unknown) was not reported. The outcome of pronounced injection site reaction with redness, soreness and swelling was not reported. Additional information is not expected.
Vertigo began at 1:00 am, continuing through the night. Still going on now, 24 hours after vaccine was administered.
Tingling in the left-hand same day.  Couple of days later severe dizziness for over a weak.
Headache, SkinRash, Urticaria Pruritus,  induration and itching at injection site Per patient report: I had my 1st shot on January 8th and on last Thursday [Jan. 14th] I noticed that my arm was itching profusely. Upon looking at my arm, I noticed a large raised red patch/rash and it was hot to the touch. I have been taking 1 benadryl at night and using the benadryl gel during the day. Initially it was so bad that it would wake me out of my sleep during the night. As of today, the area is not as red & not as large but the rash is still visible and still itches but not as much. Basically, on friday evening  through Sunday, I had a slight headache and the arm but didn't notice anything else until Thursday of course
This spontaneous report was received from a physician refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported. Physician reported that an unspecified patient received the first dose in the HPV vaccine series with GARDASIL lot number and expiry date unspecified on an unspecified date and then the same patient received the second dose in the HPV vaccine serious with GARDASIL 9, M011117, expiry date 07-DEC-2017, pm 08-AUG-2016. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Cut his finger requiring a bandaid; One of the two finger flanges broke off; This spontaneous report was received from a Licensed Practical Nurse, refers to a male patient, who was a physician of unknown age. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      On 28-SEP-2021, the physician administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with lot # U003306 has been verified to be a valid lot number and expiration date on 15-OCT-2022 to a patient (captured in MARRS # 2109USA007035) for prophylaxis.  While administration, one of the two finger flanges of  the vaccine broke off (syringe issue), which caused a cut on his finger requiring a band aid (skin laceration). The vaccine was administered to the patient.  The physician disposed pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe into sharp container. Product was not able to be retrieved.  At the time of the report, the outcome of skin laceration was unknown. Causality between the event skin laceration and vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  This is one of two cases received by the same reporter. ; Sender's Comments:  US-009507513-2109USA007035:
Pt stated approx 24 hours after receiving vaccine that she developed generalized hives all over her body that progressively got worse over the next 2-3 days. She did not take any OTC meds or go to any ER or urgent care but did stated that they took a while to go away.
PATIENT DEVELOPED A KNOT AT THE INJECTION SITE WHICH SHE CONSULTED A DERMATOLOGIST ABOUT. THE KNOT IS SLOWLY RESOLVING BUT IS STILL PRESENT CURRENTLY.
Small growth between testicles and butt. Slightly painful to touch.  No treatment attempted yet.
Scratchy throat, pressure & tightness in chest, headache, malaise, nausea, cramping(gastrointestinal pain), diarrhea, migraine, extreme exhaustion, fatigue, muscle and joint pains, cold flashes, extreme weakness, off balance, feeling faint
I have a rash all over my body, my chest and all my arm and all my legs; I am broke up real bad and this above all my neck and my chest; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiry date were not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received a first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiry date were not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date the patient experienced i have a rash all over my body, my chest and all my arm and all my legs; i am broke up real bad and this above all my neck and my chest. The outcome of the event was unknown at the time of the report.  No follow-up attempts are needed. No lot/batch number cannot be obtained.
Nausea, tired, fever, sore arm, rolling chills, headache the arm was sore after about two hours the fever and tired started about 3:30 and the chills, fever and headache were all night long, the next day I was tired and still had a fever but had take Tylenol to help with symptoms.  By Friday morning I was feeling better from the above symptoms but had a weird numbness in my fingers on Friday afternoon that is still there today.
Chills; Fatigue; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep6955), via an unspecified route in the left arm on 23Mar2021 at 13:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included sickle cell anemia. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 07:00, the patient experienced chills, fatigue and headaches. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the events chills, fatigue and headaches. The clinical outcomes of the events chills, fatigue and headaches was unknown.   No follow-up attempts are needed. No further information is expected.
I feel disgusted; She says that she cannot sleep at night due to the pain; She says that she was sick for a day; knees have been very painful; wasn't able to do anything on Sunday, hard time getting in and out of bathtub; started having flu-like symptoms; sore throat; aches and pains; headache; very fatigued; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub) and FEELING ABNORMAL (I feel disgusted) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), HEADACHE (headache), FATIGUE (very fatigued) and PYREXIA (fever). On 07-Nov-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub). On an unknown date, the patient experienced FEELING ABNORMAL (I feel disgusted), SLEEP DISORDER (She says that she cannot sleep at night due to the pain), ILLNESS (She says that she was sick for a day) and ARTHRALGIA (knees have been very painful). On 08-Nov-2021, INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), HEADACHE (headache), FATIGUE (very fatigued) and PYREXIA (fever) outcome was unknown. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub), FEELING ABNORMAL (I feel disgusted), SLEEP DISORDER (She says that she cannot sleep at night due to the pain), ILLNESS (She says that she was sick for a day) and ARTHRALGIA (knees have been very painful) outcome was unknown.            No treatment medication reported. Concomitant medication contains Allergy shot   This case was linked to MOD-2021-242526, MOD-2021-242504 (Patient Link).
Aches and pains, metallic to site, no energy, no appetite, headache had vaccine on 8-11-16-started w/sx Aug 15. Spoke to her MA, said couldn't be sure if sx are due to vaccine. Came in 8/22. Still has some sx.
Moderna Booster (0.25ml) vaccine was drawn up after max 20 drawn doses allowed. Proper aseptic techniques were used during dose extraction and vaccine was inspected prior to administration.  Patient was given correct dose (0.25ml) and was monitored for 15 minutes after vaccination. No adverse event occurred after administration.
Pt recvd Varivax 7/11/96 and broke out with a mild varicella rash mid May 2001.
For the first time my legs swelled up little bit and my feet and this time I got the last shot; my feet is still swollen and my leg is still swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation, reaction(s): "my legs swelled up little bit and my feet".  The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "For the first time my legs swelled up little bit and my feet and this time I got the last shot; my feet is still swollen and my leg is still swollen".  Additional information: patient got the side effect like legs were swelled up, when patient took the Pfizer shot, for the first-time patient legs swelled up little bit and feet was still swollen, and leg was still swollen. NDC, UPC numbers for the Pfizer dose was unspecified expiry dates was unknown. consumer was informed about the Pfizer medical information and provided with number; further probing could not be done as consumer hanged up the call abruptly hence limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extensive local reaction, redness, mostly, mild tender to R lateral thigh, likely site of TRIPEDIA injection.
Most likely an injection site reaction. Red, swollen, itchy, hard, about 1 1/2 in. diameter. Patient used ice. Swelling and redness did go down after about 1 week.
Pt reported experiencing heart racing, extremity weakness  and redness on skin in neck and upper chest area. Pt reported that symptoms were relieving within approximately 5 minutes of injection. Pt was observed for additional 45 minutes. Pt then reported that she went home and took a Benadryl and felt completely better within an hour of taking Benadryl.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 06-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the second time was 1172 hours with the lowest recorded temperature of -3 Celsius degree. The total cumulative excursion time of the third time was 16 hours with the lowest recorded temperature of 30 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Immediately upon receipt of H1N1 vaccination IM, child's head fell back, eyes rolled up, went limp and unresponsive, very pale, pulse thready, heart rate WNL. After 5-6 seconds, child began gasping and regained consciousness.  He was in no respiratory distress, but was diaphoretic, clammy and pale, c/o "not feeling well" and being tired. Rescue called, paramedics assumed care of child and ultimately transported to ED.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-395985 (Patient Link).
On Monday Nov 2, 2009 received H1N1 vaccine IM. On Nov 2 at 5pm began with adverse reaction. Took Benadryl that evening. Next day rash became worse and did seek Tx in ER. Had rash and hives to chest, arms and back. Treated with Decadron 8 mg IM in ER and was given prescription for Medrol Dose Pack.
Local soreness, nausea (briefly), heavy fatigue/dizzyness (36+ hours),  mild fatigue (several days)  Breakthrough covid ~ Aug 5th, loss of smell/taste (all but 'rot' smells lost), severe fatigue, short memory loss, headache/lightheaded.  Frequently forgot what/where I was going.. eg. why am I in the kitchen. Very dry but stuffed nasal.  My son also had covid, lives with me, full loss of taste smell, severe fatigue, memory issues, headaches, plus very runny nose.  Rapid Test positive. Same injection symptoms, worse nausea, but shorter recovery. (Same day/place).  My  son  had no symptoms, also lives with me. No test. No injection symptoms outside mild local soreness. (Same day/place)
Patient had a doctor's visit yesterday and complained that she has been having soreness and pain on left shoulder about two days after the first dose of Shingix.
This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. The patient's medical history included dizziness and syncope. The patient's concomitant therapies included VYVANSE. No information was provided regarding the patient's concurrent conditions. On an unspecified date in 2013, the patient was vaccinated with all three doses of GARDASIL. On an unspecified date in 2014, the patient complained of dizziness, tachycardia, shortness of breath and chest pains. The patient went to two different Hospitals, nevertheless, the reporter did not know when the patient went to these hospitals and did not know if the patient was admitted to either hospital or not. The physician sent the patient to a pulmonologist, a cardiologist and a gastroenterologist for medical attention. On an unknown date, the following laboratory tests were performed : X-ray, Holter monitor, echocardiogram, "tested for Lyme disease" nevertheless, no results were provided. At the time of the report, the outcome of dizziness, chest pain, dyspnoea and tachycardia was unknown. Additionally, the reporter did not provide causality assessment between the events and vaccination with GARDASIL.
HERPES ZOSTER IN A VACCINEE. CLINICAL DIAGNOSIS ONLY. STRAIN TYPE UNKNOWN. UNCLEAR IF RASH WAS DUE TO  VACCINE STRAIN REACTIVATION OR WILDTYPE REACTIVATION