chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness; A spontaneous report was received from a consumer concerning a 72 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event vaccination site pain.  ~ The patient's medical history was not provided. No relevant concomitant medications were reported.   On Date 19-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) in the left for prophylaxis of COVID-19 infection.   On date 19-Jan-2021, the patient experienced the event Soreness at the injection site which stopped on 22-Jan-2021.   Laboratory details was not provided.   No treatment information was none.   Action taken with mRNA-1273 in response to the events was not reported.   On date 22-Jan-2021, the outcome of the event soreness at the injection site was resolved/ recovered.
For 15 hours, pain radiating from injection site, up arm to shoulder and down arm to fingers. Ice and 500mg Motrin are helping with comfort
Approx 2.5 hrs after vacc. into L deltoid, pt had increasing discomfort. She had increasing pain into the night with diff. sleeping. She had c/o L lateral neck pain, decreased L arm range of motion, some swelling over injection site, but no redness. Today, neck feeling better, but onset of some left conjunctivitis. She has not taken any medication today.
Patient received Zostavax 2/4/14 and began to develop itching, redness, somewhat firm area to posterior left arm on 2/6/14.
Patient's mother reported that child had a small bleed after needle was removed pressure and cotton ball was applied by RN. The child removed band aid at 48 hrs, a small soft blister was seen approx 10mm away from injection site.
So on Jan. 13, I started developing severe itchiness all over my upper extremities, my back, arms, this happened back and forth for about two weeks I would say, I started using an over the counter steroid, it did not get any better, so started using Benadryl and topical Benadryl, as well, and like two week later it was not getting better but worse and I would get like whelps on my body from where I scratched at. Then the two weeks after it started is when I contacted my doctor. I sent him picture and he said it was hives and he seen a few cases where patients developed hives after the vaccine, so he prescribed me a prescription steroid cream for the neck down for two weeks, and Zyrtec once a day and Benadryl as needed which is like 4 times a day. I did all of that and I stopped taking the cream because I was only supposed to take it like for those two weeks. Since then, I now only take the Benadryl 2-3 times a day and it has gotten better but if I don't take it the hives began to spread down my legs and lower part or my body as well.
Patient developed Guillain Barre Syndrome. Proximal upper and lower extremity weakness.  12/15/09 and 12/17/09 HMO PCP Medical records and hospital records received. Service dates 11/30/09 to 12/13/09. Assessment: Botulism vs Guillain-Barre Syndrome. Patient presents with progressive muscle weakness, recently ate uncooked salmon and peanuts, drank honey. Headaches. Difficulty walking, chewing, swallowing, and dressing. Unable to raise arms. Chills. Decreased strength facial muscles, proximal muscles shoulders and lower extremities. Reflexes decreased. Numbness feet and hands. Slurred speech. Facial droop. Botulism Trivalent Antitoxin administered. Fall. Plasmapheresis. IVIG. Unable to tolerate IVIG. Using Walker Tachycardia when ambulating.
exercise induced hives. began day 2 after vaccination.  responded to anti-histamins but recurred for three consecutive days to date
After administration of vaccine, we were notified by Agency that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of CDC guidelines that recommend revaccination.  Patient returned on 10/21/2022 for revaccination.
Patient was complaining of being light headed, sweaty, and he stated his arms were feeling numb and that he could not feel his legs. We laid him on the floor and he started to shiver and said he was cold. We monitored his pulse and contacted emergency services. An ambulance came at 10:45 AM and they asked which vaccine he was given and took over care of the patient. We gave the paramedic the EUA facts sheet for the Johnson & Johnson vaccine and they took the patient.
Arm pain, severe body aches, headache, severe nausea, chills, shakes, 101.8 temperature, no appetite.  Lasted for approximately 36 hours.  Tylenol was given for symptoms every 4 hours.
The pt had his vaccines at 10:00 and at 1:30 vomited 3 times. Mom states that he appeared to be choking or vomiting and when mom picked him up he was staring ahead and would not respond to her voice or shaking. This lasted for approximately 1 minute. No color change and breathing did not stop.
received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to-MODERNATX, INC.-MOD-2021-363460 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-363460:Cross linked case/ Master case
Formation of large bruising near injection site (continues to grow) similar to instances of improper blood draws
first dose of Shingrix in 2018/ Two months ago (April 2021) she received the second dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date in 2018).   In April 2021, the patient received the 2nd dose of Shingrix (intramuscular). In April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lenghtening of vaccination schedule. The patient asked the pharmacist to restart the series and to schedule her for a third vaccine, but the pharmacist refused to administer a third vaccine.  The reporter consented to follow up.
Armpit pain, pain in back at shoulder blade, pain down arm, unable to make a fist, pain at elbow.  Unable to use my arm and hand effectively due to pain and lack of being able to control muscles in hand.
Left deltoid red, swollen - no itching of arm. Itching abdomen. BENADRYL 25 mg po given.
tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; given water& crackers - lightheadedness subsided but states is itching all over; offered to call 911 - refused. stated is going to primary care physician. total observation 45 min
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
Right lower leg cramps; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9810) in the left arm on 09Feb2021 at 16:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had a known allergy to codeine. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249) in the left arm on 19Jan2021 at 14:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  On 10Mar2021 at 13:00, the patient experienced right lower leg cramps. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of lower leg cramps. On 28Dec2020, the patient underwent a nasal swab COVID-19 test and the result was negative. The clinical outcome of the event right lower leg cramps was recovered with lasting effects on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient received Moderna Covid-19 vaccine as third dose for booster instead of Pfizer vaccine. Patient had been previously vaccinated with Pfizer Covid-19 vaccine for first 2 doses.
Received dose 2 of Moderna vaccine Wednesday morning and had expected symptoms (fever, chills, muscle aches, upset stomach) then Saturday developed an oblong patch of red (2-3 inches long, 1 inch wide) on my right arm about 4 inches below the injection site. The patch was bright red and very tender, as if abraded. Then Sunday night discovered hives on my chest, shoulders, arms, and upper back, down to my rib cage. None below that. Took a benadryl. Monday morning, hives were worse and now down my trunk, onto my thighs and calves in addition to upper body.
The symptoms were similar as what I had both when I had COVID 19 in November 2020 and who I had the first vaccine.  The evening of the (5/4/21) shot I felt achy, feverish and had the chills.  I had difficulty sleeping the first night and my left arm ached severely.  I took Tylenol to relive all of the discomfort.  The day after the shot (5/5/21) I didn't feel well, and took some Tylenol, upon starting to feel feverish.  In the morning I could function normally until about 3:00 pm, when I was very fatigued, achy and had a mild fever, and chills. I continued taking Tylenol, and slept from about 4:00 pm through the night. The third day (5/6/21), I felt better but still fatigued.  The achiness and chills were gone. However that evening I felt a bit feverish.  The fourth day (5/7/21) I felt 100% back to normal. Subsequent days I have some fatigue in the afternoon but am not sure it is related to the vaccine.
moderate to severe malaise for almost 48 hours; aches; fever up to 103; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (moderate to severe malaise for almost 48 hours), PAIN (aches), PYREXIA (fever up to 103) and CHILLS (Chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Foramen ovale patent since 01-Aug-2019, Menopause since 01-Oct-2020 and Multi-vitamin deficiency since 01-Oct-2018. Concomitant products included ACETYLSALICYLIC ACID (ECOTRIN) from 01-Aug-2019 to an unknown date for Foramen ovale patent, PROGESTERONE from 01-Oct-2020 to an unknown date and ESTRADIOL (VIVELLE DOT) from 01-Oct-2020 to an unknown date for Menopause, ASCORBIC ACID, CALCIUM, MAGNESIUM, SILICONES NOS, VITAMIN D NOS (OSTEO [ASCORBIC ACID;CALCIUM;MAGNESIUM;SILICONES NOS;VITAMIN D NOS]) from 01-Oct-2018 to an unknown date for Multi-vitamin deficiency.   On 06-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (moderate to severe malaise for almost 48 hours), PAIN (aches), PYREXIA (fever up to 103) and CHILLS (Chills). At the time of the report, MALAISE (moderate to severe malaise for almost 48 hours) had resolved and PAIN (aches), PYREXIA (fever up to 103) and CHILLS (Chills) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: up to 103 (High) up to 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported   This case was linked to MOD-2022-469510, MOD-2022-461325 (Patient Link).
Got pain in the arm, just a little in the area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Got pain in the arm, just a little in the area".  Additional information: While the caller was reporting AE/ MI with the COVID vaccine and PCs on two other products. During this report she mentioned: Her son's wife lives in the same house as the caller and she got the Pfizer COVID vaccine and she got pain in the arm, just a little in the area. Caller declined to complete a report on her son's wife. Unable to obtain further details.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"shooting pain down right arm" / shooting pain through both legs; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles). Previously administered products included shingles vaccine (received year ago). Concurrent medical conditions included tick bite (tick bite of the stomach).   On 11th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.Additional details were provided as follows: The patient received Shingrix in the left arm and within a day she had shooting pain down the right arm. The patient reported that after a tick bite of the stomach, she had shooting pain through both legs. The patient had shingles before receiving the Shingrix vaccine and had other shingles vaccine years before receiving Shingrix.  The patient was unable to confirm the name of the other shingles vaccine.  The patient gives consent to follow up with doctor.  The patient unable to provide lot number and expiration date from dose but was able to provide NDC number. The reporter consented to follow up. The NDC Number reported as 58160082311.
Passed out and broke foot; broke foot; lightheaded; Massive headache and couldn't lift her head up; Not feel good; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out and broke foot) in a 65-year-old female patient who received mRNA-1273  (batch nos. 025B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced FEELING ABNORMAL (Not feel good). On 06-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out and broke foot) (seriousness criteria medically significant), FOOT FRACTURE (broke foot), DIZZINESS (lightheaded) and HEADACHE (Massive headache and couldn't lift her head up). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out and broke foot), FOOT FRACTURE (broke foot), DIZZINESS (lightheaded) and HEADACHE (Massive headache and couldn't lift her head up) had not resolved and FEELING ABNORMAL (Not feel good) outcome was unknown. Not Provided      For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included medication for thyroid. Treatment information included for an events Advil and Aleve.  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.    Sender'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.
HEART ATTACK; This spontaneous report received from a consumer via a company representative through social media and concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack. The reporter stated that "My daughter had a stroke and her friend had heart attack after their shot" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221146283.; Sender's Comments: V0-20221143337- Heart Attack. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable
Immediately after receiving the immunization, she had pain in the left upper arm at the injection site (like she normally has after an immunization).  However, the pain has persisted in the left upper arm and shoulder.  Abducting the left shoulder is painful.  Range of motion of the left  shoulder has decreased due to the pain.  Pain has worsened in the past week.
5/22/06 Had swollen glands- neck and front of ears went to MD. Had blood tests(?) and put on antibiotics.  5/24/06 rash all over body. MD took him off antibiotics and told him all his blood work was OK. He had headaches and some dizziness."no fever or sore throat".
booster; large blood clots in her pulmonary artery. Clots were also found by her knee.; passed out twice one morning; difficulty breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 08Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unspecified dose.), for COVID-19 immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "large blood clots in her pulmonary artery. Clots were also found by her knee."; LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "passed out twice one morning"; IMMUNISATION (hospitalization, medically significant) with onset 08Nov2021, outcome "unknown", described as "booster"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "difficulty breathing". Therapeutic measures were taken as a result of thrombosis, loss of consciousness, dyspnea.  Clinical course: After receiving her booster shot on 08Nov, she started to experience difficulty breathing. Around 4 weeks later, she passed out twice one morning. She went to the hospital where they performed emergency surgery to remove large blood clots in her pulmonary artery. Clots were also found by her knee. Now needs lovenox injections and still being monitored.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Right knee pain, very terrible joint pain to the point where I couldn't sleep.  Ibuprofen didn't help.
Teen had syncopal episode after taking 2 steps when she got off the exam table - 11 feet and hit head against door frame. BP was low and remained low for about 10 minutes.
Pt recv vax on 3/9/99; on 3/10/99 pt exp swollen/ warm/ sore vax site; tx=cold packs &warm compress, Tylenol
Had delayed hypersensitivity on the right arm  which swelled from shoulder to elbow; Which swelled from her shoulder to elbow; This spontaneous case was reported by a nurse and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Had delayed hypersensitivity on the right arm  which swelled from shoulder to elbow) and PERIPHERAL SWELLING (Which swelled from her shoulder to elbow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Had delayed hypersensitivity on the right arm  which swelled from shoulder to elbow) and PERIPHERAL SWELLING (Which swelled from her shoulder to elbow). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Had delayed hypersensitivity on the right arm  which swelled from shoulder to elbow) and PERIPHERAL SWELLING (Which swelled from her shoulder to elbow) outcome was unknown.        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.   Concomitant medications were not provided.  Treatment information was not provided. It was reported that seven days after her first dose in the right arm, she had delayed hypersensitivity on the right arm which swelled from her shoulder to elbow.   This case was linked to MOD-2021-408575 (Patient Link).