chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 steps after receiving the injection, the ptient had to sit down; Felt warmth at the injection site; Armpit warmth; Leg warmth; Chest warmth; Tasted something; Heart raced; Feels hyped; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (5 steps after receiving the injection, the ptient had to sit down), VACCINATION SITE WARMTH (Felt warmth at the injection site), FEELING HOT (Armpit warmth), FEELING HOT (Leg warmth) and CHEST DISCOMFORT (Chest warmth) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced GAIT DISTURBANCE (5 steps after receiving the injection, the ptient had to sit down), VACCINATION SITE WARMTH (Felt warmth at the injection site), FEELING HOT (Armpit warmth), FEELING HOT (Leg warmth), CHEST DISCOMFORT (Chest warmth), TASTE DISORDER (Tasted something), PALPITATIONS (Heart raced) and FEELING ABNORMAL (Feels hyped). On 28-Feb-2021, GAIT DISTURBANCE (5 steps after receiving the injection, the ptient had to sit down), VACCINATION SITE WARMTH (Felt warmth at the injection site), FEELING HOT (Armpit warmth), FEELING HOT (Leg warmth), CHEST DISCOMFORT (Chest warmth), TASTE DISORDER (Tasted something) and PALPITATIONS (Heart raced) had resolved. At the time of the report, FEELING ABNORMAL (Feels hyped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Urticarial rash which developed the night the vaccines were given approx. 12 hrs later. Treated with Atarox.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Vials stored in the refrigerator on 22-Sep-2021. No temperature excursions and no adverse event were noted.  Treatment details was not reported by the reporter.
Pt developed a low grade fever one day post vax which resolved within 12 hours. Six days post vax the pt developed a red, papular rash that is spreading from face to the torso.
Agency completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dosep 01/07/21, Pfizer,Lot#EL3248 2nd dose:01/28/21 Pfizer,Lot# EL3248 Diagnosed covid positive:04/26/21 Exposure;Travel. Symptoms:Asymptomatic
Severe flu like symptoms including fever/chills, nausea and extreme body aches. On day 4, the body aches are intolerable. Severe skeletal aches and pains that are persistent, feeling like I?ve been in a car accident and each bone has been broken. Mild to strong nausea and chills. Extreme weakness. This is the most sick/in pain I?ve ever been in my life.
pt recvd vax & tested pos for hepatitis; is not sure which markers were reported as pos;
Every time I eat meat I get diarrhea, short of breath, and shakes. It feels like a panic attack. It doesn't apply to bacon. I went to the doctor, and he didn't know what it was. He did the allergy test and meat didn't come up. He referred me to a gastroenterologist.
Pt came to ER c/o headache and fatigue.  Onset one day prior.
received vaccine and stood up.  During walking out of room, fainted and potentially had seizure as she fell.  Head hit the ground.  Stayed awake, alert after she fell.  Generally knew who, what, when, where and that she just had vaccine.  EMS called who arrived and transported to ER for evaluation.
Dose #3 given too soon.  Dose #3 given 8 weeks from Dose#1 (not dose#2).   Family will be notified.  Pt doing well.  No adverse affects as have been reported.
Had difficulty getting up, redness and soreness on vaccination site, slight fevere for 2 days. Given an ice pack today 11/25/16 and advised to take Benadryl.
Adverse effects lasted 8 hours (until about 6AM). Significant discomfort throughout the night, restless sleep, woke up multiple times. Started having extreme fatigue (really difficult to move around) and then I started having something that felt like sinus pressure/pain. Headache began from the middle of my forehead and went around the sides and back. Got really cold, then got really hot while going to bed. Continued feeling very hot (feverish) throughout the night. Felt like the flu. When I woke up I felt relatively fine other than being fatigued for the entire day.
developed cough and muscle aches on 11/02/2021. Symptoms worsened and admitted to hospital on 11/09/2021. NO ICU, no ventilation.
Patient stated, "Dizziness, shakiness, chest discomfort, and throat tightening", treated in Emergency Room with dexamethasone and Benadryl , as well as receiving cardiac monitoring and monitoring of O2 sat along with vital signs.
Anaphylaxis, severe body rash with hives that?s spread all over upper and lower body, along with neck and face.
Presented  with SOB; Admitted 9/26 to medical with CHF exac and Covid PNA; tx with zinc, singulair, steroids, O2 @ 2 LPM initially COVID-19 Pneumonia with acute hypoxic respiratory failure and without sepsis Patient presented with SOB and hypoxia and tested positive for COVID on 9/26, symptom onset for several weeks. Patient placed in airborne isolation and started on supportive care as below.Stable at the time of dc. Admission O2 needs: 2 LPM via NC Current O2 Needs:none, adequate sats on RA Zinc / Singulair / Antitussives received while in house  Steroids: Dexamethasone  (6mg daily) - to complete upon dc  Remdesivir: Deferred due to timing of onset of symptoms Convalescent Plasma: Deferred due to timing of onset of symptoms Tocilizumab: Deferred due to limited O2 needs or lack of cytokine storm Anticoagulation: On eliquis
Pruritic, urticarial rash, 2.5 hrs after Hep B immunization given, 6th Hep B shot given, Non-responder to first series, given Zyrtec and Tylenol.
So tired and sleepy; So tired and sleepy; swollen face, neck, hands, lower legs; swollen face, neck, hands, lower legs; swollen face, neck, hands, lower legs; headache; aching muscles, bones and joints (could hardly turn over in bed); aching muscles, bones and joints (could hardly turn over in bed); aching muscles; Fever; chills; Stayed in bed all day; With 1st shot had 2 full days of flu-like side effects, but this 2nd shot was so much worse; With 1st shot had 2 full days of flu-like side effects, but this 2nd shot was so much worse; This is a spontaneous report received from a contactable consumer (patient). The 76 years old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number: EN6207) via an unspecified route, administered in left arm on 18Mar2021 at 11:00 AM (76-year-old at vaccination) as Dose 2, Single for Covid-19 immunization. Facility of most recent COVID-19 vaccine was administered was reported as Other. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetic, blood pressure, thyroid, cholesterol, arthritis. There were no allergies to medications, food, or other products. The patient's concomitant medications were included insulin, levothyroxine, losartan potassium (LOSARTIN) and metoprolol within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number EN6200) via an unspecified route, administered in left arm on 23Feb2021 at 11:45 AM (76-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. With 1st shot had 2 full days of flu-like side effects, but this 2nd shot was so much worse. The patient stated that her blood type as A-positive and enquired if that could be bearing with flu-like side effects. On 19Mar2021, the patient experienced fever and chills all night, aching muscles, bones and joints (could hardly turn over in bed), headache. On 20Mar2021(next morning) the patient had swollen face, neck, hands, lower legs, stayed in bed all day. The patient haven't left home for 5 days. The patient was slowly recovering. She was so tired and sleepy. Since vaccination the patient was not tested for covid-19. The patient did not receive any treatment medication for resulted events. The outcome of events flu-like side effects and condition aggravated was unknown and the outcome of other events was recovering.  No follow-up attempts were needed. No further information was expected.
Pt reports approximately 20 minutes after vaccination she started experiencing tingling in the arm the vaccine was administered in. She states that she started feeling funny like she was intoxicated and decided to go home from the school she was at. Patient reports that by the time she got home she could no longer lift the affected arm and that she her speech was slurred. Patient reports that she contacted her sister in law who is a nurse and told her to take some benadryl. Pt reports an hour later she had no remaining symptoms.
Client stated she received a Td Booster Monday afternoon (6/3/02), due to hand injury. Client has received Td in the past and only experienced soreness around injection and swelling. Shortly after receiving Td Booster on 6/3/02, client experienced shooting pain in arm and neck, low grade fever that evening. Has taken ibuprofen and muscle relaxants on 6/3/02 and 6/4/02. On 6/5/02 still having severe pain and nausea. Referred to physician.
(1) Raynaud Phenomenon left hand on 3-17-08 (2) Pain (L) elbow- 3-15-08 on 3-16-08 (3) Pain (L) shoulder 3-20-08
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: (currently under control with diet and without medication).; "Had nonalcoholic fatty liver disease" (unspecified if ongoing), notes: Had nonalcoholic fatty liver disease but recently reversed through diet.; "Gall bladder disease" (unspecified if ongoing), notes: Gall bladder disease; "Gall bladder disease; removed in 2007.", start date: 2007, stop date: 2007, notes: Gall bladder disease; removed in 2007. The patient had no known allergies. Concomitant medication(s) included: AMBIEN, start date: 01Jan2017; ATORVASTATIN, start date: 01Jan2019, stop date: 14Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
FEVER LIKE SYMPTOMS; This spontaneous report received from a health care professional concerned a male of unspecified age. 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 not reported, batch number: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-MAR-2021, the subject experienced fever like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever like symptoms on 09-MAR-2021. This report was non-serious.
heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (heart inflammation) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (heart inflammation) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (heart inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
This spontaneous report was received from a pharmacist referring to a currently 61 years old female patient. The patient had no pertinent medical history besides a sulfa allergy. On 23-MAR-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU lot # L032399 expiration date 26-NOV-2016 in the arm (route and dose unknown). The patient's concomitant medications included PROTONIX, levocetirizine, vitamin D, venlafaxine hydrochloride and Naproxen. On an unknown date, patient developed a localized reaction on her arm where ZOSTAVAX was administered. The patient also stated, she had a rash on both legs following the administration of ZOSTAVAX. On an unspecified date, the patient sought for attention with the pharmacist but no treatment was provided for the adverse event. Laboratory diagnostics studies were not performed and no product quality issue was involved. At the time of report, the outcome of vaccination site reaction and rash was reported as not recovered and relatedness between the adverse event and vaccination with ZOSTAVAX was not provided. Additional information has been requested.
High fever (103 plus), shivering, aching joints, freezing cold. Lasted about 12 hours. This was second dose of the two vaccination series. I had an identical reaction after the first dose (June 2018). Second dose was 11/8/18. First dose reaction resulted in trip to ER for fainting secondary to severe dehydration. Did not report to HHS although did report to physicians office.
This case was reported by a consumer and described the occurrence of nausea in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, exhaustion, fever and influenza. On an unknown date, the outcome of the nausea, exhaustion, fever and influenza were unknown. It was unknown if the reporter considered the nausea, exhaustion, fever and influenza to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had horrible side effects, including nausea, exhaustion, and a high fever of 101. The patient literally could not get up, she was so exhausted, like the worst flu she had. This case has been linked to the US2018GSK182295, reported by the same reporter.
Child had red blood in bowel movement.  Child was fussier then usual. Child continues to have red blood in bowel.  Child is breastfed only.  Has never had a reaction to mothers milk other then to citrus foods. Mother was advised to watch diet.  She went on a elimination diet for 8 days and there was no change to bloody bowel.  Bowel may be bloody for a week at a time then no blood for 2 days then it will return.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE vaccine for prophylaxis. On 27th September 2018, the patient received the 1st dose of SHINGRIX 50 µg and FLUZONE vaccine. On an unknown date, less than a year 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 case was reported by patient's wife. The patient received the vaccines one in each arm. The patient experienced soreness in both arms with both the vaccines. For tolerance of dose 2 refer case US2019GSK027918.
12 yo female with increased redness, swelling induration 48 hrs after vaccine given- (Tdap) with increased pain. 3.2 x 4.5cm area of induration no redness no fever.
outbreak after the first dose; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, 56 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced an outbreak after the first dose of shingrix. The physician assistant needs information on Shingrix dosing schedule. The reporter consented to follow up.
not feeling well / Malaise; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (not feeling well / Malaise) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL for Pulmonary arterial hypertension and TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 10-Feb-2022, the patient started TREPROSTINIL (Oral) at an unspecified dose. On 10-Feb-2022, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 3.125 milligram three times a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 2.5 milligram. On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .25 milligram and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .125 milligram. In May 2022, the patient experienced MALAISE (not feeling well / Malaise). At the time of the report, MALAISE (not feeling well / Malaise) 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 considered MALAISE (not feeling well / Malaise) to be related.    No concomitant medication was reported. The reporter did not provide causality for the event of malaise with PO Orenitram. No treatment medication was reported.
Pt came in for a physical and stated she wanted a Hep A because she was traveling. I forgot we only had pediatric Hep A and gave her that one.
Starting on March 13, I noticed the injection site was extremely red and swollen. On March 14 the muscle stiffness had moved from the injection site to my left shoulder. The muscles felt tight and bruised. The following morning, March 15 @ 10:30 a.m, the same pain has spread to my upper chest, around the collar bone. The area around also appears to be swollen, most noticeable on the neck. This is all accompanied by headaches increasing in severity as well as extreme exhaustion.
On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullness or pressure in my left ear, mild sinus congestion, and chills. The congestion and chills ended after one day, but the feeling of fullness in the ear has persisted to this day. Then, on January 29, I had a bout of positional vertigo and vomiting that lasted two to three hours. I also experienced ringing or roaring in my left ear. Ever since, I have a bout of vertigo approximately every 24 hours, and the ringing and sense of fullness in the ear ebb and flow on 24 hours cycles as well. This experience has been debilitating and affected my ability to work. My doctor has diagnosed Meniere's disease and says he has been seeing similar symptoms apparently linked to the COVID vaccines. I started taking prednisone on doctor's orders yesterday (February 5), which has stopped the vertigo. Ringing and occasional fullness in the ears persist.
After vaccination, the father of the patient who was with her at the time said she wasn't feeling well. He said she feels squeamish from needles. At the time of the vaccine she was sitting down during the vaccination. She did not mention any issues with vaccines prior to vaccination. She walked to the bathroom. I approached the patient who said she wasn't feeling well. Her face looked very light in color compared to the rest of her body. I asked if she thought she was going to pass out. She said yes. She was sitting on the floor. I told her to lay down and got her a cold compress to put on her forehead. She laid down for about five minutes and then proceeded to feel better. Ten minutes later she.
36 hours of headache and neck pain; neck stiffness; headache; 36 hours of headache and neck pain; a fever of 101.5-101.6; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (36 hours of headache and neck pain), MUSCULOSKELETAL STIFFNESS (neck stiffness), HEADACHE (headache), HEADACHE (36 hours of headache and neck pain) and PYREXIA (a fever of 101.5-101.6) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NECK PAIN (36 hours of headache and neck pain), MUSCULOSKELETAL STIFFNESS (neck stiffness), HEADACHE (headache), HEADACHE (36 hours of headache and neck pain) and PYREXIA (a fever of 101.5-101.6). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. On 14-Mar-2021, PYREXIA (a fever of 101.5-101.6) had resolved. At the time of the report, NECK PAIN (36 hours of headache and neck pain), MUSCULOSKELETAL STIFFNESS (neck stiffness), HEADACHE (headache) and HEADACHE (36 hours of headache and neck pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 101.5-101.6. (High) 101.5-101.6..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant was provided.