chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THERAPEUTIC RESPONSE DECREASED; ACHY; SHIVERING; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 51 year old female. 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: 1808978, and expiry: 13/JUN/2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, Laboratory data included: Antibody test (NR: not provided) no antibodies. On 30-APR-2021, Laboratory data included: Antibody test (NR: not provided) no antibodies. On an unspecified date, the subject experienced therapeutic response decreased, achy, shivering, chills, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F, 103 F, and MRI (NR: not provided) no blood clots. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy, fever, shivering, chills, headache and therapeutic response decreased was not reported. This report was non-serious.
beginning about 16-17 hours after administration, patient had severe chills. She sat in 86 degree shower for 28 min, stood in front of a fire, wore thick clothes with 2 blankets - she could not stop from freezing no matter what she did. I told her to take a temperature and informed her that normally these reactions occur more so after the second dose. I'm not sure if they were so severe the first round because she had covid? I advised her to follow-up with a walk-in if her symptoms became to severe.
Rash soon after injection locally, resolved after 1-2 hours. Over next several weeks, a pruitic rash occured for approx 1/2 hour daily at various times at injection site. Per pt he has had same reaction with each injection of anthrax vaccine he has received but never reported.
this is 1 of 6 pt from this site to have an unspecified adverse exp p/vax;pt treated w/ATB;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX on 11-NOV-2012  that had expired on 01-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome of expired vaccine used is unknown. Expired vaccine used is not related to ZOSTAVAX. Additional information has been requested.
Headache, Myalgia, fatigue Narrative:  Employee reported moderate headache 02/05/21, mild muscle pain 02/05/21, moderate fatigue 02/05/21. Resulted in 1 day unable to work. Did not seek medical attention for symptoms.  Other Relevant History:
Received 2 doses in 2 days; A spontaneous report was received from a physician concerning a patient of unspecified age and gender, who received one dose of Moderna's COVID-19 vaccine (mRNA-1273) and then received another dose on the next day/inappropriate schedule of product administration.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On the next day, after the first dose, the patient received the second of two planned doses of mRNA-1273 (Batch Number: unknown) for prophylaxis of COVID-19 infection. No treatment information was provided.  The reporter stated to his knowledge the patient did not experience any complications.  Action taken with mRNA-1273 in response to the event was unknown.    The outcome of the event, received two doses in two days, was considered as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
pt recv vax & exp pain in the periumbilical area & hard stool;CXR was performed & was nl;pt was referred to cardiologist;
Temp. to 104. Fever greater than 48 degree - not sure if resolved yet. Myalgias. Sensation of weakness but fine when up moving.
Day after receiving shot, client developed a stiffness in his neck.  Denies much pain, but describes it as sleeping crooked. states it feels like it would feel better if it would pop, but it won't.   Never had neck problem before.  Called his MD and got to speak with nurse. She told him it would go away and did not give him an appointment for evaluation.   If he takes Ibuprofen, feeling resolves, but returns.  Asked him if he felt like he had swollen lymph nodes.  Client stated he did not know how to check.  Advised to call MD and ask for evaluation for a condition that has been going on for 63 days.  Client was asked to call for F/U once he sees MD.
c/o blurred vision rt eye, 24hr p/vax which lasted 1/2hr then was gone;
Vertigo; fell on our dog cage because he lost his balance; fell on our dog cage because he lost his balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 13:00 (Lot number: ER8732) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset 01May2021 23:30, outcome "unknown", described as "Vertigo"; FALL (non-serious), BALANCE DISORDER (non-serious) all with onset 01May2021 23:30, outcome "unknown" and all described as "fell on our dog cage because he lost his balance". The event "fell on our dog cage because he lost his balance" and "fell on our dog cage because he lost his balance" was evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.
C/O LOWER LEFT SIDED CHEST PAIN FOR OVER 1 WEEK, MILD AT ONSET BUT INCREASING IN SEVERITY. ON 15JULY HAD SOME TEETH EXTRACTED. WHILE WAITING FOR HIS PRESCRIPTIONS PASSED OUT. HE WAS TREATED IN ER AND RELEASED. RETURNED WITHIN 24 HOURS WHERE AFTER A WORKUP, SENT TO A CIVILIAN HOSPITAL FOR CARDIAC CARE WITH THE DIAGNOSIS OF PERICARDITIS
Patient came in to get the annual influenza vaccine at 10:30 am. At 11:20 am he complains of itching arms, neck, and chest-similar reaction to morphine in the past. Blood pressure and Pulse regular. Patient declined Benadryl due to excessive drowsiness. One hour later patient seen at E.D. due to allergic reaction involving itching and minimal raised papular rash on arms. No wheezing, SOB, or voice changes. Patient discharged with Pepcid 20 mg every 12 hours, and Benadryl 25 mg 2 capsules every 6 hours as needed for itching.
Additional information provided patient demographics, change in adverse event, suspect vaccine, event details and test results. Information regarding PREVNAR was received from a healthcare professional regarding a female patient who experienced erythema mulitforme. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Additional suspect medication included PEDVAXHIB. Concomitant medications were not reported. The patient experienced erythema multiforme three days after being administered the vaccine. The patient was taken to the Emergency Room. The patient recovered. Physical examination (results: developmental milestone were within normal range: head circumference: 46 cm) was done on an unspecified date. See related case (s): US WYE H15204410 (adverse event, non expedited) and US WYE H15204510 (adverse event, non expedited). No additional information was available at the time of this report.
Balance was off; feel dizzy; Trouble talking last night; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel dizzy), DISORGANISED SPEECH (Trouble talking last night) and BALANCE DISORDER (Balance was off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced DISORGANISED SPEECH (Trouble talking last night). On an unknown date, the patient experienced DIZZINESS (feel dizzy) and BALANCE DISORDER (Balance was off). At the time of the report, DIZZINESS (feel dizzy), DISORGANISED SPEECH (Trouble talking last night) and BALANCE DISORDER (Balance was off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment was reported.   Reporter did not allow further contact
Five minutes after shot was administered, severe arm pain that lasted for about five minutes. After that, sore arm that night. Next day at 8 AM ,I had waves of nausea and sore neck and body. Around 2 PM ,(24 hours after injection) flu like symptoms started appearing and by 4 PM I had 100° fever and Bodyaches and flu like symptoms that were severe. Around 8 PM the following day from my injection I started to feel better but not fully recovered until 4/9/21. Not one to get sick often and the sickness and tiredness was severe.
About 10-15minutes after my 1st dose vaccine, I experienced a strong headache. When I stood up I felt dizzy and light headed and I felt like passing out. They took me to see a doctor and my face was flushed and red and I was sweating . They gave me Benadryl and I did not go to the ER and went home. The remainder of my day I still continued with headaches and the next day I felt better still felt light headed and these symptoms lasted two days.
The adverse effect is unknown. The nurse is not able to get a hold of the patient. The nurse is advised to keep trying to get a hold of the patient.
pt recvd vax; exp fever & fatigue & devel a papule on face; the next day, 20 widespread pox appeared on face & trunk;
DTAP (4TH)GIVEN TO CHILD ON 3/27/09 ON EXAM CHILD PRESENTED 12X8 ERYTHEMA, TENDERNESS AND WARMTH AT SITE OF INJECTION. (LOCAL SKIN REACTION TO INJECTION) WT 26#4OZ
Less than two hours after injection, patient (me) experienced novel flank pain on both sides of chest, wrapping around the sides. Immediately after the injection, patient shopped for groceries and went home: found it very painful to unload the groceries because of the flank pain. By evening patient had a fever of 102 (mercury thermometer), pain all over her body, including buttocks (also never had before) and joint pain. Shoulder that received injection was very sore and redness covered about 3-4 inches of upper arm.   Patient took 600 mg of  ibuprofen and went to sleep. In the middle of the night, woke with urge to urinate, but light headed and nauseated. After using the bathroom, passed out and hid head on tub, awaking on the floor. Returned to bed and woke with a lower fever and diffuse pain, which lasted all day. On the third day, awoke without fever. Pain was much less bad.  Cheek bone hurt from fall for about 4 weeks. Acute shoulder pain and redness lasted 1 week. Seven days after Shingrix was injected, developed a stinging rash on right cheek, an arc of pustules running from the corner of the mouth in the direction of ear. These dried out the next day and the rash healed over the next several days.
The patient reported his whole arms get red & swollen, especially around the elbow area where the shot was given. Saw MD & got antibiotics for infection. Patient also had low grade fever.
This spontaneous report was received from a medical assistant concerning multiple unknown patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L037554, expiry: 25-DEC-2017. There were no previous temperature excursion. The information on current excursions were as follows: Time/temperature for high excursion: 40 hours at highest 55.2 F (Fahrenheit). Time/temperature for low excursion: 456 hours at lowest 26.2 F. No adverse effects reported. No further information provided. This is one of two reports received from the same source. Additional information has been requested.
Fever, difficulty breathing, chills. Patient went to ER, seen, treated and released.
This case was reported by a healthcare professional and described the occurrence of injection site pain in an 18-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline).  The reporting nurse is the mother of the patient.  There were no concurrent medications.  On 09 April 2007 the subject received the first dose of Havrix (720 mIU/mL, unknown).  On 09 April 2007, less than one day after vaccination with Havrix, the subject experienced "severe" pain with injection, burning with injection, and shortness of breath.  The subject also experienced racing heartbeat.  At the time of reporting the events were resolved.
Headache, Diarrhea, Sore arm, runny nose, and no apetite Narrative:
Information has been received from 2 healthcare workers referring to a patient's medical history was not reported. On 14-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication war snot reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
When I caught COVID-19 I had cold and flu like symptoms. I also had tightness in my chest. I took cold and flu medicine. I talked to a doctor and he prescribed paxlovid for a 5 day course. On Saturday morning the tightness in my chest was gone. I also had a cramp or knot in my lower right calf.
Pt came to pharmacy today, she said that she got her Monderna Covid-19 vaccine (Spikevax) on 11/01/2023. Upon inquiring and looking at the vaccine site I observed redness, swelling & soreness (Local Reactions at Injection Site). Pt also mentioned that two days later on (11/03/23), she felt a single episode of dizziness (almost vertigo feeling) for a brief moment. She is feeling fine now.
coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing). At the time of the report, COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Around 6:30 pm pt had pain in RUE, where vaccine was administered.  Around 7, mother noted swelling of RUE.  Swelling progressed down R arm to mid forearm and was tense and tender.  By 2:30 am, no further swelling.  No hives, erythema, or respiratory symptoms.
pt recv vax 16JUN98 & later that evening devel hives on rt ankle & rt bicep;the hives were small round & a bit raised 9size of mosquito bites);reported itching for 4 days;pt felt impossible that is allerg react to strawberries;
Pt states after receiving 2nd Shingrix dose she was sick in bed for 24 hours with shaking chills, generalized body pain, neck + shoulders especially hurt. Missed important day at work.
Injection site reaction; Initial information was received on 27-May-2021 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional).  This case involves a 29 years old female patient who experienced injection site reaction while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical treatments, past vaccinations, concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Suspension for injection, lot number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious injection site reaction (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Laboratory data was not reported.  It is unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  There will be no information on the batch number for this case.
A feeling of a loss of circulation flushing through arms, face, and chest. Went to urgent care, an EKG was taken but symptoms were dismissed as irrelevant. Sensations  continued through the night and into the next day (still present but slightly dulled)
arm itching; arm hurt bad; arm was red; arm was hard; muscle pain; fever(low grade); vomiting; headache; chills; she started going in slow motion; felt very bad; felt like the flu; This spontaneous case was reported by a consumer and describes the occurrence of BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), PRURITUS (arm itching) and PAIN IN EXTREMITY (arm hurt bad) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), PAIN IN EXTREMITY (arm hurt bad), ERYTHEMA (arm was red), INDURATION (arm was hard), MYALGIA (muscle pain), PYREXIA (fever(low grade)), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills). On 19-Apr-2021, the patient experienced PRURITUS (arm itching). On 17-Apr-2021, BRADYKINESIA (she started going in slow motion), FEELING ABNORMAL (felt very bad), INFLUENZA LIKE ILLNESS (felt like the flu), MYALGIA (muscle pain), PYREXIA (fever(low grade)), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, PRURITUS (arm itching) had not resolved and PAIN IN EXTREMITY (arm hurt bad), ERYTHEMA (arm was red) and INDURATION (arm was hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines include Vitamins  No treatment medications were provided.  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: On 22-May-2021: Follow up received (Source document-not readable)
Site redness noted that did not resolve with ice, rest, or Benedryl.  No swelling noted at throat.  Site continued to worsen until mom took child to PMD and was dx with cellulitis and prescribed AB
I had my intern giving COVID-19 shots yesterday. This was the first one of the day. I asked her if she has done COVID shots before and she claimed she had. She said she has done them for her employer. I told her where she could find the vial of vaccine as well as the diluent supplied to reconstitute it. After giving the first shot, I asked her if she drew up the remainder of doses from the vial. She told me no, that it was just the single dose vial. I then asked her if she added the saline diluent, and she said no. She ended up injecting the full 0.45 ml of undiluted vaccine. I spoke to the patient 24 hours after the shot and she was experiencing the normal adverse reactions of injection site pain and joint pain. No other adverse reactions were reported.
7 days after vaccine, 1/20/2021 shot site red, itchy, and raised.  1/21/2021 entire shoulder swollen, itchy, hot to the touch. Began antihistamine and anti-inflammatories. 1/22/2021 area still hot to the touch, spread past previous borders but not as swollen. The nurse, returned call and asked me to report as an adverse reaction and ask for protocols.  Left message but have not gotten a response.  Antihistamine and anti-inflammatory continued to present, 1/25/2021, area still red and warm to the touch, progressed around bicep area,
Evening after vaccine she experienced soreness, by next AM: swelling, redness, soreness at site. No fever. Symptoms decreased but not gone by day 3.
No known adverse effects at this time.  Patient received a single dose of Moderna that had been at room temperature since 10:15AM on 08/08/21, he was given the dose at 12:05PM on 08/09/21.
Left Thigh 8 cm x 14 cm red area with pale center.  No pain, no fever, no swelling.    Right Thigh  3 cm x 4 cm red area.  No pain, no fever and no swelling. Immunizations administered on 06/05/2008.  Prescribed Benedryl.