chrisvoncsefalvay/vaers-outcomes huggingface dataset:
*Vomiting and diarrhea by 4:30pm *Headache by 6:30 *Fever of 101.3 by 10:00 continued until 4:00am on January 22 *Extreme fatigue for 24 hours *muscle pain and weakness for 24 hours
This case was reported by a other health professional via call center representative and described the occurrence of injection site discomfort in a elderly male patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site discomfort. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site discomfort was recovered/resolved. It was unknown if the reporter considered the injection site discomfort to be related to SHINGRIX. Additional details reported as follows: The caller was GlaxoSmithKline employee from R and D that was made aware of two individuals who received SHINGRIX. The consumer here reported injection site discomfort with both doses. First dose received two months ago and his last shot on 3rd August 2018. The employee reported he first heard of these events this week. Employee would reach out for additional info and encourage consumer to call. This case has been linked with US2018144842 and US2018144839, reported by same reporter and linked with case US2018144841 (reported for same patient for 1st dose).
Felt very tired and achy all over on 29-April-2021.  30-April-2021, large lump in left arm pit, very painful, hot, swollen.  The injection site is hot, swollen and red also. Still not better today.
Patient given Novavax vaccine following a second dose of J+J on 4/11/21. No adverse event noted.
Experienced anxiety; Dizzy; Weak; Not able to get out of bed; Flushed under her arm; Nausea; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Experienced anxiety), DIZZINESS (Dizzy), ASTHENIA (Weak), BEDRIDDEN (Not able to get out of bed) and FLUSHING (Flushed under her arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ANXIETY (Experienced anxiety), DIZZINESS (Dizzy), ASTHENIA (Weak), BEDRIDDEN (Not able to get out of bed), FLUSHING (Flushed under her arm), NAUSEA (Nausea) and FATIGUE (Tired). The patient was treated with IBUPROFEN in March 2021 at an unspecified dose and frequency; PARACETAMOL (TYLENOL) in March 2021 at an unspecified dose and frequency; SODIUM CITRATE DIHYDRATE (NAUZENE [SODIUM CITRATE DIHYDRATE]) in March 2021 at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) in March 2021 at an unspecified dose and frequency. In March 2021, DIZZINESS (Dizzy), ASTHENIA (Weak) and FATIGUE (Tired) outcome was unknown. At the time of the report, ANXIETY (Experienced anxiety), BEDRIDDEN (Not able to get out of bed), FLUSHING (Flushed under her arm) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.
Pt recv vax on 11/4/98; on same day pt exp swollen Rt arm, stomach cramps, HA, vomiting; pt imp 11/5/98
This spontaneous report as received from a consumer refers to unspecified number (reported as "some') of children of unknown age and gender. On an unknown date, the patients were vaccinated with either M-M-R II (frequency was not reported) or ATTENUVAX (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patients experienced allergic reaction to vaccine. The outcome of the event was unknown. Event was considered to be related to suspect therapy. Additional information is not expected.
A couple of weeks after the vaccine I woke up unable to lift my chin up from my chest.  I was eventually diagnosed with isolated neck extensor myopathy and I am being treated with high dose steroids IV and IVIG two days every three weeks.
Medication error during mass vaccination event, patient received Pfizer for second dose instead of Moderna.  No issues observed during monitoring period.
Headache, Myalgia, Fever, Nausea Vomiting,  CHILLS
Pt recv #3 dose DTaP & Hib 9/28/98; pt recv #4 dose DTaP & Hib 10/27/98
I completed my 2 doses of the Pfizer vaccine and 1 booster. Prior to me getting the vaccine my periods were regular. Meaning they came every month consistently. However, I noted as reported to my doctor that after my first two doses and booster I missed my period for 3 months before it regulated again.    I had my period at the start of March (3/1/21-3/5/21). I then completed my two doses and did not see my period until June 21st. Not to long after my period regulated back to normal and I had no issues until after my booster shot on 12/09/21. After my shot I missed my period from January to March and did not see my cycle again until April 23rd. Since all of my doses my periods have not fully regulated .
1st shot:3 Days of severe all over body pain, hot then chills, severe headache, nausea, very week, fatigue continued after the 3 days. Video chat with my doctor. Tylenol taken during this time. Missed 1 day of work. 2nd shot: 7 days  of severe all over body pain, hot then chills, severe headache, nausea, very week, fatigue continued after the 7 days. Contacted my doctor. Tylenol taken during this time. Missed 1 day of work then worked from home. fatigue continued
Started having bloody nose non-stop for two weeks, petechia in arms legs and back front of torso, large bruises on arms and legs, Went to ER on the 24th of December - no test ran, they packed her nose and sent us home same day. Continued to have bloody nose, weakness, couldn't stay up and was constantly tired, high heart rate and high blood pressure.  Fainted on January 9th, called Ambulance and she was rushed to Hospital ER.  Was admitted and diagnosed with ITP.  She had 2-3 blood transfusions and 1 platelet transfusion.  Was discharged on the 12th or 13th.  Went in for a follow-up appointment on the following Monday, the 17th, and was admitted again because platelets dropped back to 0.  Was discharged on the 19th.  On the 20th rushed her back to ER for heavy bleeding and she was admitted again to the hospital until the 23 or 24th.  Bleeding has kept to a minimal since discharged, but she was rushed back to the ER on the 8th of February with other issues.  She was diagnosed with tachycardia, hypertonia, adrenal insufficiency, fatigue, hyperthyroidism and tremulousness and was then discharged on the 11th of Feb.  She is currently on steroids, promacta, iron pills, atenolol, tranexamic, and methimazole.
Pain to right shoulder since the day I received the flu shot. Hurts to pull my arm across my body, hurts to remove my top "shirts" or put on.
Tight painful lungs at 2:30AM on the 20th, along with feeling I had the flu. I tracked my vitals all night. I remember struggling to get full breath into the night and next day I went to Urgent care. On the 26th after all the flu like symptoms had gone away I had horrific arm pain around my injection sight, it pulled into lump and spread up to my shoulder and shoulder blade, the pain was level 10. I had a fever of 100.5. I treated it with ibuprofen, CBD lotion. Wednesday 28 went to level 8 pain and then it disappeared. I'm now using an albuterol inhaler 4 times a day.
8/10 pain in her left deltoid area, lump in her neck, neck pain on right, migraine headache after injection.
Moderna 3/3/21, 3/31/21, 12/1/21. Pfizer 7/11/22. Positive on 8/21/22
Systemic: Dizziness / Lightheadness-Mild, Additional Details: None
10 minutes after administering vaccine noted redness approximately 5-6 cm at site no edema or respiratory distress noted - noted blotchy redness on arms and flushed cheeks at 1300 spoke with mother redness resolved
within 6-8 hours started with holocephalic headache, myalgia, low-grade temp and chills, nausea and fatigue. Incident last ~ 24 hours then abated with Tylenol and Advil
Urticaria swelling hives when anything touches my skin. It starting with itching all over my body then turned to welts and hives if I scratch you can see raised scratch marks so over my body that doesn't go away unless I put hydrocortisone or take Benadryl but comes back after it wears off
Breakout; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (Breakout) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 RASH (Breakout). At the time of the report, RASH (Breakout) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The caller reported that someone from her church had the same symptoms post covid 19 vaccination and has a current condition of lupus.  The treatment medication was not provided.
MOTHER NOTICED RED KNOT - 8-20-05.  KNOT TURNED PURPLE - 8-22-05.  LOW GRADE FEVER - 8-18 & 19.  SPOTS - 8-20-05.
This spontaneous report was received on 04-OCT-2016 from a pharmacist, referring to a patient of unknown age and gender. Prior medical history, concomitant therapies and drug/allergies reactions were not reported. On 04-OCT-2016, (reported as: today) the patient was vaccinated inadvertently with a dose of VARIVAX, (route, dose and concentration were not reported), instead of ZOSTAVAX no adverse effects were reported. Additional information has been requested.
Narrative: Patient reported mild tingling at the top of the head when they stood that resolved shortly thereafter. They required no intervention and were able to go home without assistance.
had shot but had shingles/Suspected Vaccination Failure; Had shinlges; Awful pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot but had shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Had shinlges) and pain (Verbatim: Awful pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient had his/her shingles shot but he/she still had shingles.  The reporter further stated that awful pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
Muscles in shoulder and left arm began twitching this was on a Thursday or Friday on Sat 1-2 days later woke up with stiff muscles as if I slept wrong and arm fell asleep. The more I moved the arm the more severe the shoulder pain became, could not hold an empty coke bottle, raise hand higher than waist, comb hair, or lift hand to steering wheel of car. Pain was so excruciating was unable to properly drive to the ER, gate guard had to allow me in gate the back way to ER. Pain med was given but pain continued physical therapy for 1 year and then surgery the following year. After surgery was placed on a permanent profile and was unable to do pushups again for the physical fitness test. Now when muscles are fatigued they hurt longer than normal recovery time for muscles when working out on weights, sensitive and usually has nerve pain or muscle pain.
Patient came back to the pharmacy today and showed an injection site reaction where the skin was red, inflamed, knotted, and sore where the injection was placed. The injection site looked to be lower and more towards the back of the arm instead of into the deltoid muscle. Patient has been monitoring and utilizing warm compresses for relief.
EXTREME SWELLING TO UPPER AND LOWER LIPS, LEFT MOUTH DROOP; SORENESS TO LIPS; NUMBNESS TO LIPS; TINGLING TO LIPS; EXTREME GUM TISSUE IRRITATION; LEFT EYE DROOP; SORENESS TO RIGHT ARM; FEVER; ITCHING TO RIGHT ARM; PANTING; This spontaneous report received from a patient concerned a 52 year old female. The patient's past medical history included had covid-19 on november 2nd, and aspirin, codeine, nsaids, morphine, class of erythromycins, barbiturates, sulfates, sulfonamides allergy, and concurrent conditions included hashimotos (hypothyroid), asthma, socially drinks, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient was previously treated with diphenhydramine hydrochloride for allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included formoterol fumarate for asthma.  On 11-APR-2021, the subject experienced panting. On 11-APR-2021, the subject experienced itching to right arm. On 11-APR-2021, the subject experienced soreness to right arm. On 11-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced extreme swelling to upper and lower lips, left mouth droop. On 12-APR-2021, the subject experienced soreness to lips. On 12-APR-2021, the subject experienced numbness to lips. On 12-APR-2021, the subject experienced tingling to lips. On 12-APR-2021, the subject experienced extreme gum tissue irritation. On 12-APR-2021, the subject experienced left eye droop. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme swelling to upper and lower lips, left mouth droop, panting, and itching to right arm on 11-APR-2021, left eye droop on 13-APR-2021, soreness to right arm on 14-APR-2021, and fever on 12-APR-2021, was recovering from soreness to lips, numbness to lips, and tingling to lips, and had not recovered from extreme gum tissue irritation. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
tenderness to injection site with a minor pink rash, benadryl 50mg given immediately then 50mg BID PRN x48 more hours, encouraged ice and Tylenol for comfort
symptom's: confusion, fever, chills,  severe body aches, runny nose, pressure on chest, shaking,.
Felt her blood pressure go up and reclarifies, early Saturday morning at 1 am it was 185/91; She was not breathing properly; Her heart was pounding in her chest and had palpitations; Her heart was pounding in her chest and had palpitations; She began to shake forcefully/the next day she was feeling shaky again; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 28Jul2021 13:35 (Batch/Lot Number: EW0198) as dose 1, single (at the age of 75 years old) for COVID-19 immunisation.  Medical history included ongoing hypertension from: maybe 15 years ago, around age 60, diabetic type 2 from 2006 and ongoing, thyroid condition from 2012 and ongoing, pericarditis in 1996 she had her first episode, a small effusion, and a couple years later, another small effusion, and in 2016, a moderate effusion and was hospitalized, ongoing glaucoma for more than 10 years, suspected covid-19 from 13Mar2020, she was never tested for Covid. Her symptoms lasted 8 weeks. She believed she might have gotten inflammation in chest but was not diagnosed. She felt chest tightness, but the doctors didn't want to do test that year.  In May2020, she was negative for Covid, and all the other symptoms went away, except chest tightness and chest tightnessConcomitant medications included valsartan (DIOVAN) taken for hypertension, amlodipine besilate (NORVASC) taken for hypertension, insulin human injection, isophane (HUMULIN N) taken for diabetes mellitus, levothyroxine taken for thyroid disorder, acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, brimonidine tartrate (ALPHAGAN P) taken for glaucoma from 2008 and ongoing; bimatoprost (LUMIGAN) taken for glaucoma.  The patient will be seeing her PCP this week to double check her health, her heart rate and her blood pressure. She did experience and adverse effect, she is considering where to get the second dose which is suppose to be two weeks from Wednesday. She has a history of pericarditis and does have hypertension. She felt her blood pressure go up and reclarifies, early saturday morning at 1 am it was 185/91 on 31Jul2021 01:00. She was not breathing properly, hypertension, her whole body was shaky, at around 10 in the evening, she began to shake forcefully and the next day she was feeling shaky again. Her heart was pounding in her chest and had palpitations.  She did not go to the emergency room, because her blood pressure came down to 143/82. On Saturday morning, she had a normal blood pressure of 141/79, but she still had the shakes and palpitations. The outcome of blood pressure go up was recovered on an unspecified date, not breathing properly was unknown and other events was not recovered.
nausea; body aches; weakness; headache; chills; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a day after receiving Shingrix, the patient experienced nausea, general body pain, weakness, headache and chills. On an unknown date, the outcome of the nausea, general body pain, weakness, headache and chills were recovered/resolved.   It was unknown if the reporter considered the nausea, general body pain, weakness, headache and chills to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's friend. The patient received the vaccine at the same location and time where his friend received the vaccine. Within few hours of vaccination, the patient developed body aches, nausea, weakness, chills and headache. All these symptoms had resolved within 4.5 to 5 days. The reporter did not consent to follow-up. The reporter did  not consent to health care professional (HCP) follow up. This case had been linked to US2019123828, reported by the same reporter for her friend.
Swollen, pruritic, erythematous rash around the injection site 1 week after injection
1035 am - pt c/o difficulty breathing, tightness in chest, flushed skin both upper extremities, hives on lateral abdomen. BENADRYL and Epipen given on site - ER ordered prednisone.
Tender macular rash about injection site that lasted 4 days; lethargy, myalgia and arthralgia the day after vaccine; and Headache lasting at least 6 days not been relieved with ibuprophen or tylenol (last symptom is the reason for the submission)
This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 1-year-old patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: Nurse reported that a 1 year old patient was inadvertently administered FLUARIX but did not have any further information.
death  - Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung  - Acute kidney failure, unspecified
First dose - lower lip and chin swelling; First dose - lower lip and chin swelling; Itchy chest and bumps; Woke up week later unable to walk- left knee severe joint pain.; Woke up week later unable to walk- left knee severe joint pain.; Itchy chest and bumps; This is a spontaneous report from a contactable consumer (patient).   A 58-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0158, Expiry date not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 10:15 (at the age of 58 years) as dose 1, single for COVID-19 immunization. Medical history included high heart rate, blood pressure, prediabetic, and known allergy to Valium, all from an unknown date and unknown if ongoing. Concomitant medications taken within 2 weeks of vaccination included atorvastatin (LIPITOR); hydrochlorothiazide, triamterene (MAXZIDE); and duloxetine hydrochloride (CYMBALTA), all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. The patient experienced lower lip and chin swelling; itchy chest and bumps; and woke up week later unable to walk- left knee severe joint pain on an unknown date. Patient took second dose of bnt162b2 (Lot number: EW0172, Expiry date not reported) via an unspecified route of administration, administered in left arm on 06May2021 14:45 as dose 2, single for COVID-19 immunization. The patient underwent lab tests and procedures which included Nasal Swab COVID test: negative on 09May2021. The event lower lip swelling was not recovered, and the outcome of rest events was unknown.  No follow-up attempts are needed. No further information is expected.
sick; Initial information was received on 18-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case is linked to 2020SA330568 and 2020SA357039 (reporter and Reporter's Mom).  This case involves a female patient (age unknown) who was sick (illness), when she received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  No laboratory data was reported  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.