chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Body Aches; Extreme fatigue; Myalgia; Shivering; Facial swelling; Tachycardia; Headache; Low Oxygen level; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 13th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 12 hrs after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), general body pain (serious criteria hospitalization), fatigue (serious criteria hospitalization), myalgia (serious criteria hospitalization), shivering (serious criteria hospitalization), facial swelling (serious criteria hospitalization), tachycardia (serious criteria hospitalization), headache (serious criteria hospitalization) and oxygen saturation decreased (serious criteria hospitalization). On an unknown date, the outcome of the fever was unknown and the outcome of the general body pain, fatigue, myalgia, shivering, facial swelling, tachycardia and oxygen saturation decreased were recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain, fatigue, myalgia, shivering, facial swelling, tachycardia, headache and oxygen saturation decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient experienced fever, body aches, myalgia, extreme fatigue, shivering, facial swelling, tachycardia and headache. The patient was hospitalized on 18th July 2020.  The patient had low oxygen levels.  The patient was released from hospital on 19th July 2020.  Till the time of reporting, the patient had headache and did not know if the patient still had fever.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020136675:same reporter
Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL.  Subsequently the patient experienced renal failure and was hospitalized.  The physician thought the patient's hospitalization due to renal failure was related to GARDASIL.  No outcome was reported.  This is one of several reports received from the same source.  Additional information has been requested.
Local swelling, erythema with pruritus around injection site. Dephenyldramin prescribed with cool compresses.
Left armpit lymph began to swell to beyond normal measures stretching my Brachial artery and plexus causing loss Of blood flow to my hand and feeling
per pt husband a few hours after flu shot pt started exhibiting a dry cough, watery/swollen eyes, and slight breathing difficulty,  felt that throat was tightening
Patient received first dose of Pfizer Covid-19 Vaccine on 1/13/21. Patient was seen in office on 1/27/21 and reported symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors causing change in handwriting for the past 1.5 to 2 weeks after receiving vaccination of first dose of Pfizer Covid-19 Vaccine. Upon review of Neurological symptoms, patient was positive for loss of balance and coordination, 4/5 strength in all extremities, and 4/5 grip strength. CT of Head with and W/O contrast was ordered. CBC, CMP, Free T4, HgbA1c, lipid, TSH, Urinalysis, Vitamin B12, Folate and CK laboratory ordered.
Information has been received from a physician concerning a pt who in Nov 05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. In Nov 2005, the pt developed localized reaction in the vaccinated arm. The arm was red and swollen. The pt recovered. The pt has a previous dose of Pneumococcal 23v polysaccharide vaccine in 2004. There was no product quality complaint involved. Additional information has been requested.
Fever,chills,headache,vomiting,tiredness, sore arm for 6 days
Been waking up with vertigo that typically lasts for a few hours. Ibuprofen before bed seems to help prevent it. No history of vertigo before. Been happening consistently upon waking up every morning. Fullness in right ear with slightly increased perception of tinnitus.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 14-AUG-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # I049744, expiration date 12-OCT-2017, dose and route were not reported). No adverse reactions were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Felt a burning sensation in my hands right after getting the shot.  Went home,  took 2  Aleve and iced my arm for 5 minutes at a time on and off about 4 times.  Hours later,  about 8 pm I was laying down on the couch on my left side for at least 20 minutes.  When I was getting up my upper left arm was very numb and I had a strange sensation on my left side like my blood had pooled over there but it was very numb in the area.  I never have felt anything like that.  The sensation did go away over the course of a few minutes.  Soon after I was having shooting pain in my hands.  It felt like arthritis pain.  This did not last too long but came back here and there.  My lower back started hurting a little bit out of nowhere.  And then when I went to bed I started having random body aches all over.  Like brief shooting pain in different parts of my body.  I did have some dryness, weird sensation in my throat at times. The body aches kept me up until 2 or 3 am.  It was resolved by the time I woke.  I never felt that I had a temperature.  And I was not sick prior so I felt it was a cause and effect from the vaccine.  I took 2 Aleve and I went to work.  Temperature checked at work and I was 97.1,  normal.  Wore a mask all day,  social distanced at work and I had mentioned to my manager upon arrival that I had symptoms/reaction? after my shot.  I did still have some residual,  arthritis type pain in my hands during the day and more so when I got home.  I also felt fatigued when I got home from work but I was half awake most of the night before due to the body aches.  Felt pretty good,  normal on the second day after the vaccine.
On 12/4/2021, at 7 pm, patient complained of pain on the left-side of her chest that worsened with laying flat. Unable to breath well (she stated) when laying flat as well. Needed to sleep sitting up. Continued to have pain with laying flat. Two times had pain with activity: playing soccer outside on 12/10/2021 and 12/12/2021.
he is already past the 42 days for getting the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (he is already past the 42 days for getting the second dose) 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 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (he is already past the 42 days for getting the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (he is already past the 42 days for getting the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided    Reporter did not allow further contact
6/21 37y.o. female with a PMH significant for hypertension and generalized anxiety disorder. Who presented from home with a chief complaint of chest pain of 1 day duration
Moderna dose administered > 12 hours past vial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered > 12 hours past vial puncture) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered > 12 hours past vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered > 12 hours past vial puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. The vial was punctured on 10-May-2022 and the vaccine administered on 11-May-2022 (Lot number: 059M21A, Expiration date: Unknown).None of the patients had reported any adverse reactions to the expired dose. HCP wanted to know if the vaccine was viable or should the patients be revaccinated   This case was linked to MOD-2022-567445 (Patient Link).
Information has been received from a physician concerning a female who on 28-MAY-2007 was vaccinated with Gardasil. On 30-MAY-2007 the patient experienced rash. It was reported that the patient sought unspecified medical attention. Subsequently, the patient recovered from rash. No further details were provided. Additional information has been requested.
Pt. received (client or employee) Influenza vaccine 0.5 ml intradermally. Nurse took influenza vial from container that was labeled for Mantoux Vaccine. Mantoux vaccine was intranasal. (R) forearm, where influenza vaccine was administered became swollen, red, and warm for a few hours. S/S decreased after by AM.
A minute "gray out"and could not see; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (A minute "gray out"and could not see) in a 74-year-old female patient who received mRNA-1273  (batch nos. 046A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, LOSARTAN for Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273  (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021 at 12:00 PM, the patient experienced LOSS OF CONSCIOUSNESS (A minute "gray out"and could not see) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (A minute "gray out"and could not see) and NAUSEA (Nausea) was resolving. Not Provided          Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Company Comment - 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.
8 days after 2nd dose, ended up in ER with atrial fibrillation
Reporting soreness, redness at first but after day 3 it became painful and continues to be painful on a daily basis.  Reports that certain sleeping positions cause her to awaken with pain.
20 minutes after vaccine was driving home and noticed face feeling flush.  Then itching, tingling on lips eyelids and cheeks along with mild chest tightness.  My husband observed that my face was visibly flushed.  We drove to Hospial and parked outside the emergency room in case it got worse.  I took 20 mg hydrocortisone that I have as an emergency medication for my adrenal insufficiency.  We waited until one hour after I?d been vaccinated and agreed my face was less red, the itching had also decreased and decided it was safe to go home.  This is the same reaction I have if I eat shrimp, my perception is that it was a mild allergic reaction.
4/3 to 4/5: Fever over 101.  General malaise.  Extreme chest congestion and productive cough. 4/5 to 4/9:  Difficulty breathing, congestion and sever productive cough continued.  Chocking on chest mucus.  O2 levels 89-91. 4/7:  visited urgent care.  EKG was irregular.  Chest x-ray indicated needed further CT scan.  Rapid Covid-19 test was negative. 4/8: Outpatient CT Scan.  Indicated Interstitial Lung Disease. 4/10 to 4/12:  Coughing and congestion started to clear.  Extreme fatigue with any activity.  O2 level starting to rise: 91-93. 4/13 to 4/15:  Cough and congestion much better.  Still some production.  O2 level at 93 to 94 (95 - 96 with breathing exercises)
Raised wheal inferior to site of VARIVAX vaccine left outer thigh. Ice applied, liquid BENADRYL (12%mg/5 ml) 2.5 ml given, monitored for 90 minutes on clinic.
Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose; 3rd dose administered 10MAY91;
THE PATIENT INFORMED THE PHARMACIST, THAT HE HAD A MASSIVE UNSUAL HEACHACHE AT NIGHT THAT KEPT HIM UP ALL THROUGH THE NIGHT.
Immunization expired on 06/22/2021 and was administered on 7/6/2021
pt recv vax 17JUL97 & 19JUL97 pt devel a fever of 101 & 2 bumps;
No adverse reaction. Vaccine temperature excursion. Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
extreme fatigue; brain fog; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There were no other comorbidities or underlying issue. The patient experienced extreme fatigue and brain fog for 3 weeks after receiving his second dose of the Pfizer COVID-19 vaccine, that it is so severe they are considering taking him out of work for long term disability. Patient went to a neurologist and was given steroids but the symptoms are continuous and ongoing. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
multiple organ failure, w/hypothermia, hypotension, paneytopenia, prerenal failure, elevation of liver enzymes x8, 10 days p/vax w/complete recovery in 10 days;
Rashes or lesions, shot area swollen, body aches and stiffness in neck, knot on arms, neck and back, abdominal tightness, disoriented and cloudy feeling, nausea
Patient broke out in rash down arm following vaccination.  Arm was red, itching, and swollen at injection site.
Adverse events: syncope (10 seconds); Nausea and constant vomiting (20 minutes then transported to hospital via EMS)
This spontaneous report was received from a pharmacist regarding unspecified patients of unknown age and gender. The reporter stated that on an unknown date unspecified patients might have vaccinated with ZOSTAVAX (dose, route, product lot# not reported) that was exposed to 21F on multiple occasions for an unknown time frame. No adverse effects were reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
pain in my arm, going towards my neck and arm; pain in my arm, going towards my neck and arm; pain in my arm, going towards my neck and arm; chills; feel very cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 16:30 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), NECK PAIN (non-serious) all with onset 16Mar2021, outcome "not recovered" and all described as "pain in my arm, going towards my neck and arm"; CHILLS (non-serious) with onset 16Mar2021, outcome "not recovered", described as "chills"; FEELING COLD (non-serious) with onset 16Mar2021, outcome "not recovered", described as "feel very cold". Therapeutic measures were not taken as a result of pain in extremity, pain, neck pain, chills, feeling cold.  Additional information: It was reported that may be an hour or two later after vaccination, the patient started to have these symptoms. It was further reported that that the pain is going to her neck, and to the middle of her arm.  No follow-up attempts are possible. No further information is expected.
Pt. states after receiving the Phizer 04/26/2021, started experiencing extreme soreness in the right shoulder, tender to the touch, difficult to move/extend, and stiffness. Still experiencing extreme pain in the right shoulder feeling as if being stabbed with a knife. Slight  Arthritis noted in the right shoulder. Taking Gabapentin in attempt to control the pain. Feels like it moving down to the wrist with moments of stiffness, possibly nerves.
I had typical reactions after vaccine for 3 days (chills, foggy/on and off again headache, extreme lethargy,  aches from arm to shoulders to other arm, sleeplessness (insomnia) for 2 days, soreness in injection site). No fever.  My concern is today is TEN days after vaccine injection and my injection site has a round redness and hardness at the injection site. About 1 inch in diameter. It's itchy off and on but no pain. It's hard, red, round, and the skin of it is raised similar to like a hive. I don't know if this is normal.  Especially because it's 10 days out from initial injection. I'm due back for 2nd injection on Feb 9th.
Few weeks after my second dose, starting having neck issues and tremors and made it difficult to drive and ended up in the ER and did a cat scan and referred me neurologist and he diagnosed me with Cervical Dystonia and I have been under his care.. with medication   botex injection and physical therapy.   . still having issues... had an MRI and nerve issues
Site of injection feels warm; Site of injection is itchy; Site of injection is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Site of injection feels warm), VACCINATION SITE PRURITUS (Site of injection is itchy) and VACCINATION SITE ERYTHEMA (Site of injection is red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Site of injection feels warm), VACCINATION SITE PRURITUS (Site of injection is itchy) and VACCINATION SITE ERYTHEMA (Site of injection is red). At the time of the report, VACCINATION SITE WARMTH (Site of injection feels warm), VACCINATION SITE PRURITUS (Site of injection is itchy) and VACCINATION SITE ERYTHEMA (Site of injection is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported
After normal side effects subsided by 3/2/21, I noticed pain in left arm, not muscle pain, that came and went, progressively getting worse and then occurring especially at night (level 7 pain in 1-10 scale) and then disappearing during the following morning and occurring again at night. Pain on night of 3/20 extended from left arm across upper chest and down right arm...worst night. The next night pain started to subside and is now better by 90%. Saw PCP on 3/11/21; he ordered an EMG which I had on 3/22. At follow-up consultation Dr. diagnosed condition as neuralgic amyotrophy aka brachial plexitis aka Parsonage Turner Syndrome, triggered by second vaccine shot.
This subject is a one year old female, who was admitted to the hospital due to systemic inflammatory response syndrome while enrolled in a Phase IV Daptacel study. The subject received one dose of Daptacel vaccine: along with other pediatric vaccines on 3/17/03. The subject developed symptoms 65 days post immunization and was admitted to the hospital three days later 5/25/03. The subject was transferred from hospital to another hospital on 5/26/03 with the diagnosis of acute respiratory failure, presumed streptococcal sepsis and hepatitis. While at hospital, the pt expired on 5/31/03 with a diagnosis of SIRS, acidosis and acute liver necrosis. The event of systemic inflammatory response syndrome was reported by the investigator as unrelated to the study vaccine. No autopsy was performed. Follow up on 04/21/04: "New version created to place Infanrix into pt's history screen." Medical Records received on 8/05/2003 states kidney failure and thrombocytopenia.
pt developed covid on 1/17/2022, passed away on 1/22/2022
A patient asked for B12 shot and received the flu vaccine no AE; The patient received a flu vaccine had a flu vaccine a month ago no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Regulatory authority (Reference number- 00811126) and transmitted to Sanofi on 13-Oct-2021.  This case is linked to case 2021SA343570 (same reporter).  This case involves a 70-year-old male patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and had a flu vaccine a month ago too (extra dose administered) instead of CYANOCOBALAMIN [B12 shot] (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 12-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ7725AA, expiry: 30-Jun-2022) via intramuscular route in the right arm for prophylactic vaccination instead of CYANOCOBALAMIN [b12 shot].  It was a case of an actual medication error due to wrong vaccine administered and extra dose administered (latency same day).  It was reported "Medical assistant reports two patients who are husband and wife came in for B12 shot and received the flu vaccine. They both had the flu vaccine a month ago. She asks for appropriate follow-up. She asks what specifically to monitor for and also any information regarding one patient has history of renal transplant."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On April 26 I tested positive for Covid-19 via antigen test, which I administered because I wasn't feeling that well. I had a high fever for about a day followed by a few days of low grade fever. Had a bad head cold and lost taste/smell for 2 days (but I think that was due to clogged sinuses. I felt like crap for about 3-5 days and tested negative on antigen test 7 days following the first positive test.
Stomach Pain and diarrhea lasting 12 hrs. No treatment. Recovered after 12 hrs.
Pt recvd vax 19OCT90 & devel swelling, redness & tenderness @ the inject sites; sx lasted for about 1 wk & then resolved; JAN91 pt devel polyarthralgia of the small joints & spread to involve large joints as well; rheumatoid arthritis;