chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache within 2 hours that lasted all day.  24 hours after shot - headache, fever, body aches fatigue lasted 12 - 16 hours.  This morning (22 hours after shot) woke up with a lump in my armpit of my right arm.  Arm soreness within 15 min of shot and continues.
Fever of 101, muscle aches, joint pains, malaise, h/a, dizziness, abdo pain, diarrhea & redness @ inject site;
covid; cough; aches all over; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Cancer (seven and half years ago).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache). On an unknown date, the patient experienced COVID-19 (covid) (seriousness criterion hospitalization). The patient was hospitalized for 24 days due to COVID-19. The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid), COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 100.3 °F (High) 100.3°F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant products included blood pressure medicine (unspecified).  Reportedly, the patient had COVID five days after the first shot of vaccine. The patient had to stay three and a half weeks in hospital that destroyed her immune system and she said that it was coming back after medications.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: 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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Case upgraded to serious, includes- serious event of covid-19 (hospitalization) and historical condition of cancer and had chemotherapy.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: 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.
This spontaneous report was received from a medical assistant and refers to a 4 month old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was inadvertently administered a dose GARDASIL 9 intramuscularly, lot # L024993, expiration date 17-OCT-2017 (dose  was not reported). It was confirmed by medical assistant that this was not due to product confusion. No adverse effect reported. Additional information has been requested.
Round circle around injection site 1 week post injection. No pain, warmth, swelling, or fever.
p/vax pt exp arm spasms; ache in legs/arms; chills; low grade fever & h/a
with shortness of breath and pressure on my chest.; with shortness of breath and pressure on my chest.; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in left arm on 23Mar2021 11:00, at 46 years of age, (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization. Medical history included pernicious anaemia from an unknown date and allergy to sulfa and pethydine hydrochloride (DEMEROL). Concomitant medications included iron, cyanocobalamin (B12-VITAMIN), zinc, folic acid (FOLATE), ascorbic acid (C) and colecalciferol (D), all taken for an unspecified indication since an unknown date. The patient didn't receive any other vaccine within the previous 4 weeks and was not diagnosed with COVID-19 prior vaccination. The patient reported that, on an unknown date after the first vaccine dose, she ended up at hospital with shortness of breath and pressure on her chest. They sent her home after hours of observation saying it was vaccine related symptoms. The events resulted in Emergency room/department or urgent care, the patient received an unspecified treatment and the events resolved with sequelae on an unknown date.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021487210 Same drug/reporter/patient, different dose
I received  both  doses of the vaccine, one in each arm. The first dosis i received in the right arm, the arm was sore for about two days and then it went away.  When it was time for my second dosis iI received it on my left arm.,  The day of the injection  i did not experience  any soreness, however as time passed i started feeling at lot of paint on my left arm. i cannot my my arm in a certain position because it hurts too much. I an unable to sleep on my left side because of pain  it causes. I have loss strength on the arm and  it feels  sore to the touch .
cough; voice changes - hoarseness; nausea; diarrhea; flu-like symptoms; shivering; injection site soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-MAY-2023, the patient received the 1st dose of Shingrix. On 25-MAY-2023, 30 min after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site soreness), nausea (Verbatim: nausea), diarrhea (Verbatim: diarrhea), influenza-like symptoms (Verbatim: flu-like symptoms) and shivering (Verbatim: shivering). On 28-MAY-2023, the patient experienced cough (Verbatim: cough) and hoarseness (Verbatim: voice changes - hoarseness). The outcome of the injection site pain was resolved and the outcome of the cough, hoarseness, nausea, diarrhea, influenza-like symptoms and shivering were not resolved.   It was unknown if the reporter considered the injection site pain, cough, hoarseness, nausea, diarrhea, influenza-like symptoms and shivering to be related to Shingrix.     It was unknown if the company considered the injection site pain, cough, hoarseness, nausea, diarrhea, influenza-like symptoms and shivering to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023 The patient self-reported this case. The patient called to ask about Shingrix side effects.   The patient began experiencing shivering, flu-like symptoms, diarrhea, nausea and soreness at injection site one-half hour after her shot.   All symptoms remained with patient except injection site soreness, which resolved after a couple of days. About 4 days ago from reporting, the patient began having voice changes and cough.  She did not provide consent to contact her health care professional, as she would prefer to have a conversation with her health care professional first. The reporter did not consent to follow-up.
Extreme flu like symptoms. Fever, Chills, Sweats, headache, body ache
I received the first dose on May 4th. I started to feel some problem with my left eye on May 10th. My left eye was blurry and floater and foggy. I did not take it seriously because I thought I need to clean and replace my eye contact lenses by then. Then it was getting worse after I received the second dose. I saw a few different eye doctors and I was told my left eye vision got dramatically lost in June at Eye doctors. I was asked to go to emergency right away because the doctor suspected something was going on my brain to affect optic nerve. I went to emergency room of local hospital and completed MRI with my brain and the results was normal. The hospital referred me to see neurologist . Then I started a few month long period to see different doctor in various states. So far all doctors ordered almost all procedures and test they could think of being correlating to my eye vision loss  problem. All results are good. No one can give me firm diagnose about what are causing  my eye problem. I have no ocular disease history as well as my family. I am near sight only. There is a timeline correlation between my vaccination dates and problem onset.. I am reporting this to see if any solution can help to get my vision back.
Resulted in Guillain-Barre Syndrome. I had full body paralysis, fatigue, ventilator required, double vision, and loss of reflexes.
pt arrived  at the site, pt was given moderna instead of Pfizer, no immediate symptoms noticed .notify client and education was provided.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
Pt with headache frontal swelling on the face, chills, next day after receiving the vaccine  pt seen at ER, received IV fluid and tylenol, Toradol, Decadron and sent home in Motrin. Pt still has headaches and frontal swelling.
9/20/2018. SHINGRIX Vaccine administer in L deltoid. Mild discomfort and minimal erythema at injection site in the evening. 9/21/2018 Evening-  spreading erythema and markedly increased pain extending distally toward elbow from the site of injection. 9/22/2018 AM awoke with fevers, chills increased pain and worsening of erythema down L arm. Diagnosed with cellulitis. Started on AUGMENTIN for treatment. 9/24/2018 Fevers, chills resolved. Erythema and pain nearly resolved.
Vesicles on trunk and extremities that crusted, then cleared; assoc. with fever. Symptomatic care: Resolved without complication in about 1 week.
IMPROPER STORAGE OF PRODUCT IN USE; This spontaneous report received from a pharmacist 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: 1808978, expiry: UNKNOWN) .5 ml, 1 total, administered on 05-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the HCP called and stated that, the vaccine which was administrated to the patient was possibly being thawed once as during storage it went back to freezing temperature (26F) as there was an issue with the fridge where it went down to freezing temperature. The exact day of when the incident with the fridge was unknown and 4 vials where involved on the issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administrated after possibly being thawed once and go back to freezing temperature (26f) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210409103-Covid-19 vaccine ad26.cov2.s-Improper storage of product in use. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
9/9/2021 REDNESS IS STILL THERE. WHEN IT WAS FIRST GIVEN COUPLE HOURS LATER FELT FATIGUED, SORE ARM, LUMP AT INJECTION SITE. ARM STILL FEELS SORE AND LUMP WENT AWAYS 1 WEEK LATER.
returned approx 30min p/vax w/itching all over, throat tight, visibly anxious;1/2cc epi given;sx eased w/in 2min;second dose epi given 7min later;rescue squad arrived @ scene 3min p/2nd dose;
The must important efect was today the Dr.toll me his LIVER get a little damage,the result from the laboratory give as this matter, he always have BIG headache, and I catch white dot in his skin. Now i'm worry on his HEALTH!!!!
My previously manageable tinnitus has become unmanageable starting within a week of the second Pfizer shot. The tinnitus is extremely loud 24/7 making my days feel like I have PTSD and my nights difficult to sleep. I need music, TV, or white noise on 24/7. The elevated level of tinnitus has not subsided since it ramped up.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Comorbidities include CKD, anemia, DM2, CAD, HTN, HLD. On 2/19/21 it was reported that patient spent some time in the hospital over the last week after suffering several falls while a resident in a nursing home. He underwent back surgery for spinal decompression on 3/2/21 . He passed away at the hospital on 3/31/21 with unknown cause of death. Patient also had CHF, COPD, Crohns Disease, anxiety/depression.
Side effects after each dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effects after each dose) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects after each dose). At the time of the report, IMMUNISATION REACTION (Side effects after each dose) outcome was unknown.            Concomitant medication information was not reported.  The patient had also received first, second, third and fourth doses of Moderna COVID-19 vaccine.  Treatment information was not reported.   This case was linked to MOD-2023-723955 (Patient Link).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. The initial case was missing the following minimum criteria: product. Upon receipt of follow-up information on 01Mar2022 this case now contains all required information to be considered valid. A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 10:30 (Lot number: FJ8767) at the age of 61 years as dose 3 (booster), single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Body aches", "Fever"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Body aches", "Fever". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 16Dec2021 11:00, outcome "recovered", described as "Passed out"; SYNCOPE (medically significant) with onset 16Dec2021 11:00, outcome "recovered", described as "Fainted"; COLD SWEAT (non-serious) with onset 16Dec2021 11:00, outcome "recovered", described as "Clammy"; NAUSEA (non-serious) with onset 16Dec2021 11:00, outcome "recovered", described as "Nauseous"; DIZZINESS (non-serious) with onset 16Dec2021 11:00, outcome "recovered", described as "Dizzy". Therapeutic measures were not taken as a result of loss of consciousness, syncope, cold sweat, nausea, and dizziness. Additional information: The patient reported issues (side effects, complaints etc.) with a Pfizer product and the reported issue occurred after use of a Pfizer product. Approximately 24hrs after the patient received her third Pfizer Covid vaccine she passed out. She became clammy, nauseous, and then fainted. She experienced no other side effects associated with this shot, like she did with the first 2. She expected fever and body aches but did not experience those this time. It was a shock to be picked up from the floor. No additional vaccines administered on same date of the Pfizer product. There are no other products that were taken together with those indicated above. No prior vaccinations received (within 4 weeks). There was no predisposing factor, and no culture was performed. The patient was not admitted to hospital due to the event. Follow-up attempts are completed. No further information is expected.
post herpetic neuralgia following chronic pain after the shingles outbreak; erythematous macular rash noted over her right face with burning pain/ diagnosed with shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 20-MAY-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date in 2016 (reported as within two weeks after vaccination), she suffered from an erythematous macular rash noted over her right face with burning pain. The patient was ultimately diagnosed with shingles and later diagnosed with post herpetic neuralgia following chronic pain after the shingles outbreak. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient suffered severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The events were considered to be disabling.
Initial information received on 22-Jun-2018 regarding an unsolicited valid non-serious case received from an office person medical assistant. This case involves a patient (age and gender was not reported), who was vaccinated with an expired dose of ACT-HIB (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used because the vaccine was expired by one day. it was reported that it was only expired by one day. The patient had not experience any adverse event. 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 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. Documents held by sender: none.
Soreness of Rt upper arm began 4-7-10 in a.m. Progressed with warmth, redness and swelling of area. Symptoms remain, with confirming swelling 4-8-10 p.m. from shoulder to elbow.
by 12hr p/vax pt had erythema on neck, face, scalp exp puffiness @ rash site, pruritis, warmth to touch;denies rash on other body surfaces, denies resp distress;unaware of contact w/new cosmetics soaps, lotions, shampoos, etc;
Constant aching pain from shot area, traveling to whole arm, shoulder and neck.  On scale from 1 to 10 would said 9 being extreme pain, still to this day 11/1/2016.
After flu injection, Patient stated she could taste salt in her mouth. Followed by her nose and throat felt funny/weird. Patient continued to say she had only received one flu vaccine in the past and had a "reaction" to it. She states she has a history of anxiety with medical procedures. Pulse Ox 96% on room air and heart rate 98. Patient declined the need to call emergency medical services. Patient continued to be alert and active. Vital signs remained stable. Benedryl 50 mg PO oral solution given. Patient observed for 30. No signs or symptoms of distress noted.
Trouble extending arm due to pain deep located between shoulder and elbow of  left arm; looks swollen; Hardly lift her arm; Pain while lifting/Trouble extending arm due to pain; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), PERIPHERAL SWELLING (looks swollen), LIMB DISCOMFORT (Hardly lift her arm), PAIN IN EXTREMITY (Pain while lifting/Trouble extending arm due to pain) and ARTHRALGIA (Trouble extending arm due to pain deep located between shoulder and elbow of  left arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Blood pressure high.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 18-Mar-2021, the patient experienced PERIPHERAL SWELLING (looks swollen), LIMB DISCOMFORT (Hardly lift her arm) and PAIN IN EXTREMITY (Pain while lifting/Trouble extending arm due to pain). On 11-May-2021, the patient experienced ARTHRALGIA (Trouble extending arm due to pain deep located between shoulder and elbow of  left arm). At the time of the report, VACCINATION SITE PAIN (Sore arm), PERIPHERAL SWELLING (looks swollen), LIMB DISCOMFORT (Hardly lift her arm), PAIN IN EXTREMITY (Pain while lifting/Trouble extending arm due to pain) and ARTHRALGIA (Trouble extending arm due to pain deep located between shoulder and elbow of  left arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-049843 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow-up added on 11May2021 includes new events were added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049843:First dose
Left arm swollen and warm to the touch, Pt advised to apply ice to area and take antihistamine and anti-inflammatory such as BENADRYL and ibuprofen.