chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced achey, chills, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and the outcome of fever, chills and achey was not reported. This report was non-serious.
I woke up and went to restroom and I could only see from the outside of my eyes but it went away about an hour later. I woke up every morning after that with the same symptoms and it would go away after an hour. So I got referral to an Ophthalmologist and I am going to many appts. & haven't gotten a dx as of yet.
pt recv vax & devel red erythema size of grapefruit, red, hot, very painful, barely move arm or lift, h/a;
Cold chills, pain through out entire body. Disoriented. Couldn't sleep. Unable to get comfortable nor warm. Unable to stop pain. For two days. Third day pain subsided, but still had chills. Before waking I sweated untill my bed, blankets, and pillows were saturated. Same thing on the next night. The day following, very weak, and groggy. Urine for all those days very dark yellow, even with plenty of water and other fluids(soups). Am still weak as of today.
Head lag and change in muscle tone (decreased tone) within 4 days of 2 month vaccines.
My wrist, finger and joints were inflamed, I did have bloodwork ran to determine what could be causing the inflammation. I am currently awaiting the results from the bloodwork to find out what is causing the inflammation and if there is anything that can be done to help me.
This spontaneous report as received from a 65 year old male registered nurse refers to himself. There was no Pertinent Medical History and no Drug Reactions/Allergies. On 25-MAR-2014 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # not provided), subcutaneous in the arm. There was no concomitant medication. The nurse reported that on 25-MAR-2014, 4 hours after being administered PNEUMOVAX 23, his entire arm, where he had the injection administered, developed edema. The patient was unable to bend his arm or even touch his face with that arm that had edema. There was no laboratory studies performed. Patient did not seek medical attention. The patient was treated with BENADRYL. The outcome of events was reported as not recovered/not resolved. The events were considered to be disability by the reporter. This is one of the several reports received from the same source (linked MARS # 1404USA000194). Additional information has been requested.
administered to patient younger than indicated age; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Physician reported that a medical assistant inadvertently administered a dose of Kinrix to a patient. The patient was younger than the indicated age for Kinrix, which led to inappropriate age at vaccine administration.  The physician asked to provide the rest of the adverse event information via follow-up. The reporter consented to follow-up via email.
34 y.o. male with history of depression admitted to the hospital on 4/23/2021 for chest pain and leg pain found to be due to Deep Vein Thrombosis and bilateral Pulmonary Embolism. Patient started on heparin infusion in the hospital with stabilization of vital signs then transitioned to apixaban at DVT/PE dosing prior to discharge
1052- pale, light - headed, vomit x 1 episode following Hep A + Hep B administration. VSS- pt lying in fowlers position - 156/69, P-64, R-16. Pt. reports no prior reaction to vaccination. 100cc clear soda given to pt. 1058: pt. sitting - 99/60, P-67. 1100: (sitting) 106/64 HR-60, 1105: 105/68 (sitting), HR-63 pt. reports feeling "better".
Pt felt dizzy, developed a headache and nausea.  BP remained within normal limits as well as other vital signs.
Low grade fever; headaches; joint pain; This is a spontaneous report from a non-contactable consumer (patient herself). A 39-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) via an unspecified route of administration, administered in arm left on 26Feb2021 (age at the vaccination 39-year-old) as dose 2, single for COVID-19 immunization (Nursing Home/Senior Living Facility). The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) via an unspecified route of administration, administered in arm left on 05Feb2021 as dose 1, single for COVID-19 immunization. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since post the vaccination. On 26Feb2021, the patient had experienced low grade fever, headaches, joint pain. The patient underwent lab tests and procedures which included Nasal Swab (sars-cov-2 test) as negative on 26Feb2021. The outcome of events was recovered on 08Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reports feeling fine immediately following administration.  Patient was ambulating back to the waiting area and the next thing she recalls was waking up face down on the floor.  She does not recall falling.  She denied pain after the fall.  She reported feeling dizzy and generally not feeling good.  No lacerations, abrasions, swelling, or bruising were seen on face or hands.  Patient was transported to the emergency department.
Approx 1wk after vaccine began having urticarial skin lesions, 'lumps' possible lymphadenopathy, malaise, loss of appetite, dysphagia, presented to clinic 2/13/23 and given medrol and hydroxyzine. Returned to clinic 2 days later with ongoing symptoms, ongoing sense of something getting stuck in esophagus with fluids/food different from typical GERD.  Denied similar reactions to prior Covid imms
Patient discharged following a (7) day inpatient admission for COVID 19. Patient is a 59 y.o. male who presented secondary to a chief complaint of ?cough".  Patient states his symptoms started on 12/01/2021.  He noted cough, shortness of breath, nausea and fatigue.   He tested positive on a home COVID test a couple days after his symptoms started.  In the emergency department, chest x-ray revealed bilateral infiltrates. The patient was hypoxic at 88% on room air.  He was placed on 2 L nasal cannula.  He was admitted for COVID-19 pneumonia to the hospitalist service.   Patient was started on dexamethasone 6 mg daily as well as remdesivir.  He completed 5 days of remdesivir therapy.  Patient had elevated O2 requirements, requiring 50% venturi mask.  A CT angiogram was obtained, which revealed bilateral infiltrates consistent with COVID-19 pneumonia, and ruled out pulmonary embolism.  Patient was encouraged to lay prone, and utilize incentive spirometry.  A procalcitonin was obtained and negative, NT proBNP was checked and normal.  Patient was seen in consultation with Pulmonary Medicine for consideration of increased   Steroid dosing.  It was recommended that he complete the standard 6 mg of dexamethasone x 10 days.   In regards to the patient's acute hypoxemic respiratory failure, this clinically improved, he will discharge on 3 L of O2.  He is felt to be a good candidate for the COVID at home program.   Pt is stable for DC home on 12/13/2021.
Pt received 3 doses of Engerix B 2 months /p last dose titers ck & pt was non responder, no treatment given
Swollen arm at site of injection, tenderness. Warm. Patient felt nauseated. Little itching. Advised patient to go to ER. Given FLUVIRIN and PNEUMOVAX. Reaction due to PNEUMOVAX.
within 5 minutes of recieving the vaccine, felt light headed, nauseated and had a dry mouth. Pt was placed supine with legs up and monitored. Symptoms resolved within 15 minutes.
Slight local soreness the day of the vaccination. The day following vaccination: headache, muscle fatigue, sore arm (spread up to collar bone), general fatigue, Nausea and congestion but that may have just been life.
Went to Clinic for medical clearance.  They recommended three shots:  MMR, Anthrax, and Typhoid.  I decided to spread them out and only get one at a time.  I only took Typhoid in right arm on 1/26/21.  By that night I had a headache and on 1/27/21 had a headache, and today on 1/28/21.  I took Alleve yesterday and today.  Will monitor, but am hesitant to take other vaccines.
AFLURIA vaccine given (L) deltoid. Sitting in chair against wall. Customer passed out approx. 30 sec. after giving vaccine. Passed out for approx. 10 sec and then woke back up. Did not fall out of chair. No injury noted. Customer rested for approximately 10 minutes. Grandfather assisted customer out of store. Grandfather this happens to customer with blood draws, vaccines.
Client had a local reaction to the TDAP immunization and a systemic reaction: rash in left arm and stated fever of 102 degrees. Client continued to have low grade fever following TDAP for sev days with muscle aches and joint pain.
Arm hurts, still hurt; Feing sick; Cold chills; Sleepy; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th August 2022, the patient received Shingles vaccine. On 6th August 2022, 1 days after receiving Shingles vaccine, the patient experienced feeling unwell, chills and sleepiness. On 7th August 2022, the patient experienced pain in arm. On 7th August 2022, the outcome of the feeling unwell, chills and sleepiness were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, chills and sleepiness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-Aug-2022 Reporter's comment: The patient self-reported the case via via interactive digital media. The patient got shingles shot on Friday and by Saturday he/she felt sick, cold chills and sleepy and by Sunday felt fine just his/her arm still hurt. The patient asked if anyone else had gone through this. The patient stated that just got shot, yesterday (day before reporting) arm hurt but was worth it and hopefully it would feel better tomorrow. On 7th August 2022, 2 days after receiving Shingles vaccine, the patient experienced pain in arm. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Complaint of redness, heat and swelling at site of injection. The site is warm touch, red and swollen. Child pushes examiner away. Keep site clean. Tylenol given, Benadryl.
On 4/1/13, pt received PPSV23 in (R) deltoid. Tuesday pt developed fever 103 degrees with malaise and 3+, large localized reaction. No respiratory effects.
This spontaneous report was received from a registered nurse referring to a patient of currently 9 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
I started feeling dizzy and then I started feeling nauseas. My heart was racing so I called the nurse line, and she told me to go to the emergency room because I might be having a heart attack. Once I arrived at the emergency room, I was present with ILI/PUI and had a fever nausea and vomiting. I had a metabolic panel, EKG, chest x-ray, and urine analysis. I also received intravenous sodium chloride. After that I went home and went to sleep, I woke up feeling better the next day. I think more than anything I was dehydrated.
Swollen Bottom Lip/lower lip was very swollen/Swelling of upper airway (lips, tongue, throat, uvula, or larynx); lip was very swollen as were cheeks on both sides/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)/oral issues; Tenderness of the Mouth; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen Bottom Lip/lower lip was very swollen/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)), TENDERNESS (Tenderness of the Mouth) and SWELLING FACE (lip was very swollen as were cheeks on both sides/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)/oral issues) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder. Concomitant products included UBIDECARENONE (COQ10 [UBIDECARENONE]) for Heart alternation.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced TENDERNESS (Tenderness of the Mouth). On 26-Jan-2021, the patient experienced LIP SWELLING (Swollen Bottom Lip/lower lip was very swollen/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)) and SWELLING FACE (lip was very swollen as were cheeks on both sides/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)/oral issues). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 28-Jan-2021, LIP SWELLING (Swollen Bottom Lip/lower lip was very swollen/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)) and SWELLING FACE (lip was very swollen as were cheeks on both sides/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)/oral issues) had resolved. At the time of the report, TENDERNESS (Tenderness of the Mouth) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication includes Anti-Histamines   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received and it contains No New Information. Second dose information picked from Follow up 1 source document and action taken with suspect drug updated accordingly. Concomitant product indication added as medical history.
This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported that:  Is the Reporter a Healthcare Professional (HCP): No, Occupation/Specialty: Unknown Is the reporter the prescribing HCP: Name: Unknown Address: Unknown Occupation/Specialty: Unknown Is the reporter's contact information available to you or a sub-contracted party: Yes  Suspect Product(s): (provide Name / Indication/Dosage/Start and Stop date where possible) Pfizer Covid-19 Vaccine Start Date: 21Jan2021  Stop Date: Unknown  Verbatim and Event Description: Caller Concern: Caller said she got disconnected earlier while being transferred to PMI. Caller said her 2nd dose is scheduled 4 weeks (18Feb), she got her first dose on 21Jan. Caller said she knows that it should be in 3 weeks. Caller asked if it is okay.  Information on the lot/batch number has been requested.  Follow up (08Mar2021): This is a Follow up spontaneous report from a contactable Consumer. This Consumer reported in response to the Non-HCP letter sent that included:  Pfizer/BioNTech COVID-19 Vaccine Follow-up Questionnaire Patient Age at Time of Vaccination: 70 (Years)  Pfizer/BioNTech COVID-19 Vaccine Details: Dose: 1st Date/Time:  Date: 21Jan2021 Time: 2.00 PM Site and route of injection:  Anatomical Site of injection: Upper Left Arm Route of administration: Intramuscular Batch/Lot number: EL9263  Dose: 2nd Date/Time:  Date: 18Feb2021 Time: 1:00 pm Site and route of injection:  Anatomical Site of injection: Upper Left Arm Route of administration: Intramuscular Batch/Lot number: EL9267  Vaccination Facility Type: Other, please specify: (Address) Vaccination Administered at Military Facility: No Vaccination Facility address: USA  Prior vaccinations: None Concomitant drugs: None  Patient's medical history:  Illness/AE: MS Stop Date: ongoing Pertinent Details: None  Adverse events: Seriousness criteria:  Not Serious  Adverse events: Seriousness criteria:  Not Serious  Follow-up attempts are completed. No further information is expected.
delayed cutaneous hypersensitivity (COVID arm). Ater first vaccine only.; indurated and was very itchy; A red area reaction around the site of injection.; rash with sharp boundaries; This spontaneous case was reported by a physician and describes the occurrence of SKIN REACTION (delayed cutaneous hypersensitivity (COVID arm). Ater first vaccine only.), PRURITUS (indurated and was very itchy), VACCINATION SITE ERYTHEMA (A red area reaction around the site of injection.) and VACCINATION SITE RASH (rash with sharp boundaries) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa, omeprazole). Concomitant products included DULOXETINE for Depression, DENOSUMAB (PROLIA) for Osteopenia, GABAPENTIN for Peripheral neuropathy, FAMOTIDINE for Reflux gastritis, CALCIUM, VITAMIN D NOS, MAGNESIUM and ASA.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 14-Jan-2021, the patient experienced PRURITUS (indurated and was very itchy), VACCINATION SITE ERYTHEMA (A red area reaction around the site of injection.) and VACCINATION SITE RASH (rash with sharp boundaries). On 20-Jan-2021, the patient experienced SKIN REACTION (delayed cutaneous hypersensitivity (COVID arm). Ater first vaccine only.). At the time of the report, SKIN REACTION (delayed cutaneous hypersensitivity (COVID arm). Ater first vaccine only.), PRURITUS (indurated and was very itchy) and VACCINATION SITE ERYTHEMA (A red area reaction around the site of injection.) had resolved and VACCINATION SITE RASH (rash with sharp boundaries) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SKIN REACTION (delayed cutaneous hypersensitivity (COVID arm). Ater first vaccine only.) to be related. No further causality assessments were provided for PRURITUS (indurated and was very itchy), VACCINATION SITE ERYTHEMA (A red area reaction around the site of injection.) and VACCINATION SITE RASH (rash with sharp boundaries).    Treatment include hydrocortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up information included concomitant medications and outcome of events.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a Nurse Practitioner for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
mixed 2 diluent of Menveo without the powder portion; ixed 2 diluent of Menveo (without the powder portion) and administered it to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA977A, expiry date OCT-2025) for prophylaxis.   On 16-JUN-2023, the patient received Menveo. On 16-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: mixed 2 diluent of Menveo without the powder portion) and inappropriate dose of vaccine administered (Verbatim: ixed 2 diluent of Menveo (without the powder portion) and administered it to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The Pharmacist mixed 2 diluent of Menveo (without the powder portion) and administered it to a patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Felt like a lump in throat and ears feeling clogged for about 2 minutes before going away. Had patient sit down away from everyone. Verbalized he was okay. O2 sat 96%
July 3, started with Leg Cramping and pain in both legs, calves and quads - weakness. Arm weakness, joint pain, Left side of face paralysis drooping and unable to smile. Left side of body numb tingling from fingers, side of body to toes. Headache, Rash on cheeks of face, Tired Fatigue all the time, Hips achy and weak. Four times in the Emergency Room with severe pain that was so bad I could not control the pain. All these symptoms just kept getting worse and ER only wanted me to follow up with primary care Dr. 7/15/2018 Date seen by Dr., He was concerned and wanted to run more lab tests and speak to neurology for possible hosp admission for further tests. Then noticed Right side of face can not move paralysis Dizziness when standing, problem with short term memory Hips weak and achy. Can not close mouth enough to drink from a straw, Eye tears, eyesite both eyes weak even with new glasses on, mouth drooping, fingers to toes tingling, joint pain in hips knees, fingers, abdomen numbness and on the side of body Pain in chest, and back by upper rib cage.