chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported., however it could be 60 or 61 years. The patient had pain at the injection site that lasted about a week.  The reporter consented to follow up.
Patient brought into Covid Observation Area stating that immediately after receiving Booster dose Pfizer vaccination, she noticed itchy prickly feeling in tongue, lump on left side of her throat and itchiness to lips. Patient also reports that after her 2nd dose Moderna vaccine she experienced numbness to tongue, tight itchy lips and numbness to right side of her face. Patient states that after her 2nd dose Moderna she was observed for 30 minutes without any medications, her symptoms resolved and she was discharged home.  10:15 am- VS Temp 97.8, BP 159/80, HR 77, RR 20, 97% RA  10:34 am- VS- BP 139/83, HR 72, RR 20, 99% RA. Patient reporting that right side of her face/upper cheek area feels numb and tight. States Right side of face feels tight when she smiles. No swelling noted to right side of faces, eyes, lips or tongue. Face is symmetrical when patient smiles and no drooping noted. Patient denies any weakness or numbness to right side of body and able to move extremities normally. Patient speaking in complete sentences. Denies any difficulty breathing. Able to swallow saliva and water without difficulty.   10:38 am- Call placed to on call ED physician, , informed of patient symptoms above. Verbal order given from Dr.  to give Benadryl 50 mg orally x 1, continue to observe patient for additional 30 minutes and if symptoms improved, ok to discharge patient home. Verbal order repeated and confirmed.   10:40 am- Benadryl 50 mg orally x 1 given to patient as ordered.   10:47 am- VS- Temp- 97.8, BP 142/83, HR  68, RR 18, 02 SATs 98% RA. Provided patient with an Ice pack to apply to right side of face.  11:05 am- Patient reports lips feel normal, prickly sensation to tongue improving, and tight feeling to right side of face improving. States ice/cold is helpful.  11:07 am- VS- BP 140/78, HR 68, RR 20, 02 SATs 100% RA. Will continue to monitor.  11:24 am- VS- Temp 97.9, BP 137/76, HR 69, RR 20, 02 SATs 97% RA. Patient reports feeling much better. States itchiness to lips resolved, prickly feeling to tongue resolved, lump in throat has improved. Denies any difficulty swallowing or breathing. Also reports that tight feeling to right side of face has improved.   11:25 am- Patient discharged home in stable condition, husband awaiting in car and will drive patient home. Advised to continue to apply ice/cold compress to right side of face, rest, drink plenty of fluids. Also advised to go to ED or call 911 if worsening symptoms return. Patient verbalized understanding.
Chills, body aching, nausea, extreme tiredness, loose gassy bowel movements.  Chills and extreme tiredness went away after a couple of days.  Have been using occasional Pepto-Bismol.  Loose gassy bowel movements have continued and have not subsided, dull pain in stomach/upper abdomen persist.  Occasional nausea still present.
Covid19 breakthrough.  1st vaccine received on 03/21/2021.  82 y/o with PMHX of CAD/CABG, DM, HTN, HLD, Metastatic prostate cancer, chemotherapy, Left nephrostomy tube presents to ED via EMS   on 3/7/2022.  Pt was receiving home PT and after assessed by the therapist, pt was found to have generalized weakness, inability to walk and hypotension so EMS called.   In ED, Pt hypotensive, with Leukocytosis/UTI, possible sepsis, ARF.  Room air sat 95%, afebrile.  Covid test not done on admission.  However, pre-procedure Covid test performed on 03/16/2022 -positive.  Repeat test on 3/18/2022 also positive.  Pt on IV ABX and IVF's.
Information has been received from a physician's assistant concerning a female patient who on 16-JUN-2008 was vaccinated with a dose of GARDASIL vaccine (yeast). On 17-JUN-2008 the patient experienced shortness of breath and tingling in the arm were the vaccination had been given. The patient was then sent to the emergency room to be evaluated. Additional information has been requested.
experiencing internal Shingles; shooting pain on temple areas of their head, it continues; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number LG2XJ, expiry date unknown) for prophylaxis.   On 10th September 2022, the patient received Shingrix. In September 2022, 10 days after receiving Shingrix, the patient experienced shingles and head pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the head pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and head pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The patient self-reported this case. Concomitant products included antiviral medication. The patient received first dose of Shingrix on September 10 2022 left arm. The patient experienced upward shooting pain in the right side of the head 10 days after receiving dose.  The patient made appointment with healthcare professional and being told she was likely experiencing a case of internal Shingles.  Health care professional did not officially diagnose them with Shingles, but made the suggestion based on patient's report of her systems. Patient continue to experience shooting pain on both sides of their head, around the temple areas. Reporter consented to follow.
5 MONTHS YO patient received 1st dose of rotarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number PC473, expiry date 27th June 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 11th January 2022, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On an unknown date, the patient started Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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: The reporter stated that a 5 months old patient received his first dose of Rotarix on the day of reporting, which led to  inappropriate age at vaccine administration. The reporter consented to follow up.
Pt had large, very firm 2.5cm diameter, spherical lump on left thigh at injection site.
facial swelling; swelling of the lips; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling) and LIP SWELLING (swelling of the lips) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A OR 006B71A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 27-Mar-2021, the patient experienced SWELLING FACE (facial swelling) and LIP SWELLING (swelling of the lips). At the time of the report, SWELLING FACE (facial swelling) and LIP SWELLING (swelling of the lips) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. Patient received Benadryl medication. At ER patient received saline drip and did some blood work and said they are suspecting possible cellulitis and prescribed antibiotics which patient refused and got discharged.
The pt experienced irritability and was up several times along with fussiness at night. Decreased appetite was also experienced.
Began with constant clogging after the first vaccine. Became progressively worse after the second vaccine with loud constant ringing in both ears.
By afternoon on day of injection 1/18/2021 left arm injection site sore, increased through 1/19/2021.  Ringing in ears and elevated BP started 1/19/2021 and lasted one week (150/90 most of the time), low grade temp started on 1/20/2021 until the morning of 1/22/2021.
About 11 hours after my vaccine shot (1st dose) I experienced constant racing rapid heart palpitations, a dull but constant stomach pain, overall dizziness and disorientation, and a feeling of being "hot" but no fever (temperature was just 98.4 degrees).   The stomach pain and dizziness and feeling hot subsided but the rapid heartbeat continued into the morning 19-20 hours later after the vaccine. I am submitting this 19-20 hours after the vaccine still experiencing heart palpitations and reporting on my over-night complications.
Autism spectrum disorder; fatigue; Fever/101.3 F tempature orally taken; ADHD; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), as dose 2 , single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Trumenba (DOSE 1, SINGLE), for Immunization. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever/101.3 F tempature orally taken"; ATTENTION DEFICIT HYPERACTIVITY DISORDER (non-serious), outcome "unknown", described as "ADHD". The patient underwent the following laboratory tests and procedures: Body temperature: 101.3 Fahrenheit. Therapeutic measures were taken as a result of autism spectrum disorder (Autism spectrum disorder medications). Additional information: Fever fatigue at the 4 hour mark after 2nd dose administered.   The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available the serious event Autism spectrum disorder is coincidental and unrelated to TRUMENBA.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Chest pain, low resting heart rate, arrhythmia, racing heart beats, dizziness
Initial unsolicited misuse report received from a nurse on 13 January 2016. This case involves a 49-year-old female patient who was vaccinated with a first dose of ADACEL (batch number U5263AA, expiry date 21 January 2018, route of administration were not reported) in the left deltoid on 20 November 2015 instead of a dose of TENIVAC (batch number, expiry date, site and route of administration were not reported) on an unspecified date for the indication dog bite. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies included cat allergy and no birth defects and medical conditions were reported. Patient had no other vaccinations within four weeks of vaccinations. On 20 November 2015, few hours "same night" following the vaccination patient developed injection site pain in the left deltoid and continuous headache. On 4 December 2015, 14 days following the vaccination patient experienced awful taste in her mouth. On an unspecified date, following the vaccination "During the week of Christmas" patient experienced bilateral foot pain and since then she had numbness and tingling in bilateral hands and feet with intermittent pain. She was worried she may have an autoimmune disorder. It was a wrong vaccine administered case, as patient received ADACEL in error instead of TENIVAC vaccine. It was reported that she didn't want ADACEL as it contained extra chemicals that she did not need. Patient had no laboratory investigation. Corrective treatment was not reported. The outcome of events was not recovered for events bilateral foot pain, numbness, tingling in bilateral hands and feet with intermittent pain and autoimmune disorder and recovered from the events awful taste in her mouth (lasted for four days), injection site pain in the left deltoid (lasted for three days) and continuous headache (lasted for four days). Upon internal review, the company decided to consider the event serious because of important medical event: she may have an autoimmune disorder. List of documents held by sender: none.
Information has been received from healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients received unspecified improperly stored doses of PROQUAD (Merck) (strength, frequency and route unknown, Lot# L033697, therapy type rHA and unknown Exp. date in 2017). The vaccines were exposed to 9F for 3 hours. This was the first excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt got flu shot 11h31 on 10/22/11. Called at 16h50 to complain about being weak, shaky & aching all over. Pt was not sweating, but was cold. Arm hurts, travelling, down back from shoulder & neck, pain in lower back. Pt was already presenting with a cold at the time of administering the flu shot. Pt was advised to see MD or got to ER. MS was informed.
Shortness of breath, fatigue, body ache to left lower limb, fever 99.6F.  Lasted approximately 8.5 hours.
Covid-19-Pfizer-Gray Top was diluted with 1.8 ml of diluent in error. Patient received diluted dose
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 29-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Diluent MRK Inj was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261; US-009507513-1808USA004381: Original Case : 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case : 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case : 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case : 1808USA001261; US-009507513-1808USA004362: Original Case : 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case : 1808USA001261; US-009507513-1808USA004363: Original Case : 1808USA001261; US-009507513-1808USA004364: Original Case : 1808USA001261; US-009507513-1808USA004389: Original Case : 1808USA001261; US-009507513-1808USA004390: Original Case : 1808USA001261; US-009507513-1808USA004391: Original Case : 1808USA001261; US-009507513-1808USA004392: Original Case : 1808USA001261; US-009507513-1808USA004365: Original Case : 1808USA001261; US-009507513-1808USA004393: Original Case : 1808USA001261; US-009507513-1808USA004394: Original Case : 1808USA001261; US-009507513-1808USA004395: Original Case : 1808USA001261; US-009507513-1808USA004396: Original Case : 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA00126.
left deltoid injection site pain with swelling. Tylenol was given, resident refused ice pack/warm pack
The vial was initially stored in the refrigerator on 04-Apr-2022 and on 19-Apr-2022 administrated to patient; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and on 19-Apr-2022 administrated to patient) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and on 19-Apr-2022 administrated to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and on 19-Apr-2022 administrated to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported.
In prep for a heart pacemaker implant, tests revealed I had emphysema. Exam with my PCP revealed I actually had pneumonia which I think was triggered by vaccine.
Headache, Myalgia, Arthralgia, Fever, injection site pain/swelling, chills, fatigue Narrative:  Employee reports injection site pain/discomfort and swelling, as well as fever (99.5 F), chills, headaches, joint pain, body aches, and fatigue. Reports took Tylenol (unknown dose/frequency).
On 12/18/20 the next day at ~0830 he experienced SOB, heart palpitations, and fever.  He was taken to the local hospital via ambulance. He was tested for Covid-10 at hospital.  Unknown result.  Discharged from hospital around 1545.
In mammogram taken 13 days after the 2nd dose, the images and ultrasound indicated swollen lymph nodes under my arm on the left side.   Quite alarming as I had been diagnosed with breast cancer the year before.   I had a followup ultrasound on April 27, 2021 and the lymph nodes had returned to normal.
PATIENT WAS ADMINISTERED PFIZER VACCINE INSTEAD OF MODERNA PATIENT HAD NO SYMPTOMS OR REACTION
This spontaneous report as received from a 74 year old female patient reporting on herself. The patient's medical history included shingles. In AUG-2014 the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dose, lot number and expiration date not reported). On 05-NOV-2014 the patient just contracted shingles but it was worse than when she had shingles before without a vaccine shot. It was a lot more pain and a lot more blisters. At the time of the report the outcome of the event was reported as not recovered. Additional information has been requested.
The patient recently had a TDAP shot at the pharmacy, administered by a pharmacist. Besides soreness at the site of injection on the left arm, the patient claims to have a large lymph node on the right side of his neck. There is visually an enlarge protrusion of the skin the size of a dime in diameter where the patient claims.
Chest pain like if you have a chest cold. Like deep down in. It's now 9:55PM and I still have the chest pain.
Received vaccines 10/23/13 (see below) and on 10/24/13 right arm had increased redness, warmth, swelling. Pt. very fatigued. Seen in office 10/25/13 at 1440, right deltoid with 6 cm diameter area of redness, mild swelling and warmth. Mom states it is improving.
Information has been received from a medical assistant concerning a female patient who in approximately October 2008, was vaccinated with GARDASIL vaccine.  The patient experienced rash from waist up after receiving GARDASIL vaccine.  On an unknown date in 2008, the patient recovered from the rash.  Additional information has been requested.
Arm hurt really bad; Tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (Formulation: Solution for injection), administration date 12Feb2021 (Lot number: EL9267, Expiration Date: 31May2021) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Feb2021, outcome "recovered" (15Feb2021), described as "Arm hurt really bad"; FATIGUE (non-serious) with onset 13Feb2021, outcome "recovered" (15Feb2021), described as "Tired". Additional information: reporter states after her first vaccine, her arm hurt the next day really bad and she was tired and wanted to sleep and lounge around all day so she slept and then the next day her arm was a little sore on Sunday and then it was gone the next day. Second vaccine received on 5MAR2021. No vaccination prior to covid vaccination. Prior Vaccinations (within 4 weeks): None.  No follow-up attempts are needed. No further information is expected.
Patient's medical record showed that she was received her first HEPB 9/14/17 and was due for her second HEPB as of 10/12/17. It was given along with other imms due at her 2m well child visit today. Upon documenting in chart it was discovered that the patient had received a HEPB on 8/16/17 that was never placed into her medical record. The pt experienced no adverse reactions to the injection.
I had normal side effects as mentioned in my paperwork, such as; injection site pain, neck pain on the left side, fatigue, joint pain, weakness, difficulty being mobile. There was also depression, the extreme joint pain and weakness made the depression feel worse. I didn't have any treatment but the pain lasted 3 or more days and the depression and joint pain for more than 7 days.