chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient had no known pertinent medical history or drug reactions/allergies. On 10-SEP-2014, the patient was vaccinated with a dose of PNEUMOVAX 23, (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On 10-SEP-2014 by that evening, the patient stated that her arm was really sore. The pharmacist stated that the patient called the pharmacy on 12-SEP-2014 and reported that she had limitation of her arm movement. The pharmacist stated that the patient cannot move her arm above her elbow and her shoulder was immobile as well. The patient had not received any treatment for the events. No laboratory test has been performed. At the time of the report, the patient had not recovered from events and the relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Pain and arm swelling "in the arm I got the pneumonia shot in". Right arm and shoulder with a headache. Used Advil.
Pt recvd 2 doses of Engerix-B & had local inject site pain on 2nd dose;
Information has been received from a medical assistant (MA), concerning a female patient (age not specified) with no pertinent medical history and no known allergies, who was vaccinated (date not specified) with the third dose of Gardasil (lot # not reported).  There was no concomitant medication.  After the third vaccination, on 26-NOV-2007 (time duration to onset not specified), the patient experienced headaches, and dizziness that has been so severe, that "she needed to sit down very often."  At the time of this report, the patient had not recovered.  The MA considered the events to be serious as disabling/incapacitating.  Additional information has been requested.
Injection site on left lower / upper arm became swollen, hot and red about 2 inches in size.  No itching, no pain.
fever started 3/3/21 by 3/4/21 it was reaching 103.6 and difficult to get down. I had to get into a tepid bath to get it down to 103 then I alternated tylenol and advil every 3 hours to keep it at 101. I ran a temperature until 3/6/21. Severe headache from 3/5/21 to 3/11/21. Gland under right arm so swollen I couldn't put my arm down until 3/10. 2 glands in my face and near jaw line remained swollen until 3/12/21. Mucus seemed to be thick and unable to drain from 3/5 -3/14 despite taking Musinex daily (3/8 -3/12 it was even a little hard to take deep breaths). Sore appeared in my nose on 3/6. I know the vaccine does not contain a live virus, but my symptoms after this first shot made me feel like I had Covid all over again.
3/22 Patient had clinic visit for cough, fever and post nasal drip that started 3/20 evening, tested COVID-19 positive. Patient reported to ER on 3/23 with worsened cough, shortness of breath, fever, myalgias and headache. Noted to be tacycardic with wheezing and rhonchi present, low 90s O2 on room air. Treated with IV fluids, Remdesivir, dexamethasone, oxygen, acetaminophen, duoneb, xopenex, albuterol inhaler
received first dose of Moderna COVID-19 vaccine under 18 years of age; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine under 18 years of age) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine under 18 years of age). On 23-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine under 18 years of age) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported and no adverse reactions following vaccination as per the nurse. The nurse stated the patient waited 15 minutes after vaccination and they were fine.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-329314.
This spontaneous report was received from an office manager and refers to a 13 month old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 15-DEC-2016, the patient was vaccinated with the second improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517.
Severe tooth and jaw pain, used Advil for 5 days to control pain, eventually prescribed amoxicillin for 7 days
Information has been received from a consumer concerning his 76 year old wife with severe headaches and no allergies, who on 12-NOV-2007 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included LIPITOR, LOPRESSOR, ZOLOFT and rizatriptan benzoate (MSD). On 12-NOV-2007, later in the evening, the patient experienced headaches later in the evening. The patient took rizatriptan benzoate (MSD) which helped but she still had the headache. At the time of report the patient had not recovered. There were no laboratory or diagnostic tests performed. Medical attention was not sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received Shingrix for prophylaxis. On 2nd October 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, general body pain and feeling cold. On an unknown date, the outcome of the injection site pain, general body pain and feeling cold were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain and feeling cold to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but it could be 51 or 52 years. The patient had received both doses of Shingrix. After each dose he had some pain at the injection site, but his whole body ached like he got beat up and he felt very cold as well. The symptoms resolved after a day and a half. The consent was provided for follow-up. For tolerability of the second dose of Shingrix, refer case US2018GSK232277.
Approx 20-30 minutes after immunization, developed swelling and chemosis left eye. Benadryl 2 tsp given, Patomol 2 drops bid; Rx-Atarax 10 mg bid given.
I woke up with a ringing buzzing high pitched noise in my ear, I took CBD gummies and it helped a tad bit. This has been an ongoing issue for weeks and I'm currently awaiting to see the doctor on April 14th 2022 to get diagnosed.
shivering; muscle soreness; dizzy; tired; in bed; could not work; This case was reported by a consumer and described the occurrence of shivering in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2019, the patient received Shingrix. On 8th August 2019, several hours after receiving Shingrix, the patient experienced shivering, muscle soreness, dizziness, tiredness, bedridden and inability to work. On an unknown date, the outcome of the shivering, muscle soreness, dizziness, tiredness, bedridden and inability to work were unknown.   It was unknown if the reporter considered the shivering, muscle soreness, dizziness, tiredness, bedridden and inability to work to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the wife of a patient. The patient received his Shingles shot a day before reporting. The patient started last night with shivering and extreme muscle soreness through his entire body.  The patient was also very dizzy and tired to the point he could not work today and was in bed. The reporter did not give permission to follow up.
About 10 minutes after receiving Gardasil vaccine - while patient sitting in waiting room she drew her Rt arm up to face and became rigid and fainted. She was immediately placed supine on floor. Appeared alert, but weak and pale. B/P 110/62 - O2 Sat 100% - Remained in office for 1 hour then home with mom - B/P back to normal, color pink. Doctor attended to patient.
After vaccine continues sitting in waiting rm - observed by father and mother. Losing consciousness for approx 30 seconds, mild shaking, gurgling. I observed pt slumped in chair and incontinent of urine, helped assist pt to floor, once on floor pt conscious, no injuries apparent, once on floor orient x 3 BP 112/68 P 60 R 18, c/o fatigue monitored x 15 min, ambulating out of clinic seen by PCP immediately after.
Pt states that she lost taste and smell since her first dose and it has only intermittently recovered. For example, ranch now burns her tongue.
Redness, swelling, pain at location of injection. Spreading redness and swelling over 3 days. Patient saw doctor after 3 days. Was given a course of antibiotics. At 5 days after vaccine given, patient reports decreased redness and swelling.
Patient became clammy and sweaty and developed a headache within 5 minutes of receiving her 2nd dose of Moderna.  About 10 minutes after receiving the vaccine , patient stated " It feels like it is hard to swallow the crackers and my throat is feeling tight at the top".   Patient denied any shortness of breath, tongue thickening, throat swelling, hives, or rash at that present time.   Patient's throat tightness was resolved 10 minutes after taking one diphenhydramine 25mg capsule.
SUDDEN ONSET OF NEUROPATHY BEGINNING WITH FEET AT 2PM AND SPREADING TO 80% OF BODY BY 4PM, ESPECIALLY PREVALENT STINGING AND BURNING IN RIGHT HAND AND FOREARM. TREATMENT IS GABAPENTINE AND NORTRIPTYLINE. ADVERSE SYMPTOMS HAVE LIMITED MY ABILITIES BY ABOUT HALF. NEUROPATHY HAS PROGRESSIVEY WORSENED IN BOTH FEET AND LEGS OVER THE PAST 2 YEARS. I EXPERIENCE TINGLING, SHOOTING PAINS, NUMBNESS, PINS AND NEEDLES, BURNING SENSATIONS, DIFFICULTY USING HANDS, FEET, AND LEGS, EXTREME SENSITIVITY TO TOUCH, LACK OF MOTOR COORDINATION, INABILITY TO SENSE TEMPERATURE CHANGES, INCREASED EPISODES OF FALLING, BALANCE ISSUES AND VERTIGO, MUSCLE WEAKNESS AND CRAMPING, UNUSUAL SWEATING, EXTREME COLDNESS IN HANDS AND FEET, BLADDER PROBLEMS AND INCONTINENCE, DIZZINESS, AND HAIR LOSS.
Patient states developed redness and swelling at injection site within in hours. Spread from left shoulder to left elbow. Painful : had temp 99.6 which she describes a fever for her. Lasted 3 days. 12/14: no redness, no swelling.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Pt was counseled to seek immediate medical attention at urgent care. pt urged to call back 02/12/22 to report findings from urgent care and to assure that pt is doing better. if pt fails to call, will call pt on 02/12/22
Patient experienced sweating, lightheadedness, nausea, vomiting, diarrhea, fever and numbness throughout his body. Patient also noticed his eyes were white without the normal coloring. Patient also had a site-reaction of swelling, and redness to his left arm.
Started with headache almost 9 hours after vaccine. Headache went away 18 hours after vaccine. Chills & slight fever (99*) started 21 hours after vaccine. A full 24 hours AFTER the vaccine, I was at my worst with 101.5 fever with body aches, chills and joint pain. Slept for 14 hours then woke up felling better - which was 39 hours after the vaccine, however I still had joint pain. Joint pain started at the 24 hour mark after the vaccine thru 54  hours after vaccine, then I went to sleep. I felt back to normal when I woke up, a total of 63 hours after the shot.
Dose administered >12 hours post puncture; stored at room temperature beyond 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (stored at room temperature beyond 12 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (stored at room temperature beyond 12 hours). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (stored at room temperature beyond 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patients received the second dose of Moderna COVID-19 vaccine from a vial that was punctured and stored at room temperature beyond 12 hours. no of vials is given as 1 , vial was initially stored in the refrigerator 2-oct-2021,first punctured on 10-oct-2021,administered on 11-oct-2021 at noon. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 30 hours. no concomitant and treatment medications are provided by the reporter.   This case was linked to MOD-2021-348346 (Patient Link).
achy; fatigued/felt tired; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy), FATIGUE (fatigued/felt tired) and VACCINATION SITE PAIN (sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (achy), FATIGUE (fatigued/felt tired) and VACCINATION SITE PAIN (sore arm). At the time of the report, MYALGIA (achy), FATIGUE (fatigued/felt tired) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-365922, MOD-2021-365923 (Patient Link).
Chest Pain; Chills; Migraine; Cold Sweat; Light Headedness; Dehydration; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration in the left arm on 15Feb2021 at 08:15 (at the age of 23-years-old) as a single dose for COVID-19 vaccination.  The patient had no relevant medical history reported. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration in the left arm on 25Jan2021 at 08:15 (at the age of 23-years-old) for COVID-19 vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine or any other medications within two weeks of vaccine. The patient did not have COVID-19 prior to the vaccination. The patient was tested for COVID-19 on 11Feb2021 with nasal swab and the result was negative. On 15Feb2021 at 20:30 the patient experienced chills, migraine, cold sweat, chest pain, light headedness, and dehydration. The patient did not receive any treatment for the chills, migraine, cold sweat, chest pain, light headedness, and dehydration. The clinical outcome of the chills, migraine, cold sweat, chest pain, light headedness, and dehydration was not recovered.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX vaccine. Concurrent medical conditions included shingles. Concomitant products included Influenza vaccine Quadrivalent (2018-2019 season) and Hepatitis A vaccine. In October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, Influenza vaccine Quadrivalent 2018-2019 season and Hepatitis A vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX vaccine on unknown arm at her physician office and experienced arm soreness. The patient also received either a flu shot or a Hepatitis A shot at the same time in the opposite arm. The patient could not recall that which arm the patient received the SHINGRIX. This case has been linked to US2019056486 by same reporter for the second dose.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP; "High Colesterol" (unspecified if ongoing), notes: High Colesterol; "spinach caused loose bowels" (unspecified if ongoing), notes: spinach caused loose bowels. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient took anti-viral paxlovid as part of covid-19 treatment (treatment start date:13Jul2022, treatment stop date:17Jul2022) and other antibiotics (11Jul2022 to 15Jul2022). The reason for lot unknown was unable to locate or read the details.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore in the arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 19, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 29, 2021, patient experienced pain in extremity (sore in the arm). At the time of the report, pain in extremity (sore in the arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
terrible cough; Diarrhea; couldn't eat or drink anything; couldn't eat or drink anything; Low grade fever; lost a little bit of my sense of smell; In between, I came down with Covid.; In between, I came down with Covid.; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 73 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYNTHROID; FLUTICASONE + SALMETEROL; LETROZOLE; CLOBETASOL; IRON; LOSARTAN POTASSIUM; MECLIZINE HCL; BIOTIN; CALCIUM; AMLODIPINE BESYLATE; XARELTO; TYLENOL; XGEVA; KEFLEX [CEFALEXIN MONOHYDRATE]; METHOTREXATE. Past drug history included: Sulfamethoxazole, reaction(s): "Allergies". Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "In between, I came down with Covid."; DIARRHOEA (non-serious) with onset 24Dec2021, outcome "unknown", described as "Diarrhea"; FEEDING DISORDER (non-serious), DYSPHAGIA (non-serious) all with onset 24Dec2021, outcome "unknown" and all described as "couldn't eat or drink anything"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Low grade fever"; ANOSMIA (non-serious) with onset 2021, outcome "unknown", described as "lost a little bit of my sense of smell"; COUGH (non-serious), outcome "unknown", described as "terrible cough". The patient underwent the following laboratory tests and procedures: body temperature: low grade. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Approximately 12 hours post vax, pt experienced extreme irritability, screaming for 1 hour and a low grade temperature.
Lt leg redness, swelling, warmth, discomfort. Pt treated with cephalexin for 10 days & prednisone for 5 days, follow up appt in 4 days.
On the 28th I was in bed all day. On the 29th I had UTI symptoms. I tried to treat them with over-the-counter medication and cranberry juice. I was not successful. I contacted the now clinic through an app on Tuesday. They gave me antibiotic (Macrobid) and Pyridium. It's a 5-day course and I'm halfway through it.
Itching internally, vomiting for 3 days, blood sugar ran up between 48-400.