chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 30-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot # K00, expiration date 17-NOV-2016). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Injection given 12/12/05 and noticed swelling 9cm below site (left deltoid) given in deltoid area. Swollen, tender, and slight numbness and progressively got more numb no sign of infection. Area of swelling 5 cm x 5 cm. Seen 12/18/05 swelling gone away, no numbness.
Severe boil-like swelling of area where injection was administered.  Also had fever of 102 degrees.
Information has been received from a physician concerning a 24 year old female with an iodine allergy, a bicornuate uterus, endometriosis and a "partial duplication of the left renal collecting system" who on 17-MAY-2007 was vaccinated with a first dose of Gardasil.  On 18-JUL-2007 the patient was vaccinated with a second dose of Gardasil (Lot # 658094/0524U).  Concomitant therapy included YAZ.  In July 2007 a couple of days after vaccination she developed an erythematous rash on her chest, back and arms.  The patient was treated with BENADRYL.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
pt recv vax & 2/in 2hr of vax pt exp dizziness & inability to walk straight;able to walk straight by the next morning but dizziness cont;
This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with and improperly stored dose of ZOSTAVAX (lot # reported as L029481 with expiration date of 19-NOV-2016 and lot # L012478 with expiration date of 10-JUL-2017 (anatomical route of vaccination and dose number were not provided). No adverse event was reported. The Certified Medical Assistant (C.M.A.), reported the following temperature excursion for ZOSTAVAX: -10.6 degrees C for 1 hour and 26 minutes. The vaccine underwent and additional temperature of -6.7 degrees C for 2 hours and 25 minutes on an unspecified date. No product quality issues was involved. Additional information has been requested.
pt recvd vax 16SEP92 & devel sore shoulder & mobility limited w/sudden pull assoc w/shoulder;
Patient turned 12 years old 8 days ago. Mother requested appt for Pfizer (5-11yo) and the vaccine was administered prior to the pharmacist realizing the patient turned 12 years old. Patient should have been given adult dose of Pfizer Covid-19 vaccine.
Nurse administered JYNNEOS Vaccine intradermally to patient. Nurse did not obtain a wheal. Nurse repeated JYNNEOS Vaccination intradermally 2 inches from initial injection site. Nurse obtained a wheal.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Microscopic colitis" (unspecified if ongoing); "Drug allergy: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLUCONAZOLE, start date: 19Sep2022. Past drug history included: Amoxicillin, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association the causal association of suspect drug BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) and for reported events -drug ineffective and COVID-19                             cannot be excluded
Within one week of vaccination--numbness to right side of face, throat, progressed to right arm, right leg and left leg within a few days. Had right sided headache, and became dizzy and ataxic.  Symptoms have slowly resolved over approximately 1 month, with residual right leg weakness and intermittent headache.  12/28/07 Reviewed pcp medical records which reveal patient experienced numbness of right side, numbness & tingling of right hand/arm, HA,  difficulty walking.  Improved w/steroids. No neuro consult done. FINAL DX: limited right polyneuropathy.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested positive on a rapid test after having tested negative for 9 days (7 days post finishing paxlovid treatment); (21Jul2022) Positive, notes: Tested positive on a rapid test after having tested negative for 9 days (7 days post finishing paxlovid treatment). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product: COVID-19 Treatment, treatment start date: 11Jul2022, treatment stop date: 15Jul2022, indication: Treatment of COVID-19. No other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AE details available; Vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a Medical Assistant, referring to a 17 month old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 14-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), with lot # T032932 and expiration date on 28-SEP-2022 (route was not provided) for prophylaxis, after the vaccine experienced a temperature excursion (product storage error).  Varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit (8.5F), for 0 hours, 18 minutes 0 seconds and 6 degree Fahrenheit to 14 degree Fahrenheit (11.9F) for 1 hour 0 minutes 0 seconds. Cumulative timeframe of the exposure was 1 hour and 18 minutes.  The vaccine was not exposed to any other previous temperature excursion. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA007438:
Information has been received from a physician concerning a 12 month old male who on 26-Feb-2008 was vaccinated subcutaneously with 0.5ml of VARIVAX (Oka/Merck). On 14-March-2008 the patient developed chickenpox. The patient had less than fifty lesions and they were mostly on his scalp and trunk. At the time of reporting the patient had recovered, date unspecified. Unspecified medical attention was sought, which included an office visit. There was no product quality complaint. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA: Systemic: Rash (other than injection site), Nausea, Vomiting. Rash developed on the rash, per dr doctor, gave one dose of EPIPEN on the left upper leg. rash subsided.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 20-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Fever for 24 hours as high as 103 F, body/muscle aches, fatigue, headache. Symptoms lasted in total about 36 hours soreness at injection site and general soreness in entire left arm for about 72 hours after vaccine administration
Pain in right hip bone, later extending into back of both legs. Groin discomfort. Still ongoing at 10 days in.
Expected fever, myalgia, malaise for a couple days after the second dose. Approximately April 2021 I started to notice palpitations and vague chest discomfort that was not associated with exertion. It resolved in late June 2021, and I had a normal stress test on July 14. I have no symptoms now.
radiating pain from injection site resulting in loss of muscle strength, pain is chronic, felt in shoulder, elbow, under scapula
A nurse reported that a resident of a long-term care facility received a dose of flu shield in November 2001. In January 2002, the resident developed a "severe" respiratory infection characterized by congestion and fever. A rapid antigen test was negative for influenza A. The resident recovered. No further info was available at the date of this report.
Received DTaP and IPV in the right arm on 03/12/2002. On 03/15/2002 mom noticed red area on deltoid 12cm x 10cm hot to touch. Mom stated no fever and pt did not complain of discomfort. Mom did not see rash.
Skin rash; Red itchy disc shaped rashes appeared on legs.; Now there are numerous rashes on both legs. One on chest; Now there are numerous rashes on both legs. One on chest; Within a week after 2nd shot prickly uncomfortable sensations in legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "not recovered", described as "Skin rash"; PRURITUS (non-serious), outcome "not recovered", described as "Red itchy disc shaped rashes appeared on legs."; RASH (non-serious), RASH (non-serious), outcome "not recovered" and all described as "Now there are numerous rashes on both legs. One on chest"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Within a week after 2nd shot prickly uncomfortable sensations in legs".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately 1 1/2 hours after receiving vaccines pt started with myalgia, very bad headache, nausea, chills throughout the evening. (Approx 12 hours). Pt also c/o ear and jaw pain, fever and arm pain.
patient suffered a 2-minute long seizure. She has a history of known seizure disorder. Her last seizure was 3 months ago. She also suffers from severe anxiety. patient was alert and oriented times 3 and refused transport to a local hospital by EMS.
right arm swollen and red. 40 cm x 40 cm Benadryl and Tylenol
I had no reaction for approximately 4 hours after my vaccination. Then I got the shakes and all the muscles in my body seemed to be vibrating. I could still walk but found a comfortable chair. The shakes would rise and fall in amplitude causing my hands and legs to oscillate then recede after about 30 seconds.   This lasted for about 20-25 minutes and simply went away and has not recurred. I have had no other symptoms.  As chills were a listed side effect, I assumed at first  that it was chills or some variant but I was not cold. It was the chills without an apparent temperature effect although I did not measure my temperature.
pt developed erytema, edema & induration w/ warmth in a 13 X 11 cm area surrounding the injection site after receiving TTF vaccine
J96.00 ACUTE RESPIRATORY FAILURE 1/14/2022 ABNL PLASMA PROTEIN J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/10/2022 ABNL PLASMA PROTEIN J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/3/2022 ABNL PLASMA PROTEIN J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/10/2022 ABNL PLASMA PROTEIN R09.02 HYPOXIA 1/9/2022 ABNL PLASMA PROTEIN J96.00 ACUTE RESPIRATORY FAILURE 1/14/2022 GERD (GASTROESOPHAGEAL REFLUX DISEASE) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/10/2022 GERD (GASTROESOPHAGEAL REFLUX DISEASE) J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/3/2022 GERD (GASTROESOPHAGEAL REFLUX DISEASE) J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/10/2022 GERD (GASTROESOPHAGEAL REFLUX DISEASE) R09.02 HYPOXIA 1/9/2022 GERD (GASTROESOPHAGEAL REFLUX DISEASE) J96.00 ACUTE RESPIRATORY FAILURE 1/14/2022 ALLERGIC RHINITIS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/10/2022 ALLERGIC RHINITIS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/3/2022 ALLERGIC RHINITIS J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/10/2022 ALLERGIC RHINITIS R09.02 HYPOXIA 1/9/2022 ALLERGIC RHINITIS
Right upper arm with increased warmth and approximately 5 inches of swelling surrounding injection site.  Denies pain.  Advised to apply warm packs and take Ibuprofen.
Pt c/o'd of itching of (R) arm 10 06 10 5pm when mom returned from work. Mom is RN; she describes hives from pts neck to her waist on (R) side of body; hives also down (R) arm. Mom felt it was warm, reddened, ?swollen, inflamed. Mom tx'd with oral BEANDRYL and applied hydrocortisone cream. She continued tx for 1 more day. Pt improving but 10-13 PM and 10-14 AM began running fever, "high" per mom but she did not take temp.
Patient given Pfizer as the second dose of the covid vaccine instead of Moderna as was the first dose. No signs or symptoms of adverse reaction. Patient states she feels good.
Patient's mom called verbalizing a hard red spot, measuring about nickel sized at site of varicella vaccination. Varicella vaccine given on right thigh, subcutaneously. Mom verbalized no warmness et that patient has had this since two days after administration.
At time of injection I had swelling and redness along with muscle soreness.  After about 4 days the redness and swelling went away.  However on day 7 the redness returned with intense itching and hives.  Today is day 9 and it is red, swollen, and very itchy, with hive like bumps.
Erythema multiforme diagnosed 9/21/09 Seen in ER 9/21/09, 9/22/09. Seen in office 9/23/09.
Lethargic; Slight fever; Headache; Nausea; Chills; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 14Apr2021 at 08:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine, adhd and arthritis. The patient did not have any allergies to medications, food or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADERALL) from unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 13:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 20:00, the patient experienced lethargic, slight fever, headache, nausea and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lethargic, slight fever, headache, nausea and chills were resolved on an unknown date in Apr2021.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable nurse. This  nurse reported that a 79-years-old, female patient received PREVNAR13, lot number G15075; expiration date MAY2014) on 14JAN2013 at 0.5 ml single dose due to Chronic Obstructive Pulmonary Disease (COPD). Relevant medical history included blood pressure problem and cholesterol problem since an unknown duration. Relevant concomitant medication included amlodipine at 10mg daily, nitroglycerine at 0.5 mg as needed, metoprolol at 50 mg two times a day, furosemide at 20 mg two times a day, aspirin at 81 mg daily, quinaprila t 50 mg two times a day, all since an unknown duration for blood pressure problem, simvastatin at 40 mg daily since an unknown duration for cholesterol problem and SPIRIVA at an unknown dose daily, VYTORIN at an unknown dose as needed, ADVAIR DISKUS at 500/50 mg four times a day, DUONEB at unknown dose (strength 0.5/2.5 mg/3 ml) four times a day, all since an unknown duration for Chronic Obstructive Pulmonary Disease (COPD). On 15JAN2013, when the patient woke up, her tongue was swollen, she had red hives and itching. Relevant laboratory data was unknown. Therapeutic measures taken in response to the events included visit to the emergency room on 21JAN2013 where she was administered VISTARIL at an unknown dose and frequency. She was also prescribed BENADRYL at 24 mg at an unknown frequency both on 15JAN2013 and prednisone at 20 mg for seven days followed by 10 mg for seven days on 21JAN2013, she was applying betamethasone cream at 0.05% two times a day since an unknown date. Clinical outcome of all the reported events was recovering as the nurse mentioned that she has improved a lot from the events but right now still had some red hive. It was also reported that the patient also visited a infectious disease specialist on 22JAN2013.
X/XX/12 - TWINRIX administered to a patient at the XXXXXXXX county department of health that had already had full series of Hep B shots. TWINRIX lot # AHABB225AA, 1cc administered left deltoid. Pt notified. No adverse reactions noted. Series of Hep B not given at XXXXXXXXX county department of health, I will make sure to check NCIR before administering immunizations.
Had all common symptoms to include; chills, fever, vomiting, pain in muscles and joints, swollen nodes around injection site, and migranes. The adverse event that also followed was/is nerve pain shooting up behind left ear up into  skull  causing intense pain. These occur 2-4 times every few hours or sometimes every hour. Over 48 hours has passed since getting the vaccine and the pain still occurs.
10 patients administered vaccine past the beyond use date/ vial that had been punctured on 04NOV2021 and is now past the 12 hour beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date/ vial that had been punctured on 04NOV2021 and is now past the 12 hour beyond use date) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date/ vial that had been punctured on 04NOV2021 and is now past the 12 hour beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date/ vial that had been punctured on 04NOV2021 and is now past the 12 hour beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
This spontaneous report as received from a consumer refers to herself, a 91 year old female patient with an unspecified lung condition. The patient had no history of drug reactions/allergies. In early July 2013 the patient was vaccinated with a dose of ZOSTAVAX in the upper arm. Lot number, strength, dose and exact vaccination date were not provided. Concomitantly the patient used unspecified blood pressure medication and unspecified medication for the lung condition. A few days after the vaccination the patient developed shingles. She developed a rash on the right side of her tummy and trunk and around to her back. The patient did not state how the diagnosis was made. The patient had not contacted her physician and did not seek medical attention. No lab diagnostic studies were performed. The patient stated the rash hurts. No treatment was provided for the event. The outcome of shingles was unknown. Additional information has been requested.
Covid Vaccine given on 1/5. Headaches started within two hours. Fatigue and headache next two days. Followed by leg weakness in both legs and uncontrollable tremors in my entire body. I was hospitalized for 5 days. I am still having headaches and shakes all over my body with major weakness all over.