chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pregnant; This spontaneous prospective pregnancy case was reported by a non-health professional and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) 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 an unknown date, the patient received 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 an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Developed the Covid virus; cough; trouble breathing; Itchy; Sneezing; Runny nose; Diarrhea; 100.4 fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed the Covid virus), COUGH (cough), DYSPNOEA (trouble breathing), PRURITUS (Itchy) and SNEEZING (Sneezing) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (Developed the Covid virus), COUGH (cough), DYSPNOEA (trouble breathing), PRURITUS (Itchy), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), DIARRHOEA (Diarrhea) and PYREXIA (100.4 fever). On 17-Jan-2021, PYREXIA (100.4 fever) had resolved. At the time of the report, COVID-19 (Developed the Covid virus), COUGH (cough), DYSPNOEA (trouble breathing), PRURITUS (Itchy), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and DIARRHOEA (Diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: 100.4 (High) for two days over the weekend. On 16-Jan-2021, Oxygen saturation: 98-100 normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included an unspecified birth control pill.   The patient took Allegra and Motrin for treatment of the events.
pt recv vax & post vax exp an arthus type rxn;was stiff & sore all over & knees & joints were inflamed;
3 INCH DIAMETER RASH. WARM . "FEELS HARD" STARTED THE DAY AFTER VACCINATION. WAS EVALUATED BY MEDICAL DOCTOR AND CONCLUDED AS LOCAL SITE REACTION
Redness on nose, cheeks, mouth, ears that later developed on the rest of her body.  Skin was itchy.  Welts on back, tummy, legs, arms, hands, and feet.  Swelling of hands, and feet.  Noticed redness at 4:30 PM when I picked her up at daycare.  Gave her 2 t. BENADRYL at NOC and in A.M.  She seemed ok this A.M.  No noticeable signs.
musce aches; Feeling tired; slight headache; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 5th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced myalgia, tiredness and headache. On an unknown date, the outcome of the myalgia, tiredness and headache were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the afternoon on the day before reporting. After vaccination the patient felt tired, muscle aches and slight headache. The patient asked how long did the side effects last.
Pain; Incomplete course of vaccination; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for an unknown indication.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th September 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, the patient received the 2nd dose of Shingrix. On 29th January 2020, 231 days after receiving Shingrix, 133 days after receiving Influenza vaccine Quadrivalent 2019-2020 season and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced pain and incomplete course of vaccination. On an unknown date, the outcome of the shingles, pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that, there patient received dose of Shingrix and flu vaccine. After vaccination, the patient diagnosed with shingles and after going to an emergency room due to pain. Less than 2 years after vaccination with flu vaccine, the patient experienced shingles. Less than 9 months after Flu vaccination, the patient experienced pain. The reporter stated that on 18th September 2019, the patient received Flu vaccine and therefore waited to receive the 2nd dose of Shingrix. The reporter consented to follow up.
3:00 PM school nurse received Flu vaccine, 3:15PM  began c/o itch, rash present on left flank-Benadryl 50mgm.po, B/P 160/82. Called PCP, he requested no epinephrine be given because her B/P going up. Patient c/o swollen tongue and chest pain-transported by ambulance to Hospital.
5 days after shot began with headache; progressed to feeling like she had a cold, sneezing and coughing - began itching et developed red, raised bumps on abdomen et arms et felt war; feels it lasted x 2 days.
Patient received the Moderna vaccine (that she requested) but her age wasn't noticed until after vaccine was given. Patient stayed in clinic 25 mins after vaccine was given, no reaction.
I was coughing up a lot of blood. I had hemoptysis. I went to the ER by ambulance. The infections disease doctor found the bacterium, I had called shimoidei. I wasn't prescribed any medications. I was coughing up a lot of blood for 8 hours and then it just stopped.
Sore and swollen at the shot site. 24 hours after shot I experienced chills, and a bad headache that lasted all day off and on even with use of Motrin.  Headache went away but still had chills and a low grade fever next day. Was really tired and fatigued for 48 hours sore hips and aching joints. Now 3 days after just a swollen itchy shot site.
Joint closest to site inflamed, hot to touch, felt as if glass shards presents. Then spread to rest of joints with same response. Bed ridden for 2.5 days drinking only fluids through this time. General malaise with low grade fevers. Chills with night sweats at bedtime over that 2.5 days. Took approximately 2 weeks to get back to normal energy levels and routine.
Patient fainted soon after the vaccine was given. Patient was not injured. Patient came to quickly. Patient later admitted this has happened before after previous vaccines/blood work. I had patient stay in store for 30 minutes after to make sure patient had no further reactions. Patient was feeling better after 30 minutes, I let patient go home.
MISSED THE THIRD DOSE; A spontaneous case report was received from a nurse on 20-May-2019 for two consumers.  Based on the information obtained from a nurse, two individual case safety reports PVX201905-000399 (PVX2019-1263; first child) and PVX201905-000400 (PVX2019-1264, second child) were created and cross-linked in the database.  This case describes a male child consumer who "missed the third dose", while being on Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif, but missed to take the third dose, which was due on Friday as he went to another location and his mother forgot to carry medication with her.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the third dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000400:
Post vax, the pt developed stiffness of arm and swelling, and flu-like symptoms. On 12/13, she developed swelling and itching around injection site. Also, soreness from shoulder to elbow, light-headed, slight fever, and chills.
Chills fever weakness fatigue no appetite Started Friday day after shot lasting till about 1100 pm on Sunday. Three days total.
Pt had chills, fever, body aches and headache along with malaise. Stayed in bed the next day because didn't feel good. Was ok in about 24 hours.
Information has been received from a physician concerning a 17 year old female with a history of asthma, who on 13-OCT-2007 was vaccinated with her first does of Gardasil vaccine (Lot# 654539/0742U). Concomitant therapy included Colbiocin for acne and inhalers for asthma (therapy unspecified). On 25-OCT-2007, the patient experienced hives and itching behind her knees, her thighs and her elbows. The patient's hives and itching behind her knees and thighs and on her elbows persisted. The patient sought medical attention by calling the office. Patient was advised to see her family physician for evaluation. This is in follow-up to report(s) previously submitted on 11/14/2007. Information (and additional information via a B form) has been received from a physician concerning a 17 year old caucasian female with a history of asthma who on 15-OCT-2007 was vaccinated with her first dose of GARDASIL (Lot# 654539/0742U). Concomitant therapy included Colbiocin. On 24-OC-2007 at 9:00 pm the patient experienced red, raised papules behind her knees and thighs and on her elbows. She stated they were very itchy. The patient took BENADRYL that evening. The patient's red, raised papules and hives and itching behind her knees and thighs and on her elbows went away when she awoke the next morning. The patient sought medical attention by calling the office. Patient was advised to see her family physician for evaluation. As of 26-OCT-2007 the patient had recovered. Additional information has been requested.
slight leakage from typhoid vaccine from syringe with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 75 years old female patient who had slight leakage from Typhoid Vi Polysaccharide Vaccine [Typhim Vi] from syringe, with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect Typhoid Vi Polysaccharide Vaccine, Solution for injection (lot: V2A451M, strength,  Expiry date: Not reported) via intramuscular route in unknown administration site for optional travel vaccine (immunization).  On 07-JUN-2023 the patient had slight leakage from typhoid vaccine from syringe with no reported adverse event (incorrect dose administered) (latency: same day).  There were no lab data/results available  Action taken with Typhoid Vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On 3/3/00, this 5 month old male had tonic clonic seizures. It was witnessed by the ER physician. The child was given Ativan and the seizure stopped. The child had a low grade temperature of 100.6. The child has received immunizations on 3/1/00. The pt was treated with antibiotics for 48 hours and was discharged on Phenobarbital and Ceclor.
Eyes became red, itchy & swollen. Developed cough, wheeze & difficulty breathing, throat tightening. Took BENADRYL 50 mg PO. Then chills, achiness, nausea & vomiting. Fell asleep feeling better by 2 am in morning. Fell asleep feeling better by 2 AM in morning. 9/30/09 - developed rash/hives on chest & abdomen.
Feeling unwell; sore arm; Myalgia; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), VACCINATION SITE PAIN (sore arm), MYALGIA (Myalgia) and FATIGUE (Tiredness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling unwell), VACCINATION SITE PAIN (sore arm), MYALGIA (Myalgia) and FATIGUE (Tiredness). At the time of the report, MALAISE (Feeling unwell), VACCINATION SITE PAIN (sore arm), MYALGIA (Myalgia) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not provided  Concomitant medication were not provided   This case was linked to MOD-2021-207560 (Patient Link).
Headache, Myalgia, CoughWheeze, UrticariaPruritus & Diarrhea Narrative:  Employee states she took 800mg Ibuprofen on Friday & then again on Saturday. None on Sunday or today. Other Relevant History:
This spontaneous report has been received from a pharmacist concerning to an unspecified patient of unknown age and gender. Current conditions and medical history were not reported. On an unknown date, the unspecified patients were vaccinated with ZOSTAVAX, lot # J001698, expiration date 08-MA-2014, (dose and route not reported). The diluent lot# was reported as J006364, expiration date August 2015. Concomitant medication was not reported. The reporter stated that dose of ZOSTAVAX have been measuring a volume of less than 0.65ml, a PQC filed for diluent underfill. No adverse effects reported. Additional information is not expected.
One day post vax the pt became irritable, crying, screaming for 7 hours with only brief periods when she could be consoled. Possibly low grade temp and had Tylenol.
About 9 hours after the vaccine I had a very strange reaction. I don't know if it was a panic attack or a little heart issue. Suddenly my chest hurt badly in the middle, and then my back hurt in the middle, and then my head hurt, and then my legs hurt. I was full of anxiety and started crying. It lasted about 10 or 15 minutes and then everything went away and I was back to perfectly normal. A few seconds before this ?episode? I had an auditory hallucination which was the first and only one I have ever had. In my 57 years of life I have only had one ?panic attack? which was 22 years ago during a divorce. Nothing else unusual or out of the ordinary happened on this day except for the vaccine. I was in a normal good mood and having a normal day before it happened, and it went away as fast as it came after about 10 - 15 minutes.
c/o lt arm paralized hurts so much unable to move it; home visit made; lt shoulder & arm very tender to palpation but no lumps; unable to squeeze hand very hard; eyes dull;
Swelling of eye lids and around the eyes. Red and itchy. watery and stinging of the eyes. red itchy rash under the eyes and on the neck
At 6:49pm the Pfizer COVID19 Vaccine was administered and at 7:00 the patient reported his tongue  was swelling and thought he needed an epi-pen. pharmacist asked the patient to come in the the clinical services room for assessment. patient was seated and asked if he was certain he needed an epi-pen. In about 30 seconds, the patient's speech was slurred, difficult for him to speak due to his tongue swelling up. He removed his cell phone and the pharmacist administered 1 dose of Epi-Pen 0.3mg. The patient stated he felt jitters. At 7:15pm, the patient's blood pressure was 156/106 mmHg and pulse was 80. At 7:20pm, the blood pressure was 137/95 mmHg and pulse was 80. Patient refused EMS transportation and his boyfriend drove him to Hospital. He arrived at Hospital and had over 30 minutes to wait before vitals were taken. At 8:28pm, his blood pressure was 126/83 mmHg, pulse was 80, and temperature was 98.2. He was told he would have a 4-5 hour wait. He decided to leave hospital due to the overwhelming experience at check in.
It has spread ever since but has not quite reached the elbow; Warm to the touch; That was developing some redness where shot was injected. It has spread ever since but has not quite reached the elbow; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It has spread ever since but has not quite reached the elbow), FEELING HOT (Warm to the touch) and VACCINATION SITE ERYTHEMA (That was developing some redness where shot was injected. It has spread ever since but has not quite reached the elbow) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 26-Feb-2021. Concurrent medical conditions included Lymphoma. Concomitant products included IBRUTINIB (IMBRUVICA), FUROSEMIDE, WARFARIN, VITAMIN D3 and VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced ERYTHEMA (It has spread ever since but has not quite reached the elbow), FEELING HOT (Warm to the touch) and VACCINATION SITE ERYTHEMA (That was developing some redness where shot was injected. It has spread ever since but has not quite reached the elbow). At the time of the report, ERYTHEMA (It has spread ever since but has not quite reached the elbow) and VACCINATION SITE ERYTHEMA (That was developing some redness where shot was injected. It has spread ever since but has not quite reached the elbow) had resolved and FEELING HOT (Warm to the touch) outcome was unknown.        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.   Concomitant medications also included two heart medications.  Patient received antibodies on 27-FEB-2021  No treatment medications were taken by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow up information received, included event (Redness recovered in 7-8 days) outcome was updated to recovered.
Patient presented to recovery following vaccination with a red hive like rash starting at her chest and spreading upwards to the right side of her jawline.  Diphenhydramine 25mg caps 2 caps given once.  Vital signs were monitored and were within normal limits.  Patient closely monitored one on one for about 50 minutes following vaccination and about 40 minutes after diphenhydramine administration.  Rash was greatly improved.  Instructions given including signs and symptoms to watch out for, where/how to seek care.  Patient verbalized understanding and denied having any further questions or concerns at the time.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-MAY-2011, a physician administered the ZOSTAVAX to the patient. On or about 21-OCT-2011, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Heart racing and pounding; light headed; felt really hot; This is a spontaneous report received from contactable female consumer (patient) via Pfizer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not re-ported. On an unspecified date in Apr2021, the patient experienced heart racing and pounding, light-headed, felt really hot after her first dose but after a few minutes it was all gone. Patient was asking if she can still take the 2nd dose. The medical questions were addressed by this program forwarded/referred to Medical Information. The outcome of events was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.