chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4:00PM on 10/12/2013 Hives were first noticed on abdomen. Size and quantity of hives increased as the day went on (having more than doubled in both by 8:00 pm). By 10:00 pm they were a solid mass on the sides of her abdomen and began to spread to her arms and legs. We went to the ER at 11:00 pm. Hives were spreading into her hairline by 12:00 am. Dr. gave a steroid and Benadryl at ~1:00 am. Spread of hives slowed and stopped. 12:00 pm on 10/13/2013 hives were beginning to disappear and were no longer raised welts.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced arm pain after receiving SHINGRIX vaccine. This is 1 of the 12 linked cases, reported by same reporter.
Flu like symptoms- Day 1 was the worst with fever and flu-like symptoms, symptomsare improving but have not resolved completely as of AM of 8/8/18 (no fever but still feeling run down, etc).
States he woke up in the middle of the night with a "terrible" headache, nausea and injection site pain. Was unable to return to sleep. Eventually took MOTRIN 800mg and was able to fall asleep.  Presented to the clinic this AM approx. 1000 for scheduled Primary Care appointment, states only mild injection site pain now, otherwise symptoms have resolved.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with case 2018SA271096 (same patient for Flu vaccine). This case involves a patient (age and gender not reported), who experienced "being really sore" all over her body, and injection site soreness while received vaccine ADACEL. The patient's past vaccination(s) included influenza vaccine and it was reported that patient had an "immune response" after receiving the flu vaccine last year. She does not know what brand of flu vaccine she received. She reports within 2 weeks "being really sore" all over her body. Reports her HCP advised her to take BENADRYL and APAP before the shot. On an unknown date, the patient received a dose of suspect ADACEL lot number not reported. On an unknown date, the patient developed a non-serious "being really sore" all over her body (pain) and injection site soreness following the administration of ADACEL. No Lab data was reported. Final diagnosis was "being really sore" all over her body and injection site soreness. The patient was treated with BENADRYL for Product used for unknown indication and APAP for Product used for unknown indication. The patient outcome is reported as Unknown for the events. Documents held by the sender: none.
Patient has some level of increased inflammation with possible mild component of myocarditis or pericarditis. It is still unclear to me if this is vaccine related or this quite possibly could be related to a recent viral infection.
Hives; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included allergic reaction.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Flu vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced hives with the flu vaccine. The pharmacist inquired if a patient who was allergic to the flu shot (unknown if it was a GSK brand or non-GSK), would be okay to get the Shingrix vaccine. The healthcare professional declined to leave any patient demographics. The reporter consented to follow up.
Dizziness & NauseaVomiting Narrative:  SOOTHING SENT GIVEN. BP CHECKED. INDIVIDUAL STATED HE WAS FINE AT TIME OF DEPARTURE~1525 AND DECLINED ANY FURTHER TREATMENT.  Other Relevant History:
patient reports shingles outbreak on back, side of torso he received vaccine 1 day after receiving vaccine. No other complaints
This medically confirmed report (initial receipt 28-Feb-2014) concerns a female patient who had a medical history of cerebral palsy, peripheral neuropathy, an unspecified liver issue and a demyelinating disease. On an unspecified date many years ago, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed an unspecified neurodegenerative disorder after the administration of the influenza vaccine. Outcome was not reported.
No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    No concomitant information was reported. Suspect product dosage text was reported as unknown. Doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15MAY-10JUN2023. This case is reported for patient 6 out of 14 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:
Patient had swelling, redness and pain at site of injection, Pain was 9/10 on pain scale. Patient had reaction start evening/morning of 10/9-10/10.
Complaints of seeing stars and feeling faint. Wheel chair and stretcher pad with legs up. Mom states she passed out with needle sticks or the sight of blood. 94/62, pulse 92, resp 14. Passed out a for few seconds. Mom declined EM. Pretty sweaty. 97/65, 92/14 states she feels better. Given water and cool cloth. 10:45 am 91/63, 97/14. Patient states no longer feels faint. Setting up . 11:00 Patient states she feels normal. Skin warm, dry and pink. Standing vital signs 116/86, 16. Mom and patient comfortable and walks without problems. Instructed to notify staff prior to vaccine so she can lay done before administration.
Dizziness, Intense Sweating, Systolic pressure dropped to 60 and Diastolic pressure to 45 (Normal blood pressure 110/70).
The night I got the shot I got chills a fever body aches and Nausea which lasted for six hours. Three days after the shot I noticed a lump above my collar bone which is still there. It was a lump the size of a large marble. The doctor said my Lymph node is inflamed and it is still a little swollen after ten days but it is going down.
Headache, Myalgia, Fever, chills, fatigue,  Narrative:
Nausea; arm pain; general malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number:2), for COVID-19 Immunization; Bnt162b2 (Dose number:1), for COVID-19 Immunization.The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; MALAISE (non-serious), outcome "unknown", described as "general malaise".  Additional information:Description of Event: Nausea, arm pain and general malaise after Covid vaccine booster 12 hours after administration.Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Numbness in hand; Throbbing pain; Tingling feet/hands; Carpel Tunnel Syndrome; Pain in arm; Joint pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hand), PAIN (Throbbing pain), PARAESTHESIA (Tingling feet/hands), CARPAL TUNNEL SYNDROME (Carpel Tunnel Syndrome) and PAIN IN EXTREMITY (Pain in arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBUPROFEN (ADVIL 12 HOUR) for Adverse event.    No medical history was reported by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and PANTOPRAZOLE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (ADVIL 12 HOUR) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in hand), PAIN (Throbbing pain), PARAESTHESIA (Tingling feet/hands), CARPAL TUNNEL SYNDROME (Carpel Tunnel Syndrome), PAIN IN EXTREMITY (Pain in arm), ARTHRALGIA (Joint pain) and FATIGUE (Tiredness). At the time of the report, HYPOAESTHESIA (Numbness in hand) had not resolved and PAIN (Throbbing pain), PARAESTHESIA (Tingling feet/hands), CARPAL TUNNEL SYNDROME (Carpel Tunnel Syndrome), PAIN IN EXTREMITY (Pain in arm), ARTHRALGIA (Joint pain) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-085423 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow up: Outcome of the event is ongoing. On 25-Jul-2021: Non-significant follow-up received on 25 Jul 2021.
I had acute sepsis, colitis, pancreatitis, I had a bunch of things going wrong at one time, I had severe abdominal pain and vomiting, pain so severe I was passing out. They gave me ciprofloxacin, Flagyl, morphine during my hospital stay. They also gave me Norco and Phenergan. They removed my gallbladder.
Very sore upper left arm/shoulder. Very warm to the touch. Very sore to the touch. Sometimes itchy. Slight swelling, no rash.
A cluster of blood blisters formed on skin of the same arm as vaccine injection site, at the crease of elbow.
muscle aches; Nausea/vomiting; Nausea/vomiting; general malaise; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 03Feb2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced muscle aches, nausea/vomiting and general malaise on an unspecified date. The events were non-serious, and it was unknown if the patient received treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Soreness in the arm (left arm where received shot); deep muscular pain; half of body went numb (left side); left arm turned purple; splotchy coloring in hands; chest pains and tightness; hives; swelling in lips and cheeks and a migraine.
positive covid test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive covid test) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced COVID-19 (positive covid test). At the time of the report, COVID-19 (positive covid test) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
11/7/22  I was doing routine lab draws. My HIV screening came back positive. After being referred out and having another screening, it came back negative. The first test was a false positive.
Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2021-044433 (Patient Link).
fatigue; fever; diarrhea; nauseous; This case was reported by a consumer via media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2021, the patient received Shingrix. On 17th October 2021, 2 days after receiving Shingrix, the patient experienced fatigue, fever, diarrhea and nausea. On an unknown date, the outcome of the fatigue, fever, diarrhea and nausea were unknown.   It was unknown if the reporter considered the fatigue, fever, diarrhea and nausea to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported.  The patient received dose of Shingrix vaccine and experienced fatigue, fever, diarrhea, and felt nauseous. The follow-up would not possible as no contact details were available.
Gagging, coughing, nausea, back neck and abdomen pains, aching, tiredness, headache and running fever
Pain and swelling over right deltoid in morning after vaccine administration. Fever at MD office - 104.5. Admitted with R/O cellulitis and necrotizing fascitis.
light headache for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (light headache for 5 days) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced HEADACHE (light headache for 5 days). On 09-Apr-2021, HEADACHE (light headache for 5 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified thyroid medication (small dose). No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-104091 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-104091:Husband case
No additional AE; HCP reported an adverse event. Caller explained GARDASIL 9 was administered to a 4 year old patient. No additional AE or PQC reported. No additional information provided.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 02-AUG-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot number: 775811 (strength, expiration date and route of administration were not provided) for prophylaxis (Product administered to patient of inappropriate age). No adverse events were reported (No adverse event).  Lot number 775811 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
The pt experienced redness, swelling, and warmth to the touch of the LAT. No fever was noted. Treated with Motrin and Benadryl.
04/19/2013 5:00 Pm some swelling and pain at injections site. 04/20/2013 12:00 PM Pain and swelling at injection site intensified, very red and sore. 7:00 PM headache and tired. 8:00 PM Paleness, muscle weakness, loss of coordination, heachache worsened. 04/21/2013 7:00 AM nausea, throwing up, headache continued muscle weakness.
Pregnant patient reported on 8Apr2021 that she received the vaccine on 15Mar2021.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 8Apr2021 that she received the vaccine on 15Mar2021.) in a 31-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 027B21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 27-Nov-2013 and Pregnancy (Live, full-term birth) on 29-Jul-2016. Concurrent medical conditions included Hypothyroidism (hypothyroidism/Hachimoto's diagnosed at age 7) since 1996. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, VITAMIN B6 for Nausea, VITAMIN D [VITAMIN D NOS], MAGNESIUM and PROBIOTICS NOS for an unknown indication.   On 15-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Feb-2021 and the estimated date of delivery was 19-Nov-2021. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 8Apr2021 that she received the vaccine on 15Mar2021.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 15-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 8Apr2021 that she received the vaccine on 15Mar2021.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Pregnancy test: positive (Positive) Positive.         No concomitant medication provided. No treatment medication provided. The patient's expected date of conception was 26-Feb-2021. The patient had previous 2 pregnancies. First full term birth was on 27-Nov-2013 in 40 weeks and second was on 29-Jul-2016 in 39 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 2-jun-2021 contains COVID-19 vaccine dose two  and linked case details.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported  07-May-2021 was the date of refrigeration.