chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWOLLEN ARM; RED ARMS; SLIGHT FEVER; SORENESS AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned a 78 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced soreness at the site of injection. On 02-APR-2021, the subject experienced slight fever. On 02-APR-2021, the subject experienced swollen arm. On 02-APR-2021, the subject experienced red arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at the site of injection, slight fever, swollen arm, and red arms on 02-APR-2021. This report was non-serious.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe
Patient fell off chair, appeared to be having a seizure.  Patient was very pale, clammy and reported nausea.  Patient was given cold compress to back of neck, blood pressure and pulse monitored.  911 was called and arrived approx 10 minutes after event.  Patient was conscious and aware when EMS arrived.  Patient reported history of fainting and appearing to have seizures in the past.
Patient had hives on both arms. Assessed by EMT and provider on site 25 MG benadryl admin to right delt.
Day of shot soreness in left deltoid that ran from shot site to inner arm started about four hours after shot and lasted 24-72 hours.  No redness at that time.  Pain went away then returned Day 8.  Day 8, today January 8th, woke up to pain again in left arm starting at injection site running to inner arm.  Redness is mild at site of injection, as it runs to inner arm gets redder and then ends with a warm, red, swollen lump.  Lump is not in lymph node, it is on inner side of left arm.
Lymph node swelling on 12 April and joint swelling, stiffness and pain on 19 April.  Joint symptoms progressively getting worse from only one joint (left thumb) to second joint affected on the Right hand 4th metacarpo-phalangeal site. Symptoms are worst at nigh after rest, swelling of the palm, affected hand grip and range of motion. NSAIDs are mildly helpful during daytime.
burning; armpit pain; lymph nodes are enlarged bilaterally in both arms; This is a spontaneous report from a contactable nurse. This 29-year-old (at the time of vaccination) female nurse (patient) reported for that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number; unknown, unable to locate or read the details intramuscular on 08Jan2021 at 06:30 pm at single dose on right leg for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient's medical history was not reported (Known allergies: None). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot; unknown, intramuscular on 18Dec2020 at 10:30 am at single dose on right leg for covid-19 immunisation. Vaccine facility was reported as hospital. Concomitant medications in two weeks) included metformin, levothyroxine, loratadine (CLARITINE). If other vaccine in four weeks; no. Nurse reported that At 2 weeks post first vaccine, on 30Jan2021 at 08:00 pm I experienced heart burn for about a week. Not a huge deal. At 3 weeks post the second vaccine, I have severe armpit pain. My lymph nodes are enlarged bilaterally in both arms despite receiving doses in same arm. It feels like a constant burning as if someone injected icy hot into my armpit with a needle. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given for the adverse events. AE treatment: Went to my PCP where additional labs were drawn CBC, CMP, covid antibodies, and covid test with unknown results. Patient did not have covid prior vaccination. Covid test done post vaccination on 09Feb2021 included nasal swab and test resulted as negative. The outcome of events was recovering.
About ten minutes after receiving a VARIVAX and MENACTRA injection patient complained of his nose becoming congesed. He also complained of itchiness, PH of allergies to hamsters. His BP was 140/70, pulse 80. The nose was patent and were no wheezes. He received EPINEPHRINE, 1000, 0.3IM, BENADRYL 50 + oxygen increased 4. He was observed for an hour then was fine.
No adverse event. Grabbed Ped/Adol. dose instead of Adult. Called pt. to come in and get 2nd half of dose. Ped/Adol. (0.5 ml) - Adult (1 ml)/Pt. Will return for 2nd dose between 8/1/16 - 8/5/16.
Hospitalization: 12/1/2022 - 12/3/2022 (2 days) Presentation to the ED: vomiting/nausea/diarrhea x 2 days. COVID + date: 12/1/2022  Treatment: Paxlovid  Discharge to: Home  Moderna 2/4/2021 Lot# 031L20A Moderna 3/8/2021 Lot# 027A21A
pt recv vax 20FEB98 & 13MAR98 pt devel an inj site rxn that had gradually enlarged since administration;it was the size of a quarter, circular, flaky, & raised on upper lt arm;
A few days after my shot I woke up and lost 80% hearing in my ears, the next two days it improved slightly but now over 10 days after the vaccine I still have not perfect hearing and daily headaches that feel like extreme pressure in my head.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 01-APR-2015, at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about  04-MAR-2016, the patient was treated by a physician for a painful rash that was diagnosed as herpes zoster (shingles). On or about 17-MAR-2016, the patient was treated at the same facility for ongoing and worsening symptoms, that were diagnosed as post herpetic neuralgia, a chronic condition involving nerve damage as a residual effect of severe shingles outbreaks. Although shingles and post herpetic neuralgia are incurable conditions, the patient was prescribed valacyclovir hydrochloride (VALTREX) and lidocaine (LIDODERM) for management of her symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
BLOOD CLOT; STROKE ISSUES; HEART ISSUES; This spontaneous report received from a consumer via a company representative via social media on 09-FEB-2022 and concerned multiple patients of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, it was reported that "More and more people I know have heart issues, blood clot and stroke issues after getting the jab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart issues, blood clot and stroke issues was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220224963.; Sender's Comments: V0:20220227232-COVID-19 VACCINE AD26.COV2.S-Blood clot, stroke issues. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
more than 6 months since first dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose, which led to incomplete course of vaccination. The patient also inquired what can be done if 1st dose of Shingrix vaccine has been more than 6 months.
Vomited; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomited), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-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 VOMITING (Vomited), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, VOMITING (Vomited), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided.   This case was linked to MOD-2021-077325 (E2B Linked Report).; Sender's Comments:  MOD-2021-077325:First dose case
Patient presented for second dose of vaccine and given an undiluted dose of Pfizer vaccine.   After administration, nurse noted smaller than normal quantity remaining in vial and immediately notified pharmacist (who noted a remaining syringe with unused dilutent).    MD immediately notified patient of situation, observed patient over an hour (no adverse reaction), MD also notified patient's primary care physician, and MD also called Pt for a followed up 24 hours after event(no symptoms).       Called Pfizer and reviewed CDC recommendations regarding administration of undiluted vaccine.
numbness on surface of skin;upper 1/2 of lt arm extending to anterior shoulder;sx started the day p/vax 2nd hep b vax;
Pt received GARDASIL #1; approx 15 min later c/o dizziness some sweating altho was not diaphoretic).
Flu like symptoms, arm red and swollen at site of injection, continued to swell, went to doctor red area was 5 cm by 8 cm and was still feeling bad, no energy and weak.(Shingles vaccine)
Vial was stored greater than 12 hours post-puncture; 3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Vial was stored greater than 12 hours post-puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022 at 11:40 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022 at 11:40 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored greater than 12 hours post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Vial was stored greater than 12 hours post-puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 22 Apr 2022 Date and time vial was first punctured on  22 Apr 2022 at 9:55 AM. The vial stored post puncture in  Refrigerator. The vial did not undergo any temperature excursions Total amount of time the vial was exposed to room temperature range (8° to 25°C/46° to 77°F): 1.5-hours on  26 Apr 2022. No concomitant medication were provided No treatment details were provided Product used   This case was linked to MOD-2022-551983, MOD-2022-551989 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Follow up received: Added suspect details, event onset date  and updated narrative supplement.
pain in left arm started approximately 6-8 hours after receiving the vaccine. The pain was much higher 24 hours later, and I found it difficult to move my arm in any direction. The pain was mainly muscular, involving movement. Only slight pain when touching the location where the shot was administered. The pain did not subside until at least 48 hours later.   After 48 hours a new symptom began. I am now experiencing extreme fatigue. The fatigue continues today, so it has lasted at least 3 days. I am a runner and normally do not have this kind of heaviness. I have been unable to run since receiving the vaccine.
4 month old female accompanied by parents with upper respiratory infection symptoms x 6 hours.  Primary symptom includes a fever after patient received their vaccination today.  Symptoms viewed as moderate by parents. Better with nothing, worse with nothing.  No history of other contacts with same symptoms. No travel.
arm was sore; itchy rash near my chest; red itchy rash across my chest; allergic reaction; feel tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (itchy rash near my chest), FATIGUE (feel tired), RASH ERYTHEMATOUS (red itchy rash across my chest) and HYPERSENSITIVITY (allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Herbal products for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (itchy rash near my chest), FATIGUE (feel tired), RASH ERYTHEMATOUS (red itchy rash across my chest) and HYPERSENSITIVITY (allergic reaction). At the time of the report, PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (itchy rash near my chest), FATIGUE (feel tired), RASH ERYTHEMATOUS (red itchy rash across my chest) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 06-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration at Right Arm on 27Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced right arm pain on 28Jan2021. The date of her second schedule dose on 17Feb2021. The outcome was recovered on 28Jan2021.
Erythematous maculopapular lesions after 3rd injection. Tx: IV BENADRYL 50 mg, SOLUMEDROL 125 mg, ZANTAC 50mg.
Fleeting headache after vaccination. Chest tightness last night which is a little more than usual. Feels fine today.
Night of 2nd dose had chills/body aches.  Developed diarrhea next day.  Arm became swollen and sore, red and itchy.  Continued to get progressively more red, sore, itchy and swollen.  On day 5 post vaccination, seeing by primary care doctor and diagnosed with cellulitis.  Placed on antibiotics.
Pain in the left collar bone area.; pain and Inflamation in the Armpit; Pain at the site of the injection (upper left arm).; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in the left collar bone area.), INFLAMMATION (pain and Inflamation in the Armpit) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left arm).) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.    On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN (Pain in the left collar bone area.), INFLAMMATION (pain and Inflamation in the Armpit) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left arm).). At the time of the report, PAIN (Pain in the left collar bone area.), INFLAMMATION (pain and Inflamation in the Armpit) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left arm).) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
5/19/03 Dx shingles. Onset 1 blister, round, red rim with dark center after blister broke. Other lesions, blisters, red then scabs looking like shingles. Only 1 "pox like sore" located on inner aspect left breast at sternum, size 3/8", no drainage. Low grade fever only. Sever pain from spine to sternum left side.
fussiness, irritability, high pitched cry starting 3hr p/vax & lasting 10hr;
Patient arrived to clinic for other complaints include need for MMR as the school system has requested patients prove they have had all MMR vaccinations. We were unable to prove patient had received vaccines therefore vaccinated child per request by school district.
COVID symptoms started on the evening of 08/19/2021 when I had a 102 degree fever. I tested negative for COVID on 08/20/2021 and then I went the whole weekend and they had given me antibiotics anyways and then on 08/25/2021 I tested positive. I experienced only the fever thus far. I went to get the infusion on 08/28/2021 and they couldn't do it because my oxygen was low and they said it was low enough to go to the ER. I went to the ER and was hospitalized and I don't remember a whole 3 days. I was hospitalized for 10 days and they had to put me on a BiPap Machine. I had gotten pneumonia, a DVT in right leg, and I got a PE in my left lung. Since they let me go I have been sitting at home on oxygen. I did get my booster and flu vaccine though. I also had no taste whatsoever.
2nd Dose administered beyond 30-day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot #023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant drugs are not provided.
Adverse events: Redness, warmth, tenderness, swelling. Pt declined going to urgent care.
Pain in upper left side, spleen enlarged, ear infection, fever on and off two weeks, vomiting, severe abdominal pain that is still persistent almost two months later.
A report was received from a health care professional on 11/20/03 concerning a male vaccinee of unspecified age who inadvertently received ID Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received ID Fluvirin instead of tuberculin purified protein derivative. At the time of reporting the vaccinee did not exhibit any adverse events. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
pt recv vax;had swelling,redness & warm to touch;had no fever;referred to MD;dph given & warm soaks instructed;
Patient called back about an hour later having blurred vision, followed up a couple hours after and was not longer having.
Received COVID-19 vaccine on 1/4/21, right arm.  On 1/11/21 about 5:30 pm, my right upper arm became itchy, red, swollen, warm and hives/welts developed around the vaccination site.  The itching lasted about an hour, the hives/welts resolved about 11:00 pm the same evening but the redness, warmth and swelling  are still present at time of reporting (9:21 am on 1/12/21).  To note, on 1/11/21 I received the PPD skin test in the left arm around 10:30 am.  As of this morning, there is no reaction, or symptoms noted in the left arm.  I reported symptoms to the Medical Director of the vaccine site (MD), and to my primary care provider (MD)
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: patient became very dizzy immediately after dose.  Vision was closing so he lay down on the floor.  Reported being sweaty & clammy.  Found him sitting up again, said he was fine.  Asked him to stay another 10min, when i went back to check on him said he had another episode and was lying on the floor again. Reported still sweaty & clammy and injection arm hurting.  After another 15 minutes reported his head was clear, but still had some arm pain.