chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient noticed a rash similar to hives on her arms, legs, and one on her hand the next day, and; Patient had itchiness all over her body in the late afternoon few hours after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient had itchiness all over her body in the late afternoon few hours after the vaccination) and RASH PRURITIC (Patient noticed a rash similar to hives on her arms, legs, and one on her hand the next day, and) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (Patient had itchiness all over her body in the late afternoon few hours after the vaccination). On 18-Feb-2021, the patient experienced RASH PRURITIC (Patient noticed a rash similar to hives on her arms, legs, and one on her hand the next day, and). At the time of the report, PRURITUS (Patient had itchiness all over her body in the late afternoon few hours after the vaccination) and RASH PRURITIC (Patient noticed a rash similar to hives on her arms, legs, and one on her hand the next day, and) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Product temperature excursion issue; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue).    The case was reported for 49th patient out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant medication was provided.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe
Developed 5 pin point macules to shoulders; reported started after Varivax,fever 99.8 26.7 hrs,  seen 2d later, 1 d later seen and noted pinpoint papules to baby neck to ankles >40 plus itch not sleep well, given Benadryl.
Extreme thirst starting the day of the injection and into the following day.  The next day, I experienced painful body aches, fever, and chills.  I never take naps, but had very little energy and wound up needing to take a 3 hour nap on the day after the shot.  It is now the second day after vaccination, body aches have lessened, mild grade fever, no chills.
inadvertent use is reported in a pt who recvd flu vax on 8OCT93; on 22oct93 pt recvd a hepatitis vax & 2nd dose of fluogen; pt is asymptomatic as of 22OCT93; pt had recvd the flu vax in the past;
vaccination site was initially sore. Around 1/23 site started to itch and medium size swelling appeared at injection site, turned red, and began itching. Redness and itching has continued and worsened.
On July 27, my leg buckled and I fell to the floor and couldn't move it. Hit my head and had to get 6 staples with mild concussion.
Narrative:  Patient died in hospice care from Stage 4 colorectal cancer with mets to lung on 6/12/202 64yo male. He had received a covid vaccine (J&J EUA) on 8/26/2021. This death is not related to the covid vaccine. Reporting death post vaccine since EUA status vaccine.
Patient received an expired dose of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 16th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: On 16th June 2021, the patient received Pediarix, which was expired on 14th June 2021. No symptoms were reported. The reporter consented to follow up.
Red rash around my neck area, also on both insides of my elbows, and on my right armpit.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. 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 unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided  as follows: The age at vaccination was not reported. The reporter herself is the patient. The reporter stated that her arm hurt after her first dose of SHINGRIX. The reporter also stated that her mother also experienced flu like symptoms, refer case US2018GSK164084. The reporter did not agree to be contacted for follow up.
4DEC91 began vomiting x 3, upset, crying t99 ax, began jerking (poss sz) took to ER continued w/sz admitted to hosp x 2 days;
Client was administered an IM injection from an empty syringe. The vaccine administration error was not realized until after the patient left the clinic. Client was called back to the clinic for administration of the Johnson & Johnson vaccine in the other arm. Contacted CDC to get guidance on any safety issue from receiving an IM injection with an empty syringe. CDC reported back "we are not aware that administration of an empty syringe of an IM injection would cause a safety problem." Contacted patient for follow up of CDC response. Patient reported no adverse side effects outside of normal signs and symptoms after vaccination with Johnson & Jonson.
Patient is a 73 y.o. female who presents today with multiple complaints worsening shortness of breath, cough, weakness, headache, nausea, and diarrhea.  Symptoms began with a cough 3 days prior.  She went to dialysis on her usual time.  Sent to ER to be evaluated due to cough.  Positive COVID-19 4/27.  Other family members positive.   Patient became progressively more weak, short of breath that she was unable to go to dialysis today.  She has had poor intake with intractable nausea and diarrhea.   Audible gurgling.  In ER, potassium elevated and chest x-ray with congestion consistent with overload.  Nephrology intending on dialysis today while inpatient.   Due to poor respiratory status now requiring oxygen typically only at night.  Decadron added.  Not a candidate for remdesivir.
MIGRAINE; BLOOD PRESSURE ABNORMAL; WEIGHT LOSS; COVID-19; OVERACTIVE BLADDER; BLOOD PRESSURE HIGH; This spontaneous report received from a patient concerned a 68 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date in JAN-2021, the patient experienced covid-19. On an unspecified date, the patient experienced migraine, blood pressure abnormal, weight loss, overactive bladder, and blood pressure high. The patient had issues with blood pressure, high blood pressure and was feeling tired. The patient thought those issues were side effects to having Covid-19 in JAN-2021 (date unspecified), it took several months to recover. The patient stated that she was admitted to the hospital on 10-JUL-2021 due to migraines and blood pressure issues. She thought she was discharged on 12-JUL-2021. The neurologist gave her Botox (botulinum toxin type a) to help with the issues. She had migraines for nine weeks. She had lost 15 pound and was not able to keep food down as of 11-AUG-2021. The patient stated that she had an overactive bladder. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Abnormal, High, and Weight loss (NR: not provided) lost 15 Ibs. Treatment medications (dates unspecified) included: botulinum toxin type a. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from migraine, and covid-19 on 2021, was recovering from blood pressure abnormal, and blood pressure high, and the outcome of weight loss, and overactive bladder was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211053693- Covid-19 vaccine ad26.cov2.s-migraine and blood pressure abnormal. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Started having pains in chest two weeks after the shot . Thought it was indigestion. The pain kept getting worse went from chest to his back as well. Called primary care physician was told to go directly to the er  this was on the 18th of October . Was checked for  a heart attack , has a ct and eg . Had blood work taken. was found to have three blood clots in my lung. Two in the bottom lobe and one on the top . Was given a shot of levinox was to to check back with his primary care dr . Went to primary care Thursday 21st of October. She checked everything and the only thing that caused the blood clots was the J&J shot , Was told he was very lucky he could have died , Am now gonna be on blood thinner for the rest of life,
Information has been received from a health care professional concerning a pt who in March of 1999 was vaccinated with a first dose of Hep B vaccine. It was reported that the pt also received other unknown vaccination concomitantly. Subsequently, the pt developed painful soreness in elbow. Additional information has been requested.
Chills, headache, joint pain including shooting pains to fingers, stomach cramps, and fatigue.
Information has been received from a pharmacist referring  to a patient of unknown age and gender The patient's concurrent and historical conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, injection, site location, lot # and expiration date unknown) subcutaneously. Concomitant medication was not reported. The reporter stated that when the needle was removed, a drop of ZOSTAVAX came out of the injection site into the patient's skin. Outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Day after patient's arm was hot and starting to swell around the injection area.  Two days later she had a softball size (little larger) swollen, hard, hot, area surrounding the injection area.  One week later she began having small red dots with red around them on her lower back.  It spread clear across her back with the red area around the dots going from a pencil size dot to a half dollar size.  Over the sencond week in October she continued to have the rash with more areas appearing.  The area surrounding the red dots has starts turning a light brown as it heals.  As of October 16th they are still visible and trying to heal.
no adverse effect; patient received improperly stored pneumovax23; This spontaneous report was received from a pharmacy technician refers to a patient of unknown age. Information on pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 15-AUG-2019, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R010724, expiry date: 13-JUN-2020, anatomical location and dose were not reported) via intramuscular route for prophylaxis (product storage error). The vaccine was exposed to a temperature of temperature above 470F/90C (70 F) for a time frame of 4 days which was recorded in a digital data logger. There was no previous temperature excursion noted. No adverse effects reported. No PQC involved.  This is one of three reports received from same reporter.; Sender's Comments:  US-009507513-1908USA007171: US-009507513-1908USA007170:
Swelling of cheek 2 days after shot.  Lasted about 48 hours. I had radiesse filler in my cheeks in Nov. 2020. Then on day 8 a very red and itchy upper arm under injection site and up to it. Rashy itchy bumps also showed on day 8 under arms, on neck and hands, arms, ankles. They are still here.
Itching started on toes second day, lasted for 5 days. Ankles and lower legs started itching on the third day, when scratched, swelling was noted, then hives after the 4th day. Itching above the knee started on day 6. Hives were only seen after scratching affected area. Hands and forearms started itching day 9, hives again noticed only after scratching affected area. Lower legs stopped itching day 11. Upper arms, shoulders, scalp, and neck started itching, with hives showing up after scratching on day 10. Unable to observe hives on scalp. Headache on day 8, 10, 11, lasting less than an hour. No medication taken for headache, and no antihistamines taken for hives or itching. I thought it was allergies, but nothing has changed in my lifestyle, and I've never had symptoms like this before. I searched online for Covid 19 vaccination side effects, and found similar symptoms reported. I know it's not severe or life threatening yet, but I wanted there to be another corroborating report of these possible side effects.
Felt a fire tingling sensation up legs and neck, stood up to get a wash cloth, fell down, starting feeling very nauseas, tongue swelled. hands and feet became numb. severe head ache.  thought I was having a heart attack or panic attack or maybe reaction to vaccine. . It lasted 12-15 minutes..
Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 15-JAN-2016, the patient was inoculated at a physician office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-MAY-2016, the patient was treated at physician office for onset of a severe vesicular rash, accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. 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, pain and suffering and other damages. Additional information has been requested.
Severe Burning in both legs at night, lasting up to 3 hours, preventing sleep much of the time.  Patient describes it as a "blowtorch " on the legs.  This burning pain has lasted off and on for several months and still happens sporadically now, too.   Patient also describes pain throughout the arms off and on, feeling like burning and tingling and shaky.  She describes here whole body being "quivering" on and off and this still happens now occasionally  now.  Also when this happens she feels weakness in the legs and feels wobbly.  She says she never had these symptoms before vaccination, and feels her life is worse now than before she was vaccinated.
Acute muscle weakness; muscle pain; moderna 1st&2nd dose, pfizer booster dose; moderna 1st&2nd dose, pfizer booster dose; moderna 1st&2nd dose, pfizer booster dose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An 88-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE), administered in arm left, administration date 05Nov2021 14:30 (Lot number: unknown) at the age of 88 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Bladder infection" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1, Lot number: unknown, Location of injection: Arm Left, Vaccine Administration Time: 14:30), administration date: 01Mar2021, when the patient was 87 years old, for Covid-19 immunization; Moderna covid-19 vaccine (Dose 2, Lot number: unknown, Location of injection: Arm Left, Vaccine Administration Time: 14:30), administration date: 01Apr2021, when the patient was 87 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 05Nov2021 14:30, outcome "unknown" and all described as "moderna 1st&2nd dose, pfizer booster dose"; MUSCULAR WEAKNESS (non-serious) with onset 05Nov2021 15:00, outcome "not recovered", described as "Acute muscle weakness"; MYALGIA (non-serious) with onset 05Nov2021 15:00, outcome "not recovered", described as "muscle pain". The events "acute muscle weakness" and "muscle pain" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of muscular weakness, myalgia.  Additional information: Prior to 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 other vaccine in four weeks of vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Post vaccine shingles 18 days post vaccine crops of pox on (L) shoulder blade lesion --> crusted over & resolved, treated for possible superinfection - SEPTRA. Newborn sibling admitted for fever rule out sepsis 9/18-21 no pox, sepsis ruled out.
Moderna COVID?19 Vaccine EUA  At at the injection site - red skin irritation in a circular form.  Sore, itches.
Patient experienced fever, edema and redness to injection site, neausea, headache, and diearrhea as well as body aches for 3-4 days.
Child was inoculated with 6 separate vaccines at approximately 3:40 p.m. and after about 2 min., Mom noticed that child's face had broken out with hives.  Immediately assessed child for shortness of breath. Called for help and PA came in to the room immediately and assessed child.  Child playful and no apparent wheezing. Administered Benadryl 25 mg po.
On the evening of 03/27/2023, I had postnasal drip, a little cough, the next morning I had the chills but no fever. I took a home COVID-19 test that came back positive. I was using over the counter products, I called my doctor to let him know I was positive for COVID-19, he had me come in to run bloodwork on my kidneys. I was prescribed the PAXLOVID, after reading the side effects I have decided against taking the medication.
vaccines from vials that had been thawed more than 30 days ago were administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) had resolved.        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.
Syncopal episode with fall from chair.  Unresponsive approx 30 seconds. Pt was GCS 15 within 60 seconds after syncope. EMS was called because the pt hit his head on the ground but did not sustain any life threatening or injuries. No signs of trauma to note. Pt was AOx4 and GCS 15 by the time he was dismissed from the clinic.
1)  Severely disrupted menstrual cycle since the time of the first vaccine. 2)  Swollen Lymph nodes, which led to an irregular mammogram. 3)  Experienced heart racing and shortness of breath after second vaccine (Moderna Lot 003C21A on 5/7/2021 at
Detached retina; This is a spontaneous report from a non-contactable consumer (patient). A 67-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262, on 23Jan2021 at 14:00 at single dose in left arm for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The patient had no Known allergies. The patient experienced Detached retina on 01Feb2021. The event resulted Physician Office Visit. Treatment received included Surgery. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 Since the vaccination. Lab data included Nasal Swab with unknown results.  No follow-up attempts are possible. No further information is expected.