chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; the liquid dripped down his arm; is afraid he did not get the whole dose; This spontaneous report was received from a consumer refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-JUN-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.   On 27-JUN-2023, the patient experienced exposure via skin contact and underdose. It was reported that the liquid dripped down on patient arm, and he was afraid he did not get the whole dose. No additional adverse event reported (no adverse event).
Dermatographia outbreak, hives, itchyness, skin redness after touching, sensitivity to heat. Affects entire body, can be treated with large doses of anti-histamines but come back when doses wear off. Also includes heartburn. Never had either of these conditions before vaccine. Conditions have persisted for a month, and are ongoing.
Patient received first shot of Moderna vaccine at age 16 years; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-050270, US-MODERNATX, INC.-MOD-2021-050287, US-MODERNATX, INC.-MOD-2021-097800, US-MODERNATX, INC.-MOD-2021-098102 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-050270: US-MODERNATX, INC.-MOD-2021-050287: US-MODERNATX, INC.-MOD-2021-097800: US-MODERNATX, INC.-MOD-2021-098102:
Fever, muscular pain, shooting nerve pain, joint pain, bone pain, trouble walking, pain at site of previous shingles infection, weakness, dizziness and light headed.
Patient presented to vaccine clinic one hour post vaccination complaining of severe left side facial pain.  Vital signs were monitored by paramedic on scene.  Patient was transported to Medical Center by Fire /EMS.
0800 "dizzy & light-headed" 0807 "still dizzy" 0812 "I feel better".  BP 134/80, HR 100.
Moderna COVID-19 Vaccine EUA: patient in clinic for follow-up visit after reporting four days after vaccination left arm pain and difficulty moving arm. Symptoms not relieved by ice or acetaminophen. Patient prescribed prednisone and referred to physical therapy. On follow-up patient states patient experienced facial swelling after three doses of prednisone and stopped taking it. Reports improvement in symptoms. Started on NSAIDs and topical steroids.
Vaccine vial MAY have not been diluted prior to use, as a result the patient may have received a higher than approved dose. Parent/Caregiver was notified, no concerns or adverse effects noted.
pink, small, blanching maculopapular rash w/halos, on trunk only;possible chickenpox vaccine reaction;
pt recvd vax; devel redness, swelling & tenderness at inject site,lasted x 2 days;
I tested positive for COVID 01/28/2022 with a home test. At was a mild to moderate. I didn't have to go to the hospital. I had trouble breathing, a cough, chills, fever, and body ache. I spent most of the time in bed. I had it for about 5 days. I had COVID twice. I can't remember the first time.
He developed episodes of vertigo like dizziness, allong with feeling  like he was going to pass out, feeling  unsteady, sweaty, nauseated.  They would last for about less than a minute, but he had several episodes.  He had pulsatile tinnitus.  He also had an elevated LFT.
Initial tingling in arm and a pain in my abdomen at injection that went away within the 15 minute wait time. That day began a series of numbness, tingling, and burning sensations throughout my body (top to bottom, both sides, random throughout the day).  Thursday, June 3 I felt numb in my face (left), neck and left side of my body. I was diagnosed with a TIA. I presented with stroke symptoms and was treated by the ER stroke unit, neurologists, and a team of doctors.
I thought I had bug bites. One  on the right side of my next swelled up and filled with pus developed into pus filled blister and was very painful.  After popping, burning sensation remained on side of next for about 8 hours.  Other "bug bite" hive-like bumps emerged sparsely on the my arms and legs and then disappear, coming and going.
He contracted Sars-CoV-2 in-between doses/ her husband tested positive with Covid a week after his first dose on 03/11/2021; Still has symptoms of illness; extremely dizzy; was tired before this, but is still tired all the time; This is a spontaneous report from a contactable consumer (patient's wife). A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date a week after taking the first dose, the patient experienced he contracted Sars-CoV-2 in-between doses/ her husband tested positive with COVID a week after his first dose on 11Mar2021 and still has symptoms of illness. The reporter stated that her husband was extremely dizzy and was tired. The reporter stated that the patient was tired even before this, but was still tired all the time. The reporter wanted to know whether dizziness be a symptom of vaccination. The reporter is due to receive his second dose on 01Apr2021. The patient still has symptoms of illness. The reporter wanted to clarify whether the patient should go for his second dose as scheduled. On an unspecified date, the patient underwent SARS-CoV-2 test: positive. The reporter classified the event as non-serious. The outcome of the event extremely dizzy was unknown and was not recovered for the rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 11:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 11:37 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.81 for dose administered on 03-Mar-2021 and 67.89 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature range 51 to 35 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Quarter-sized red area that enlarged.   SKIN: 12 cm x 10 cm area of macular erythema (blanching ) with slightly increased warmth, no induration or fluctuance, no drainage, slightly TTP, swelling of left upper arm
shingles breakout near site of injection; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 31st January 2022, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine 4 months ago and experienced shingles breakout near the site of injection (left arm). The patient stated that it was a size of a quarter. Shingles was confirmed with her doctor. The reporter did not consent to follow-up.
On March 13, 2023, I developed a scratchy throat, hoarseness and a hacking cough with a little bit of phlegm. I consulted a doctor and I am being treated with amoxicillin. I have not received the results from the PCR test taken at the doctor.
The day my husband received the SHINGRIX vaccine he became ill. After 2 Dr. visits, he was sent to the ER and was admitted, there for 19 days. His symptoms kept changing and worsening. First, apparent pneumonia, then to critical care unit for respiratory failure.Then severe "migratory pain" starting in chest and ending in excruciating right flank pain. Drs ran LOTS of tests...Xrays,CT's, MRI, even a PET scan. His C-Reactive Protein was 299 (normal is less than 2). Found nothing to explain this "inflammatory cascade" and finally said it was probably a severe reaction to the SHINGRIX (I have more info, here and other #'s but Continuation Page won't work.).
Presented on 22June06 with c/o myalgia and fever and erythema at vaccination site. Followed up at ER on 23June06 for increased erythema from quarter size on the 22nd to 11x14cm in diameter. Swelling and erythema continued and followed up at ER on 25June06. Was given Clindamycin at that time. Seen on 26June06 for follow up and area is much improved. Diagnosed as Smallpox reaction with secondary infection. To continue antibiotic treatment and follow up prn.
Patient states had violently vomiting, diarrhea about 3 hours after vaccine, high fever, on 10/28/20 got rash. Vomiting and fever stopped after 3 days. She is still has nausea.  She thinks reacted from Shingrix.
Third of the vaccine leaked out of patients arm; A spontaneous report was received from a nurse, concerning a 57-year-old female patient, who received Moderna's COVID-19 vaccine and the third of vaccine leaked out of patient's arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Feb 2021, prior to the onset of the event, the patient received her first of two planned doses of mRNA-1273 (Lot number: 013M20A) for prophylaxis of Covid-19 infection.  On 05 Feb 2021, while nurses was administering patient's first dose of vaccine, the dose was leaked out of patient's arm (almost third of the dose leaked out). However, the nurse was not exposed to the vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not reported.  The event, third of vaccine leaked out of patient's arm was considered resolved on 05-Feb-2021.; Reporter's Comments: This case report concerns a non-serious unexpected event of a 57-year-old female patient who experienced third of vaccine leaked out of patient's arm. (Incomplete dose administered) for mRNA-1273, lot # 013M20A. There were no reported AEs associated with this case of incomplete dose administered.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included premenstrual syndrome, and other pre-existing medical conditions included the patient never had a reaction to a vaccine. she takes flu shot every year. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 04-MAY-2021, the subject experienced suspected covid-19 infection. On 11-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine  was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be management approval - confirmed no PQC was identified within the reported complaint reported. complaint is approved for void. void: yes based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Patient started having severe dizziness, with a racing pulse.  Pt stated she felt very warm.  Given ice pack and cold cloths.  BP was slightly elevated.  Pulse initially was about 112.  Had patient lay down and she felt better.  Thought to be vasovagal response.  Starting at 01:30 on 1/7/21 she had a severe headaches, eyes watering, runny nose, dry throat.  Injection site reaction
Onset high fever the day of vaccines, given by 5 pm temperature 103. Spiked again to 104 around 2 am, overall symptoms lasted a little over 24 hours.
On Tuesday March 16 started having difficulty breathing went to ER. Blood Clots in both lungs. Was admitted and was treated in hospital until Friday March 19.
About 2 hours after the immunizations mom noted redness and swelling of the scrotum more on the left. Patient napped and woke w swollen tender red scrotum on the left side. He was seen by me Dr with firm tender red swollen L side scrotum concerning for torsion of the testes. He was urgently referred to a pediatric urologist who ordered an US done -- he was noted to have epididymitis and mild orchitis on the L side. He was sent home and given ibuprofen. On follow up am 11-3-18 redness improved some and still swollen on the left side.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Medium, Additional Details: OSat: 92 Respiratory Rate: 22 Temperature: 97.5 F Blood Pressure: 135/93 Pulse 117
This case was reported by a nurse and described the occurrence of anaphylactic reaction in a 25 year old female subject who received hepatitis B vaccine recombinant. On an unspecified date in March 2005, on or before 3/25/05, the patient received the first dose of Engerix B in the arm (lot AHBVO077AB). At an unspecified time following the first dose of Engerix B, on 3/25/05, the subject experienced tingling in the fingers of the injected arm and an injection site reaction characterized as a red lump that was warm to touch. The subject was diagnosed with anaphylactic reaction and was treated with an unspecified antibiotic. The events resolved on 4/3/05. The nurse considered the events to be related to vaccination with Engerix B. Comment: Anaphylactic reaction was assessed as medically serious (OMIC).
Nose bleeds every 4-6 hours; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm right on 28Apr2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm right on 07Apr2021 at 14:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021 at 13:00, the patient experienced nose bleeds every 4-6 hours since Saturday from the same nostril. The patient had no nose bleeds in years. The clinical outcome of nose bleeds every 4-6 hours was unknown.   No follow-up attempts are needed. No further information is expected.
Dizziness, light headiness, weakness, around 7:35ish the next day of vaccination, had a head ache pretty much all day.
eye pain, redness and rash around left eye and left side of  forehead and scalp  Narrative: Employee seen and following up with  Ophthalmology. Seen Ophthalmology on 11/22/2021.
Rash and Faint lines going down back of left arm and on the outside of left arm; Rash and Faint lines going down back of left arm and on the outside of left arm / faint red line on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash and Faint lines going down back of left arm and on the outside of left arm) and VACCINATION SITE ERYTHEMA (Rash and Faint lines going down back of left arm and on the outside of left arm / faint red line on left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2022, the patient experienced VACCINATION SITE RASH (Rash and Faint lines going down back of left arm and on the outside of left arm) and VACCINATION SITE ERYTHEMA (Rash and Faint lines going down back of left arm and on the outside of left arm / faint red line on left arm). At the time of the report, VACCINATION SITE RASH (Rash and Faint lines going down back of left arm and on the outside of left arm) and VACCINATION SITE ERYTHEMA (Rash and Faint lines going down back of left arm and on the outside of left arm / faint red line on left arm) was resolving.            Patient was instructed by physician to take Benadryl and to watch reactions. Patient was also instructed to go to ER if she developed difficulty breathing or swallowing. Concomitant medications were not reported. Treatment details were not provided
Whole left arm is achey and tingly. Has chills and when walks little distance feels like she walked a marathon.
Information has been received from two registered nurses concerning a male with no past medical history and no known allergies who on 07/20/2001 at 10:30 was vaccinated with the first dose of varicella vaccine SC in the lower right thigh given more intradermally then subcutaneously. Concomitant vaccination the same day at 10:30 included the third dose IM in the right upper thigh of hep B vaccine. There were no other concomitant medications. On 07/20/2001, within minutes of being vaccinated, the pt developed a raised, red blanched area, local redness, swelling and pain. The one nurse reported that there was leakage of the vaccine onto the skin at the time of injection . The pt did not seek medical attention. Subsequently, approximately 2 weeks after the injection, the pt recovered. No further info is available.
A little delirious; Very tired; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (A little delirious) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided.).    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DELIRIUM (A little delirious) (seriousness criterion medically significant), FATIGUE (Very tired) and VOMITING (Vomiting). At the time of the report, DELIRIUM (A little delirious), FATIGUE (Very tired) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.