chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient immediately passed out after injection. He started shaking having what looked like a seizure. Patient later started shaking, eyes fixed, having what seemed like a seizure again. Patient transported via EMS to Hospital.
pt recvd vax & began spitting up formula feedings (this previously was not the case); vomited p/each feed for 24 hrs-then formula changed;
Covid +, SOB, chest x-ray shows bilateral infiltrate with a possible postobstructive pneumonitis CT angio of the chest was obtained which is pending.
Headache, Myalgia, NauseaVomiting, weakness Narrative: Recveived 2nd vaccine 2/3/21, was fine for a few hours except instant headache then 2 am developed nausea, bad body aches, head feels heavy, legs are weak. She experienced the same type of reaction to 1st dose. Was advised to continue to monitor signs and symptoms and follow up with PCP if does not reside in 24-48 hours.
Pt is 71 yrs of age and given Adacel package insert is for ages 11-64.
the vials were being used past the recommended 12 hour post puncture time; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the vials were being used past the recommended 12 hour post puncture time) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (the vials were being used past the recommended 12 hour post puncture time). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (the vials were being used past the recommended 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The dose given at the time at the time of puncture was 03-Sep-2021, was obtained on 01-Jun-2021 and kept in freezer until date of puncture, then stored in refrigerator.   This case was linked to MOD-2021-418964, MOD-2021-423000, MOD-2021-423024, MOD-2021-423025, MOD-2021-423026, MOD-2021-423027, MOD-2021-423028, MOD-2021-423048, MOD-2021-423050, MOD-2021-423052, MOD-2021-423053, MOD-2021-423056, MOD-2021-423058, MOD-2021-423308, MOD-2021-423320, MOD-2021-423321, MOD-2021-423339, MOD-2021-423351, MOD-2021-423357, MOD-2021-423365, MOD-2021-423371, MOD-2021-423372, MOD-2021-423373, MOD-2021-423395, MOD-2021-423396, MOD-2021-423397, MOD-2021-423398, MOD-2021-423431, MOD-2021-423432, MOD-2021-423433, MOD-2021-423434, MOD-2021-423435, MOD-2021-423436, MOD-2021-423438, MOD-2021-423439, MOD-2021-423440, MOD-2021-423449, MOD-2021-423450, MOD-2021-423451, MOD-2021-423452, MOD-2021-423458, MOD-2021-424031, MOD-2021-424075, MOD-2021-424078, MOD-2021-424081, MOD-2021-424082 (Patient Link).
I was driving and R arm became heavy and very weak. I experienced and overall body heating and tingling sensation. My throat started to close up and my nose started to bleed. R arm weakness and decreased sensation lasted approximately 30 minutes and resolved. Went to ER and was admitted to the hospital for stroke protocol.
Fever woke me up the next morning around 5 am. Sweating, chills, muscle soreness. Tired, weak, slight headache. Was fine after 24 or so hours.
Chronic inflammatory demeylinating polyneuropathy; Information has been received from a lawyer referring to a 59 years old male patient. Information about concurrent condition, history condition and concomitant medication was not reported. In or about 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for the long-term prevention of shingles and zoster-related conditions. As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer Chronic inflammatory demyelinating polyneuropathy (CIDP) in on or about 2014, including any and all of it sequelae. Subsequently, the patient was treated by a provider for the following injuries resulting from Zostavax (ZOSTAVAX): CIDP. As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s manufacturing defect, the patient suffered severe and permanent physical injuries, including but not limited to CIDP, as well as other severe and permanent health consequences. The patient has endured substantial pain and suffering, has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The patient has lost past earning and has suffered a loss of earning capacity. The pt had suffered and will continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The patient's injuries and damages are permanent and will continue into the future. The outcome of the event CIDP was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events CIDP to be disability.   Upon internal review, CIDP was determined to be medically significant.
general body aches; and general body aches, described as similar to flu symptoms; headache; This is a spontaneous report from a contactable consumer reporting for a patient. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced headache that lasted about a day and a half and general body aches, described as similar to flu symptoms. Outcome of the events was resolved. This case was reported as non-serious.   Information on the lot/batch number has been requested.
Received 2nd Hepatitis vaccine 6/10/16. States Sunday had come erythema and pruritus.
This spontaneous report was received from a other health professional refers to a 18 month old male patient. On 22-OCT-2014, the patient was vaccinated with VAQTA (lot # K008219, expiry date: not provided) dose 2, intramuscular in the left leg (reported as left vastus lateralis (VL)), that had been improperly stored. Number of previous doses reported as 1. There had been no reported adverse events and no need for revaccination from the time of administration. The staff was still gathering information regarding the reported adverse event of incorrect product storage. No adverse reaction was reported. This is one of several reports received from the same source (MARRS # 1411USA008692, MARRS # 1501USA004614 and MARRS # 1501USA004616). Additional information has been requested.
7/19--7/30 69-year-old with a PMH of GBS meningitis and bacteremia in addition to osteomyelitis and discitis with abscess diagnosed in 6/22 and treated with IV ceftriaxone. The patient received a PICC and was sent home with instructions to continue ceftriaxone until 7/31. She presented to the ED with strokelike symptoms on 7/19 in addition to leukocytosis. On admission screening she tested positive for COVID-19, CXR showed groundglass opacities, and she was placed on remdesivir per infectious disease. Her urine culture grew 2 drug-resistant organisms but her UA was clean and ID deferred treatment given clinical improvement. Neuro scheduled an MRI brain and lumbar spine which showed progression of osteomyelitis
lymph nodes in my underarm now are swollen; I am sore; fever; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 2nd November 2021, the patient received Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced enlargement of lymph nodes, pain and fever. On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved and the outcome of the pain and fever were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, pain and fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received booster dose on Tuesday and his/her lymph nodes in his/her underarm were swollen (at the time of reporting). The patient read that it's a common reaction in women after the booster. The patient was sore and bit of fever. The patient felt better after 2 days.
pt recv vax & devel an inj site rxn characterized by redness, induration & tenderness;pt also exp pain from inj site down to fingertips;pt recovered;
12hr p/vax edema from face shoulder-hand;nausea, h/a, fatigue;
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.   This case was linked to MOD-2021-395985 (Patient Link).
A few blisters developed at the roof of my mouth and feels like back of throat (throat feels very very dry and swallowing is as if I had a sore throat).  Reaction much less than my reaction to the magic mouthwash.
Breakthrough case admission after three vaccines Moderna 3/18/21 Lot# 002B21A;  Moderna 4/15/21 Lot# 040B21A;  Moderna 11/23/21 Lot# 033F21A
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.39.   Concomitant products were not provided.  On 07-Jan-2021 Excursion time was reported at 09.00 am, and 10:00 am with  temperature as 34 and 34 degrees Fahrenheit, total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021 , vial was moved to clinic on 07-Jan-2021. 6 vials were sent to clinic. Vaccine BUD date was 27-Jan-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
The night of my vaccine I shot straight up in bed filled with fear and screamed out my husbands name. Then I proceeded to violently throw up all over myself and my bedroom on the way into the bathroom; The night of my vaccine I shot straight up in bed filled with fear and screamed out my husbands name. Then I proceeded to violently throw up all over myself and my bedroom on the way into the bathroom; I had nothing left to throw up but the violent retching wouldn't stop for another 7 minutes or so; It was so loud and painful; After that I felt immense sadness; I was crying uncontrollably bc I felt so much pain and sadness; I was seeing black shadow spirits and lying pigs along with visions of China./ it sounded like a devil was coming out of me; Manic depression; Suicidal thoughts; Memory loss; Loss of impluse control.; This is a spontaneous report from a contactable consumer.  A 35-years-old non-pregnant female patient received second dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EW0181), via an unspecified route of administration, administered in Arm Left on 15Jun2021 at 09:00 AM at the age of 35 years as dose 2, single for covid-19 immunization.Medical history included coeliac disease. The patient had allergy to codine. Concomitant medications received within 2 weeks of vaccination included sertraline (SERTRALINE)100 mg, betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES) and iron (IRON). The patient previously received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EWO161), administered in Arm Left on 18May2021 at 10:00AM as dose 1, single for covid-19 immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior vaccination. Since the vaccination, the patient has not been tested for covid-19. On 15Jun2021, at night of vaccine the patient shot straight up in bed filled with fear and screamed out her husband's name. Then she proceeded to violently throw up all over myself and my bedroom on the way into the bathroom. Once in the bathroom she continued to retch, and she was seeing black shadow spirits and flying pigs along with visions of China. she prayed to God that she wouldn't die, the patient then took a shower and went back to bed. Around 2 hours later it happened again, this time she was retching so hard it sounded like a devil was coming out of me. She had nothing left to throw up, but the violent retching wouldn't stop for another 7 minutes or so. She though her neighborhood could have heard me it was so loud and painful. After that she felt immense sadness as she cleaned up her vomit again. She was crying uncontrollably, she felt so much pain and sadness and she could hear sobbing from COVID victims. The days after she suffered from manic depression, suicidal thoughts, and memory loss as well as loss of impulse control. Therapeutic measures were not taken for the events. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was recovering from events.
Fever chills Narrative:  Employee stated after receiving 2nd vaccine around 10:30 last night developed chills and low grade fever which has persisted today.
red with swelling and rash at site of reaction starting day after vaccine given and has lasted about a week so far
He left the clinic and immediately felt dizzy.  He stumbled and fell to the ground in the parking lot, saying he couldn't see and felt dizzy. Mom helped him up to try to get him to the curb. He fell limp in my (mom's) arms. I laid him down in the parking lot & he fainted. I ran back to the door and yelled for help.  He came to and the nurses helped him back into the clinic , laid him down and gave him water and ice pack and tended to him.   He was sweating profusely and then started throwing up.  We stayed approx. 15 min, he had a small snack and started to feel like he could leave.  At home, he has had a very sore right arm and is tired.
Saturday, 11/20 - ~3am: Chest pain, below left breast, around 3am, couldn't sleep on left side, hurt to breathe - 7am: Chest pain, below left breast, when taking a breath. The deeper the breath, the sharper the pain on left side only, below left breast. - Muscle pain in left shoulder - No rapid heart beat - Not experienced this before
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 04-APR-2021 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, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Arm swelling 2 days after vaccine with red streaking 3 cm above site then severe axillary lymph node swelling and tenderness. Mild body aches fatigue.
I had a psoriasis flare up on my right leg.  I have a very mild case of psoriasis.  It shows up on my body on my left leg as 2 quarter size dry skin looking patches.   This psoriasis showed up as bright red blister rings and patches on my right leg.  I got it the day after my booster shot (3rd) Moderna.  I treated it with the cortisone cream I use on my other mild patches.  as of 1/1/2022, the psoriasis is slowly getting better.  The skin is no longer blistered, just red.   This is not a life threatening event or something that can be readily controlled, so I just treated it as I do my other 2 mild patches.
Extreme stomach distress:  Nausea, diarrhea, stomach unsettled/growling, afraid to eat.  Gradually better by 02/21/2021 (light eating all day) and feeling pretty well today (02/22/2021)
Had flu and PNEUMOVAX on 10/5/09. Started with fever, chills, temp >102 on 10/7, 10/8. Treated with TYLENOL - Pneumo site, red and warm on Tuesday, with pain. Wednesday less painful and no further spread of redness or warmth.
I noticed in the middle of May 2021 several small, raised bumps on my scalp. They were treated by a dermatologist. Several were biopsied. One turned out to be basal cell carcinoma, two were squamous cell carcinoma, and the rest were precancerous lesions. The cancerous growths were removed with Mohs surgery. About a month later, a new spot popped up on my scalp, and it grew rapidly to the size of a quarter. Initially, it was thought to be benign, but since it continued to grow, it was then removed with Mohs surgery and examined. It was determined to be noncontained squamous cell carcinoma. Shortly after this was discovered, they conducted a fine needle biopsy of the lymph nodes in my neck. Following that, they did a CT scan of the neck, shoulders, head, and upper body. After that, they did a lymph node dissection. Following these procedures, they began a regimen of radiation treatment. Before I got the vaccines for COVID-19, I had a previous history of sporadic lesions on my scalp and forehead that were treated successfully by a dermatologist. After I received the first two COVID vaccine injections, though, the cancers seemed to return with a vengeance. At the time of this writing, I have 14 lesions on my scalp alone that are being treated. I am currently an outpatient at the cancer hospital.
Temperature Excursion; HEPLISAV-B Temperature Excursion Product Administered; Initial Report Received on 22-Jun-2021  A nurse reported that a male (age, race, and ethnicity unknown) was administered HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a temperature excursion occurred that was above the recommended temperature and time.  Medical history was reported as none.  No relevant concomitant medications were reported.    On 07-Jun-2021, the patient received a dose of HEPLISAV-B (Lot # 934600, expiration date 25-Feb-2022 and NDC # 43528-003-05) from a nurse at a travel clinic.  The HEPLISAV-B had a temperature excursion that was above the recommended temperature and time. On that day, the temperature reached 12 degrees Celsius for 24 hours. Another excursion occurred in which the temperature reached a high of 13.9 degrees Celsius over a 2-3-day period.  No additional information was reported.   Company Comment: The company assessed the events as non serious.; Sender's Comments: The company assessed the events as non serious.
A few minutes after getting the vaccine I had a fast heart rate and my throat felt like it was closing up. I let the personnel know and the EMTs hooked my up to O2, blood pressure and EKG, I had a jump in heart rate on EKG every couple minutes and my blood pressure started off very high. It gradually decreased. I then had the feeling after about 20 minutes that I needed to poop. I was unhooked and went to the bathroom. I proceeded to have diarrhea for the next 2-3 hours. The EMT let me go home after about 40minutes of total care because my oxygen level never dropped below 100.  I would have feelings of flushing and throat tightening until about 6pm. They did not reoccur after that. I have never had a reaction like this before to a vaccine or any medication.
Patient with intractable headache not relieved by OTC Tylenol. Presents today with right calf tenderness on palpitation. Headache, visual disturbance.
Pt recv vax on 4/14/99; post vax pt exp body aches, joint pain, headaches, chest pains, diarrhea, stomach cramps, blisters in mouth, sweating/chills, coughing up blood/phlegm, tremors
Returned to facility approximately one hour post injection c/o numbness in throat moving to back of tongue and roof of mouth given Benadryl po at 1005 at 1030 stated numbness gone from back of throat and is decreased in tongue and roof of mouth, returned to class.