chrisvoncsefalvay/vaers-outcomes huggingface dataset:
been sick twice; Initial information received on 14-Oct-2020 regarding an unsolicited non-valid non-serious social media case received from a consumer.  This case involves adult patient who have been sick twice (Illness), while patient received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient have been sick twice (Illness), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.    It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Within the first 72hrs of receiving the vaccine I had what would be described as "flu" like symptoms or perhaps a sinus infection. Mild congestion, lethargy, clear nasal drip, mild difficulty swallowing my own secretions. Those symptoms in my opinion were to be expected, what wasn't expected is how my ability to swallow got progressively worse. September 2nd, I had to resort to giving myself the heimlich maneuver because I was unable to swallow food mid meal. That evening ended with me in the Emergency Department, I would go five other times between then and now as I write this. In all my years of being aware of my food intake that is very abnormal.
Pt received dose #2 Pfizer COVID vaccine 1/29/21 @ MAC vaccine clinic. Reported flu like symptoms over the next two days (fatigue, nausea, anorexia). 2/2/21 awoke with abdominal pain and distension. Presented to MHN ED 2/2/21 @ 1100 for workup and initially declined admission and went home. Was called and asked to return for admission and further workup, admitted to MHN 2/2/21 @ 1750. Fever, myalgias, headache. CT abd/pelvis "There is mild diffuse mesenteric edema surrounding the abdominal aorta and proximal branches. Additionally, there is mild bowel wall thickening involving the stomach without discrete mass. This is nonspecific and may represent infectious versus inflammatory changes." Per provider note "flu-like sx over the weekend that easily coincide with the timing of the COVID Pfizer vaccine. In addition, I wonder if her CT scan findings might also be related to the vaccine." Discharged home the next day.
won't stop itching/itching is just driving me crazy/Itched all day and all night; Very sore arm/Arm hurt terribly for a couple of days; Arm is tender; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (won't stop itching/itching is just driving me crazy/Itched all day and all night), TENDERNESS (Arm is tender) and PAIN IN EXTREMITY (Very sore arm/Arm hurt terribly for a couple of days) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced TENDERNESS (Arm is tender). On 10-Feb-2021, the patient experienced PRURITUS (won't stop itching/itching is just driving me crazy/Itched all day and all night) and PAIN IN EXTREMITY (Very sore arm/Arm hurt terribly for a couple of days). At the time of the report, PRURITUS (won't stop itching/itching is just driving me crazy/Itched all day and all night) had not resolved and TENDERNESS (Arm is tender) and PAIN IN EXTREMITY (Very sore arm/Arm hurt terribly for a couple of days) outcome was unknown.
Very high fever doctor could not figure out the cause of the fever at one point the fever was as high as 105.
Severe itching all over body within five minutes of injection. Received an injection of Benadryl to treat itching.
Information has been received from a RN and a consumer concerning an approximately 19 month old white female with a history of patent ductus arteriosus which closed with medications who, on the morning of 16-OCT-2001, was vaccinated in the right arm with the first dose of varicella virus vaccine live. There was no illness at the time of vaccination. In January 2002, three months after being vaccinated, the patient started urinating frequently, drinking "a ton", eating alot and breathing funny. A diagnosis of Type I diabetes was made. The patient was subsequently hospitalized for nine days. The patient's mother indicated that her daughter had never been sick or had any diabetes signs before being vaccinated. At the time of this report, the Type I diabetes persisted.  The Type I diabetes was also considered to be life threatening.  Additional information has been requested. A 15-day follow up report received 6/26/2003 adds no new info. A 15-day follow up report received 7/29/2003 adds: The pt was subsequently hospitalized for 9 days (Also reported that pt was discharged from the hospital on 01/17/2002). The pt's mother indicated that her daughter had never been sick or had any diabetes signs before being vaccinated. The RN indicated that the pt's parents were having difficulty regulating the child's blood glucose levels (blood glucose levels are "all over the place") as the child's HgbAlc showed poor control of her diabetes. The child was also noted to be frequently ill. The RN also reported that the parents noted regression and control issues with the child. The pt was also hospitalized in January 2003 for a stomach virus and was discharged on 01/28/2003. At the time of this report, the pt's Type I diabetes persisted and she was still being treated with insulin. The outcomes of the pt's other experiences were unknown. The Type I diabetes was also considered to be life-threatening. No further info is available.
can not go to work or focus properly; covid 19; Fever; chills; cough; Muscle aches; insomnia,Unbale to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia,Unbale to sleep), DISTURBANCE IN ATTENTION (can not go to work or focus properly), COVID-19 (covid 19), PYREXIA (Fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Right bundle branch block.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Jan-2021, the patient experienced INSOMNIA (insomnia,Unbale to sleep), COVID-19 (covid 19), PYREXIA (Fever), CHILLS (chills), COUGH (cough) and MYALGIA (Muscle aches). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (can not go to work or focus properly). On 28-Apr-2021, COVID-19 (covid 19) had resolved. At the time of the report, INSOMNIA (insomnia,Unbale to sleep) and DISTURBANCE IN ATTENTION (can not go to work or focus properly) had not resolved and PYREXIA (Fever), CHILLS (chills), COUGH (cough) and MYALGIA (Muscle aches) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, Body temperature: 100.4 High. On 10-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 28-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medications were provided Patient treated his symptoms with melatonin and other sleep-aid   This case was linked to US-MODERNATX, INC.-MOD-2021-077749 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up information received on 17-MAY-2021, added medical history and lab data , added events , updated action taken (N/A) , updated event outcome; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077749:Second dose case
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 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced 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 47.64. No concomitant medications were reported. Batch number 041L20A administered on 11-Jan-2021 underwent temperature excursion with temperature range of 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-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 Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
About 10:30 pm, 1/11/21, became very cold teeth chattering headache, sharp pains in muscles then aches, uncomfortable to touch skin.  Took 2 acetaminophen, lots of blankets, able to sleep.  No fever, woke up with same symptoms but milder.
08/28/2021---painful arm, beginning from site of injection site a few hours after the injection was administered 08/29/2021---migraine headache, painful arm, tiredness during the day, queasy feeling as though I m about to throw up during the day, along with fever in the night 08/30/2021---tiredness and queasy feeling during the day. Diarrhea began in the evening/night and persisted for a few hours.
Numb lips, itchy throat , fever, chills, sick to stomach, cough, difficulty breathing, headache, metal taste. sick and out of work for 1 week.
Pt felt lightheadedness after getting vaccine. For about 15 seconds pt passed out. I was about to give epipen and he came back as felt better. So did not need epipen. Called 911 and EMS came and took over. Pt felt better afterwards only little lightheadedness and nauseated. Pt waited about an hour at pharmacy and then brother took him home.
103.4 fever; vomiting; arm hot to the touch; bright red - cellulitis - on meds AUGMENTIN 400 BID.
Hives; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and PRURITUS (Itchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones. Concurrent medical conditions included Allergy to insect sting (Allergy to bees.). Concomitant products included GABAPENTIN, AMLODIPINE and FLUOXETINE for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced URTICARIA (Hives) and PRURITUS (Itchy). On 08-Apr-2021, URTICARIA (Hives) and PRURITUS (Itchy) had resolved. 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.   Concomitant medication includes sulfur containing antibiotics for kidney stones.  Treatment: Took 1 cap of Benedryl and had liberal amount of Cortisone cream on the infected area.
Delay allergic reaction- welt on arm and severe itching at injection site. hot to the touch, tender.
Headache, Myalgia, Arthralgia, Fever, UrticariaPruritus & NauseaVomiting Narrative:  dose 1-day 2-4- tenderness at inj site; day 5-itching at inj site; day 2- 3 fatigue dose 2-day 1-2-muscle ache; fever 101.2; chills;ha;fatigue;sensitive skin;upset stomach;loss of appetite day 2-3- swelling;tenderness and itching at inj site   Other Relevant History:
Symptoms included tightness of the throat and trouble breathing. They took my blood pressure and it was also very low. I took benadryl and they gave me some water and a shot of epinefrin. I got to the hospital probably around 6:45. They gave me more benadryl, and started giving me prednisone and another steroid. It took a few hours for it to improve, and there wasn't any immediate relief. I was released at around noon and took 2 more days of steroids before feeling better.
Loss of language, social skills, unusual and repetitive play, "autistic-like behaviors, all within 30 days of vaccine.  Follow up 10/19/2000: "The following is a summary of our evaluation and recommendations.  The evaluation included a speech and language evaluation, psychological evaluation, and physical examination.  A full report will follow in 4-6 weeks.  The patient is a 33 month old male who has a history of speech delays.  He has had a hearing evaluationi which was normal.  According to his mother, he is receiving one hour of speech therapy per week, half hour of physical therapy per week, one hour of developmental time individually per week and one and a half hours of group developmental work per week.  The patient is a very impulsive child both history and evaluation.  He has poor limits and barriers.  He often puts himself and others at risk with his behavior.  He has minimal interactions with others.  He seeks out very tactile stimuli and responds well to deep pressure.  He has many perseverative behaviors and is very poor with transitions.  He does responds to men and male voices more positively.  The patient had a normal physical examination.  He showed strong gross motor skills as well as fine motor skills.  The patient had severe communication difficulties.  He has approximately 10 words, signs or gestures he uses to communicate.  He is jargonning but it is not being used for communication.  He responds better to language with in routines.  He also responds to changes in intonation.  He showed a cognitive level at 14 months by the Bailey evaluation.  He does have a scatter of skills to 24 months.  He is very self-directed and active.  He was able to transition with the use of crayons.  He was very impulsive and indiscriminate with his interactions with strangers.  Overall based on our evaluation, the patient has global developmental delays.  In addition, he is autistic.  He is a high risk child because of his poor ability to act in a safe manner.  The primary concern of this team is ensuring that the patient has a safe environment to learn and live.  Our recommendations will address these concerns.  RECOMMENDATIONS:  1)  The patient will need to have a TEAM evaluation to determine the appropriate placement within the education system.  He will need to be in a year round autism/pervasive developmental delay program.  2) Secondary to concerns about his safety, the patient will need one to one supervision at least initially.  His safety and the safety of the other children must be guaranteed.  3) In an effort to manage the behaviors and his own safety, the patient will need to work with a behviorist.  He would be helped by an intensive program with intervention involving both his home and school involvement.  4) The patient will need to have a BEAM study to determine whether he is having seizures.  In addition, he will need a MRI of his brain secondary to his previous dermoid cyst. "
This case was reported by a healthcare professional and described the occurrence of influenza in a child female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified), FLULAVAL. There were no concurrent medications. On an unspecified date in 2010 the subject received a dose of Influenza vaccine (unspecified, manufacturer unknown). At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced influenza. Outcome and attribution of the event to vaccination with Influenza vaccine was not known. On 31 August 2011 at 12:00 the 5 year old subject received a dose of (dose 1 for 2011) of FLULAVAL at 0.5 ml in the left arm. This was the wrong vaccine for administration as FLULAVAL is not indicated for use in subjects under the age of 18. No additional details were provided. It was reported that this event occurred in three siblings. See linked sibling cases A0943421A and A0943422A. Follow-up information received on 27 September 2011 indicated that there were "no adverse reactions to report." No additional details were provided.
Shingrix / was given / by error to a 12-year old female patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 16th November 2022) for prophylaxis.   On 9th July 2021, the patient received the 1st dose of Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were reported as follows: This case was reported by a clinic coordinator and a nurse. The Shingrix vaccine was given by error to a 12-year old female patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Reaction to 13b PROQUAD - MMR/V redness/swelling L 5in x W 4.5in no fever/pain.
While receiving vaccine some came out of shoulder; vaccinator re administered the amount they thought came out; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (While receiving vaccine some came out of shoulder) and UNDERDOSE (vaccinator re administered the amount they thought came out) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (While receiving vaccine some came out of shoulder) and UNDERDOSE (vaccinator re administered the amount they thought came out). On 24-Mar-2021, DEVICE CONNECTION ISSUE (While receiving vaccine some came out of shoulder) and UNDERDOSE (vaccinator re administered the amount they thought came out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of Device connection issue and underdose for mRNA-1273, lot # 037a21b,  with no associated AEs.
Tired, muscle pain, headache, shivering, fever, stomach pain, kidney pain, nausea & diarrhea
After about a week, on Feb. 27th,  my upper left arm got hot and puffy and extremely itchy. This was right around the injection site. It's been sore and tender and itchy for almost a week - better today [March 5th], but still not completely back to normal. After reading online articles about others who experienced this same secondary reaction - and the doctors' comments that it was harmless - I just did my best not to scratch or bump the area, expecting that the symptoms would go away after a week or so.
Full body excruciating pain/Paralyzing pain in the evenings from chin down; Hips killing him/Knee pain; Get so bad in evenings cannot walk, legs lock up, fingers, and toes hurt; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 17Jun2021 14:45 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation at the age of 41-year-old. Medical history included ongoing crohn's disease that diagnosed about 9 years ago. Concomitant medicationt included azathioprine (IMURAN [AZATHIOPRINE]) taken for crohn's disease from an unspecified start date and ongoing. The patient previously took remicade 3 weeks prior to his Covid Vaccine, the doctor discontinued it to put him on a different medication at that time. The patient received bnt162b2 dose 1 administered in Arm Left on 27May2021 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation at the age of 41-year-old. On 23Jun2021, the patient experienced Full body excruciating pain, the patient states pain is excruciating from his chin down. States it could be called paralyzing, especially in the evenings.  Says it gets so bad in the evenings that he cannot walk, his legs lock up, his hips are killing him, his fingers and toes are hurting, his knees are hurting.  Patient states it has not improved, only gotten worse. The events resulted in visit of Emergency Room and Physician Office. The doctors are not able to diagnose what is going on, some of them will say its the vaccine but will not verify it or put it on paper. The patient thinks his reaction may have to do with his underlying condition of Crohn's disease. The outcome of event was Not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101009308 same product/event, different patient
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: patient called on saturday 10/23/2021 and said she had an allergic reaction and hives and I adviced the patient to take a bendryl and she said she alreadt did, and I told her to go to the urgent care or emergency room