chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Herpes zoster in a two dose varicella vaccine recipient. Never had chickenpox. Seen by Dr. where he thought it was poison ivy on 10/18/2013. Upon pain onset on 10/19/2013, patient's mother called doctor's office, and they then said it was herpes zoster.  Symptoms: unilateral rash, in one dermatome, very painful. Treatment: acyclovir taken for 7 days. Time course: lasted less than 4 weeks.
Started with refusing food the following day. By that night, diarrhea had started. The following day, she had 15 diarrhea diapers. This lasted for 8 days total, between 8 and 15 diapers a day. On the 6th and 7th day, she also began throwing up. Her appetite was greatly reduced throughout the duration, and she was refusing food more than half the time. By day 6 she was so sick that I was concerned she was dehydrated. She was also arching as though she was in a great deal of pain, and her bottom appeared to be infected. I brought her to the doctors office at that point, and she was seen by a physician who seemed to also believe this illness was a result of the vaccination.
top of tongue got all chopped like when she had allergic reaction to nicotine; Also start having a little pain in left ovary.; Not a painful, not a shape pain, but it feels like tooth ache; lips are red; I have a fever, 100; injection site hurts; throat was swollen; lower legs got numb/her left side became numb, whole left side became numb; tongue got swollen; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot number was not reported), via an unspecified route of administration, administered in right arm on 08Apr2021 13:30 (at the age of 59-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included asthma, bronchitis and allergy to shellfish, exotic fruit, Dust, Pet Dander, wine. Concomitant medication in which the patient received within 2 weeks of vaccination included loratadine, pseudoephedrine sulfate (CLARITIN D 12 HOUR). The patient previously took nicotine and experienced allergies. After shot (on 08Apr2021) for 20 minutes the patient stayed at the clinic. About 40 minutes later (on 08Apr2021 at 14:30) her lower legs got numb. Her tongue got swollen. By the time she came home around 14:50 her throat was swollen. She can still breath. Then, she administered Epipen. After the epipen, her left side became numb, whole left side became numb. Slowly her tongue, her throat became less swollen. She started to feel her left fingers, toes, left side face.  It took 4 hours for her to feel normal. Then 22:38 her tongue was swollen, her throat felt like when she had bronchitis, her lips were red as if she had a fever, 100, injection site hurts. She can still breath. Then it gets better, tongue get less swollen, throat feels better. Then these symptoms repeated throughout the night. Also, on unspecified date her top of tongue got all chopped like when she had allergic reaction to nicotine. She also started having a little pain in left ovary on unspecified date. Not a painful, not a shape pain, but it feels like tooth ache on unspecified date. The adverse events result in Doctor or other healthcare professional office/clinic visit. Treatment was received for the reported adverse events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Patient states Right neck pain, middle and down Right arm, not sharp, in the evening after shot. Afib evening of 1-19-21, patient took nitro pill and called Dr.
Pain on the inner arm of the injected area; Intense abdominal pain above the liver area; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Intense abdominal pain above the liver area), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE PAIN (Pain on the inner arm of the injected area) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced ABDOMINAL PAIN (Intense abdominal pain above the liver area) and VACCINATION SITE PAIN (Injection site pain). On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain on the inner arm of the injected area). At the time of the report, ABDOMINAL PAIN (Intense abdominal pain above the liver area) and VACCINATION SITE PAIN (Injection site pain) had resolved and VACCINATION SITE PAIN (Pain on the inner arm of the injected area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Erythema, pain, itching x 2 days after injection. Redness continuing to extend in size.
pt got flu shot. he was standing and watching his dad get his flu shot when he passed out.
Patient describes "itchy hands" in the afternoon following injection on 3/4.  On 3/5, she developed additional rashes and "bumps" over body.   She phoned the administering facility (she is not a routine patient) at 1200 on 3/5.  Advised by FNP to take benadryl 50 mg po.  Advised to go to ER/Urgent Care for worsening of symptoms or difficulty breathing.  On 3/8, patient states she awoke with eyes almost swollen shut.  Went to Urgent Care.  Given Prednisone 20 mg in decremental dosing.  Also given 4mg Dexamethasone IM.   To follow up with PCP in 3-5 days.  As of 3/17/2021, patient states she is all better.
Body pain; Run a low fever; Vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (Body pain), PYREXIA (Run a low fever) and VOMITING (Vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 PAIN (Body pain), PYREXIA (Run a low fever) and VOMITING (Vomiting). At the time of the report, PAIN (Body pain), PYREXIA (Run a low fever) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
The patient received an expired dose of the vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Regulatory Authority (RA) (Reference number- 00870596) and transmitted on 23-Nov-2021..  This case involves a 65 year old male patient who was received an expired dose of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 22-Nov-2021, the patient received a 0.7 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ537AB, expiry: July2021, formulation: pre-filled syringe (PFS)) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Registered Pharmacist (RPH) calling in on FLUZONE high dose (HD) PFS. Caller states that a patient received an expired dose of the vaccine and would like to know if they should revaccinate? Caller also asked what information should they provide to the patient? Patient mistakenly received expired FLUZONE HD from last year."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
dizziness; could not walk; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 62-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included allergy (allergic to PEG) and penicillin allergy.   On 20th June 2020, the patient received Boostrix (intramuscular) .5 ml. On an unknown date, less than 2 years after receiving Boostrix, the patient experienced dizziness and unable to walk. The patient was treated with dramamine (nos) (Dramamine). On an unknown date, the outcome of the dizziness was not recovered/not resolved and the outcome of the unable to walk was unknown.   It was unknown if the reporter considered the dizziness and unable to walk to be related to Boostrix.  Additional details were provided as follows: The patient received a dose of Boostrix and experienced dizziness. She was not sure how long after the vaccine she began dizziness.  She had several episodes of dizziness that had lasted from one to three days.  One episode of dizziness was so severe that she could not walk confidently.  She still had episodes of dizziness occasionally.  She took Dramamine for the dizziness which was unresolved. The reporter did not consent to follow up.
I received the Moderna vaccination around 10:00am. It was confirmed that it was okay to get the vaccine being that I tested positive for Covid on 12/23/20. Around 19:00 I started to get cold and by midnight I was shivering uncontrollably, I had a fever and had a massive headache. I alternated ibuprofren and Tylenol which did not work. I was only able to sleep from midnight to about 3:00am. The entire day I was shivering with a massive headache. It hurt so bad that I wanted to cry but it hurt worse when I did cry. My highest fever was 101 degrees. My fever broke around 19:00 on 01/05/2021 but the massive headache and body aches lasted the entire week. I felt like I was "hit by a bus" and my entire top part of my arm was in pain . I was seen by a doctor  at HS on Thursday the 7th to have my medical condition documented. My arm felt better by then. She had me take off the rest of the week and to return to work on the 11th. I finally started to feel somewhat better by the 9th
Sleeplessness for 2 nights post-vaccine. Very tired but unable to actually fall asleep. First night slept maybe 30-45 minutes, second night slept 2-3 hours non-sequentially, finally slept a normal 7-8 hours the third night. Approximately 5 hours post-vaccine I also experienced extreme lethargy and a very light fever for 2-3 hours only.
Client had very sore, reddened and swollen arm with pain radiating to neck region.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had a sore arm lasting 2-3 days. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-392249, MOD-2021-392282 (Patient Link).
Severe sore throat, headache, muscle soreness,  earache, body aches & severe cough.  All symptoms peaked on the 2nd day (12/04/2021) & started to subside around 12:30pm on 12/05/2021. As of 12/06/2021 @ 8:30am I still have a headache, earache & sore throat but not severe.
Initial report received from the patient's spouse on 02 November 2010. A pregnant female patient (date of birth not reported) had received a first dose of ADACEL (lot number not reported) on 23 October 2010. The patient's estimated date of delivery is 09 December 2010. At the time of this report, the patient had not experienced any adverse events since being vaccinated with ADACEL. Follow-up information received from the patient's spouse on 14 and 18 February 2011. Upon receipt of this information, it was determined this case meets seriousness criteria and has been upgraded to serious. The patient was reported as being 34 years of age; however by calculation from the patient's date of birth the patient was 32 years of age at the time of vaccination. Confirmation of the patient's date of birth has been requested. The patient had received the ADACEL vaccination at "11:00 pm" on 23 October 2010. She had also received a flu shot in October 2010 of which the trade name, manufacturer name, lot number, route and site of administration were not reported. The patient had no reported medical history, no maternal drug use, and no infertility treatments. Obstetrical history included no prior pregnancies. The date of the patient's last menstrual period was 01 March 2010 with expected date of delivery 04 December 2010. Current pregnancy history included high blood pressure (reading not provided) and swelling of face and legs with no dates of onset. Per the spouse, the patient was followed by a mid-wife and experienced pregnancy complication on 04 December 2010 when she presented with "placenta rupture and detachment" that resulted in emergency cesarean section and delivery of a single 6 pound healthy male baby. It was reported that the baby is healthy and fine and the baby had no congenital anomalies. Hospitalization was not mentioned. No other medical information was provided. At the time of this report, the patient had recovered. Documents held by sender: None.
Left arm injection site has a big red lump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Left arm injection site has a big red lump) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 032M20A and 010M20A) for COVID-19 vaccination.     Previously administered products included for Flu: flu vaccine (a day later she  was fine), flu vaccine (a day later she  was fine) and flu vaccine (a day later she  was fine). Past adverse reactions to the above products included Cold with flu vaccine; Dizzy with flu vaccine; and Feeling hot with flu vaccine.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced VACCINATION SITE MASS (Left arm injection site has a big red lump). At the time of the report, VACCINATION SITE MASS (Left arm injection site has a big red lump) had not resolved.            Patient States that she takes "many medications" as concomitant medications & declined to provide. No Treatment Information were provided by the reporter
Fatigue, Headache, right in the inner aspect of the eyes, lowe abdominal pain, fatigue in legs, Narrative:
BECAUSE OF A MINOR ALLERGIC REACTION ON MY FIRST SHOT, I TOOK A BENADRYL A FEW HOURS PRIOR TO SECOND SHOT.   I SHARED INFORMATION WITH REGISTRATION AND NURSE WHO GAVE SHOT.  WITHIN A FEW MINUTES MY THROAT WAS SWELLING AND EMT NOTED I WAS FLUSH(RED)IN FACE, NECK AND CHEST.  HE NOTED MY EYES SWOLLEN AS WELL.  EMT RESPONDED BY GIVING ME A 50 MG SHOT OF BENADRYL, MONITORED MY VITALS AND CONVINCED ME TO GO TO HOSPITAL TO BE WATCHED FURTHER IN CASE REACTION GOT WORSE.  THEY TOOK ME IN AMBULANCE.  HOSPITAL MONITORED ME FOR 1.5 - 2.0 HOURS AND RELEASED ME.   THE NEXT DAY, MARCH 25, 2021 I AWOKE WITH A 100.1 FEVER AND IT ROSE TO 102.9...MIGRAINE HEADACHE, CHILLS AND BODY PAIN(QUITE INTENSE), FATIGUE, COUGH AND SOME SHORTNESS OF BREATH.  RESTED AND CARED FOR MYSELF WITH TYLENOL AND FLUIDS.  MARCH 26, 2021 AWOKE WITH NO FEVER, BUT INTENSE HEADACHE AND FATIGUE FOR NEXT TWO DAYS.  STARTING TO RECOVER AS OF MARCH 29, 2021
Increases heart rate. Normal resting heart rate increased to about 105bpm and lasted for 48 hours.
Around his neck lot of itching; His arm was puffy, warm and swollen; His arm was puffy, warm and swollen; Around his neck he had a very bad red rash; Arm hurt like crazy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt like crazy), PRURITUS (Around his neck lot of itching), PERIPHERAL SWELLING (His arm was puffy, warm and swollen), FEELING HOT (His arm was puffy, warm and swollen) and RASH (Around his neck he had a very bad red rash) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt like crazy). On 07-Mar-2021, the patient experienced PRURITUS (Around his neck lot of itching), PERIPHERAL SWELLING (His arm was puffy, warm and swollen), FEELING HOT (His arm was puffy, warm and swollen) and RASH (Around his neck he had a very bad red rash). On 05-Mar-2021, PAIN IN EXTREMITY (Arm hurt like crazy) had resolved. At the time of the report, PRURITUS (Around his neck lot of itching), PERIPHERAL SWELLING (His arm was puffy, warm and swollen), FEELING HOT (His arm was puffy, warm and swollen) and RASH (Around his neck he had a very bad red rash) outcome was unknown. Not Provided          For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No Concomitant medication was reported. No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up was received on 22-Jun-2021 contains Non- Significant Follow-up (  Reporter Email address was updated)
Patient is experiencing minor redness, very mild tenderness at the injection site (or close to it). There is no swelling in the area. She says it's a little bit sore.
After 2nd dose  I felt sluggish and started running a fever of 103 I was taking Tylenol to bring it down I was in bed till Saturday was taken on Saturday to the ER where they told me I had pneumonia and my lab work said I had MDS and I was transferred to a different hospital.  at the hospital I got a picc line and got  chemo I'm pending a bone marrow transplant.
Menveo was prescribed by physician but there is a possibility that patient only received the diluent and not the vaccine.
I started having a fever and very short of breath. My oxygen dropped to 85 and was having chest discomfort, tightness.
High fever 101 - 104 degrees x 3 days with rash. 2 weeks after vaccine whelp like rash with mild fever.
Loss of appetite; Aches; chills; Fatigue; Undisclosed reaction after receiving the 2nd dose; Second dose administered within 1 month; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Undisclosed reaction after receiving the 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered within 1 month), DECREASED APPETITE (Loss of appetite), MYALGIA (Aches) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered within 1 month). On an unknown date, the patient experienced VACCINATION COMPLICATION (Undisclosed reaction after receiving the 2nd dose), DECREASED APPETITE (Loss of appetite), MYALGIA (Aches), CHILLS (chills) and FATIGUE (Fatigue). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered within 1 month) had resolved. At the time of the report, VACCINATION COMPLICATION (Undisclosed reaction after receiving the 2nd dose), DECREASED APPETITE (Loss of appetite), MYALGIA (Aches), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment details was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Additional information was received from the initial reporter: Date of second dose was updated and vaccine batch number added. Ne events Myalgia, Decreased appetite, Chills Fatigue and Inappropriate schedule of product administration were added.
devel chronic sinusitis, strep throat, impaired immunoglobulin levels, IGB deficiency;varicella vax given 2 wk apart;
Patient developed febrile seizure about 11 hours after administration of immunization and was brought to medical center.
pt recvd vax 2NOV93 & on 4NOV93 had fever, h/a & rash devel; myalgias & weakness; urticaria & cough;
A small lump in my clavicle area developed, was briefly painful, then shrank somewhat to its current size. Lump now causes a slight unpleasant tugging sensation on my neck and shoulder.
Patient & brother had similar sx following vaccination - nausea/vomiting headache, low grade fever.
Initially after injection was fine. On 3/27 afternoon, experienced sinus fullness and throbbing headache Extreme light sensitivity  Felt like head was going to explode, hard to sleep. (saturday, 3/27)  Went to urgent care the next day, care provider said it was a sinus migraine and prescribed antibiotics. (sunday, 3/28) Symptoms did not get better and continued to persist, headache became even worse / unable to work. (monday, 3/29 to 3/30) Stopped taking antibiotics 3/31  Went to see PCP on 4/2, was prescribed sumatriptan. Didn't seem to help.  Found out a week later that covering one eye would help with the headache.  Went to optometrist 4/8, confirmed that there was strabismus (left eye pointing down, right eye pointing up, prescription adjusted.   Initial relief, but headaches returned a week later even with updated prescription (with prism) Had a follow-up with PCP 4/26 and got referral to a head and neck specialist.  CT scan of sinus performed on 4/27, nothing weird spotted.  Was prescribed verapramil.  Made me extremely dizzy and did not help - stopped taking after a week.  Continued to work with HNT, confirmed nothing wrong (physically) with brain after MRI. Saw specialist for strabismus - the misalignment at that point was no longer present.  Continued to have on and off headaches and facial pain during this whole time period. Most recently, saw ophthalmologist who started treatment for very dry eyes.
Bloody diarrhea starting day following administration of 2 mo old immunizations-diarrhea is persisting, blood has resolved.