chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First I noticed that my eyes were very sensitive to light, I was also feeling light headed and dizzy on my walk back to the car. (about 30 minutes after injection). I had someone else drive because I felt like I could not drive in my condition. On the ride home, about 40 minutes after injection, I began to have an increased heart rate and had a hard time swallowing. It was also slightly difficult to breathe. I felt like my head was cloudy and I had a hard time concentrating. I felt like my brain was responding about a half a second slower to what I saw. Like if I wanted to turn my head, I would think try to turn my head and my body would react a second later. When I got home, about 1 hour after the injection, my girlfriend told me my hands were freezing cold. I was also having a hard time walking in straight because I was so dizzy. I was still having some minor trouble breathing and swallowing. It was difficult to drink water. After about 2 hours my breathing returned to normal. My mind was cloudy all day, I felt like I was drunk.  On the second day, I woke up with an intense headache. It lasted for 3 days. My arm started to hurt on the second day as well, no pain at all the first day. My head was still cloudy and I had difficulty trying to recall memories or answer questions. By the third day this was basically gone. I was extremely tired for three days total. My mind remain cloudy for about a week.
SORE ARM; MILDLY TIRED; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with non-company vaccine BNT162 (Pfizer) (dose number in series: 1) (Form of admin, route of admin, batch number and expiry were Unknown) dose was not reported, administered for prophylactic vaccination. It was unknown whether patient had any adverse events (Dose number in series: 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: Unknown) dose, start therapy date were not reported, administered 1 in total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm and mildly tired (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm and mildly tired. This report was non-serious.
a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 hrs; temp of 100.6; body aches; nausea; This is a spontaneous report from a contactable consumer.  A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3302), via an unspecified route of administration in the left arm on 21Jan2021, at  08:00 a single dose for covid-19 immunization.  Medical history included breast cancer stage one  from Oct2019.  There were no allergies to medications, food, or other products.  Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), benazepril (MANUFACTURER UNKNOWN).  The patient experienced the following event on 21Jan2021, at  03:00: a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea.  The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 21Jan2021. Details were as follows: a few hours after injection, the patient noted that her arm was unusually sore past elbow chills that lasted for about six hours. Temp of 100.6 body aches nausea. It was reported that treatment was not received for the events; however she used a heating pad to relieve the pain. The events were non-serious. No diagnosis of COVID-19 prior to vaccination was noted. Since the vaccination, the patient has not been tested for COVID-19.  The outcome of events, a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea was recovered in Jan2021.
little bit swollen; pink; sore; A spontaneous report was received from a consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site is a little bit swollen, pink, sore, not excruciating.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the events injection site is a little bit swollen, pink, sore, not excruciating. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events injection site is a little bit swollen, pink, sore, not excruciating was considered unknown.
Information has been received from a registered nurse concerning a female who approximately on 25-JUN-2009 was vaccinated with the first dose of GARDASIL. The day after, on approximately 26-JUN-2009, the patient experienced fever, chills and vomiting. The patient sought unspecified medical attention. The patient reported this reactions to the nurse when the patient went into the office for her second dose of GARDASIL. The determination was made not to continue the GARDASIL series. The patient was not going to received the second or third dose of GARDASIL. On an unspecified date, the patient recovered. Additional information has been requested.
pt received a shingrix and fluzone on 09/29/20. pt called back on 10/10/20 to report a possible allergic reaction that started on 10/08/20.  she experienced a rash on her face and neck. she was not certain that it was caused from the shingrix shot, but wanted to report to the pharmacy.  she has taken benadryl and the rash has gone away. she has had several flu shots in the past and has never had a reaction.
DVT/PE and CHF, symptom onset per documentation 1-2 days prior to vaccination, was seen in and treated in ED and during hospitalization  3 days after vaccination
The pt experineced a fine red rash on both arms and cheeks. It itches slightly.
Patient complains of right arm pain beginning the next morning following the vaccines. He was seen by his primary care physician and told to rest and use nsaids. Patient is now due for his second dose of Shingrix but is still having arm pain especially when the muscle is strenuously used.
Patient complained about muscle aches, chills, fatigue, headache, flu like symptoms, and swelling at the injection site.
Left arm swollen w/ redness. Pt. received Tdap in left arm. Pt states fever of 100.9 w/ soreness swollen and redness on left arm.
Symptoms started at 1am: fever of 101°, chills, body aches and headache. Still experiencing all symptoms 10 hours later
Pt received moderna 2/23/21 and 3/26/21. Then pfizer 11/10/21 and 12/02/21. pt made aware and reported no symptoms
Started to feel tired, muscle aches and fatigue. Around 1 PM and took 2 TYLENOL.  I left my office at around 2:45 PM to go home and rest and continued to feel tired and muscle aches, as well as itchy (arms, back, legs). Took 2 more TYLENOL around 6 PM. Woke up around 11:30-12:00 and felt feverish. Started to shake and took my temperature, which was 100.1 around 12:30 AM. I took 2 more TYLENOL around 1:00 AM and it took about an hour before the shaking stopped and I fell back to sleep around 3:00 AM. Restless sleep, but woke up around 7:00 AM - fever of 99.8 and feeling muscle aches and tired. My concern is the SHAKING last evening and that this could happen again during the night. The fever was 100.1 but the shaking was a bit scary.
Pt became ill 3 days p/flu shot; rt upper outer abdominal pain, fever, chills, jaundice, elevated white blood count 14,000; elevated liver function tests; hepatitis;
Patient reported lower arm pain on 12/20/17 and stated its from her flu shot on 8/21/17. She stated lower dull arm pain. Dull pain, consistent, always there -no redness, no swelling.
The day after getting second dose I started getting a headache, general feeling of not feeling well, and really tired. I was still having problems from when I had COVID back in September. I went to my PCP just for a check up because I was feeling worse after second vaccine, but mainly for still having previous symptoms. The Dr. was going to change my medication for headaches, and wanted me to get into the association . I ended up getting COVID again May 11th, 2021. Still experiencing symptoms.
Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breast feeding) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 041L20A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breast feeding). The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE VIA BREAST MILK (Breast feeding) outcome was unknown.            Concomitant medication information was not reported. Treatment information as not reported.
Normal initial stick pain, but immediately intensified and went  down my arm.  I got up and walked back over to my waiting chair and my Husband got up and received his vaccine.    Besides the pain in my left arm,  I started feeling weird tingling sensations and spaced out.  When my Husband sat back down next to me,  my stomach had a burning sensation and I felt slightly nauseated.  Then I felt like I was about to faint.  My Husband and the Staff kept me from falling, The Staff brought ice packs to put on my neck.  They said I turned white and profusely sweat.   I don't remember all of it, my Husband filled in the blanks.  I started feeling better and we left @4:30.
Patient vaccinated PNEUMOVAX23 on 01-JAN-2014 and with pneumococcal (PCV13) ON 11-DEC-2015; This spontaneous report was received from a 67 year-old male patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.   On 01-JAN-2013 the patient was vaccinated with pneumococcal polysaccharide PPV23 (manufacturer unknown) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided). Therefore, it was reported that on 11-DEC-2015 another dose of pneumococcal 13v conj vaccine (manufacturer unknown) was administered to the patient (inappropriate schedule of product administration). No adverse event was reported.   This is one of two reports received from the same patient.; Sender's Comments:  1903USA006160:
Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and difficulty focusing eyes (symptoms of ocular migraine). Severe symptoms lasted 5 hours, mild symptoms lasted through the evening and next day (today I still have a mild headache and nausea). I have previously had 1 migraine (~5 yrs prior) in the setting of repeated fume exposure during a renovation at my workplace, no other history of migraine.
multiple staged red based vesicular lesions. 50 or more lesions over entire body. Zovirax and Benadryl. Oatmeal and baking soda soaks.  Atarax 10mg/5ml- 5ml po qid also prescibed on 11-12-04 due to benadryl not helping
2 minutes after Gardasil administered, pt leaned forward and tumbled to floor. Eyes rolled back. Immediately refocused and speaking. BP 104/56. Monitored pt for 20 minutes no further adverse effects. Bruise to right hip where landed on floor.
Fatigue; Body aches; This is a spontaneous report from a non-contactable other health professional (HCP). A 38-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 13Jan2021 at 14:30 on left arm at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 on 24Dec2020 at 12:30 PM on left arm. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient experienced fatigue and body aches on 13Jan2021 at 21:00. The patient did not receive treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a physician via a company representative, concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date (reported as "a few years ago"), the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, for prevention of shingles (dose number, route of administration, lot # and expiration date were unknown). Concomitant therapies were not reported. Then, on an unknown date (reported as "the next day"), the patient developed shingles (herpes zoster). At the time of reporting, the outcome of the herpes zoster was unknown. The causality assessment between the herpes zoster and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Immediately after needle withdrawal during vaccine administration a small amount of vaccine estimated to be less than 1/4 dose exuded from the vaccine site.  Clinical lead was called to the table to evaluate. It was determined that greater  than 3/4 dose was successfully administered therefore per protocol no further counter measures were taken.
Patient received COVID-19 Vaccine at 8:23 am, complained of itching, a rapid response was called, the employee was taken to the ED and signed in at 8:57am.
Case number PHEH2014US003779 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 17-year-old male patient who was accidentally vaccinated with FLUCELVAXZ 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 23 DEC 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).    Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Partial Seizures. A physician reported that 2 days post vax on 01/29, child experienced a seizure that lasted 5-6 seconds. 01/30, he experienced another seizure and on 01/31, he experienced 2 seizures each of which lasted a 'few' seconds. The pt was seen by a physician. There he developed a seizure, an EEG was done and blood sample (unspecified) was taken. He was admitted to a hospital, where EEG, MRI and blood draw (unspecified test) were performed. During the EEG, he experienced a partial seizure. The pt was treated with valproic acid and discharged. The pt had seizures ever hour while on the valproic acid. Tegretol was started and valproic acid discontinued.
This was my second dose of Moderna vaccine.  On April 19 I was vaccinated   at about 5:30 pm . That night at about 12 pm , around 6 hours after vaccination I woke up with diarrhea  and painful cramps in lower left quadrant .  Diarrhea continued for about 2 hours. More than 3 times and after they stopped the cramps continued all through the night. In the morning again I vomited once and then evacuated and  saw  blood in my feces . Saw blood about  3 times more after that. I do no know if currently I have permanent damage in my intestines or gastrointestinal system. I have  persisting  headaches and migraines still after 4 days .  As I write I have a dull migraine .
Patient developed itching on arms and one hive on her right arm approximately 5 minutes after dose. She stayed at site for approximately one hour. Her head and back started feeling itchy as well but she remained stable, given Benadryl by mouth.  Patient was driven to urgent care locally and given Benadryl IM, prednisone and Zofran.  No shortness of breath. Released with a Medrol dose pack.
Afternoon of shot he was dizzy and lightheaded, cold sweats, felt yucky all over, headache. Slept over 14 hours, that night. Woke up yucky again. Felt itchy all over. 5 inch itchy rash around shot site.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with GARDASIL (lot # (661953/1130X), expired on 13-MAR-2011) on 21-SEP-2012. No adverse effect reported. This is one of several reports received from the same source. (MARRS 1210USA006583). Additional information has been requested.
I fevered and muscles ached fri -sunday then my stomach started to hurt with severe pain and diarrhea. I'm 17 days out from shot and still experiencing  severe pain. I have accute stomach problems that had been well managed until the shot. This problem is above and beyond my normal illness.
Dysautonomia, tinnitus, muscle fasculations, paresthesias, irretractable insomnia, irretractable headaches. Heart palpitations, shortness of breath.
Within 3 or 4 hours after injections pt. began to be irritable and soon began a fever as high as 102 degrees F and had several episodes of diarrhea.
Pt is only 16 years old and received Moderna for 1st dose of COVID-19 vaccine. No adverse effects, just error in administration. Moderna was notified and states is ok to give 2nd injection as off label use to complete the series.
Yellow patch on left side of chest on next day after vaccination. Painful but pain subsided after 1 day. Has not resolved since.
12/28 sore arm, nausea, 12/29 slight headache, fatigue  and nasal congestion, 12/31 Red pin dot rash on abdomen and large  hives  on back, headache subsided . Hydrocortisone  1% applied  to  rash and itchiness subsided within 24hr. 1/03/21 headache.
75 year old male admitted for hypoxic respiratory failure due to COVID infection. Admitted to hospital medicine. Followed by pulmonary and ID services. Completed five day course IV remdesivir. Felt better. Respiratory status improved. He did qualify for home O2 at discharge. Care mgmt helped set up home O2. Will need close o/p follow up with pcp and consultants. To return to ER should admission symptoms reoccur. Discharged home in stable condition.
Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product use was reported. Health care professional (HCP) administered expired vaccine to 450 patients, after the manufacture date of expiration. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. Dates of administration of vaccine were reported as 10-Nov-21, 11-Nov-21. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received on 08-Jun-22, non-significant information reporter details added.
Arm where shot given L arm very swollen down to elbow and wrist, went to ER area was itching & hurting, ER doctor thought it was an infection, was given Benadryl & antiboitic Cephalexin; had 1st dose H1N1 on 11/2/09.
This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The medical assistant reported that on an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route, indication not reported). Concomitant medications were not reported. On an unknown date it was reported that "something effected him and now he walked with a cane". Outcome of the event was not provided. Additional information has been requested.
No additional AE/PQC reported; HCP calling to report T.E for MMR II vaccine. T.E case filed 02358855. MMR II vaccine was administered to the patient and a AE case was filed. Permission given to contact the physician. No additional AE/PQC reported.; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-MAR-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 1 dose, administered for prophylaxis, lot number reported as U205199 but upon internal review established as invalid, expiration date reported as 13-AUG-2023 (strength and route of administration were not provided) after a temperature excursion (product storage error). No additional adverse event reported.
p/vax pt exp a red, raised welt @ the inj site;also reported that child was grumpy p/inj;