chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines given in office at appointment time around 1pm on 8/19/2021.  No reactions noted in office and normal exam.    8/19/2021 around 9pm mom called and reports she has noticed patient doing some weird eye movements and a little twitch for about the past week. She did not think much of it and that is why she didn't mention it at todays appointment. However, patient did it again this evening and mom started googling and became concerned about "infantile spasms". Mom reports her eyes will roll back and to the side briefly and she will do a little twitch then cry. No loss of tone, no LOC, no color change or breathing changes. The episodes are very brief. She has had no vomiting, no fevers, no other symptoms. She had a normal exam in office today. I advised that if she has fever, loss of tone, syncope, color change, or the episodes last more than a few seconds to call 911 tonight. Otherwise will monitor closely and order a stat EEG and neurology referral in the morning. Mom agrees to plan.  8/20/2021 9:00am - Facility is unable to do a stat EEG today outpatient. I called the on call pediatric neurologist Doctor and she advised baby go to the ER for concerns of infantile spasms. Advised the ER doctor call the on call neurologist when baby gets there. I called and spoke with ER physician and advised why we were sending baby and what the neurologist said. Mom notified as well and will take baby now.
SEVERE DIZZINESS - ROOM SPINNING WITHIN 30 MINUTES OF THE VACCINE ADMINISTRATION. SEVERE NAUSEA AND REFLUX. SEVERE EYE IRRITATION, BURNING, ITCHING, DISCHARGE, BLOODSHOT EYES, AND EYE SWELLING. MALAISE, SEVERE LETHARGY.
Extreme arm pain when moving arm, enlarged redness around injection site, injection site is very warm to the touch, sporadic sharp pains at injection site
Menstral cycle started 3days aftervaccine. "Im" have normal cycles and they begin the 1st week of each month. "Iv" never had a cycle mid month.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 15Apr2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021, the patient experienced menstrual cycle started 3 days after vaccine. The patient had normal cycles and they begin the first week of each month and she never had a cycle in mid of the month. It was reported that it was unsure how long it would last as it was lighter than usual but still odd for her body. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle started 3 days after vaccine, she had normal cycles and they begin the first week of each month and she never had a cycle mid-month was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
acute encephalopathy; This case was reported by a physician via sales rep and described the occurrence of encephalopathy acute in a unspecified adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced encephalopathy acute (serious criteria hospitalization and GSK medically significant). The patient was treated with medication unknown (Fluids). On an unknown date, the outcome of the encephalopathy acute was recovered/resolved.   The reporter considered the encephalopathy acute to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient was hospitalized and given fluids and released after one day. The reporter felt that this event might have been caused by Shingrix. The reporter consented to follow up. This case is one of 3 cases, reported by the same reporter.
Changes to circulation of feet, mottled blue discoloration of both feet when sitting down, color change is pronounced. Normal color returns with movement and warm foot baths.
10:28am- Patient brought into Covid Observation Area after reporting itching to scalp, chest, back and arms 10 minutes after receiving Pfizer booster vaccination. Redness and scratch marks noted to these areas but no visible rash or hives noted. Patient denies any difficulty breathing or itching in throat. Lungs clear to auscultation, no wheezing. No swelling noted to face lips tongue or throat. Patient alert and oriented x 4, able to speak in complete sentences. Patient states she experienced itching after 1st dose Moderna, took Benadryl 25 mg when she got home and itching resolved within 20 minutes. Patient also states she took Benadryl 25 mg  prior to 2nd dose Moderna and did not experience any itching after 2nd dose. States she did not take any Benadryl today Accompanied by her husband who drove.  10:30 am- VS- BP 148/93, HR 82, RR 20, 02 99% RA, no pain  10:34 am- Call placed to on call physician informed of patient symptoms above. Verbal order per Dr. to give Benadryl 25 mg capsule x 1 now, continue to observe patient for 30 minutes and call Dr. back in 30 minutes to provide update. Also informed Dr. that patient accompanied by her husband who drove. Verbal order repeated and confirmed.  10:35 am- Benadryl 25 mg capsule x 1 given orally as ordered.  10:38 am- VS: Temp 97.8, BP 149/90, HR 78, RR 20, 02 SATs 98% RA,   11:08 am- VS: BP 130/73, HR 64, RR 20, 02 SATs 99% RA- No further redness or scratch marks noted to chest, arms and back. Patient reports that itching is not completely resolved but improved significantly and that she feels much better.   11:14 am- Call placed to Dr., informed of patient improved symptoms. Per Dr., patient ok to be discharged home and  to take Over the Counter Benadryl 25 mg every 6-8 hours as needed as the itching may return.  11:20 am- Informed patient and husband of discharge instructions above, understanding verbalized. Patient discharged home in stable condition.
Information has been received from a medical assistant concerning a 17 year old female patient who on an unspecified date was vaccinated with her second dose of GARDASIL (lot # 661953/1130X) and a dose of RECOMBIVAX HB (manufacturer unknown). After receiving the GARDASIL vaccine the patient experienced seizures. Unspecified medical attention was sought. Upon internal review, seizures were determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a consumer concerning his 15 year old daughter with acne, no known allergies and no pertinent medical history, who received her first dose of GARDASIL vaccine in 2008 (lot not reported) On 20-JAN-2009 the patient was vaccinated with 0.5 ml of the second dose of GARDASIL vaccine (yeast) (Lot not reported) intramuscularly.  There was no concomitant medication.  On the night of 21-JAN-2009 the patient developed upset stomach, headache and a fever (the reporter stated that the patient felt hot to touch).  The father stated it could be viral since his daughter was a teenager and was in high school.  As of 22-JAN-2009 the patient has not recovered.  Follow up information has been received from a physician concerning a 15 year old female patient with acne and asthma who in 2008 was vaccinated with the first dose of GARDISIL. On 20-JAN-2009 the patient received the second dose of GARDISIL (lot: 658558/1061U) intramuscularly on the left deltoid. On the same day she received a dose of ADACEL intramuscularly on the left deltoid. The reporter stated that the adverse events mentioned were not reported in their office. Additional information is not expected.
severe dizzyness, headache 2 days after rash like spot next to injection site 7 days after shot.....  grew after 1 day continued with dizzy spells on and off since day of shot
Information has been received from a registered nurse concerning a patient who on 14-Nov-1997 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed "mild breakthrough" with "less than 50 lesions". It was noted that the patient was part of 7 children reported, 4 male and 3 female, some of which were siblings who were vaccinated with varicella virus vaccine. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned six other patients who were vaccinated with varicella virus vaccine live and experienced similar reactions (WAES #0312USA00884), (WAES #0312USA00885), (WAES #0312USA00886), (WAES #0312USA00887), (WAES #0312USA00888) and (WAES #0312USA00889). Additional information has been requested.
Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ATOGEPANT for Migraine.    Concurrent medical conditions included Migraine.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ATOGEPANT (unknown route) at an unspecified dose once a day. On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. The patient had only one pill left of Qulipta (Atogepant), and patient was going to her HCP , o would be skipping one day of therapy.
Given wrong vaccine on 9/05/2017. I am a healthcare provider and work for a GI doctor. I was required to get the Hep B series. I went in for the 1st dose of the Hep B vaccine but was given the Tdap in error. I then went back on 9/8/2017 and received the 1st dose of Hep B Right arm-Red swollen arm, joint pain, body aches, headache, nausea, confusion lasting 2 days. Site pain still present at 4 days.
I had a difficult time swallowing on June 22nd. I started to get muscle weakness and muscle pain. It got worse in July 28th. In Sep 1st I started getting muscle tingling, fatigue and weakness. I'm still experiencing the symptoms. They game bactofilin to help relax my muscles.
Pain at injection site; swelling at injection site; fever; chills; body aches; muscle pain; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm, on 23Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history was unknown. Patient is not pregnant. Patient did not have COVID prior vaccination. Patient did not have other vaccine in four weeks. Concomitant medications included Ibuprofen and Acetaminophen. Patient previously received first dose of BNT162B2 (Lot number: EK9231) via an unspecified route of administration in the left arm on 02Jan2021 11:15 at the age of 32 years for COVID-19 immunisation. Patient experienced pain at injection site, swelling at injection site, fever, chills, body aches, muscle pain, nausea on 24Jan2021 03:00. The patient did not receive treatment for the events. Patient tested COVID post vaccination through nasal swab which revealed negative on 08Jan2021. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
After vaccines administered, she took a nap. Later that day, after nap, she woke up and was refusing to bear weight on left leg. Eventually when she started to bear weight, she was dragging that leg
seizure / hospitalized for having seizure; trouble talking; biting her lips and as a result was bleeding all over.; feel sluggish.; Fatigue; runny nose; sneezing; A spontaneous report was received from a consumer concerning a 75-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced was Seizure, trouble talking, runny nose, sneezing, biting her lips and as a result was bleeding all over, Very upset / frustration, feel sluggish, and fatigue.  The patient's medical history was not provided by the reporter. Current history includes stroke. Concomitant medications were carvedilol 12.5 bid, losartan 100mg, rovastatin 20mg, ezetimibe 10mg, levothyroxine 75 mcg, aspirin 81mg  On 28-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the unknown location for prophylaxis of COVID-19 infection.   On 25-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26-Feb-2021, the patient experienced seizure which occurred less than 24 hours after receiving the 2nd dose of the Moderna vaccine.  At approximately 10:00 am, the patient wasn't able to formulate a sentence, similar to when she had a stroke. Husband drove her to the ER and she had a seizure in the car. CT Scan showed no stroke, showed a seizure. Patient was admitted, kept overnight, intubated and administered anti-seizure medicine. On 27-Feb-2021, the patient was discharged and developed flu-like symptoms (runny nose, sneezing, fatigue). Flu-like symptoms have cleared. The reporter feels the seizures are related to the prior stroke history.   On 10-Mar-2021, a follow-up was received. Patient feel huge disappointment and frustration on reporting serious adverse reaction. New information about the event include that on 26-Feb-2021, her husband noticed she was biting her lips and as a result was bleeding all over. Patient stated she has never had history of seizure but after this incident neurologists put her on high dose anti-seizure medications twice daily. These medications make her feel sluggish.   Treatment details provided was Keppra, anti -seizure medications.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event seizure, fatigue, runny nose, sneezing  were recovered on 27-Feb-2021 and 01-Mar-2021 respectively. The outcome of the events trouble talking, biting her lips, feeling upset and frustrated and feeling sluggish were unknown.; Reporter's Comments: Based on reporter's causality and the described prior history of stroke, the event is assessed as unlikely related to mRNA-1273.
tingling in their left hand / tingling mostly in their left pinky; numbness in their left hand/ numbness mostly in their left pinky; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in their left hand / tingling mostly in their left pinky) and HYPOAESTHESIA (numbness in their left hand/ numbness mostly in their left pinky) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PARAESTHESIA (tingling in their left hand / tingling mostly in their left pinky) and HYPOAESTHESIA (numbness in their left hand/ numbness mostly in their left pinky). At the time of the report, PARAESTHESIA (tingling in their left hand / tingling mostly in their left pinky) and HYPOAESTHESIA (numbness in their left hand/ numbness mostly in their left pinky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. The concomitant medication was not reported.
Complaint of headache, runny nose/congestion, loss of taste/smell, and malaise
Damage to cranial nerve 6, left eye, resulting in double vision. On the MRI there was no sign of any bleed or other problem to explain the double vision. My shot was just 5 days before, leading the doctors to conclude the vaccination was the likely cause. At the same time, from the MRI they determined that a pituitary adenoma they had been following for 5 years had enlarged and needed to be removed so I had surgery for that right away. But they were confident that the tumor was not the cause of the double vision.
Initial report was received on 14 September 2011 from a health care professional which involved a cluster of six patients who experienced adverse events after receiving FLUZONE, lot number UH476AB. This case captures one of the two patients who had additional adverse events. The other patient with additional adverse events and the cluster of six have been captured in case numbers 2011-08644 and 2011-08645. An unidentified patient, had received FLUZONE SV 2011-2012, lot number UH476AB (route, site and date of administration not reported) and an unspecified amount of time later, experienced redness and swelling at the vaccination site. The patient also experienced a feeling of their throat closing and redness of the arm, across the chest and breasts. Concomitant medications and past medical history were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Large, warm, red area at site of injection (above elbow) itchy. Large hard area below elbow on same arm possibly related. Scratchy throat.
pt recv vax OCT95 & 17APR96 pt exp chicken pox (80 lesions) from head to toe;there was no assoc fever;pt recovered;
Swelling at site, swelling involves upper arm and shoulder, arm mobility decreased to 30° or less, pain encompassing entire area, chills, abdominal cramps, swelling in arm becomes size of tennis ball, pain, swelling and discomfort begin to dissipate 24 hours after vaccination.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: fainted after shot. has happened before but in response to blood draw as per patient info. pt fully recovered after being put in supine positiomn. never lost consiousmnes
FLU LIKE SYMPTOMS...EXTREME FATIGUE, CHILLS,SHORTNESS OF BREATH
This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's medical history included shingles. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (dose and lot # not reported). On an unknown date, reported as "within a week or so", the patient experienced an unspecified rash on an unspecified location of their body. The outcome of rash was unknown. The relatedness between vaccination with a dose of PROQUAD (Merck) and rash was not reported. This is one of several reports received from the same source. Additional information is not expected, physician disagreed to be contacted.
Blurry vision, loss of concentration, palpitations, twitching, horrible headache lasted exactly one month, numbness in neck and entire face. Post orbital shocks, brain zaps, tingling in toes and fingers, stabbing pains in arms, legs, fingers and toes. Some days unable to walk. I had to crawl to get up into my room. Gait off, falling over constantly, vertigo and migraines. Muscles don't fire how they normally would. I squeeze and barely anything would happen. Some days I couldn't even lift my legs from bed.
My sister in law received the Maderna vaccine 3 months ago.  I was in close contact with her afterwards & I have now had periods lasting OVER 2 weeks for the past 3 cycles!  My period has always been 5-6 days & all of a sudden it?s iver 2 weeks.
Redness, swelling, with about five raised itchy bumps similar to mosquito bites inside the red area around the injection site. Entire red area is approximately two inches in diameter, total. Symptoms are mild and I haven't sought medical treatment. Symptoms started on day 9 after injection and they are still present now, day 10.
he received the first dose of the vaccine and then got COVID-19 and was treated with COVID antibodies; he received the first dose of the vaccine and then got COVID-19 and was treated with COVID antibodies; This is a spontaneous report from a contactable pharmacist via a sponsored program. A male patient of an unspecified age (reported as older than 60) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. On an unspecified date, the patient received the first dose of the vaccine and then got COVID-19 and was treated with COVID antibodies/antibody therapy. The patient was wanting to get the second dose. The pharmacist was calling for recommendations on what to do. The pharmacist did not know when he got his first dose, or when he tested positive for COVID. The outcome of the event was unknown.   Information on lot batch/lot number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on available clinical data, a causal relation between reported events and vaccination with BNT162B2 cannot be excluded. This case will be re-evaluated upon receipt of additional relevant information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Headaches, Body Aches, Severe Joint Pain, Muscle Spasms, Shortness of Breath, Chest pains, Asthma, Exhaustion.  Two years later I am diagnosed with COPD - Asthma and Emphysema.  I  was perfectly fine and very active, I could run distances, work all day doing labor, now I can hardly breathe, and have the symptoms above.
FLUZONE High Dose vaccine on 11/17/17. Severe arm pain (in arm receiving vaccine) extending across shoulder to neck began 3 hours later and lasted 2 to 3 days, then it became moderate pain for 2 more days. No swelling at injection site. Pain did not respond to ibuprofen. Extreme fatigue. Runny nose and productive cough began 2-1/2 days after vaccine. No sore throat. Low-grade fever. Mild nausea. Earache. Flu-like symptoms continued for 7+ days.
Information has been received from a physician concerning a male pt who on 06/13/1997 was vaccinated with a dose of varicella vaccine. On 09/14/2001, the pt was seen in the doctor's office with varicella. He had a rash for four days with pustules, vesicles covering his body, approximately 150 lesions and afebrile. The pt was treated with acyclovir and Benadryl. Additional info has been requested.