chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving MENACTRA pt. fell back onto exam table - shook for 1-2 seconds & then sat back up by herself - total incident time 5-7 seconds.
On 4/19 Mom called and stated the child had a fever, cough and was fussy. On 4/20 saw the doctor with a diagnosis of probable viral bronchitis. Albuterol syrup, O2 saturation was 96 %, chest x-ray suggested interstitial pneumonitis. On 4/23/01 office visit the pt still had a fever, cough, was now wheezing, dry mouth, slightly depressed fontanel. Was started on Amoxicillin. On 4/27/01 varicella injection site has erythema and a small vesicle, fever is down and dehydrated with improvement.
Sick for over a week now, the side effects from it; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for over a week now, the side effects from it) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for over a week now, the side effects from it). At the time of the report, ILLNESS (Sick for over a week now, the side effects from it) had not resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
Migraine about 3 am which I medicated with Tylenol and Imitrex. Flu-like body aches from 10 am - present.
Mom states back of L arm looked slightly red 10-2-14 but on 10-3-14. she stated the back of his L arm was red from his elbow to  his shoulder. Dr's office said redness was 7" x 7", not to touch, but no fever and no pain. Dr put pt on Keflex 250 mg TID x 1 week and mom says today it is 90% better. This was in area Varicella was given.
Patient described pain (more then typical sorness) in arm about 12 hours after injection. Was worried it was SIRVA after a conversation with a nurse practitioner.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider at the office of a physician, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a physician for herpes zoster. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
pt recvd vax; devel soreness, erythema & induration at inject site;sxs resolved approx p/ 1 wk;md felt problem w/ vax lot;
PT WAS INCORRECTLY GIVEN FLUAD 65+ WHEN WE REGISTERED HIM FOR AFLURIA. WE MADE A FOLLOWUP CALL TO THE PT 3 DAYS LATER AND HE HAD NO COMPLAINTS OR SIDE EFFECTS. THE ONLY THING THAT HAPPENED WAS SLIGHT PAIN/PRESSURE AT THE INJECTION SITE WHICH WE ASSURED PT WAS NORMAL
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (dosing details were not reported) lot # L035126 expiry date 14-SEP-2017, which was stored at a temperature of -12.5 degree centigrade for 13 hours 28 minutes. The reporter stated that "VARIVAX (Merck) is considered too warm and unstable". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported the morning after vaccine was given. She experienced significant sore arm, fever, headache, and body aches.
Pt received 2nd Moderna vaccine 3/22/2021. On 3/23/21 she experienced a headache, nausea, vomited 1 time and had fatigue. Awoke on 3/24/2021 with hives from neck down. States included back, abdomen, arms and legs but did not involve face .Complained of severe itching. Took Benadryl and rested that day at home. Saw primary care doctor 03/25/2021 because rash was more severe. Was given steroid injection and oral steroids for 5 days.
Swollen gland (lymph node?) at right collar bone about a day following injection, on same side as injection site.
Tingling in back of mouth/tongue . No hives SOB or Facial swellimg
Experienced pain and swelling at the injection site. Developed  mild fever, headache, body aches and sinus congestion.
Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) patient is a 19-year-old female with past medical history of Rett syndrome, asthma, GERD and chronic tube feeding.  She presented for chief complaint of increased pulmonary secretions and vomiting.  Patient had been tested positive on home testing for COVID earlier that day after being exposed to a sick family member.  On presentation vitals are notable for temperature 100.1°.  Labs notable for positive COVID test.  Chest x-ray was notable for bilateral perihilar opacities.  Patient was admitted initially satting well on room air but had desaturations later in her stay and was therefore started on remdesivir and Decadron for treatment of COVID.  Patient required aggressive pulmonary hygiene throughout her stay.  Nausea vomiting and increased secretions improved and patient was restarted back on to work home tube feeding formula.  Patient was weaned off oxygen requirements and will be discharged home under the care of her mother
had redness around and below the injection site.  area was slighly raised and felt warm to the touch.
Headache; Chest pain; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, the patient experienced headache and chest pain on an unspecified date. Consumer wanted to know as to what she can take following these adverse events. If she can take Tylenol for this. But definitely referred consumer to her physician as Pfizer is unable to recommend any clinical judgement as to this concern. It was advised to consult with Dr about what experienced/are experiencing. Dr was in the best position to advise about the appropriate action to take as Dr was most familiar with medical condition, clinical history, how your treatment has been conducted and any relevant information to specific case. The outcome of events was unknown.   No follow-up attempts are possible. Information about Lot/Batch number has been requested.
This spontaneous report was received from a registered nurse who is also the mother of the patient, via a company representative, regarding a currently 13 year old male patient. The patient did not have a pertinent medical history and was not taking concomitant medications. The patient's drug allergies were unknown by the reporter. In April 2015 (reported as "2 years ago"), the patient was vaccinated with a dose of GARDASIL injection (dose, route, lot number and expiration date were unknown by the reporter) for prevention of Human Papillomavirus (HPV). On unspecified dates (reported as "in two occasions after receiving each dose of GARDASIL"), the patient's arm felt "limp/heavy". This adverse experience lasted for about an hour or two after each injection. On an unknown date (reported as "the day after each injection"), the patient recovered from the events. It was unknown if the patient received a third dose of GARDASIL. No treatment was given for the events not laboratory diagnostic studies were performed. The patient did not seek medical attention for the events and no intervention was performed to prevent serious criteria. The reporter did not provide a causality assessment between the suspect therapy and the events muscular weakness and limb discomfort. Additional information has been requested.
Sore Shoulder at injection site for 1-2 days. Arthralgia, irregular heartbeat, bloating, dry mouth, headache for 5-6 days following shot.
Had some side effects on the moderna vaccine; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events side effects on Moderna vaccine/vaccination adverse reaction  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their one of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event side effects on Moderna vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 8 Feb 2021 the outcome of event side effects on Moderna vaccine was unknown.
Ten days after receiving my first vaccine I developed a rash just below the injection site.  Rash was approx 1.5"x2" and only slightly raised. Was noticeable for 2 days. Felt a little lethargic that day but not ill. No fever or pain. Did not see rash listed as a reportable event on VAERS site but was advised to report rash anyway.
On Jan 25th, 2021 experienced delayed reaction- 10 days after immunization.  Dark red rash greater than 4" on upper right arm, white hard raised bump at injection site, itching and painful to the touch. Applied topical  anti-itch medication; called physician but did not present in office. No fever or other symptoms. Was exposed to someone who tested positive during this time frame. As of todays date, 1/28/21 the rash remains the same size yet the redness is dissipating and remains itchy.
Vaccine expired on 11/5/21, was given 11/6/21.  No adverse events reported.
Woke up middle of night sweating with 200+ BPM heart rate. Blood pressure 190/100. Weight on chest. Felt dizzy and faint. Could hardly walk. Labored breathing. Had to call ambulance for transport to hospital.
After the 2nd dose she had sore arm and mild aches; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (After the 2nd dose she had sore arm and mild aches) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 007M20A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 25-Jan-2021, the patient experienced FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced MYALGIA (After the 2nd dose she had sore arm and mild aches). At the time of the report, MYALGIA (After the 2nd dose she had sore arm and mild aches) and FATIGUE (Fatigue) outcome was unknown. Not Provided          No treatment medication was reported .       Reporter did not allow further contact
Acute Ischemic stroke , left side paralysis head to toe, no warning symptoms. Hysterical laughing & crying. Hard time breathing. Began at 10pm, received TPA around 1:30am.
I received the 2 dose of moderna in my right arm on 9/14/2021, I've noticed today 9/17/2021 a fair size swollen lymph node on my right collarbone, and mild headaches.
Patient received second dose too early. Due date was scheduled for 04/09/2021. Patient experienced no adverse reactions as a result of receiving the vaccine too soon. Stated only experienced soreness in the arm where vaccine was administered x 24 hours.
Child in for immunizations. within 15 minutes of administering child with cough,wheezing,itchy nose.0s saturation 88%. Before immunizations administered lungs were clear.Benedryl po was given as well as albuterol 2.5mg neb x 1. child remained in clinic for 2 hours after incident and symptoms resolved.
Pt. went to med ctr on 5/7/11. Abscess had developed - site was I and D'd, then packed. IV antibiotics given, then sent home on oral Clindamycin. Abscess was to (L) upper arm.
Stomach upset; swelling; vaccination site warmth; Vaccination related malaise; red spot under their breast in the same side; every bone in thier body hurts; had a big red round spot where they got the shot; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), VACCINATION SITE INFLAMMATION (swelling), VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION COMPLICATION (Vaccination related malaise) and ERYTHEMA (red spot under their breast in the same side) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), VACCINATION SITE INFLAMMATION (swelling), VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION COMPLICATION (Vaccination related malaise), ERYTHEMA (red spot under their breast in the same side), BONE PAIN (every bone in thier body hurts), VACCINATION SITE ERYTHEMA (had a big red round spot where they got the shot) and PYREXIA (Low grade fever). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), VACCINATION SITE INFLAMMATION (swelling), VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION COMPLICATION (Vaccination related malaise), ERYTHEMA (red spot under their breast in the same side), BONE PAIN (every bone in thier body hurts), VACCINATION SITE ERYTHEMA (had a big red round spot where they got the shot) and PYREXIA (Low grade fever) outcome was unknown.            Concomitant product information was not provided by the reporter.  It was noted that the patient did not take any treatment medications but was probably going to take Aleve (naproxen) for the events.
Nosebleeds; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 09Apr2021 at 14:30 hours (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy (food sensitivities) and allergy to grass. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 19Mar2021 at 14:30 hours (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included escitalopram oxalate (LEXAPRO), lisdexamfetamine mesilate (VYVANSE), ascorbic acid (VITAMIN C), retinol (VITAMIN A), thiamine (VITAMIN B1) and cyanocobalamin (VITAMIN B12); all since an unknown date, for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021 at 23:00, the patient experienced nosebleeds. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event nosebleeds was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a health care student refers to patient 2 of 2 patients (no demographics provided). On 18-NOV-2013 the patient might have received improperly stored PNEUMOVAX23. Dosing information and route and administration were not provided. Lot number J005068, expire date 17-JAN-2015. No adverse event reported. This case is linked to patient 1 to 2 patients (1312USA000988-Pneumovax23) and linked to case from same reporter (1311USA008438-Afluria). Additional information is not expected.
19NOV92 productive cough, lt sided chest discomfort w/coughing & deep breathing; mod throat congestion, lungs w/rhonci;
spike in liver enzymes; This case was reported by a consumer via call center representative and described the occurrence of elevated liver enzymes in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th November 2020, 15 days after receiving Shingrix, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown.   It was unknown if the reporter considered the elevated liver enzymes to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient's blood work showed a spike in liver enzymes. The reporter consented to follow up.
Developed a rash at 9:30 the next day. Grew to 10 cm in 6 hours very red and hot. In the next 23 hours was as big as an adult hand.
Information has been received from a registered nurse concerning a 13 year old female with a history of reactive airways disease who on 06-FEB-2008 was vaccinated with the first dose of GARDASIL (Lot number 655327/1287U) 0.5 ml, IM. On 27-MAY-2008, the patient received the second dose of GARDASIL (Lot number 655327/1287U). Concomitant therapy included ORTHO TRI-CYCLEN LO. On approximately 03-JUN-2008, 1 week after the second vaccination, the patient experienced seizure. The patient came into the office on 04-JUN-2008 because the patient had several episodes in a 1 week of dizziness and black outs. Unspecified which week this occurred. The patient continues to have seizures. The last seizure was 3 weeks ago. The patient did not have any problems after the first dose of GARDASIL. The patient's seizure persisted. Upon internal service, the seizure was considered to be an other important medical event. Additional information has been requested. 11/05/2008 MR received for DOS 9/11-13/2008 with D/C DX: Seizure-like activity. Pt presented with increasing staring spells x 2 months, where pt is unresponsive. Pt has no recollection of events. Sick to stomach before and very tired after.  Pt dx with Seizure d/o dx June 2008. 12/15/08 Outpt neurology records received with impression ? seizure.
This spontaneous report was received from a 63 year old female patient reporting on herself. She reported that when she was 16-years-old she had a birthmark removed. The physician who removed the birthmark applied a topical product (name, manufacturer, dose and frequency unspecified) to help heal the wound. The consumer reported the site where the birthmark was removed started to "ooze a pus-like substance". The unspecified physician explained to the consumer that thimerosal was in the unspecified topical product and that the physician determined the consumer had an allergy to thimerosal. The patient's medical history included long history of bronchitis and ear infections. On 02-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 lot # K009874 in the left arm (dose, route of administration and lot # were not reported). Concomitant therapies included lisinopril (manufacturer unknown) and influenza virus vaccine (unspecified). The patient reported injection site reactions and other symptoms beginning two hours after she received PNEUMOVAX 23 on 02-JAN-2015. The consumer reported she experienced chest pressure, coughing that lasted for four hours, lower back pain, blood in her urine, the arm which was injected inflamed which made it sore and "unusable for twenty-four hours", and also she experienced tingling in her left hand. The consumer also reported she woke up in the middle of the night with fever. The consumer also reported she experienced a little bruise/lump at the injection site which was about four inches in length and three inches in width. The consumer reported the little bruise/lump lasted for about a week and a half. She also experienced extreme indigestion and confusion as she had not been able to eat anything that Friday 09-JAN-2015 and Saturday 10-JAN-2015. The consumer also reported that since Sunday 11-JAN-2015, she has noticed a "frequent pressure to urinate". The patient reported she tries to drink water and immediately begins to belch. She also reported almost passed out while at work on an unspecified date in January 2015. Patient visited physician's assistant on 14-JAN-2015 and was diagnosed with a kidney stone. She received therapy for the adverse event which included: acetaminophen with codeine and tamsulosin. It was also reported that the patient had urine specimen processed which results were not reported. The outcome of the events was unknown. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of pain in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, swelling arm and fever. On an unknown date, the outcome of the pain, swelling arm and fever were unknown. It was unknown if the reporter considered the pain, swelling arm and fever to be related to Shingrix. Additional information received as follows: The age at vaccination was not reported. The physician reported that the patient experienced bad side effects after Shingrix. The patient experienced pain, arm swelling and fever. The reporter gave consented to follow up. The contact details of the health care professional's assistant were reported for if follow up requested. This has been linked to the case US2018199491, reported by the same reporter.
Reported to ER within one hour with sensation of airway constriction in throat. Monitored for two hours, administered prednisone and Benadryl, released and told not to work for 2 days.
Sore arm was initial reaction, almost immediately after vaccination.  By the end of the day, I could barely lift arm greater than 15 degrees from rest at the side of my body.  General fatigue set in around 5pm.  Around 7pm, I felt cold and had chills, but no fever.  About an hour later, I measured my temperature at 99.6F.  My body started to feel achy and stiff, especially my neck.  Around 9pm, my fever rose to 100.6F.  The only way to feel warm was taking a hot shower and laying on a heating blanket.  I did not take anything for the fever, chills, or aches.  By this point, my entire body felt stiff and achy.  Even my skin hurt to the touch.  Con't on next page...