chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 15 years old female patient. The patient's medical history included vagal response to blood draw. The patient had no pertinent medical history or drug reactions/allergies. The patient was vaccinated with the first dose GARDASIL (vaccination, site, route and strength unspecified) (Lot Number reported as 0555AE, Expire date 14-DEC-2014 waiting for verification) on 17-AUG-2012. No other co-suspects were reported. Concomitant medications included ZOLOFT, PROVENTIL HFA inhaler and clonazepam. The nurse reported that a patient had an episode of syncope and seizure following the first vaccination with GARDASIL on 17-AUG-2012. The nurse reported that about 5 minutes after vaccination while sitting down the patient threw her head back, body stiffened and became unresponsive making mouth noises, with tonic motions of the upper extremities. The patient became pale and ashen. The whole syncope / seizure event lasted about 2 minutes. The patient had a headache and stomach ache following the syncope/seizure event and her blood pressure was reported to have increased on 17-AUG-2012. The patient was treated with ice to the back of the neck and given juice and water. The outcome was reported as recovered/resolved after about 45 minutes on 17-AUG-2012 and left the office. The nurse reported the patient reported remembering everything that happened during the syncope/seizure event. The patient had sought medical attention via office visit. Upon internal review, seizure was considered to be an medically significant event. Additional information has been requested.
Systemic: Seizure-Mild, Additional Details: pateint expierienced a seizure post 2nd moderna vaccine less than 5 minutes after administration. Patient has a history of seizures and refused medical attention. Patient stayed in the pharmacy for about 20 minutes and decided to leave, stating no further issues. Patient was advised to contact their primary care provided and to also report the event to the CDC V-SAFE.
Information was received on 30-JUN-2017 from a nurse regarding an unspecified number of patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients received an improperly stored dose of PEDVAXHIB (lot # M020100, exp date 07-MAR-2019; lot # M045206, exp date 27-JUN-2019), GARDASIL 9 (lot # M036059, exp date 03-JUN-2019; lot # M044717, exp date 19-JUL-2019; lot # N002720, exp date 12-MAY-2019), or MMR II (lot # M011667, exp date 08-MAR-2018; lot # M032487, exp date 05-JUL-2018, lot # M045101, exp date 10-NOV-2018) reconstituted with properly stored sterile water diluent (unknown lot # and expiration date). No adverse effects reported. Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit Time Frame: 1 hour Previous temperature excursion?: No. Was call because of a data logger?: Yes. The outcome of the event was unknown. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 30-NOV-2016, the patient was vaccinated with a dose of improperly stored VAQTA with lot number M027879 and expiration date of 24-JAN-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168:Original Case : 1701USA003168; US-009507513-1701USA007912:Original Case : 1701USA003168; US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
At the above mentioned time I started getting a headache and started getting dizzy.  Both lasted until about 7:30pm.  I had to lay down the entire time.  To light headed/dizzy to stand. I took a prescribed tylenol , which I had for knee pains.  Afterwards I felt weak, but fine.
Information has been received from a nurse practitioner concerning a 16 year old female with no known allergies and no reported medical history, who on 21-JUN-2007 was vaccinated with Gardasil.  Concomitant therapy included YASMIN.  The patient received their second dose of Gardasil (lot # 658554/0928U) on 11-SEP-2007.  After received their second dose, the patient experienced flu like symptoms.  The patient fully recovered on 20-SEP-2007 without requiring treatment.  The nurse practitioner reported that the patient did not experience an adverse reaction after her first dose of Gardasil on 21-JUN-2007.  Additional information has been requested.
After 1st dose HPV had episode lasting about 40 min of decreased consciousness, also excessive pain in arm.  After 3rd dose HPV had episode following day when felt faint, lasted about 40 min.  2 days after HPV3 had episode per mom's description:  Was in shower, Yelled 'mom' and turned white, slumped down in shower, turned pale, took 40 min to return to normal awareness.  Is fine now.
not feeling well /feel a little bit off; feel sort of in a cloud; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well /feel a little bit off) and FEELING ABNORMAL (feel sort of in a cloud) in a male patient of an unknown age 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 MALAISE (not feeling well /feel a little bit off) and FEELING ABNORMAL (feel sort of in a cloud). At the time of the report, MALAISE (not feeling well /feel a little bit off) and FEELING ABNORMAL (feel sort of in a cloud) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Patient has heard from several places that Moderna will recommend a booster shot which is half dose. Patient has not been feeling well lately and he would like to know if a third full dose can affect him adversely. Patient feels a little off and sort of in a cloud.
Injected Pediatric dose instead of a Bivalent Adult dose and the patient did not get any adverse effects.  The Moderna vial and box did not indicate any writing stating that it was a pediatric vial.
I had dizziness staring about 10 minutes after the injection, and I continue to be dizzy today.
Patient states that they woke up for work around 2:00am on 12/20/21 with swollen eyelids around both eyes.  After arriving at work around 3:00am she developed a severe headache.  She took 800mg of ibuprofen.  Around 6:00 am, she developed shortness of breath.  She left work early and returned home.  She took her blood pressure around 7:00am and states that it was normal.  Around 10:00am after resting on the couch for a few hours, she felt better.  She returned to work feeling normal the following day 12/21/21.
Large swollen bruised red area at site of injection and intense rash all over both arms, chest, back, neck. Still present after 3 days, took many photos to document reaction. Also had headache, fever, body aches and chills first day but nothing significant. Rash was significant and family member who is nurse suggested worth reporting.
Information has been received from a medical assistant referring to a 19 year old patient who on an unspecified date was inadvertently administered a pediatric dose of VAQTA (dose and route not reported). No adverse effects reported. Additional information has been requested.
pt recvd vax & exp local rxn consisting of redness & pruritus at inject site; pt had an allergic rxn w/ cough & mucous,chest tightness,lightheadness, labored breathing,burning sensation & itching & numbness feeling; burning in the throat;
On 3/27 I was diagnosed with gout following pain, redness, and swelling in my left foot. I also had pain in my shoulder. The next day I started developing a rash on the right side of my torso on my chest and back. In a follow up appointment with the doctor and a visit to the ER I was diagnosed shingles. I was prescribed acyclovir and indomethicin. The rash has mostly cleared, but pain in both my torso and foot still persists.
Vomiting, pt also  stated she lost consciousness  for a few seconds, pt denied ambulance, so I cancelled it. She drank some water, then she left store her husband drove her home
Left arm became extremely sore at injection site. After a few days, the pain lessoned, then came back for an entire month. It hurt to raise my arm or move it at all. I also experienced extreme abdominal pain 1 week after the shot. This was associated with my menstrual cycle, but I never cramped. It was so bad I could not eat, or move and lasted about 2 weeks. I almost went to the hospital for the pain it was that bad.
While I was waiting outside the clinic for 30 minutes, I first felt I ringing on my ears. It was very low level; high pitched sound low down at the back of my head. Unfortunately this ringing/Tinitus has continued every day and periodically gets worse. It has never gone away since the first day of my first dose. It seems worse at night when I am quiet. No additional tinitus with the 2nd dose.
Child started with fever on day of vaccination (8/9) and according to mom has had fevers daily since then (11 days ago). 3 days following vaccination she developed a rash behind her neck that has since spread over body, extremities and face. Mom also reports congestion and decreased appetite. Fevers reducible with tylenol and motrin--- Tmax 104.
No additional AE; extra dose adnimistered; administered a 3rd PEDVAXHIB Dose which was administered in error on 11/13/2020; This spontaneous report was received from a nurse practitioner referring to a 6 months old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  For routine vaccinations, the patient was previously administered the 1st dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) on 10-JUL-2020 and she was administered the 2nd dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) on an unknown in 2020. Then the patient was inadvertently administered a 3rd haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) which was administered in error on 13-NOV-2020 (inappropriate schedule of product administration) and which was discovered by the nurse practitioner on 02-SEP-2021. The patient was administered a haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) booster dose on 02-SEP-2021 (extra dose administered). Nurse practitioner evaluated patient on 02-SEP-2021. Patient had recovered from event on unknown date as confirmed by nurse practitioner at call time. No additional AE.
Dizziness; Metallic taste in mouth; Shortness of breath; Hot flushing sensation in torso and up the spine; Numbness on hands; Numbness on lowerlegs; Numbness in leg; Heaviness or thickness feeling of the tongue; Throat tightness; Chest heaviness; Irregular pulse; Difficulty in moving muscles; Burning armpits; This is a spontaneous report from a contactable consumer, the patient. A 50-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 00:15, (at the age of 50-years-old) as a single dose for COVID-19immunisation. Medical history included asthma, osteoarthritis, depression, penicillin allergy, brazil nuts allergy and drug allergy (protonix, aspirin and levaquin). The patient had no known allergies to food, medicines or other products. Concomitant medications included prozac (MANUFACTURER UNKNOWN) and meloxicam (MANUFACTURER UNKNOWN) for unknown indication, on an unknown date. 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 vaccination. On 06Apr2021 at 12:45 the patient experienced dizziness, metallic taste in mouth, shortness of breath, hot flushing sensation in torso and up the spine, burning armpits, numbness of the face hands and lower legs, heaviness/ thick feeling of the tongue, throat tightness chest heaviness and irregular pulse. On 06Apr2021, the patient  experienced irregular pulse rate 80-145 and oxygen dropped to 88 percent and after 5 hours the pulse rate was 96 and oxygen saturation improved to 92. No therapeutic measures were taken as a result of reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event throat tightness, chest heaviness, dizziness, metallic taste in mouth, shortness of breath, hot flushing sensation in torso and up the spine, burning armpits, numbness of the face hands and lower legs, heaviness/ thick feeling of the tongue, irregular pulse and difficulty in moving muscles was recovering.  No follow-up attempts are needed. No further information is expected.
Information and follow-up information has been received from a physician's office worker and a nurse practitioner for the Pregnancy Registry for GARDASIL, concerning an 18 year old female who on 29-MAY-2007, 30-Jul-2007 and 02-Jan-2008 was vaccinated with her 0.5 ml first (lot# 657622/0388U), second (lot# 657622/0388U) and third (lot#659055/1522U) doses, respectively, of GARDASIL. Nurse reported that it was the patient's daughter or her friend, who told her about patient's pregnancy. Nurse noted that the patient was approximately 7 months pregnant (LMP approximately 15-Aug-2007). Unspecified medical attention was sought by contacting nurse. In September 2007, it was reported that the patient had mononucleosis, and was treated with AMOXIL, 500 mg BID. It was reported that on 30-Apr-2008 (40 weeks from LMP), the patient delivered a normal male baby. The baby weighed 7 lbs 6 oz and was 20.5 inches long. The patient had no complications during pregnancy and labor. No additional information is available.
pt recv vax & 12NOV97 during physical exam pt was found to have elevated LFT's;examining MD reported did not know whether this was the result of poss celebrating the noc a/or some other cause;blood tests will be repeated;
Injection site pain, headache, tiredness, muscle pain, chills, nausea, feeling unwell, sweating, dizziness. After 45 minutes it subsided enough, except the nausea, so that I could go to the recovery area where I remained for a few more minutes. I then felt well enough to drive myself home.
Flu like for about 30 hours. Day 3 still had swollen and red at injection location. Day 6 left arm, injection arm, still swollen and pink color elbow and forearm. Taking Naproxen. Day 7, today, Still swollen and pink color.
Acute pericarditis with effusion 5.5 months after vaccination. Presented with peripheral edema, abnl cardiac MRI (evaluation done in city, state). Not hospitalized. Treated with NSAIDs, colchicine. Final outcome TBD
Patient rec. DTaP on 10/12/2016 and patient later developed redness that traveled down to elbow. Mom called family doctor and was instructed to give BENADRYL and warm compresses. 10/15/2016 mom took patient to Urgent Care as redness was not getting better. Urgent Care gave Prednisone 5mg/5ml give 4 tsp once then 2tsp x 6 days and Cephalexin 1tsp BID (250mg/5ml) for 10 days. 10/17/2016 mom called with update and stated patient's arm looks much better today.
Patient received 2 doses of AstraZeneca previously and did not disclose during D1 appointment.  Patient received Moderna 0.5mL 01/07/22 since she did not disclose previous AZ doses as indicated in this report.
pt recv vax; T of 102.5 R; adm to hosp for meningitis;
I was having shortness of breath and my heart was beating way too fast and I started to monitor it with my blood pressure cuff and I noticed my heart rate was too fast. So I drove to the emergency room and they admitted me immediately. Diagnosed with Afib
This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 83-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. On 27th August 2018, less than a year after receiving SHINGRIX, the patient experienced burning sensation. On 4th September 2018, the patient experienced anemia. On an unknown date, the outcome of the burning sensation and anemia were unknown. It was unknown if the reporter considered the burning sensation and anemia to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and over the last 2 weeks, she had experienced a burning sensation around her face, chest and abdomen. The patient went to the emergency department yesterday on 4th September 2018, less than a year after receiving SHINGRIX, the patient was diagnosed with anemia. The patient had denied permission to contact their physician.
After patient got her 1st dose of Pfizer Covid 19 vaccine, she was instructed to wait 15 minutes at the resting area in front of pharmacy. On her way from immunization room to the resting area, she fainted. Since her mom was holding her, she didn't fall. She was put down on the floor and regain consciousness within a minute. 911 was called. While waiting for paramedics, Rph took her blood pressure with result of 110/71 HR 89. Patient then walked back to immunization room with mom and Rph's help. When paramedics arrived, they took her blood and it was low. They provided IV fluid and she was taken to hospital by ambulance.
Patient's wife describes a mottled coloring along his back (rash), fever, chills, achiness all over body.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) were reported to be 1) 18-AUG-2015 and 2) 23-DEC-2015. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
pt recvd vax 12OCT93 & mid afternoon 13OCT in AM mom noted rash on trunk & head, legs; fever was 100.5 p/APAP; seen by MD 13OCT;
8/12/22 PT RECEIVED 2ND MODERNA BOOSTER. PT STATED EVERYTHING WAS FINE ON THAT DAY. SHE WOKE UP SATURDAY  8/13/22 WITH HEADACH, NECK PAIN THAT RADIATED FROM LEFT TO RIGHT. IT HURT TO MOVE NECK IN ANY DIRECTION (UP, DOWN, SIDE) FELT LIKE THERE WAS SWELLING. IT HURT TO COUGH. TEMP OF 101.1(FEVER); AROUND 2-30-3 PM ON 8/13/22 BP 125/69 PULSE 86; RECHECKED AT 4 PM IT 173/91 PULSE 88.  STAYED IN BED ALL DAY, TOOK SHOWER, TOOK TYLENOL,DRANK WATER, ATE CHICKEN NOODLE SOUP ONLY; LATER SUNDAY 6-8 PM HEADACHE EASED UP. TOOK TYLENOL EVERY 6 HIURS AND SUNDAY NIGHT TEMP WAS 99.1. HEAD HURT MORE WHEN SNEEZED, PASSED GAS, AND TALKED.  MONDAY 8/14/22 AT 12 NOON, SEEMED ALL SYMPTOMS JUST WENT AWAY. TUESDAY NOT MUCH PAIN BUT TOOK TYLENOL TWICE DURING THE DAY. WEDNESDAY ALL PAIN AND FEVER GONE. ARM ITCHED AND PT RUBBED IT-IT WAS SMOOTH TO TOUCH. PT TOOK A SHOWER AND PUT COCOA BUTTER ON- WHILE PUTTING ON COCOA BUTTER, PT FELT LITTLE BUMPS ON ARM. SHE TOOK PICTURES AND CAME TO PHARMACY.  PT WAS INSTRUCTED TO  CONTINUE TO MONITOR SYMPTOMS AND TO FOLLOW UP WITH DERMATOLOGIST.
Severe shortness of breath lasting several hours. Chest pressure lasting several hours. Extremely rapid heartbeat lasting over 12 hours. The following days heart became very shallow and could not detect heart beat at any pulse area. Breathing also became shallow.  Shortness of breath also returned off and on during following 7 days.
Patient with swelling, pain, tenderness, and erythema on the left arm. Benadryl, Clindamycin, and Ibuprofen were prescribed. Advise applying cool compresses
had some slight dizziness again; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (lot number EP6955) on left arm at single dose for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medication included colecalciferol (VITAMIN D) from 2015 and ongoing. Historical Vaccine included first dose of BNT162B2 (lot number EN6199) on 04Mar2021 on left arm for COVID-19 immunization and experienced severe dizziness and If lay down on the right side the whole room spinning. The patient had some slight dizziness again on 12Apr2021 but not a severe as 19Mar2021 after first dose. Treatment was received for the event. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
shrill crying-inconsolable crying more than 3hr;excessive swelling of inj site;extreme irritability
GENERAL FLU LIKE SYMPTOMS; CHILLS; HIGH FEVER; BAD HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cardiac problem, respiratory problem, non-smoker, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on left arm on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced general flu like symptoms. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced high fever. On 17-MAR-2021, the subject experienced bad headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general flu like symptoms, chills, high fever, and bad headache on 23-MAR-2021. This report was non-serious.