chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 59 day old male, with no medical history and no allergies, who on 9/12/06 was vaccinated with a 2 ml oral dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (lot 653755/0319F). Concomitant vaccines administered on the same day included a dose of Pediarix, a dose of Hib conj vaccine (manufacturer unknown)  and a dose of Prevnar. The pt was seen in the office on 9/15/06 after experiencing bright red streaks of blood in his stool and vomiting the night before on 9/14/06. On examination the abdomen was soft and non tender, with no fever, and in no acute distress. The pt was sent to the hospital for X rays and blood tests. At the time of the report the pt had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The pts bright red streaks of blood in his stool was considered to be an other important medical event (OMIC). Additional information has been requested.
3:30 local reaction of red swollen itchy baseball sized knot on left upper arm.  Red swollen knot still there but itching gone. So fatigued can barely walk across room, pain in lungs.  Currently feel the same
Extreme arm pain at the injection site arm hurts to move even to date 5/23 hurts across shoulders to right shoulder and back of neck
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L 024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DLL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache for two days 11/2 evening and 11/2..then dizzy 11/2 through 11/5 am.
I am now in day 7 since the vaccination and still not well.  Starting on May 29 I experienced vomiting and nausea.  Vomiting stopped.  Day 6 the on-going pain and gas in my stomach became diarrhea.  I am still experieincing diarrhea.  Several days ago I took a covid test to rue out covid causing the symptoms.  Test negaitive.  I have had headaches,shivering, fatigue, bad taste in my mouth and dizziness since the vaccination.  I am not eating due to the diarrhea.  Taking in clear fluids
Pt developed eye lid edema, 2 urticaria in forehead, scalp, 2 at hairline. breath sounds clear, some drooling developed, SC epi given, Benadryl 15mg, Orapred 12 mg, Epinephrine 1:1000 0.1mg.  11/7/06 Received medical records from hospital which indicate patient received Epi, benadryl & Orapred in PCP office prior to being sent to ER for further eval & tx.  Exam revealed facial swelling, puffy eyelids & urticaria.  Received only IV Tagemet in ER.  Improved & d/c home on steroids & benadryl. Dx:  Acute allergic reaction./ss
Face/cheek swelling.; Cheeks and mouth/teeth felt numb / Teeth felt like after dental anasthetic; Cheeks and mouth/teeth felt tingly; Flushing appearance; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 10:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and known allergies to pomegranate. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included mepyramine maleate, pamabrom, paracetamol (PAMPRIN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took levofloxacin (LEVAQUIN) and experienced drug allergy. On 08Apr2021 at 10:45, the patient experienced face/cheek swelling and no swelling of lips. The swelling and flush appearance/feeling progressed over 3 hours then subsided. Cheeks and mouth/teeth felt numb, tingly and teeth felt like after dental anesthetic. On 14Apr2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events face/cheek swelling, flush appearance and mouth/teeth felt numb, tingly and teeth felt like after dental anesthetic was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Information was received from a 24 year old female consumer. The patient reported that she was vaccinated with her first dose of GARDASIL at age 16 or 17 and since possibly receiving the initial dose she has received two subsequent doses. Because she cannot confirm the initial dose she may be receiving a final dose within the month. At the time of this report it cannot be confirmed that the doses have been given in correct dosing schedule. No adverse event reported. Additional information is not expected.
High fever and chills with hard shaking, trembling started 11/18/2005. Had all night. Next morning still had fever but chills subsided. However I started having a rapid heart beat which got as fast as 160 bpm. This lasted off and on all day scaring me. Tachycardia
Perfect Apgar, cleared bilirubin in less than 24 hours after birth, had bloodwork done on top of newborn screening which took place prior to Heb B vaccine- all was within normal limit, which included unremarkable AST & ALT.  Mother who was citizen had only ever had a baby in hospital in another country, both parents were unaware of custom to vaccinate newborn babies in hospital as is unheard of elsewhere in countries. Child was vaccinated without either parent?s knowledge or consent immediately prior to being postpartum discharged. Days later, child had grand mal seizure at home. Father carried week old baby into ER from ambulance, child/baby proceeded to have subsequent grand mal seizure upon entrance to hospital ER
1st, 2nd Local store, and 3rd booster local drugstore. Extreme headaches with loss of vision, ringing in both ears, fever, chills, muscle ache, nausea. Went to ER a few times for headache/vision loss and then on 2nd visit to ER had triple bypass in April, then 2 weeks later had blood loss that required a transfusion that I declined. Also having constant memory problems and shaking is worse than before vaccinations.
10 min after giving BOOSTRIX & MENACTRA child in parking lot & passed out - told mom prior to this he felt like he could vomit. Total time less than 1 min child was placed in supine position feet above head - given a few sips of soda & cool compress placed on head. He laid there for 10-15 min. Before allowing him to sit up. He sat up without feeling dizzy or lightheaded. He sat for about 5 min and was allowed to stand still feeling well. Was able to leave with mom 30 min after episode & symptom had resolved. During this time his glucose was checked & SpO2 results on form.
Case number PHEH2013US014789 is an initial spontaneous report received from a pharmacist on 09 Jul 2013, with a follow-up received from a consumer (patient's wife) on 06 Dec 2013. This report refers to an 88-years-old male patient. He was administered an expired dose of post-exposure RABAVERT (batch number: not reported, expiry date: May 2013) intramuscularly on 09 Jul 2013 (last dose). Therefore, he was told to come back in the next day and was given another dose of RABAVERT. It was reported that he used to get gout once a year but since RABAVERT was given, his gout had constantly flared up where he was experiencing gout more frequently than normal in Jul 2013. When he was off the medication for gout, he used to have excruciating pain. He was coughing up blood at night on 05 Dec 2013. His wife thought he was having pneumonia and planned to visit the emergency room on 06 Dec 2013. Outcome of the events was not reported. Seriousness and causality of the events were reported. Follow-up was received on 06 Dec 2013: New events (gout flare, coughing up blood, and suspected pneumonia) and other clinical information were updated.
miserable headache; stomach ache; nausea (mentioned that she was so sick); nausea (mentioned that she was so sick); This is a spontaneous report from a contactable consumer (patient, self-reported). A 64-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date was not reported), via an unspecified route of administration on 02Apr2021, as single dose for COVID-19 immunisation (Age at vaccination: 64 years). The patient medical history and concomitant medications were not reported. The patient experienced miserable headache, stomach ache, nausea (mentioned that she was so sick) after the first vaccination on an unspecified date in 2021. She thought she had to restart the series of vaccination since it's been months since she had her first dose. Vaccinator told her (not sure if pharmacist or nurse) that she is already fully vaccinated and no need to repeat the series. She was also advised to come back after 6 months for the booster. She wants to confirm if that is true. Patient got her 2nd dose of bnt162b2 (COMIRNATY) on 24Sep2021 and had headache, sore arm, a little bit of nausea. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Experienced heart palpitations, tachycardia, dizziness and numbness in hands and arms
patient developed pain, swelling and a rash in arm that evening, it has increased in size a little bit the past two days, but she states it is feeling a little better today. Told her to take some benadryl and put a cold compress on it to relieve the pain. If no relief, pt needs to consult physician.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose:  the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 11-AUG-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the events to be related to ZOSTAVAX. Shingles outbreak was reported to be disabling. Additional information has been requested.
Patient reported getting hives starting 1 week after  getting 2nd Moderna shot.  It started on the arms then progresses to stomach and then everywhere on body.   She reports no reaction after the 1st shot.
Special reaction/Having a reaction; Slight fever; Headache; Discomfort in chest; Arm is sore; Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine; metal taste; Lost her voice; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine), DYSGEUSIA (metal taste), APHONIA (Lost her voice), CHEST DISCOMFORT (Discomfort in chest) and PAIN IN EXTREMITY (Arm is sore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced FEELING ABNORMAL (Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine), DYSGEUSIA (metal taste) and APHONIA (Lost her voice). On 18-Jun-2021, the patient experienced CHEST DISCOMFORT (Discomfort in chest), PAIN IN EXTREMITY (Arm is sore) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION COMPLICATION (Special reaction/Having a reaction) and PYREXIA (Slight fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine), DYSGEUSIA (metal taste), APHONIA (Lost her voice), CHEST DISCOMFORT (Discomfort in chest), PAIN IN EXTREMITY (Arm is sore), VACCINATION COMPLICATION (Special reaction/Having a reaction), PYREXIA (Slight fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2021, Body temperature: 102.2 (High) 102.2 Degrees F.         No Concomitant medications were reported.  The patient stated she took Tylenol and Ibuprofen per the HCP's recommendation but was advised not take together.   This case was linked to MOD-2021-228922 (Patient Link).
The second dose has caused me to lose a lot of my senses such as smell and taste.  I still feel like my head is swimming and it is hard to concentrate.
Woke up from afternoon nap on 9/20/07 with hive and rash on torso and extremities. Was given Benadryl x 2 doses - hives subsided after 2nd dose.
Information has been received from a physician's assistant concerning a female who on 08-JAN-2007 was vaccinated intramuscularly with a dose of Gardasil. Subsequently the patient passed out and experienced tingling sensation from her shoulder to her fingertips. It was reported that the patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Child had a seizure approximately 3 days after receiving the vaccine. (On 1/10/2022 at 12:56am) There is currently no history of seizures for him. Seizure lasted about 10-15 seconds and it only has happened once since then. (As of today 1/20/2022 9:31am)
Patient received Shingrix subcutaneously; Patient received Shingrix in the back of the arm; This case was reported by a nurse via call center representative and described the occurrence of wrong route of administration in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2022, the patient received Shingrix (subcutaneous). On 3rd May 2022, unknown after receiving Shingrix, the patient experienced wrong route of administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the wrong route of administration and vaccine administered at inappropriate site were unknown.    Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  Nurse reported a patient received Shingrix subcutaneously, in the back of the arm on 5th May 2022. AE report had all details provided by Healthcare professional at this time. Additional Supportive Information:  The patient received Shingrix in unknown arm. The patient received Shingrix subcutaneously, in the back of the arm, which led to wrong route of administration and vaccine administered at inappropriate site.
Headache. Chills / Cold Sweats. Extreme fatigue. Confusion. Unable to perform basic tasks due to the confusion. Blurred vision at times.
HEARING THINGS; PARANOIA; 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 past medical history included hepatitis c, paranoia, and hearing things, and concurrent conditions included haldol allergy, and mental health, and other pre-existing medical conditions included mental health patient.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 14:00 for prophylactic vaccination. Concomitant medications included alprazolam. On an unspecified date, the subject experienced hearing things, and paranoia. Treatment medications (dates unspecified) included: aripiprazole lauroxil. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paranoia, and hearing things. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Shingles - rash and pain on lower back and buttocks, identified by dermatologist and treated with valtrex
3 days after I received the 2nd vaccine, I developed hives in both lower arms and a few on my left shoulder,  right chest and upper legs.  I was prescribed prednisone
Injection site reaction red, swollen, raised; fever (102), sore joints, headache
2day p/vax pt exp rash left thigh, urticaria, edema, itching
Myocarditis, chest pain, elevated troponin.  Patient presented to ED on 11/29/2021 with 3 day history of chest pain.  Patient stated he started to feel sick in the evening after he had his COVID-19 booster shot. He reported pain in the middle of the chest, radiating to the left. EKG showed ST elevation  in ant leads, labs showed elevated trops of 234. CPK 427, CPK MB 26, CRP cardiac marker 54. Mild elevated LFTs. Hba1c 5. on admission. patient was taken to cath lab for LHC, which revealed a normal ejection fraction and normal coronaries. Patient was discharged on 11/30/21 but came back on 12/1/21 with complaints of recurrent chest pain. He admits the pain is somewhat worse with deep inspiration but not movement. He describes it as a midsternal pain that can radiate to his left arm, occurs and resolves spontaneously.
Patient could feel it in her throat for a couple of days; heart flutter; shortness of breath; heartbeat was irregular; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Mar2021 (Lot Number: EN6207; Expiration Date: 31Jul2021) as single dose for COVID-19 immunization and Glatiramer acetate, via an unspecified route of administration from 22Mar2021 at 40 mg, unknown frequency for an unspecified indication. Medical history included multiple sclerosis (MS), diagnosed on 25Feb2021. The patient's concomitant medications were not reported. On 22Mar2021, with the first dose of Glatiramer Acetate, patient experienced shortness of breath and heart flutter, like her heartbeat was irregular. Patient could feel it in her throat for a couple of days since on an unspecified date. The action taken in response to the events for Glatiramer acetate was unknown. Outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Pain, redness, swelling, chills. Influenza type illness/reaction. TX: IV antibiotics, oral antibiotics, IV BENADRYL, Prednisone.
Area on right upper thigh red and swollen, area 5 1/2 cm x 7 cm in red round circle where band aid was.
sore throat and neck followed by muscle aches, slight headache, lethargy, lightheadedness when getting up,  later cold and chills around 5 or 6 pm.  I went to bed around 10 pm and awoke around 5:30 am feeling just fine. I took no medications other than my insulin and prescribed meds for that day.
PT REPORTED TINGLING IN MOUTH AND TONGUE FOLLOWING VACCINATION. SUPPORTIVE CARE PROVIDED AND PT RECOVERED WITHOUT INCIDENT. VITALS AT TIME OF INCIDENT: BP 130/100, HR 88, RR 12, SPO2 98 PERCENT
h/a, arthritis from knees/neck now still on hand; arthritis devel approx 2 wks after;
This case was reported by a nurse and described the occurrence of fever in a 5 year old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 9/9/03, the patient received an injection of Infanrix. On 9/10/03, one day post-immunization, the patient's parent telephoned the physician to report that the patient was experiencing fever, malaise, and an injection site reaction characterized by redness, swelling, and induration. The events resolved on an unspecified date prior to 10/8/03.