chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seriousness criteria: other-medically significant.  Initial case was received on 02 January 2008 from a health care professional affiliated with an organization under reference number 0712031485, who received this information from the patient's parent.  A 4-month-old female infant with no reported medical history, had experienced a seizure 397 days after she had received a transplacental dose of influenza vaccine (manufacturer and lot number not reported) on 01 October 2006.  The infant's reported date of conception was 11 September 2006.  The infant had also received the following concomitant medications transplacentally which consisted of Arava 20 mg q.d., prenatal vitamins q.d., and an iron supplement q.d.  The infant was born full-term on 02 June 2007.  The infant's mother had a past history of anemia which was diagnosed during childhood and "rheumatoid" which had been diagnosed when she was 18 years of age.  The mother of the infant reported that the infant had three seizures.  On (approximately) 02 November 2007, 397 days after receiving the vaccine, the infant experienced a seizure.  On 23 December 2007, the mother reported that the infant started shaking, her eyes rolled back and she began vomiting.  The infant was taken to the emergency room and was positive for a urine infection.  The infant was not admitted to the hospital.  On 01 January 2008, the mother reported that the infant had been shaking a lot and that the infant hit her head.  At the time of the report, the infant had not been fully evaluated by a physician and their recovery status was not provided.  The reporter for this case (infant case) is the same as was reported for case number 2008-00066 (no adverse effect for the mother).
No adverse events or reactions have been reported to this date.  Patient was pregnant at the time she received the second anthrax vaccine.
pt woke @ 230PM & cried most of time until about 11PM 8FEB93 not high pitched screaming-but off & on, irritable whining-crying;
Severe pain in left arm the evening of the injection. The pain radiated into his left wrist and leg affecting his walking ability. Symptoms improved the next day per patient's report.
AFTER RECEIVING HIS VACCINE, PATIENT WENT HOME, ATE SUPPER AND WAS SITTING IN THE LIVINGROOM. MOM STATES SHE HEARD A THUD, TURNED AROUND, AND SAW HER SON LAYING ON HIS BACK SHAKING. PATIENT STOPPED SHAKING, BECAME RIGID, AND REMAINED RIGID FOR SEVERAL MORE MINUTES UNTIL EMS ARRIVED. PATIENT PROCEEDED TO ER FOR FURTHER EVALUATION. PATIENT WAS BACK AT BASELINE WITHIN 10 MINUTES OF START OF SEIZURE EPISODE. NO PRIOR HX OF SEIZURE ACTIVITY. FOLLOWING UP WITH NEUROLOGY.
04/18/22, I noticed my voice was a little different, my throat did not hurt, but felt different. My coffee did not taste right. That day the food tasted okay. On 4/19/2022, my voice sounded a little more funny. I took a 5 hour nap because I was so exhausted. Today and yesterday, I have body aches in my shoulder, neck, hips and my left knee. I have more coughing today, my nose is running a lot more today. I have also been sneezing more. I had a brief headaches that lasted between 30 sec to 1 min on 4/19/2022 and 4/20/2022. I had a temperature on 4/20/2022, 100.6. On 4/21/2022 it was 99.4. I have also been losing my balance more, I am not dizzy.  I am still feeling exhausted. On 4/19/2022 I tested positive for COVID.
Developed myalgis & arthralgias soon p/receiving flu vax in fall of 1987; Seen by rheumatologist who felt she had a polymyalgia synd; Tx nonsteroidal antiinflammatory medication, local injects, physical therapy - (report inc);
P/shot, pt cried all evening & was up all nite; pt seemed better in AM; approx 6PM on 29APR92; crying started again pt was fussy & got hot;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 10-JAN-2013, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2016, the patient was treated at a clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. 13-JUL-2018. This is a correction. The case was opened to update the general tab with source information. Additional information has been requested.
fingers and toes numb; fingers and toes numb; ringing/humming in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "fingers and toes numb"; TINNITUS (non-serious), outcome "unknown", described as "ringing/humming in ears".  Additional information: The patient received the 2nd shot of Pfizer COVID vaccine on 27Dec2021 and reports that it made her nose run and was ongoing, ears were still humming and ringing, numbness in fingers remains and now she developed lump on her pinky finger, a lump on her left foot (toe), lump on right side of her stomach. Stated she felts 'these pains' and started rubbing it and was a lump. Also reports having had diarrhea and an ongoing raspy voice. Stated she knows it was from the vaccine. Stated she went to her HCP but her HCP doesn't know what to do. Asking for recommendations on how to get rid of humming and ringing noise in ears and the lumps on her body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
muscle soreness; trouble moving arm; Trouble walking; This is a spontaneous report from a contactable other health care professional (hcp). This other hcp reported similar events for 3 patients. This is the first of three reports.   A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, Suspension for injection, lot number CN1583, expiry date Aug2022, NDC number 0005010005), via an unspecified route of administration, on 17Aug2020 at 0.5 mL, single (also reported as 1 injection dose given twice at 6 months apart), for vaccination. The patient has no medical history. There were no concomitant medications. The other hcp stated that they give the vaccine either in the arm or in the thigh if a patient has small arms. On Aug2020, the patient had muscle soreness and had trouble moving arm or trouble walking if given in the thigh (pending clarification). The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020330145 same reporter/drug/events, and different patient;US-PFIZER INC-2020330595 same reporter/drug/events, and different patient
Patient reports he woke up the day after the vaccination with temperature of 99.4, headache, body aches, fatigue, nausea, redness and soreness at injection site. Systemic symptoms improved over the next 3 days but pain and redness at the injection site worsened. Patient was seen in the office for evaluation on 4/28/18 and diagnosed with cellulitis at the injection site, treated with 7 day course of oral KEFLEX.
Severe headache, nausea, leg aches, diarrhea, weakness - all intermittent in severity, persisting 72 hours at time of this writing.
This spontaneous report was received from a pharmacist refers to a 67 year old male patient. The patient has vancomycin allergy. On 14-MAR-2013, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23 (lot number H010515, expiry date was not reported, route was intramuscular). Concomitant therapies include doxazosin, fenofibrate, glucosamine, metformin, ZESTORETIC, NEXIUM, warfarin and cholestyramine. On 14-MAR-2013, the patient developed swollen arm from his left shoulder to his wrist after receiving a dose of PNEUMOVAX23. The patient did not have any laboratory tests performed. As a treatment the patient was given steroid and ROCEPHIN injection. The outcome of the event was reported as recovered on 16-MAR-2013. The patient sought medical attention (patient went to a urgent care). Additional information has been requested.
Cough starting 1/18/2022.  High fever and muscle aches starting 1/19/2022.  Tested positive for COVID by home test on 1/19/2022.
Nausea, arm swollen and sore. Temp 100.7 in physicians office. TX Compazine 10 mg, ice to arm.
Patient report developing mild body aches the evening that she received the vaccine.  The following day she developed worsening body aches, headache, and chest tightness.  In the early morning of 6/15/2021, she developed sensation of something in her throat making it difficulty to breath and chest tightness with a pain in her chest.  Body aches mostly resolved except pain in her upper back.   patient reported feeling the need to sit up to be able to breathe.
Approximately 1-2 hours afterwards, the patient went to ER due to swelling/ redness at the injection site & flu like symptoms.  Per patient WBC count 22,000.  Patient was discharged w/ KEFLEX (antibiotic).
Received IPV #3 on 12/17/01 and developed generalized urticaria on 12/18/01, in the afternoon. Treated with Benadryl.
3/28 - Early morning. Red, swollen, hot reaction at injection site. Went to Urgent Care and they drew a line around the red. I was told to monitor for increase in size of the red area. I applied ice and took 25 mg of Diphenhydramine. 7 hours later I took another 25 mg of Diphenhydramine.3/29 - Early morning. Redness had spread (almost double) below the original circled outline. Less swelling. Still very hot to the touch. Took 180 mg of Fexofenadine. Went to my doctor. My blood pressure was elevated. Advised continued use of antihistamine and ice. Both the doctor at the Urgent Care and the PA at Dr.'s office were concerned that it was an infection (Cellulitis). If the symptoms continue, I'm supposed to take antibiotics. I had other symptoms such as mild shivering, night sweats, flushed face.
Left Thalamic Infarction, headache and visual changes noted about April 12th
Red spot around shot size of softball, warm to touch. All over body aches, fever up to 102.5, loss of Appetite it lasted for 3 days.
Sore arm 7 hours after vaccine. Chills 24 hours after vaccine. Followed by fever of 101.6 at the 26 hour mark.  Headache at 26 hours after vaccine. Achy headache.
Started having Rash and Hives about 10 days after vaccine. It is aggressive and I got hives all over my body and it is very itchy. It's been 5 days and I am not getting any relief from over the counter Benadryl or Zyrtec. Been applying ointments and also took steroids but none are working.
She had redness and itching at injection site. No shortness of breath. Reddness then spread to her back. She was offered a Benedryl and refused it and went home and took 50mg of Benedryl. Her husband, a nurse tried to get her to go the the ER when she developed a tickle in her throat and a cough but she refused. She states she took another 25 mg of Benadryl and felt better and went to bed. When I spoke to her on 1/26/2010 at 10 am, she said some of the throat symptoms returned and she was going to make an appointment with her doctor.
Individual was given a 2nd booster 2 months after their initial booster rather than 4 months after initial booster.  No adverse reactions noted at the time of immunization, will monitor for 24 hours.
Severe headache; fever; tiredness; This is a spontaneous report from a contactable other health care professional (reported for himself). A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3247/Batch number was not reported), dose 2 intramuscular, administered in arm right on 16Feb2021 at 15:00 (at the age of 38-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in arm right on 28Jan2021 at 15:00 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation. On 17Feb2021 at 07:00, the patient experienced severe headache, fever and tiredness. No treatment was given for the events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
This case was reported by a physician to a sales representative and described the occurrence of autism in a 2 year old male subject who was vaccinated with hepatitis B vaccination recombinant for prophylaxis. On an unspecified date after 8/21/02 and before 10/02, the subject received a dose of diphtheria, tetanus and acellular pertussis vaccine as the first dose in the diphtheria, tetanus and acellular pertussis vaccination series. On an unspecified date in October 2002, the subject received a dose of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (lot DTPA572A2) as the second dose in the diphtheria, tetanus and acellular pertussis vaccination series. On an unspecified date in February 2002, the subject received a dose of Infanrix (DTPA576A2) as the third dose in the diphtheria, tetanus and acellular pertussis vaccination series. This is longer than the recommended interval of four to eight weeks between the second and third doses of Infanrix. On an unspecified date in February 2003, the subject received a dose of Infanrix (lot DTPA583A2) as the fourth dose in the diphtheria, tetanus and acellular pertussis vaccination series. On 9/22/03, the subject received the first dose of Engerix B (lot 53882 - incorrect lot number). On 3/1/04, the subject received the second dose of Engerix B (lot 55282 - incorrect lot number). This is longer than the recommended interval of one month between the first and second doses of Engerix B. On unspecified date before 5/26/05, the subject also received injections of 7-valent pneumococcal conjugate vaccine and Haemophilus influenzae type B conjugate vaccine. On an unspecified date in 2005 on or before 5/26/05, the subject was diagnosed with autism. The outcome of the autism was not reported. Comment: Autism was assessed as medically serious (OMIC).
Vaccine was not reconstituted but administered as the concentrate. Patient experienced no side effects from the injection.
Symptoms started 02/01/2022 2PM 2PM-6PM -Slight pressure around chest area 6-8PM -Chills around the body, sensation around left chest area -Aspirin made it feel better  02/02/2022 Morning - left arm was slightly numb - slight blurry vision  Lunch through dinner - Small chills around the body - Slight headache around forehead - Back of my neck had some tightness - Slight numbness around thigh area  02/03/2022 - Feeling much better - Monitoring additional symptoms - Little sensation
Localized reaction with slight redness and warm to touch. Pt c/o soreness of arm and underarm. Pt reported reaction and RTC on 8/11/05 at 8:45AM. Pt advised to return to clinic if symptoms worsen.
Dizziness and ringing in ears, Blurred vision soon after getting injection and Fatigue and low temp next 3 days.
FEVER CHILLS, BODY ACHES (DEBILITATING), DIZZINESS, NAUSEA FOR 24 HRS. SWEATING AND CHILLS. UNABLE TO SLEEP BUT NO FEVER LAST NIGHT AND THIS AM. TOOK IBUPROFEN 600 EVERY 6 HRS.
1st dose on 2018, did not receive 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 18th Apr 2022 Reporter's Comments: The pharmacist stated that the patient received first dose of the Shingrix series in 2018, but they did not receive second dose. The patient had now came in to pharmacy requesting second dose. The first dose was administered at a different location so the reporter did not have the exact date, lot number, or expiration date information. At the time of reporting, the second dose had not administered. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066312:Same Reporter
Patient was given a dose of expired ActHIB. Dose expired 10/7/23 and was administered 10/09/23
Pt got a local reaction to shots including spreading erythema & tenderness & warmness around the injection site.
Pateint returned 30 mimnutes after vaccine c/o itchy and dry throat, patient was  administered EPI-Pen
Health Technician, administered Kinrix to patient who is 9 months old. Kinrix is labelled for those patients 4-6 years old. Patient's mother contacted. No harm caused.
Pt is a 25 year old male who was transferred on 4/18/03 from medical center with a diagnosis of Guillain-Barre Syndrome. The A/I service was consulted due to recent Anthrax and Smallpox vaccinations. The pt developed symptoms of leg weakness during a run on Monday 4/14/03. On 4/15/03 pt had bilateral feet and hand weakness, he presented for his scheduled smallpox vaccination. He states he made the screening physician aware of his symptoms and they were attributed to "exhaustion" from running on the previous day. He received his smallpox vaccine in his left deltoid. On 4/16 he awoke with worsened weakness in hands and legs and was then taken to the ER and labs were done, there doctor made the diagnosis of GBS. The pt received two doses of IVIG while there. He was given 400mg/kg each dose of Venoglobulin S lot GL02015. No complications or side effects with the infusions. He was transferred and admitted on 4/18/03 for further evaluation and treatment. He completed a full five day course of IVIG receiving a total of 2gm/kg over 5 days with no worsening of his symptoms. He was discharged on 5/28/03 with a return appt on 6/3/03. Assessment: GBS temporally associated with anthrax vaccine #2; one day before smallpox vaccine.
Last night felt like someone punched her in the arm and there was a small rash. Warm/hard/swollen.
During evening and night of vaccination, experienced loss of appetite.  Woke up with nausea, had 1 episode of a cold sweat, and diarrhea.  Went back to bed, got up at noon, nausea had subsided, was able to rehydrate and eat mild foods.  Appetite not entirely back to normal at the end of the day, digestive system seems still a bit affected but I am generally feeling better.
Flushed skin on face, neck, chest. White lesions on tongue. Itching mouth and tongue. Tongue and lip swelling.
Bulging fontanelle (soft spot) was gone and high pitch screams, crying every time I lay infant down. Needed to be sitting upright at all times.
Severe rash spread all over body. Controle by clinic visit and steroid shots. Rash and swelling made it to mouth, tongue and throat which ended up putting me in hospital due to breathing problems.
Symptoms - ? EE reports pain at injection immediately after injection.  EE reports ?nickel size? knot on her arm almost immediately after, worsening to 2x2 size this morning (1/8).  1/7 morning:  body aches, chills, feelings of unwell.  Unsure of fever as she has been rotating Tylenol and motrin.  EE reports she saw RN at campus this morning for inspection of injection site.     Home remedies? -   ice pack to injection site and rotating Tylenol (last dose 20:30 1/7) and motrin (last dose 23:00 1/8)  Any improvement? ? mild improvement  Recommendation? EE encouraged to continue to ice injection site and to rotate Tylenol and motrin.  EE encouraged to continue to monitor symptoms and to call vaccine support with further questions and/or concerns.  EE denied history of COVID-19 exposure without proper PPE and denied recent travel.  EE educated to manange per Illness in the Workplace Policy.  EE encouraged to fill out V-safe.  EE verbalized back understanding and denied further questions at this time.
unable to breathe, bed ridden with bouts of unconsciousness and severe chronic fatigue for over two weeks along with heart pains and heart palpitations. The inability to breathe and bouts of unconsciousness have subsided with chronic fatigue and heart palpitations still present. I haven't sought medical treatment because I have no insurance and I can't afford it.
Woke up to pain in my middle spine at 5am.  Every time I moved I got a shooting pain up my spine.  Went back to sleep for 3 hours and it was gone.
24 hrs after receiving vaccine, the patient developed Bell's Palsy affecting the right side of her face.
Restless sleep the first night. Fever 102. and fatigue the following day. Sore arm on right and left. Swelling at sight of injection for the influenza shot.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-OCT-2017, the patient was vaccinated with a dose of GARDASIL 9 (strength and route were unknown) (lot# M040412 and expiration date 30-JUN-2019). On 13-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.