chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEE ER Summary 6-1-07 (SEE D/C Summary from ICU Low grade fever 1 1/2 days. 2-3 episodes of generalized seizure, witnessed by doctor in office 6-1-07. Parents reported tonic-clonic movement and eyes rolling back. Sent to ER by doctor on 6-1-07.  6/22/07 Hospital D/C summary accompanied VAERS report & reveals patient experienced seizure activity x 1 day.  Admitted 6/1-6/3/07.  Had fever x 2 days s/p vax then on 6/1 noted to have 3 episodes of eyes rolling back, neck stiffening & legs extending & flexing each lasting approx 10 secs.  Taken to PCP office & sent to ER for w/u.  Started on antibiotics & admitted to PICU.  Neuro consult done.  D/C to home w/neuro & PCP f/u. FINAL DX: seizures, likely secondary to DTaP; mild hyponatremia, resolved w/IVF hydration; metabolic acidosis, likely secondary to seizures.
This spontaneous report as received from a licensed nurse practitioner refers to a 61 year old female patient with hypothyroidism. On 28-OCT-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously over her deltoid, lot # K020801, expiration date 31-JAN-2016 (dose was not reported). Concomitant therapies included hypothyroidism medication (unspecified). Nurse reported that within 24 hours of administration, the patient developed pain in her thigh. On 30-OCT-2015, the patient developed a rash at an unspecified location. It was reported that the patient sought medical attention by visiting her physician in the office on 31-OCT-2015 and was diagnosed with shingles. The patient was prescribed TYLENOL W to treat the pain and VALTREX to treat the rash. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered from pain in the thigh and shingles. The reporting nurse considered the events pain in the thigh and shingles as disabling as the patient missed work for couple of days. This is one of two report received from the same source. Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cardiac disorder NOS (Heart patient). 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 29-May-2022 at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Weight decreased: decreased Decreased. No concomitant medications were reported. It was reported patient lost weight during COVID. Patient tested positive for COVID-19 after finishing the course with Paxlovid. Dosage text for Paxlovid was reported as in the morning took two tablets, in the evening took two tablets because of patient's health and it was prescribed due to patient's age and being heart patient. Patient knew that the home test for COVID-19 have two bright red lines if they are positive. The lower line was faded on patient's test. That might make a difference patient was unsure. Patient was not felt bad or sick after taking Moderna vaccines. Number of Paxlovid was reported as Unknown. Company comment: This spontaneous case concerns a 77-year-old female gender patient, with no relevant medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after the 3rd dose of mRNA-1273 vaccine. Patient was prescribed with Paxlovid for 5 days as treatment regimen. Three days after completion of treatment, patient was tested positive for COVID. Clinical course and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement. Sender's Comments: This spontaneous case concerns a 77-year-old female gender patient, with no relevant medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after the 3rd dose of mRNA-1273 vaccine. Patient was prescribed with Paxlovid for 5 days as treatment regimen. Three days after completion of treatment, patient was tested positive for COVID. Clinical course and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.
Ischemic stroke with no known risk factors in healthy, active 75 yr. old woman.
Excessive drooling and belching, green skin color and vinegar based smell, excessive alcohol intake, nihilism.
Vaccine administration error- patient was given an entire vial of Pfizer covid 19 vaccine that was not reconstituted. Patient reports that she had a really sore and stiff arm the day after the shot, but by the next day it felt better.
first dose of the Shingrix vaccine two years ago; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago from the day of reporting).   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 details were provided as follows: The case was reported by patient's wife. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter was inquiring if the patient should restart the series.  Provided medical advice disclaimer. Spoke from product information and content, was referred to Healthcare professional. No additional details were provided by the reporter. The reporter consented to follow up. The reporter provided permission to contact Healthcare professional.
Patient was given Prevnar 20 that had some kind of bubble accumulation or floaters in the prefilled syringe; Patient was given Prevnar 20 that had some kind of bubble accumulation or floaters in the prefilled syringe; This is a spontaneous report received from a contactable reporter (Nurse) from the Medical Information Team.  A patient (no qualifiers provided) received pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), LIQUID PRODUCT PHYSICAL ISSUE (non-serious) and all described as "Patient was given Prevnar 20 that had some kind of bubble accumulation or floaters in the prefilled syringe."  Additional information: Caller is seeking guidance because 2 patients were given doses of the Prevnar 20 that had some kind of bubble accumulation or floaters in the prefilled syringe. Caller also asked what to do with the box they have, since some of it has bubble accumulation or floaters as well.  The information on the batch/lot number for pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300170337 same product, same event, different patient;
7 hours after the vaccine was administered, I developed a fever of 103.2 and had chills all night. I slept from 9pm-11am ( which is unusual for me).  I got out of bed to check my temperature and get a glass of water. My temp was 101.6. I went over to the sink to get a glass of water and I woke up on the floor.  Still light headed and sore.
Normal injection site pain for 1st 2wks then started to move to shoulder then base of neck. Now only have sore shoulder on left side. I exercise and becomes very painful in different positions.
felt pain in her kidney on the right side; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program (002191). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2022 11:30 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, her 2nd dose of Pfizer Covid 19 vaccine on 18Jun2021), administration date: 18Jun2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, States she had her 1st dose of Pfizer Covid 19 vaccine on 28May2021), administration date: 28May2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: RENAL PAIN (non-serious) with onset 02Mar2022 12:30, outcome "not recovered", described as "felt pain in her kidney on the right side".  Additional Information: She was very concerned because she had never had problems with her kidneys or pain in that area, she described that the pain was constant and not sharp and she was worried that her kidney function could be affected. Stated that she is worried about kidney function and wanted to get better. Stated that if there is anything that they can help her with then do so.   The lot number for bnt162b2 was not provided and will be requested during follow up.
On 9/11/2023,  4 days after receiving the vaccine, I noticed a red tender swollen area about the size of a bandaid on my right upper arm below injection site which continued to enlarge to the size of an index card. I sought medical treatment on 09/13/2023,  day 6 post vaccine,  at Urgent Care and was seen by NP. She was unsure if cellulitis or adverse allergice reaction. Prescribed cephalexin and methylpredisone.  I had an extremely painful right upper arm, more pain than any previous vaccines. I returned to the same pharmacy and showed the inflamed area to the pharmacist who adminstered the vaccine. She indicated that she would report the lot and serial number to the manufacturer.
This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L044917, expiration date 05-OCT-2018, lot # reported as L044878, expiration date 17-JAN-2018, lot # L016959, expiration date 12-MAR-2018 and lot # L006231 expiration date 06-OCT-2016 (given before expiration date) (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperatures and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Additional information has been requested.
headache that would not go away, like her head would explode; pressure behind her eyes; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ685), intramuscular in her right arm on 06Jan2021 at a single dose for covid-19 immunisation. Medical history and concomitant medications were reported as none. On 06Jan2021, the patient experienced headache that would not go away, like her head would explode and pressure behind her eyes. Stated that both events started 30 minutes after the shot on 06Jan2021.Therapeutic measures were taken as a result of headache that would not go away, like her head would explode and pressure behind her eyes which included ibuprofen 800 and switched it out with TYLENOL. Outcome of the events headache that would not go away, like her head would explode and pressure behind her eyes was recovered on 09Jan2021.
24 hours of fever, left arm pain, achy all over, ears ringing, slight headache, sluggish
After receiving vaccination, individual developed pain/numbness in right arm.  Denied any SOB, difficulty breathing, swallowing.  Over the course of the day and days following,  site became swollen, red, warm to touch.  Individual noted a knot at injection site and also complained of nausea.
RIB CAGE PAIN FRONT AND BACK; DIFFICULTY BREATHING; FEVER; CHILLS; HEADACHE; ACHEY; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included broken ribs, and concurrent conditions included migraines.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and  expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 13:30 for prophylactic vaccination on left arm . No concomitant medications were reported. On 21-MAR-2021 22:30, the subject experienced achey. On 22-MAR-2021, the subject experienced rib cage pain front and back. On 22-MAR-2021, the subject experienced difficulty breathing. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.2 F, 99.5 F. Treatment medications included: acetylsalicylic acid/caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from achey, fever, and chills, and the outcome of rib cage pain front and back, difficulty breathing and headache was not reported. This report was non-serious.
Approximately 15 minutes after receiving the PNEUMOVAX 23 injection, the patient reported feeling tingling of the tongue and across her cheekbones. She said she was starting to feel panicked. I sat with her to assess the situation and she quickly calmed down, although her symptoms persisted. She felt the need to clear her throat but said she did not feel any tightness, swelling, trouble swallowing, or trouble breathing. She had a drink of water. Her tongue did not appear swollen, her color was good, no rash or hives were present, she was speaking calmly and normally, and she reported that her symptoms were gradually improving although a headache developed. It did not seem appropriate to administer epinephrine or diphenhydramine at this point. After about 45 minutes of monitoring she had improved and went home with instructions to take diphenhydramine and call 911 if she experienced any worsening of symptoms. I followed up with her the next morning (7/8/17 at approximately 11am) and she said that after going home, she did take the diphenhydramine because she still felt a little "funny" and went to sleep. Upon wakening her symptoms had fully resolved and she had no remaining concerns.
CHILLS; FEVER; HEADACHE; FATIGUE; MUSCLE ACHINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-OCT-2021, the patient experienced chills. On 30-OCT-2021, the patient experienced fever. On 30-OCT-2021, the patient experienced headache. On 30-OCT-2021, the patient experienced fatigue. On 30-OCT-2021, the patient experienced muscle achiness. Laboratory data included: Body temperature (NR: not provided) 100.4-100.6 F. On 01-NOV-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, headache, and muscle achiness, and had not recovered from fatigue. This report was non-serious.
When pt was given MMR & VAR pt started crying.  When pt was given HEP A. pt started crying and gasping for air.  Pt also sweating.
APPROXIMATELY TEN MINUTES AFTER THE IMMUNIZATION PATIENT STATES THAT SHE HAS SCRATCHY THROAR AND NOSE DRIP
vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and PYREXIA (fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VOMITING (vomiting) and PYREXIA (fever). On 12-Mar-2021, VOMITING (vomiting) and PYREXIA (fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
pt recv vax 25MAY95 & 28MAY95 pt exp leg pain & back aches; On 31MAY95 pt exp sl sore throat & cough 1JUN95; pt devel a mild case of the chicken pox including a fever of 102 & a rash; 5JUN95 pt recovered; pt devel pityriasis rosea rash;
Hospitalization due to COVID-19 Reporting per Pfizer COVID-19 Vaccine EUA
FEVER, HEADACHE MALAISE, FATIGUE, VISUAL DISTURBANCE RIGHT>LEFT FROM OPTIC NERVE SWELLING, TACHYCARDIA, ORTHOSTATIC HYPOTENSION. Thought to be Aseptic meningitis but pt declined LP.
Exhaustion/Tiredness; headache; Excruciating jaw pain; This is a spontaneous report from a contactable consumer (patient's mother) based on information received by Pfizer from Moderna (manufacturer control number MOD21-097310). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient's mother reported that her son received both doses, and experienced exhaustion, tiredness, headache and specifically excruciating jaw pain after the second dose for 4 days. The events did not require hospitalization. The clinical outcomes of exhaustion/tiredness, headache and excruciating jaw pain were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a nursing assistant and refers to 2 patients of unspecified age and gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with ROTATEQ (dose, lot# and expiration date were not reported; route of administration defaulted to oral) that was stored improperly. No symptoms were reported. Additional information has been requested.
Dizzy and weak - "Feels flimsy" Everything Spinning. Still with symptoms 3 mo after vaccine.
The day after vaccines patient had a 103 F fever, dysuria, and "has not been right since" per mom. Patient has felt sensitive all over her body and has been irritable.
03/18/2021 Vaccination; 03/21/2021 Started to notice the HA recurring, increased in severity, increased in length. Everything about them was just worse. This went on for weeks, months. They didn't resolve. I went to a physician, she gave me this 'rescue' medication but my insurance wouldn't pay for it. It took them from a 7-8 to a 2-3/10. Insurance wouldn't approve without approval from neurologist. Six months wait for appt. She did a neurological exam, medical history. Called in the medication to insurance, insurance still wasn't approving. Meanwhile I was given more samples. Recently I got denied because of the quantity ordered and has to be reordered. I made another appt with neurologist, telehealth. Two days before I had worst HA that thought I was going to have to call 911. Felt like my head was going to split, brought me to my knees, it was gone in a snap. It was so bad to so good, I mentioned to neurologist; 'Thunder Clap HA's'. She put me on emergency imaging for Contrast CT Scan & MRI; neg. Still having the 'Thunder Clap HAs'; neurologist thinks what I have had since COVID. Propranolol medication; COVID 10/2020; 'bad case'.
Vision went suddenly blurry; Moderate headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 09:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications included paracetamol (TYLENOL), colecalciferol (VITAMIN D3), curcuma longa rhizome (TURMERIC), unspecified multi-vit and probiotic; all taken for unknown indications from an unknown date and unknown if ongoing. 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. On 15Apr2021 at 22:00, approximately 14 hours after receiving the first vaccine, the patient's vision went suddenly blurry for about 20 minutes. On 15Apr2021, the patient also had a moderate headache that developed about 1-2 hours prior to her vision going blurry. She had never experienced blurry vision before, so this was definitely not ordinary for her. The patient's vision returned to normal, and the following morning, her headache had subsided. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events moderate headache was resolved on 16Apr2021 and the event vision went suddenly blurry was resolved on 15Apr2021 at 22:20.  No follow-up attempts are needed. No further information is expected.