chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Following vaccination, at the 15 min mark, patient started experiencing tightening around throat and tingling around lips. Benadryl 25mg PO given w/ water. Pt monitored and taken to observation area where she needed further treatment. (refer to PE)  PE:  1400- pt started 30 min motoring post vaccination.  1415- pt expressed tightening around throat and tingling. respirations unlabored, no stridor heard. no rash observed. Benadryl 25mg PO given.  1420- Pt became tearful and expressed feeling SOB in addition to symptoms. no angioedema or other symptoms observed. patient moved to monitor room where vitals were taken. 98%, 94HR, 192/115. CTAB  1423- pt distressed, 94%. unable to verbalize and making chocking sign. EPI PEN immediately administered 0.3mg IM in left vastus lateralis. Lung sounds diminished bilaterally. vitals taken.  >>>(*EPI PEN Given in prefilled syringe IM ONCE. LOT 0GM071, Expiration OCT 21)  1424- 203/125, 105HR, 97%. pt sitting upright, tearful but now able to verbalize.  1425- pt sighed in relief, able to take a deep breath, stating "ok. It passed." Lungs CTAB. 98%, 91HR, 16RR.  1430-pt sitting calmly in chair. Breathing unlabored. Denies SOB. No distress at this time. 108/101, 14RR, 98%  1432-98%, 95HR. Patient able to tolerate clear PO fluids. NO n/v or abd pain.  1436-99%, 77HR, 159/85, RR 15-16. CTAB.  1440-unlabored respirations. CTAB. patient sitting comfortable in chair. no distress.  1443- 97%, 70 HR.  1450- Regular heart rate on auscultation.  1454-12RR, 98%, 102 HR, 164/83  1512-164/82, 97.4F, 91HR, 97%, 20RR. No distress.  1527-20RR, 175/83, 98%, 91HR, 96.4F. No distress.  1542-22RR, 155/81, 98%, 82, 96.9F. No distress.  1600- pt ambulates to restroom independently without any SOB, weakness or dizziness.  1615- Pt sitting comfortably in chair. 99%, 88HR, 148/85, 96.9F, 18RR. No distress.  1650-Pt denies blurred vision, HA, dizziness, weakness, chest pain, palpitations, SOB, tightening to throat, swelling, n/v or pruritis. no rash present. pt in no distress. 157/87, 96.7F, 99%, 88HR, 15RR.  1700-Pt no distress. pt d/c to family member.
Developed erythematous papular lesions on hands, chest, back, feet and palms on day 15 after smallpox vax. Seen at a hospital day 17. Erythema multiforme not as of this writing.
pt recv vax & devel nausea,resp diff,dizziness & numbness;the pt was taken to ER for tx;
TEMPERATURE EXCURSION. vaccine was stored in the freezer longer than manufacture recommendations. Patient did not have any adverse reaction to the covid vaccine.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-334628, MOD-2021-334583 (Patient Link).
I was double vaccinated and got covid 4 and a half months later; I was double vaccinated and got covid 4 and a half months later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I was double vaccinated and got covid 4 and a half months later". Clinical information: Patient stated getting vaccinated was better than getting COVID. But he (patient) was double vaccinated and got COVID 4 and a half months later.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This 17-month-old male subject was enrolled in a study. The subject received the 1st dose of Flu Q-QIV vs FLUZONE QUADRIVALENT (intramuscular) on 24th October 2014. On 27th February 2015, 126 days after receiving Flu Q-QIV vs FLUZONE QUADRIVALENT, the subject developed severe - grade 3 dehydration. Serious criteria included hospitalization. The outcome of dehydration was recovered/resolved on 28th February 2015. The investigator considered that there was a reasonable possibility that the dehydration may have been caused by Flu Q-QIV vs FLUZONE QUADRIVALENT. Investigator comments: Dehydration. Hospital Admission 2/27/15. Discharged 2/28/15.
headache; vomiting; chills; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had COVID vaccine at Pfizer site - 5 hours later had headache, vomiting and chills. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The caller stated she got the first vaccine on 15Feb2021 and tested positive for Covid on 20Feb2021; This is a spontaneous report from a contactable consumer (patient) reported for herself via a medical information team. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via unspecified route of administration on 15Feb2021 at single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, patient had COVID-19. On 20Feb2021 patient tested positive for COVID-19 and now symptom free. She was scheduled for her second dose on 08Mar2021. She asked, if she has no symptoms but gets another test and tests positive can she still get the vaccine? The outcome of the event was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Caller is nurse reporting administration of expired PNEUMOVAX 23.; Caller is nurse reporting administration of expired PNEUMOVAX 23.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's drug reactions or allergies, concomitant therapies, medical history, and concurrent conditions were not provided.   On 16-MAY-2022, patient received an expired dose (Expired product administered) of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) syringe, piston (FMF) (dose, frequency, route of administration, formulation, strength, vaccination scheme, and anatomical site of vaccination were not reported, lot number T032003, which has been verified to be valid, expiration date reported and validated as 08-MAY-2022), as prophylaxis. The vaccine product had not presented temperature excursions. No additional adverse events were reported.
This spontaneous report as received from physician refers to a currently 20 years old female patient. No medical history, concurrent condition and concomitant medications were reported. On 13-DEC-1995, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (strength, dosing details, anatomical location were unknown). Subsequently, she received her second and third doses of hepatitis b vaccine (recombinant)(manufacturer unknown) on 12-JAN-1996 and 16-JUL-1996 respectively. On 16-JAN-1997 (also reported as on 16-JAN-1992), the patient was vaccinated with VARIVAX. On 17-APR-1997 and 21-JAN-2000, she received first and second doses of MMR. The patient received four doses of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxo(DTP) and poliovirus vaccine inactivated (unspecified)(DPV/IPV) on 16-FEB-1996, 18-APR-1996, 04-JUN-1996 and 24-JUN-1996 and 07-APR-1997. The patient received four doses of Hib conj vaccine (unspecified carrier)(HIB) on 16-FEB-1996, 18-APR-1996, 04-JUN-1996 and 07-APR-1997. On 04-JUN-1996, the patient received measles virus vaccine live (unspecified) vaccine. On an unknown date the patient experienced lack of seroconversion and the patient was transferred into the reporting physician's office. The outcome of lack of seroconversion was not known. Causality assessment was not provided. Additional information has been requested.
Hospitalization: 3/17/2023 - 3/20/2023 (3 days) Presentation to the ED: acute hypoxic respiratory failure from acute asthma exacerbation COVID + date: 3/18/2023 Treatment: high dose steroids Discharge to: HOME.  013L20A 2/3/2021 039K20A 3/1/2021 038A22A 6/9/2022
Patient complained of skin to be tender to touch and fevers some site reaction (pain, red, warmth).
Information has been received from a nurse referring to a patient of unknown age and gender. On 26-MAY-2015, the patient was administered with improperly stored dose of M-M-R II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Due date 30.04.2022  Delivery was on an earlier date wight 3.190kg Syndactyly all fingers in right hand.  Smaller hand and thinner forearm
Shortly after vaccine 2 vaccinations the patient experienced syncope and fainted. She lost consciousness but regained it within a few minutes. I layed her flat on her back and raised her legs as my technician stayed by her head and hold her hands. 911 was called as patient has a history of seizures. An EMT took her BP and HR which were w/in normal limits. Pt refused transportation but did sit with us for 30 minutes to ensure she did not return.
Her friends mom had a stroke and had the vaccine; This is a spontaneous report from a contactable consumer. A female patient (reporter friend's mother) received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown) at single dose for COVID-19 immunisation on unknown date in 2021. Relevant history and concomitant drug was unknown.  The patient had a stroke on unknown date in 2021. Outcome of the event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Person was fine at time of administration. About an hour and half later, she started complaining of slight chills and severe stomach pain that was radiating inside in the center of the abdomen, after having a bowel movement. She had yogurt and granola earlier in the day. She also had trouble walking and sitting and was crying in pain. Thinking it was a heartburn, she had some 7-up, but paramedics were eventually called to the scene. She was having pain episodes for about 30 minutes total until the paramedics arrived, and that's when she felt a lot better. Paramedics captured her vitals; they thought it may have been food poisoning. Person denied going to hospital; will contact MD about the situation. Person was fine in the end.
Joint pain and inflammation. Headache; hot and cold flashes; restlessness; tiredness.
In July 2000 the patient experienced blisters "on the forehead and tummy". Medical attention was sought. No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cardiomyopathy" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: mushrooms" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 07Nov2023 to 12Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384671  Same reporter/ patient; different drug/event;
C/O left 3rd 4th 5th finger tingling sensation 20min later he received MMR vaccine to the left upper arm. Rt arm skin: no swelling, no redness at the MMR SQ injection site. Denied burning sensation to the  left upper extremity. ROM is intact.
severe h/a, neck pain, meningitis;hosp x 3 days;fever 102.6, sweating & chills;
Patient states on 9/23/2021 patient felt weak, dizzy saw stars and slumped to the floor, did not pass out, severe sweating, L arm swollen, red with a hive like reaction around the injection site.  Very weak, went to bed did not start to feel better until 9/26/2021.
Patient got dizzy, passed out and vomited, urinated while unconscious. Will follow-up with doctor.
Information has been received from a health professional concerning an 18 year old female who on an unspecified date was vaccinated with a first dose of HPV. The patient was due to her second dose of HPV, and she developed a urinary tract infection. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested.
This spontaneous report as received from a physician via Pfizer refers to a male patient who is currently 65 year old (age at onset of event not reported). Patient's allergic condition included myalgia and impotence with ZOCOR, severe myalgia with flu vaccine (manufacturer unknown), thrombocytopenia with heparin, gemfibrozil intolerance, ZETIA intolerance, muscle cramping with LIPITOR, muscle cramping with CRESTOR, myalgia with pravastatin, anaphylaxis with plasma, myalgia with lovastatin and myalgia with TRILIPIX. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. Concomitant medications included LYRICA, warfarin, PLAVIX, aspirin, AVAPRO, TOPROL XL, NORVASC, bumetanide, KLOR-CON M10, NIASPAN ER, fish oil, GLUCOPHAGE, nitroglycerine, acetaminophen, NORCO, cholecalciferol, magnesium oxide, COENZYME Q10, multivitamin and VIAGRA. On an unknown date the patient reported that his muscle were swelled up and he could not move (disability). On an unknown date INR was 2.0-3.0. The outcome of events were unknown. Causality of events were unknown. Upon internal review, event he could not move was considered serious due to disability as seriousness criteria. This is one of the several reports from the same reporter. Additional information has been requested.
Starting feeling weird shortly after waking up.  My arm was so painful and swollen I would scream out involuntarily if it was touched at all. Started having headache, body/joint aches, fever (between 99.6 and 101.6), dizziness, fatigue, and disorientation until Thursday at around 4:30pm. Arm has red swollen ring about 2-3 inches in parameter around the injection site and is still painful, although other symptoms have subsided (as on 10:30pm).
Had covid symptoms fever headache, sore throat, fatigue malaias, prescribed paxlovid returned to work within 5 days and muscle aches
explosive diarrhea; This case was reported by a consumer via call center representative and described the occurrence of explosive diarrhea in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2019, the patient received the 1st dose of Shingrix. On 26th November 2019, 5 days after receiving Shingrix, the patient experienced explosive diarrhea. On an unknown date, the outcome of the explosive diarrhea was resolved with sequelae.   It was unknown if the reporter considered the explosive diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient reported that she experienced explosive diarrhea 5 days after receiving the vaccine. It had occurred several times since vaccination.  The patient did not experienced any other symptoms prior to the diarrhea like stomach pain or cramps. She mentioned several additional onset dates that she could remember but there were other times too when she experienced diarrhea. She experienced diarrhea on 4th, 5th, 25th, 26th, 27th and 28th January 2020. On 9th January 2020, the patient visited her doctor. The reporter consented to follow up
1st dose 2018, no 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th May 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 2018, no 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-APR-2023 The pharmacist informed that a patient had not received the 2nd dose yet. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Details pertains to 1st dose of Shingrix in product tab.
Nausea, chills,  fever.  It?s been a week but still feeling nauseated. It?s like having morning sickness. Always hungry but feeling nauseous.
Administered 3rd dose of Pfizer COVID vaccine to 12 year old (not yet approved for this age), no adverse effects reported by patent.
3 days of fever in a 2 year old girl. Friday 9/18/09 10 AM, 3 vaccines administered: MMR, PENTACEL, FLUMIST. Sat. 9/19/09 12 noon thru end of day, fever started. Varied from 100-102 degrees. Treatment liquid TYLENOL-not effective (discontinued immediately), liquid MOTRIN-every 6 hours approx. Sun. 9/20/09 all day, fever persisted 100-102 degrees. Administered liquid MOTRIN. Mon. 9/21/09 all day until late PM, fever subsided late PM. MOTRIN discontinued late PM. Fri. 9/25/09 4:45 AM-7:00 PM, vomiting every 20-30 minutes. No medication given.
Developed cellulitis of upper thigh on rt. leg from pneumococcal vaccine administered 8/3/07. Started with red, rashy, swelling that descended to lower extremity below knee. Monday 8/6/07 - went to physician and received 10 days of antibiotic - Cephalexin.
had her first dose on 1/2/2021 and has not received a 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 48-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B adult (received first dose on 2nd January 2021 with batch number 2573G and expiry date 28th May 2022).   On an unknown date, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received her 1st dose of Engerix B and did not received her 2nd dose yet which led to incomplete course of vaccination. The reporter consented to follow-up. No further details provided.
right arm has a lump on it; went to visit our healthcare provider and they took a MRI and said it seems to be an abscess; right arm is swollen; The right arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (right arm has a lump on it), ABSCESS (went to visit our healthcare provider and they took a MRI and said it seems to be an abscess), VACCINATION SITE SWELLING (right arm is swollen) and VACCINATION SITE PAIN (The right arm got sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (right arm has a lump on it), ABSCESS (went to visit our healthcare provider and they took a MRI and said it seems to be an abscess), VACCINATION SITE SWELLING (right arm is swollen) and VACCINATION SITE PAIN (The right arm got sore). At the time of the report, VACCINATION SITE MASS (right arm has a lump on it), ABSCESS (went to visit our healthcare provider and they took a MRI and said it seems to be an abscess), VACCINATION SITE SWELLING (right arm is swollen) and VACCINATION SITE PAIN (The right arm got sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Terminal lung disease; This case was reported by a consumer and described the occurrence of lung disease in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lung disease (serious criteria other: serious per reporter). On an unknown date, the outcome of the lung disease was unknown.   It was unknown if the reporter considered the lung disease to be related to Shingrix.     Additional Information: GSK receipt date: 13-DEC-2022 Reporter's comments: This report was submitted by Patient support programs via the online direct entry reporting system.  The patient self-reported this case. The patient stated that she had terminal lung disease. No additional information received and no information on other condition were provided. The reporter had consented to follow-up.
When I gave the Hep A vaccine, there was resistance so I withdrew the needle while only delivering half the dose.