chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient arrives with a chief complaint of chest tightness.  Patient states that he was breaking up cement at his house and he developed chest tightness and upper and lower lip fullness that he does not quite describe with swelling of his lips.  He says they just feel full.  Patient does take lisinopril and his last dose was last night.  Patient denies any environmental allergies.  Patient has no rash.  Patient only allergic to Levaquin and Bactrim.  Patient denies shortness of breath.  Patient says he does not have chest pain but he describes a band of chest tightness when asked to rate this tightness on a scale of 1-10 he gets at a 4.  Patient denies cough.  Patient has had some hot flashes. Patient denies previous history of MI, cardiac stent, or bypass Patient has past surgical history of tonsillectomy right full knee replacement a partial left knee replacement and a cervical fusion Patient has past medical history of hypertension and dyslipidemia he denies diabetes Patient is a none smoker that occasionally drinks alcohol Associated Symptoms: chest pain
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 13th February 2019 20:30, the patient received the 2nd dose of SHINGRIX. In February 2019, several hours after receiving SHINGRIX, the patient experienced shivering, tremor and fever. On an unknown date, the outcome of the shivering, tremor and fever were not recovered/not resolved. It was unknown if the reporter considered the shivering, tremor and fever to be related to SHINGRIX. Additional details were provided as follows: In the morning of 14th February 2019, the patient had shivering, shaking and low grade fever. The reporter did not consent to follow-up.
nausea; headache; dizziness; tired; developed very itchy skin all over; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is calling in for a family member who got their 1st Covid dose, and they had some side effects such as nausea, headache, dizziness and very tired. He stated their side effects didn't happen until later that night after getting the dose. Then after 4 days of getting the 1st dose the person developed very itchy skin all over, but it was worse on their hands. He wants to know how to best approach the 2nd dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
All over body itching, hives, swelling of eyes and mouth started overnight after receiving the vaccine.
High fever; pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 4-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2022 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 4 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 23Sep2022 at 10:00, outcome "not recovered", described as "High fever"; PAIN (non-serious) with onset 23Sep2022 at 10:00, outcome "not recovered", described as "pains". The events "high fever" and "pains" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain.  Addition information: Other vaccine in four weeks was none. Covid prior vaccination was yes and Covid tested post vaccination was none. Known allergy was none. Other medical history was none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a consumer and a school nurse concerning 41 child pt's who in approx. 1995 were each vaccinated with a dose of varicella virus vaccine live. In approx. 2003 the pt's developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parent's of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 pt's were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated pt's was a 7 y/o pt who on 29Sep1998 was vaccinated with a dose of varicella virus vaccine live. On 03Feb2003, the pt developed chickenpox.  The previously vaccinated pt's included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
p/vax pt rt hip was swollen, red & hot to touch;no lump or knot noted;
his legs were like rubber, he couldn't walk, couldn't get to the bathroom; his legs were like rubber, he couldn't walk, couldn't get to the bathroom; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown; Expiry date, NDC number: unknown), via an unspecified route of administration at an unknown anatomical Location on an unspecified date in Jan2021 (reported as, Dec2020 or early Jan2021) (age at vaccination was 87 years) as dose 2, single for COVID-19 immunisation. Medical history included cholesterol and blood pressure; both were on an unknown date and ongoing. The patient had COVID and was in the hospital on an unspecified date. Concomitant medication were not reported. Historical vaccine includes the first dose of BNT162B2 (LOT: Unknown; NDC: Unknown; Expiry Date: Unknown) on an unspecified date (age at vaccination was 87 years) for COVID-19 immunisation. No other vaccines was administered on same date or 4 weeks prior of the Pfizer suspect vaccine. No adverse event prior vaccination. The patient states when he got the second shot, which was back in Dec2020 or early Jan2021. The patient had a reaction then and it lasted 12 hours and his legs were like rubber, he couldn't walk, couldn't get to the bathroom, it was an experience experienced on an unspecified date in Jan2021. No adverse events require a visit to emergency room and physician office. No investigation assessment reported. Outcome of the events was resolved on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Immunization (PROQUAD) given in (L) arm. At injection site mom states there is a welt in the middle with smaller red welts around site. Arm swollen, red, slightly painful to touch initially.
no adverse event; A patient got 1 dose of Moderna Bivalent BUD of 01Dec2022. Administered today (14Dec2022).; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (A patient got 1 dose of Moderna Bivalent BUD of 01Dec2022. Administered today (14Dec2022).) in a 75-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient got 1 dose of Moderna Bivalent BUD of 01Dec2022. Administered today (14Dec2022).). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (A patient got 1 dose of Moderna Bivalent BUD of 01Dec2022. Administered today (14Dec2022).) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A patient got 1 dose of Moderna Bivalent BUD of 01Dec2022. Administered today (14Dec2022).).    No concomitant medicine were reported. No treatment medicine were reported.
Pt recvd 3 doses of Engerix-B 5JAN90, 9FEB90 & 13JUL90 & AUG91 titers tested & it was discovered that the pt did not convert antibody;
Patient presented to Hospital with acute onset of muscle and lower extremity weakness 25 days after receiving vaccine. Patient diagnosed with Guillain-Barre Syndrome due to acute onset and recent vaccination. Questionable if other virus related, described as "suspicious" due to recent flu vaccination.
This is a 48-year-old. She had been in her usual health until 01/13/2004. On 01/12/04 she received her 5th anthrax vaccination. Within 24 hours she noticed that her left arm (vaccination arm) was red, swollen and painful. She presented for evaluation and was told that this was to be expected. As the day progressed her swelling increased to include the area from her shoulder to her elbow.   During the night of 01/14/04, she was awakened with chest pain (5-6/10), severe shortness of breath and the sensation that her heart was racing. She called and decided that since patient would be there in a few hours to evaluate the smallpox takes of her shipmates that they would stay with her and not take her to the Emergency Department. She was seen on 03/15/04 with complaints of chest pain and large local reaction. She reportedly evaluated her and completed a VAERs Was not seen in ED or any other medical facility for her complaints.  The VHC was notified of the client's problems and asked if she could be seen for evaluation of adverse event to anthrax.
Awakened by serious chest pains. Rolling over and sitting up did not help.   I took an 81 mg aspirin, sat in a rocking chair by the wood stove and the pains went away ten minutes later.
Patient had bruise and "knot" at injection site with FLUZONE QUAD MDV injection.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
On day of vaccination, 9/18/08; immediately post vaccination with varivax to the right arm-deltoid area ; developed redness/ "splotchy: hive like reaction localized to varivax injection site.Patient noted today that 1-2 days later (9/19 - 9/20/08), increased swelling- per mother "like giant hive" and developed hives on that right arm and on back. Seen today 9/22/08 and symptoms have resolved other than localized reaction still around sit of varivax injection. Per mother, much better today than past two days.
This spontaneous report was received from a healthcare worker professional refers to an unspecified number of patients of unknown age and gender. Since 20-FEB-2015, the patients were vaccinated with ZOSTAVAX which was improperly stored and administered (dose, route of administration and lot # were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure.  Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events.  It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
feeling sick; sore arm; a lot of headaches; dull ringing in the ear; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), PAIN IN EXTREMITY (sore arm), HEADACHE (a lot of headaches) and TINNITUS (dull ringing in the ear) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced MALAISE (feeling sick), PAIN IN EXTREMITY (sore arm), HEADACHE (a lot of headaches) and TINNITUS (dull ringing in the ear). At the time of the report, MALAISE (feeling sick), PAIN IN EXTREMITY (sore arm), HEADACHE (a lot of headaches) and TINNITUS (dull ringing in the ear) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
1.~reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; 2.~FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.   This case is linked to cases 2023SA057733 (CLUSTER) and 2023SA057309 (CLUSTER).   This case involves child patient of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.   Action taken: Not applicable.   Outcome:  Unknown for both the reported events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
room spinning dizzines lastin four days, left ear hearing loss still present.  taking Prednisone.
With in an hour of the vaccine, she had redness on the arm. It look like she was washing dishes. Her arm and hand were redder the right arm. No discomfort, no itchiness.  It went away.
The pt complained of hives over 80 percent of body which appeared approximately 10 hours post vax. The pt used Benadryl cream and symptoms subsided. The next day the hives returned. The pt saw an MD and was diagnosed as a drug allergy. The MD prescribed Benadryl and Claritin. The pt was called and his only complaint then was edema of the lips and hands.
Experienced mild angioedema with lips swelling mildly. Gave Benedryl 25 MG PO, subsided and discharged in stable condition.
4 pts recvd a series of 3 Hep B vax DEC89-JUL90 from same lot # & failed to attain protective antibody titers(non-response)
Seizures; I was having trouble focusing; my eyes had trouble focusing; Big headache; Depersonalization; My legs lost function and I could hardly walk; My legs lost function and I could hardly walk; The rest of my body felt weak but kept doing involuntary movements (like hand opening and closing); I struggled to think or talk, and it felt like my body was forgetting how to work; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0171), via an unspecified route of administration, administered in the left arm on 25Apr2021 (at the age of 23-years-old) as dose 1, single for COVID-19 immunization at other. Medical history included depression, anxiety, lactose intolerance, temporal lobe seizure, migraines, post-traumatic stress disorder (ptsd); all from an unknown date and unknown if ongoing. Patient had known allergy to Lithium. Concomitant medications within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC), pyridoxine hydrochloride (B6 supplement), cannabidiol (CBD OIL); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, patient has been tested negative for COVID-19. On 09May2021, after receiving the first dose of the vaccine, the patient experienced trouble focusing and developed a big headache, eyes had trouble focusing, and patient was experiencing severe depersonalization. The patient legs lost function and could hardly walk, and the rest of her body felt weak but kept doing involuntary movements (like hand opening and closing). Patient struggled to think or talk, and it felt like her body was forgetting how to work. The patient was brought to an Emergency Room (ER). Since then, patient had seizures. The events resulted in to Emergency room/department or urgent care (ER visit) and Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test (covid test, Nasal Swab) post vaccination which resulted negative on 06Jul2021 and MRI with unknown results on an unspecified date in 2021. The patient received treatment for events with IV fluids, Benadryl, Reglan, Heart monitor and MRI (Magnetic resonance imaging). The outcome of the events was not recovered at the time of report.
Headache & SkinRash Narrative:  c/o chest tightness and itchiness on her upper extremity. noted rashes on right upper extremity, right ear and rt. eyelid.
sore arm (expected) chills (expected) swollen lymph nodes (glands) on left side just above collar bone..sore to touch. 2nd day after shot