chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient became light headed; the patient became lightheaded and was about to faint; This spontaneous report was received from a registered nurse via field representative refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, (reported as a couple of months ago) the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, units, frequency, route of administration, lot# and expiration date unknown) for prophylaxis. On the same day, the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) the patient was vaccinated with diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(ADACEL) (dose, units, frequency, route of administration, lot# and expiration date unknown) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (dose, units, frequency, route of administration, lot# and expiration date unknown). On an unknown date, the patient experienced lightheaded (dizziness) and was about to faint (presyncope). The outcome of dizziness and presyncope was reported as recovered. Causality assessment of the events was not reported.
allergic reaction to the vaccine; Chills; Shortness of Breath; Light Headedness; Numbness of the cheek; Pressure on the chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of Breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath) (seriousness criterion medically significant), DIZZINESS (Light Headedness), HYPOAESTHESIA (Numbness of the cheek) and CHEST DISCOMFORT (Pressure on the chest). On 04-Apr-2021, the patient experienced VACCINATION COMPLICATION (allergic reaction to the vaccine) and CHILLS (Chills). On 26-Mar-2021, DIZZINESS (Light Headedness) had resolved. At the time of the report, DYSPNOEA (Shortness of Breath), HYPOAESTHESIA (Numbness of the cheek), CHEST DISCOMFORT (Pressure on the chest), VACCINATION COMPLICATION (allergic reaction to the vaccine) and CHILLS (Chills) 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.   This case concerns a 69-year-old female with a serious unexpected event of dyspnea, chest discomfort, dizziness, hypoesthesia, vaccination complication and expected chills. Event onset the same day as mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 69-year-old female with a serious unexpected event of dyspnea, chest discomfort, dizziness, hypoesthesia, vaccination complication and expected chills. Event onset the same day as mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Administered Adult dose of Hep B vaccine to pediatric 11yr old. Pt was contacted following day, no adverse event noted to date.
Loss of appetite; Now experiencing digestive issues; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the past Monday midmorning (05Apr2021) at single dose for COVID-19 immunization. The patient's medical history included that part of her intestine removed two and a half years ago. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. It was reported that, the patient was currently (Apr2021) experiencing digestive issues and a loss of appetite. The patient asked whether digestive issues had been seen as side effects and that how long the side effects usually last, whether up to second dose. The patient further enquired if she could take her probiotics. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
rash is still very sore; Rash on chest/Rash under breast(s)/Very sore rash; Shingles blisters from center of chest under her right breast and around the back; hurting on right side of her breast front to back; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm was sore), BREAST PAIN (hurting on right side of her breast front to back), HERPES ZOSTER (Shingles blisters from center of chest under her right breast and around the back), RASH PAPULAR (rash is still very sore) and RASH (Rash on chest/Rash under breast(s)/Very sore rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm was sore). On 14-Mar-2021, the patient experienced BREAST PAIN (hurting on right side of her breast front to back). On 16-Mar-2021, the patient experienced HERPES ZOSTER (Shingles blisters from center of chest under her right breast and around the back). On an unknown date, the patient experienced RASH PAPULAR (rash is still very sore) and RASH (Rash on chest/Rash under breast(s)/Very sore rash). The patient was treated with GABAPENTIN at a dose of 1 dosage form; VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at a dose of 1 dosage form and PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 2 dosage form as necessary. On 13-Mar-2021, PAIN IN EXTREMITY (right arm was sore) had resolved. At the time of the report, BREAST PAIN (hurting on right side of her breast front to back), HERPES ZOSTER (Shingles blisters from center of chest under her right breast and around the back), RASH PAPULAR (rash is still very sore) and RASH (Rash on chest/Rash under breast(s)/Very sore rash) had not resolved. Not Provided          No concomitant product was reported.   Symptoms: Patient reported that she has shingles and shingles are dried but not resolved yet, she still has rash which is very sore.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received: Added event outcome, treatment medication.
Pt states arm has been painful since receiving flu shot. Presented to health center, painful, limited movement of Left arm. Physical Therapy and anti-inflammatory prescribed by provider.
Physician-Neurologist diagnosed GBS. Patient was not hospitalized with Guillain Barre Syndrome diagnosis, unknown if patient actually received influenza vaccination (seasonal or novel H1N1)-Neurologist did not know either. Initial report from program stated that "patient allegedly received H1N1 vaccine prior to diagnosis."
Patient received a Moderna vaccine for his 2nd shot instead of a Pfizer.  Patient had no type of adverse reaction and required no treatment of any kind.
Pt had active case of Herpes Zoster when he received the Zostavax vaccine.  It appears that the active case worsened following administration of the Zostavax vaccine.
Patient developed cellulitis of the arm and a nodule at injection site. Follow up on 04/08/09, 04/22/09, 04/30/09: All attempts to obtain follow up information regarding patient's recovery status failed.
COVID-19; COVID-19; vaccine dose number=4: Moderna; vaccine dose number=3: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 26Mar2021 as dose 2, single (Lot number: EP7434), in right arm and on 11Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Sep2022 as dose 4 (booster), single (Lot number: AS 7153M), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022, outcome "unknown", described as "vaccine dose number=4: Moderna; vaccine dose number=3: Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jan2023) Positive; (27Jan2023) Positive; (29Jan2023) Negative; (30Jan2023) Negative; (04Feb2023) Positive; (05Feb2023) Positive; (06Feb2023) Positive; (07Feb2023) Positive; (08Feb2023) Positive; (09Feb2023) Positive; (10Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Paxlovid Rebound. Patient tested positive for COVID 20Jan2023. Took Paxlovid 21Jan2023-25Jan2023. Tested positive thru 27Jan2023. Tested negative 29Jan2023 & 30Jan2023. Tested positive again 04Feb2023-10Feb2023.
Slightly hot and itchy rash on collarbone area; Slightly hot and itchy rash on collarbone area; A spontaneous report was received from a patient on 28DEC2022. It described a 46-year-old female patient who developed a "slightly hot and itchy rash on collarbone area" (PT: Rash pruritic, PT: Feeling hot) following administration of oral Vivotif (Typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that on 26DEC2022 at noon, the patient took the first dose of Vivotif following which, she developed a slightly hot and itchy rash on the collarbone area which she did not notice until the evening of that day. Reportedly, the rash persisted into day two of the dosing schedule and she did not take her second dose of Vivotif. Furthermore, it was reported that the rash slightly improved since stopping the medication, but not to much extent. Additionally, the patient had not received any treatment for the reported events and had not conducted any lab work/tests. The patient was recovering from the reported events, at the time of this report.  Action taken with Vivotif with respect to the reported events was drug withdrawn.  The patient's medical history included thyroid problems and a shoulder injury in the past for which she received a cortisone shot on 15DEC2022. The patient had no allergies.  Concomitant medications included 1 tablet of levothyroxine (75 mcg; daily by mouth), 1 tablet of vitamin C (ascorbic acid; 1000 mg; daily by mouth), 1 capsule of vitamin D (ergocalciferol; 2500 units; daily by mouth), 1 tablet of vitamin B12 (cyanocobalamin; 1000 mcg; daily by mouth), turmeric (Curcuma longa; 400 mg capsule, 2-3 times a day for a few weeks) and Oregano oil capsule (Origanum minutiflorum oil; 230 mg once or twice a day).  No additional information was reported.  Company comment: A consumer developed a slightly hot and itchy rash on collarbone area (rash pruritic and feeling hot) following administration of oral Vivotif. In response to the events, the Vivotif was discontinued. Considering the case information and the positive dechallenge, the causality of the events rash pruritic and feeling hot is assessed as probable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A consumer developed a slightly hot and itchy rash on collarbone area (rash pruritic and feeling hot) following administration of oral Vivotif. In response to the events, the Vivotif was discontinued. Considering the case information and the positive dechallenge, the causality of the events rash pruritic and feeling hot is assessed as probable with Vivotif. The case is considered non-serious as per medical assessment.
tested positive for COVID-19; tested positive for COVID-19; patient already has missed the second dose on schedule; This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 29Dec2020 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient tested positive for COVID-19 on unspecified date. The patient already has missed the second dose on schedule. Outcome of the events was unknown.   Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Bruise, pain, swelling started evening of injection. Three days later, unable to move her arm. Situation resolved.
This spontaneous report was received from a pharmacy technician referring to a 62 year old female patient. On 09-AUG-2017 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot number and expiration date were unspecified) for prophylaxis. In August 2017, the patient experienced injection site discolouration, injection site irritation and injection site swelling. The outcome of injection site discolouration, injection site swelling and injection site irritation was reported as not recovered/not resolved.
Initial complaint:  At 1640 the patient reported feeling lightheaded, having a lump in her throat and chest heaviness.  1645  BP 132/84  Pulse 86  Lung sounds clear.  No wheezing, chest less heavy.  Feels shaky 1650  BP 132/96  Lung sounds clear 1700  BP 12/82  Pulse 72  Feels "on a boat".  Some vertigo.  Noticeable swaying while seated.  Left arm tingling.  No change in throat lump.   1708  Vaccination site inspection.  No noticeable erythema, swelling or tenderness.  No further tingling in arm. 1711  Mild improvement in throat lump, drinking cold water.  Not flushed or diaphoretic 1719  BP 118/76  Pulse  68  PERRLA-Brisk, round, reactive, equal size.  Reports that she can not focus, "out f it" 1724  Boat feeling/vertigo subsiding.  Still feels "out of it".   Reports improvement in throat. 1729  BP 122/88  Seated.  Initial increase in dizziness/vertigo.  Sustained slight increase in symptoms.  Chest heaviness no longer present.  Neck stiffness (no pain/resistance turning) 1736  New onset headache above temples.  Pain/stiffness equal on both sides.  Pain is dull 2/10.  "Just there" 1745  BP  122/78  Pulse 62 irregular.  Seated, conversing, smiles.  Fogginess and neck stiffness continues.  Is aware of irregular heart rate.  Calling for a ride. 1848  Pulse 82 more regular.  Still no improvement.  Sister picked up and will take her to Hospital for evaluation.  Telephone call placed to notify them.  4/13 call placed for follow up.  left with no return call.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient received ZOSTAVAX (lot #, expiration date and dose were unknown) intramuscularly rather then subcutaneously. No adverse effects were reported. Additional information has been requested.
No adverse event; patient was administered a Moderna Bivalent vaccine that was 2 days past expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Bivalent vaccine that was 2 days past expiration.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2023, 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 15-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Bivalent vaccine that was 2 days past expiration.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Bivalent vaccine that was 2 days past expiration.) and NO ADVERSE EVENT (No adverse event) 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 (patient was administered a Moderna Bivalent vaccine that was 2 days past expiration.).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Vial was un-punctured and was in the freezer until the day it was administered. No prior temperature excursion occurred. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730842 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730842:Patient 2
Started to develop HA's started 9/5/04, chills, sweating. Vesicular rash started on head, face, neck, few scattered on chest, few on legs and upper arms on 9/6/04.
Severe itching, redness, rash, and swelling; 7 days after injection. Still continuing 48 hours afterward
I had uterine cramping within five minutes of administration; Then I missed my menstrual cycle for two months directly following administration.; I also developed a large painful ovarian cyst on my right ovary; This is a spontaneous report from a non-contactable consumer (Patient reported for herself).   A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EU10181), via unspecified route of administration, in left arm on 29Jun2021 (at the age of 32-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 29Jun2021 the patient had uterine cramping within five minutes of administration. Then patient missed menstrual cycle for two months directly following administration. Patient also developed a large painful ovarian cyst on right ovary. The patient receives ultrasound treatment and had a physician office visit. Outcome of all the reported events was recovering.  No follow-up attempts are possible. No further information is expected.
p/vax pt exp shaking chills; nausea & felt hot & cold the next 2 days; no tx given
At first my arm couldn?t move between my elbow and shoulder,then it started hurting so bad it felt broken.Burning,searing pain and paralysis all night and then the next day it hurt less when held still,but I couldn?t lift my arm at all from elbow up
Itching and rash that began two days after injection. By day five, the rash spread to arms, hands, legs, trunk, neck. Doctor prescribed prednisone 20mg twice daily for seven days.
This prospective pregnancy case was reported in a literature article and described the occurrence of neoplasm in a female subject who received Flu Seasonal QIV Dresden. On an unknown date, less than a year after receiving Flu Seasonal QIV Dresden, the subject developed neoplasm. Serious criteria included other: serious per author. Additional event(s) included vaccine exposure during pregnancy. The outcome of neoplasm was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was lost to follow up. The investigator considered that there was a reasonable possibility that the neoplasm may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This prospective pregnancy case was reported in a literature article and described the occurrence of neoplasia in a female aged above 10-years who was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided) during pregnancy. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after vaccine exposure during pregnancy, the patient developed neoplasia. This case has been considered serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between neoplasia and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.