chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath was reported as worsened/Sweating was reported as worsened; shortness of breath; sweating; Tiredness; pulse starts beating very fast at night; This is a spontaneous report from a contactable consumer (patient, self-reported). This 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL8982 and expiry date: on an unknown date in Jun2021), via an unspecified route of administration, in left arm, on 27Jan2021, as a single dose for COVID-19 immunization. Patient's medical history included plugged vessels/veins and high cholesterol. Concomitant medications were not included. On 03Feb2021, the patient experienced shortness of breath, sweating and tiredness. On an unknown date in Feb2021, the patient's pulse starts beating very fast at night. On 09Feb2021, the experienced shortness of breath was reported as worsened, and sweating was reported as worsened. Also, the patient was sweating at night, but even today at work, she was even sweating during the day. On 17Feb2021, the patient was scheduled for the second shot. Outcome of the event dyspnea and hyperhidrosis were not recovered. Outcome of the event fatigue was recovering. Other events heart rate increased and condition aggravated were unknown.
ACUTE RESPIRATORY FAILURE 12/20/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION ACUTE RESPIRATORY FAILURE 12/20/2022 HOSPICE CARE
Classic symptoms of Bell's Palsy- noticed first in my eyes on 2/27 and then also in my mouth on 2/28. I was started on valtrex 500 mg TID and a steroid dose pack for 5 days.  I am not in pain but full functionality of my eye and mouth have not returned yet as of 3/8/21
Patient was given Pneumovax (PPSV23) instead of Prevnar 13.
Silver dollar size swelling. Baseball size redness. No fever; no drainage. Treated with cool compress and Motrin.
Arm pain from site of injection up to jaw line and down to wrist. Has lasted from a few hours after injection and continues today ? over 3 days
Within 12 hours of the vaccination my blood vessels on my left upper arm turned color from blue to red. It was very strange looking. I took photographs and sent one to Dr. a few weeks later. After the shot I felt ill and very tired for more than 3 days, so I stayed home and slept a lot.
A 7-year-old never received Dtap fifth dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 7-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (on an unknown date patient received 1st dose), Pentacel (on an unknown date patient received 1st dose of Pentacel), Pediarix (on an unknown date patient 2nd dose) and Pentacel (on an unknown date patient received 2nd dose).   On an unknown date, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix 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 Information: GSK receipt date: 17-FEB-2023 Reporter's comment: The nurse had a patient who had never received Dtap fifth dose. The patient schedule was Pediarix, Pentacel, Pediarix and finally Pentacel. The reporter consent to follow up by email. Additional supportive information: Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination. Note: Interchange of vaccine product was not considered as event because both Pediarix and Pentacel had different antigen. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday). As patient was 7 years at the time of reporting, thus patient had exceeded age recommendation to receive all 3 doses of PEDIARIX.
received first dose 4/8/2015 at 15 months, received second dose 7/16/2015 at 18 months; no adverse effects reported; This spontaneous report was received from a nurse regarding a child patient. Information pn the patient's pertinent medical history, other concurrent conditions, drug reaction or allergy and concomitant therapy were not provided. On 08-APR-2015, (when the patient was15 months old), the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, frequency, route of administration were not provided) with therapy type of HSA, lot # K022448 and expiry date 13-MAY-2016 for prophylaxis and on 16-JUL-2015, (when the patient was18 months old), the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, frequency, route of administration were not provided) with therapy type of HSA, lot # L002421 and expiry date 23-JUL-2016 for prophylaxis (inappropriate schedule of product administration). No adverse effect reported.
Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash; Little rash on their lower right arm; It is itching so bad/ they started itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash), VACCINATION SITE PRURITUS (It is itching so bad/ they started itching at the injection site) and VACCINATION SITE RASH (Little rash on their lower right arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 088D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (It is itching so bad/ they started itching at the injection site). On 23-Sep-2021, the patient experienced RASH (Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash) and VACCINATION SITE RASH (Little rash on their lower right arm). At the time of the report, RASH (Broke up in a very bad rash/ the next day they had a little rash on their lower right arm,now it is all over their body,is in their legs,right arm is really bad and in the left one it is only a little rash), VACCINATION SITE PRURITUS (It is itching so bad/ they started itching at the injection site) and VACCINATION SITE RASH (Little rash on their lower right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
After my second vaccine, I experienced a racing heart rate that continued for approximately 8 hours. My heart was pounding and beating extremely fast.  The following morning my heart rate returned to normal but I am concerned that I may experience problems with my heart later.
Patient presented to a different pharmacy than the one she was given the vaccination at. The pharmacist there said the patient complained of swelling on the right side of face that would come and go for the last several days. The pharmacist did not believe it was associated with the vaccine but could not be sure. Patient was instructed to follow-up with primary care physician the following day.
Feeling nauseous; Arm was very tender; feeling very achy; Muscles started to hurt; felt very weak; Vomited up; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: Feeling nauseous), pain in arm (Verbatim: Arm was very tender), pain (Verbatim: feeling very achy), muscle pain (Verbatim: Muscles started to hurt), weakness (Verbatim: felt very weak) and vomiting (Verbatim: Vomited up). The outcome of the nausea, pain in arm, pain, muscle pain, weakness and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the nausea, pain in arm, pain, muscle pain, weakness and vomiting to be related to Shingrix.     It was unknown if the company considered the nausea, pain in arm, pain, muscle pain, weakness and vomiting to be related to Shingrix.   Additional Information: GSK Receipt date: 13-Mar-2023 The second day after patient got the Shingrix shot he/she started feeling nauseous and his/her arm was very tender. Later on, the same day when he/she was at work he/she started feeling very achy. The patient's muscles started to hurt, and he/she felt very weak. The next day he/she tried to eat breakfast and vomited up all of his/her food. The patient feeling all of these symptoms.
Body aches; very sick; sweating; loss of appetite; vomiting; headache; high fever at 103.2F; light chills/ Severe Chill; soreness but nothing much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness but nothing much), ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite) and VOMITING (vomiting) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (soreness but nothing much) and CHILLS (light chills/ Severe Chill). On 28-Jan-2021, the patient experienced ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), HEADACHE (headache) and PYREXIA (high fever at 103.2F). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (soreness but nothing much), ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), HEADACHE (headache), PYREXIA (high fever at 103.2F) and CHILLS (light chills/ Severe Chill) had not resolved and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.2 (High) 103.2F.         No concomitant drug reported. Action taken with mRNA-1273 in response to the events were Not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Follow up received on 02-mar-2021 contains second dose information, new event updated. On 29-Apr-2021: Follow up received on 29-apr-2021 contains no new information.
Early symptoms began as sore throat and body aches on Friday evening; took Tylenol for aches; had difficulty sleeping d/t post-nasal drainage; was bed-ridden Saturday and taking measures to reduce flu symptoms; began producing phlegm Sat. evening; color of phlegm produced today, Monday, is of light-green color; symptoms are subsiding.
Itchiness all over her body; Has not been feeling good; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2022, the patient received the 2nd dose of Shingrix. On 12th April 2022, less than a day after receiving Shingrix, the patient experienced generalized pruritus and feeling bad. On an unknown date, the outcome of the generalized pruritus and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus and feeling bad to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: The patient had her second dose of Shingrix and since that time she had not been feeling good and had experienced itchiness all over her body. The reporter consented to follow up.
Booster; mild-to moderate right arm pain at the injection site; This is a spontaneous report from a contactable consumer (patient) via pfizer colleague. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: FHBO29 and expiry date was not reported) via unspecified route of administration into the arm right, at the age of 55-year-old, on 21Nov2021 13:21 as dose 3 (booster), single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, and then dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced mild-to moderate right arm pain at the injection site on 21Nov2021 13:21. The outcome of the event was recovered on 22Nov2021 10:00.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of children. The patients were vaccinated with a dose of improperly stored VAQTA (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt received immunization in office, after 40-45 minutes, was at home called with chills, "shaking like a leaf".
Information has been received from a physician concerning an 83 year old female who "within the last six months," in approximately 2007, was vaccinated with a dose of Zostavax. Subsequently the patient developed shingles. It was also reported that the patient was deceased from causes unrelated to the experience with Zostervax. Additional information has been requested.  3/22/07 Received Death Certificate which reveals COD as sepsis, right lower lobe pneumonia with contributing conditions of COPD & s/p right mastectomy for breast cancer.  6/8/07 Received medical records from PCP which included hospital records from 2/20-2/23/07 hospitalization after patient experienced SOB, nonproductive cough, chest pain, fever & chills, decreased appetitem malaise & weakness w/multiple falls while home.  Family brought to ER & dx w/pneumonia.  Admitted to ICU due to episode of hypotension & started on IV antibiotics.  Respiratory status declined, developed respiratory acidosis & was intubated.  Consult w/pulmonology & cardiology.  Renal function then declined.  Consult w/nephrology.  Continued to decline, developed atrial fibrillation & arrested.  Resuscitation efforts were unsuccessful & patient was pronounced. FINAL DX: Sepsis due to RLL pneumonia; respiratory failure due to sepsis & RLL pneumonia. PCP office visit of 11/15/06 notes that patient had recently received Zosavax & now had faint eruption of shingles.  Tx w/Valtrex at that time.  2/2/07 office visit notes post herpes polyneuropathy tx w/cymbalta & lyrica.
Patient was administered vaccine that had temperature excursion  (was in freezer for 7 days instead of refrigerator). No symptoms were  experienced by patient
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed the event as not related to Moderna vaccine and as not reasonably possible with Rinvoq.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
mom states pt exp chest pain/tightness/SOB 1-2 hrs p/vax given; MD's suggested Advil, which alleviated pain; No ER visit, no fever according to mom; MD's notified by mom by phone;
Developed progressive abdominal pain over 10 days following vaccination. On evaluation in the emergency room he was found to have new non-occlusive thrombosis of the distal superior mesenteric vein, with occlusive thrombosis of the main and left portal veins. Mild thrombocytopenia also present. No other predisposing factors or hypercoagulability identified to this point.
3.5 days after my first dose, I had the first and only seizure I?ve ever had. I don?t recall much, but my boyfriend says he heard me ?yelling? from our bedroom, he ran in to find me yelling, shaking, and contorting my face. This lasted for 2-3 minutes and then I stopped. When I finally came to, I did not recognize my newborn child and was confused/disoriented. I don?t actually remember anything until 30 or so minutes later when my boyfriend was getting me and our son ready to go to the hospital. I went to Hospital to get checked out and all labs were normal. They released me and told me to follow up with my primary and the neurologist. I followed up within a few days with my primary doctor who referred me to a sleep study and MRI (haven?t done either yet). My appointment with the neurologist is in September.
I am feeling very ill; This is a spontaneous report from a Pfizer-sponsored program received from a contactable Consumer reporting for herself.  A 77 year old female patient  received the first dose of  bnt162b2 (BNT162B2) , via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunisation .  Medical history included ongoing osteoarthritis, and ongoing autoimmune disorder(have 3 autoimmune diseases and just went through chemotherapy).  Concomitant medication included propranolol hydrochloride (INDERAL), gabapentin (NEURONTIN), aciclovir (CYCLOVIR), vitamin C (ASCORBIC ACID), vitamin D  (VITAMIN D NOS) , danazol (DANAZOL), hydrocortisone (HYDROCORTISONE), ibuprofen (IBUPROFEN), levothyroxine sodium (SYNTHROID), prednisone (PREDNISONE) , vitamin A  (VITAMIN A RETINOL).  The patient was feeling very ill  in Jan2021 with outcome of unknown.    The patient is wondering if her regular medication  will interfere with the effectiveness of vaccine and if the reported event is  because of vaccine or her other conditions.  Information about lot/batch number has been requested.
pt recv vax & exp exhausting fatigue, n, lack of concentration,mind can't handle >1 thing @ a time;spacy feeling, memory loss, felt very weak, leg & arms felt too heavy to move-standing felt could not hold body;dx CFIDS & depression;
This spontaneous report was received from the Vaccine Coordinator referring to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 16-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
pt recvd vax 22OCT92 & exp sweating, chills, & a queasy feeling; No further details were provided;
immediate swelling at the injection,  Size of lump got to about 1.5 inch.  Lump  size reduce and soften after 30 minutes.
pt recv vax 21APR94 & 28APR94 pt devel a fever of 101, which may have been as high as 102; 30APR94 exp a grand mal sz & presented to ER; CT scan of head was nl;
Localized rash on arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Localized rash on arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Localized rash on arm at the injection site). At the time of the report, VACCINATION SITE RASH (Localized rash on arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
TIGHTNESS IN LEGS; NUMBNESS IN LEGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to follow-up to request batch/lot numbers. No concomitant medications were reported.  On 06-APR-2021, the subject experienced tightness in legs. On 06-APR-2021, the subject experienced numbness in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tightness in legs, and numbness in legs. This report was non-serious.
Swelling (L) arm "size of her hand. LDT; tender to touch BENADRYL and ice.
Patient says she can't lift her arm more than shoulder height, today is first time she has reported this adverse event since immunization was given on 10-31-18, included is soreness and inability to sleep on left side.