chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exhaustion w sleeplessness, intense muscle pain over entire body, labored breathing, difficulty moving, loss of appetite, achiness, painful joints, muscle cramps.
Syncopal episode a few minutes after the vaccine. No injury. Reported history of fainting after vaccines.
Had an allergic reaction to H1N1 shot - The following morning the reaction was a severe headache and slight fever. By the afternoon I had hives on the inside portion of both ankles. I started taking BENADRYL and that has helped with the symptoms.
Information has been received from a 67 year old female with no known allergies or drug reactions, a history of cancer in 1990 and no history of chicken pox as a child who on 07-FEB-2007 was vaccinated with Zostavax. Concomitant therapy included simvastatin (manufacturer unknown) and levothyroxine Na (SYNTHROID). On 11-FEB-2007, the patient experienced shingles with blisters on her head and neck, pain and a severe headache. On approximately 10-APR-2007, the patient recovered from shingles, pain and severe headache. No lab testing was performed. Additional information has been requested.
Covid arm, started with a small spot and now is my whole upper arm. Have been using ice. this morning anti itch lotion.
Breakthrough case admission after 3 vaccines Janssen 3/4/21 Lot# 1805018;  MOderna 10/30/21 LOt# 017F21A;  Pfizer 6/6/22 lot# FM7553
About 1 week later I devoloped a dry cough; Felt sick everyday; Patient received initial dose of J&J vaccines and booster dose of BNT162b2; The patient received third\booster dose of BNT162b2; This is a spontaneous report from a contactable reporter(consumer). The reporter is the patient.   A 59-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 at 09:00 (Lot number: FF8841) at the age of 59 years as dose 2 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing). Vaccination history included: Covid-19 vaccine J&J (DOSE NUMBER UNKNOWN, SINGLE Lot number: UNKNOWN Route of administration: Unspecified), administration date: an unknown date in 2021, for COVID-19 immunisation, reaction(s): "Cough" and Covid-19 vaccine J&J (DOSE NUMBER UNKNOWN, SINGLE Lot number: UNKNOWN Route of administration: Unspecified), administration date: an unknown date in 2021, for COVID-19 immunisation, reaction(s): "Sore throat". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 04Nov2021 at 09:00, outcome "unknown", described as "Patient received initial dose of J&J vaccines and booster dose of BNT162b2"; IMMUNISATION (non-serious) with onset 04Nov2021 at 09:00, outcome "unknown", described as "The patient received third\booster dose of BNT162b2"; COUGH (non-serious) with onset 11Nov2021 at 13:00, outcome "recovered" (an unknown date in 2021), described as "About 1 week later I devoloped a dry cough"; MALAISE (non-serious) with onset 11Nov2021 at 13:00, outcome "recovered" (an unknown date in 2021), described as "felt sick everyday". Therapeutic measures were taken as a result of cough and malaise.  Additional Information: Concomitant medications included high blood pressure medicine (unspecified medicine). Therapeutic measures were taken as a result of cough and malaise which included treatment with Omeprazole and the patient got relived from cough. The patient had a J and J shot about 6 months before. The patient coughed about every minute for 6 weeks straight and had a sore throat. Took Omeprazole for Acid Reflux to finally get rid of cough. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
No adverse effect reported; patient were each administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse referring to two unspecified patients of unknown ages and unknown genders. Information of concurrent condition, medical history and concomitant therapy were not provided.    On 24-OCT-2018, patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot#R017635 with expiration date 20-JUN-2020 (strength, dose and route were not reported) for prophylaxis and sterile diluent (STERILE DILUENT). The varicella virus vaccine live (oka/merck)(VARIVAX) vaccines experienced temperature excursion and were stored at 6 to 14 Fahrenheit degrees (9.1 Fahrenheit degrees ) for 50 minutes (Product storage error). There was no previous temperature excursion. No adverse events were reported in any patients. A data logger was involved. The outcome of the event was not reported.  Follow-up information was received from the reporting nurse on 05-JUN-2019.  The nurse reported the patient's demographics and were updated in the case.  It was also reported that on 24-OCT-2018, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (strength, dose, frequency, route of administration, anatomical site of injection, lot # and expiration date were not reported), for prophylaxis.  There was no information regarding storage of this vaccine.  This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA002233: US-009507513-1810USA011328:
NEUROPATHY 9/8/2021 PANCREATIC MASS  ACUTE PULMONARY EMBOLISM 1/9/2022 PANCREATIC MASS  NEUROPATHY 9/8/2021 BOWEL OBSTRUCTION  ACUTE PULMONARY EMBOLISM 1/9/2022 BOWEL OBSTRUCTION  NEUROPATHY 9/8/2021 ADENOCARCINOMA, BODY OF PANCREAS  ACUTE PULMONARY EMBOLISM 1/9/2022 ADENOCARCINOMA, BODY OF PANCREAS
Information has been received from a nurse practitioner concerning an 12 month old male, with seasonal allergies and no pertinent medical history, who on 8/26/04 at 18:45 was vaccinated SC in his right thigh with a first dose of varicella virus vaccine live (lot # 648049/1348N). Concomitant vaccination the same day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine and HIB conjugate vaccine given in the other leg. There was no illness at the time of vaccination. Other concomitant medication included cetirizine hydrochloride. Within 5 minutes of vaccination the injection site on his leg was slightly red and warm. Unspecified medical attention was sought and the patient was treated with diphenhydramine hydrochloride. There was no product quality complaint involved. Follow up information from the nurse practitioner indicated that on 8/26/04 at 19:45 the patient developed approximately 3cm of redness and edema at the injection site of the varicella virus vaccine live. No relevant diagnostic test were done. The patient recovered on 8/27/04.
MILD BUT PERSISTENT HEADACHE; LOW-GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced mild but persistent headache, and low-grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild but persistent headache, and low-grade fever. This report was non-serious.
Fever 99 or above; Muscle pain; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: el3249, expiry: unknown), via an unspecified route of administration on the left arm on 18Jan2021 06:00 at a single dose for COVID-19 immunization at a hospital. Medical history included hyper thyroid, type 1 diabetic and fatty liver. The patient has no known allergies. Concomitant medications included insulin glargine (LANTUS) and insulin lispro (HUMALOG). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: ej1685, expiry: unknown) on 30Dec2020 at 16:30 in the left arm for COVID-19 immunization.  The patient experienced fever 99 or above and muscle pain on 18Jan2021 19:00. The events were not treated. The patient was not tested for Covid post vaccination. The outcome of the events was recovered on an unspecified date.
On 12-04-2021, a 16-year-old young man was administered the Janssen vaccine, which is indicated for 18 years or older. The next day the patient presented symptoms of fatigue, fever and headache but today April 15, 202 the young man's mother indicates that he feels better.
Im injection placed in shoulder not deltoid.  National guard administering  improper technique and administration.  He stuck me 2 times in my shoulder too high up.  I have pain and very limited range of motion.  I am unable to lift my arm 20%.  So much pain and limited movement I sought care at ER.
pt got lightheaded and passed out. pt informed us he had not eaten all day so we are not sure if the lightheadness is from that or the vaccine
Fever 101.1; headache; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.1), HEADACHE (headache) and FATIGUE (feeling tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PYREXIA (Fever 101.1), HEADACHE (headache) and FATIGUE (feeling tired). At the time of the report, PYREXIA (Fever 101.1), HEADACHE (headache) and FATIGUE (feeling tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medication reported.   Reporter did not allow further contact
loses sense of smell again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NOVOLIN 70/30 (ongoing); PRESERVISION AREDS 2 (ongoing). Vaccination history included: comirnaty (DOSE 1; Lot number: EN6198 in the left upper arm), administration date: 20Feb2021, when the patient was 83-year-old, for COVID-19 immunisation, reaction(s): "affected my sense of smell"; comirnaty (DOSE 2; Lot number: ER2613; in left arm), administration date: 31Mar2021, when the patient was 83-year-old, for COVID-19 immunisation, reaction(s): "affected my sense of smell"; bnt162b2 (DOSE3 lot EW0181; time mid-morning in his left upper arm), administration date: 19Oct2021, when the patient was 84-year-old, for COVID-19 immunisation, reaction(s): "affected my sense of smell". The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "loses sense of smell again". Additional information: The patient received Pfizer's COVID-19 vaccine for each of the injections made available to the American public. The first injection, and each of the following, thereafter affected sense of smell. The patient states that if this continues, he will never smell again. This is frustrating for him as most foods have no flavor except for the taste on his tongue. The pleasure of eating a good meal is lost. Every vaccine he has received, he has a loss of smell and gets a little better and gets next dose or booster vaccine and loses sense of smell again. Just got latest Pfizer Covid vaccine and it happened again. He cannot identify any smells and can tell difference between some foods but not what they are; it makes a big difference on what he enjoys. The first time noticed the loss of smell was after the first two initial vaccinations he got a month apart. He remembers it was after the 2nd dose is when he realized what was going on. It has stayed about the same, it got a little better and when he got the next booster shot it went back. That happens each time he gets booster shot. He doesn't know how to explain improvement, he can tell a little difference between fruit or maple syrup but not the flavors for example. If he has a hot cup coffee in front of him, he can't smell it. But it tastes different, something there but doesn't know what it is. they only mentioned to primary care doctor and see him end of this month and will mention again. States when they see doctor on 29th this month and will talk to him about this again. Going to ask once again for recommendation or referral to ENT. Prior Vaccinations (within 4 weeks): no.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384657 same patient, same product/event, different doses;US-PFIZER INC-202300367705 same patient, same product/event, different doses;
we have a 17 year old patient who received her first and second dose of GARDASIL 9; This spontaneous report has been received from a physician referring to a 17 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On an unspecified date in 2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (strength, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. Then, on an unspecified date in 2016, the patient received the second dose. It was reported that the third dose will be administered on an unknown date (inappropriate schedule of product administration).
The pain ran through the injection arm (L) Ibuprofen 400mg. By 02/12/2010 at approximately 4 AM the pain had radiated to my shoulders, back, jaw and right arm and I felt warm. I called Dr, and was directed to take 4 (200mg) of Ibuprofen and Benadryl. I only took the 800 mg of ibuprofen and went to bed.
I experienced a breakthrough case of COVID-19 with a low grade fever for 3 days and coughing. I also have thrush which causes me to have a horrible taste in my mouth and I have been treated for it but it has not improved at all.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was an employee. This case has been linked to the case US2018GSK048935 and US2018GSK053450 reported by the same reporter.
Patient said he experience many side effects, especially vomiting, fever, severe body aches and pains.
tested positive for covid19; tested positive for covid19; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received vaccine 1st dose on 21Dec2020 and on 29Dec2020 she tested positive for covid19. She is coming up on 2nd dose on Friday (will be out of quarantine on the same day), she asked if she should get the vaccine. Her primary care physician advised her not to receive, within 30 days because there had been reports of people having reactions (ie: high fevers) to the vaccine. If she has a high fever she can't go to school. She asked if waiting 90 days make the vaccine not as effective and if she need to restart the series. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Test positive for covid19 found 7 day following the vaccination, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag
C/O lightheadedness and dizziness.  Skin moist and clammy.  Client stated he had similar reaction to dose #1 and dose #2 of COVID-19 (Pfizer) vaccines.  Medics on site evaluated client.  Client has hx of anxiety and stated he didn't take his medication for this condition today.  Client evaluated and released by medics.O2 Sat 100% on room air, B/P 130/90 and Pulse 57.
Less than 24 hours after receiving injection patient experienced burning sensation and pain in all joints of body (including jaw, toes, ankles, knees, shoulders, hips, spine, sternum, etc).  Patient also has experienced epigastric burning pain and nausea.  Multiple trips, receiving toradol and decadron injections, has not relieved pain.
This spontaneous report as received from a registered nurse refers unspecified number of patients of unknown gender and age. On an unspecified date in February 2014 until 13-MAY-2014, the patients were vaccinated with doses of VARIVAX (doses, route and lot # not reported) that were improperly stored. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
The patient should have received Moderna (6 mos - 5 yrs) presentation.  No known adverse reaction at this time.
On Wednesday August 15th at 11:00 my son went in for his five year round of immunizations. Please see attached documentation of shots received. On Thursday he began showing symptoms of what appeared to be a cold. On Friday he woke up with hives all over his body. We administered Benadryl and hives went away but cold symptoms remained. Saturday again he appeared to have a cold  and then broke out in hives again.  We once again administered Benadryl and the hives went away. On Sunday we had the same experience he appeared to have a minor cold but midmorning he broke out in hives. We administered Benadryl. Monday everything was normal. On Monday I noticed he had hives at one of the areas where he was given the shots. I would like it documented that my son had an adverse reaction to the immunizations he received. Please call me if you have any further questions.
vomiting; sore ears; overnight chills; nose burning; difficulty getting out of bed; difficulty eating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning) and HYPOKINESIA (difficulty getting out of bed) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning), HYPOKINESIA (difficulty getting out of bed) and EATING DISORDER (difficulty eating). At the time of the report, VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning), HYPOKINESIA (difficulty getting out of bed) and EATING DISORDER (difficulty eating) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021 and contains NNI.
Situation: Patient at Covid vaccination clinic, received first dose of Moderna. Background: NKA Assessment: Patient felt faint. She was transferred on a gurney in supine position from the vaccination room to an exam room for further evaluation and observation by  NP and clinic staff. The patient is diaphoretic. Cold, wet cloth to forehead applied. Lung sounds are clear throughout. She is in no breathing distress. Vital signs at 0956 am: 106/66, HR 59, 99% O2 Sat on RA.  Vital signs at 1006 am: 119/76, HR 62, 99% O2 Sat on RA. Cold water given to patient. The patient states she feels back to her normal self. The patient is sitting up on the side of the gurney. This RN informed NP about findings and obtained approval to release the patient.  Recommendation: Patient was discharged from clinic.
Miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), the second dose on 08Apr2021 at 07:30 (Lot Number: ER8729) and the first dose on 16Mar2021 at 07:30 (Lot Number: EN6207), both via an unspecified route of administration, administered in the left arm, as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included sertraline (manufacturer unknown); vitamin d3 (manufacturer unknown) and folic acid, iron (PRENATAL) all taken for an unspecified indication, start and stop date were not reported. The patient had a miscarriage on 20Apr2021 at 04:30. The patient did not receive any treatment for the event. The event resulted in a visit to the doctor or health care professional office/clinic visit and hospitalization on an unspecified date. The outcome of the event was recovering. The patient had a nasal swab Covid test on 23Apr2021 with a result of negative.  No follow-up attempts are needed. No further information is expected.
It was a delayed reaction in the shot area. It began around 6 days after the shot as a large red spot by the shot area, painful to the touch,  stiff muscles in the big red spot. In addition to chills, headaches. The size is: 3- inches wide, 2-1/2 inches length. Pain level of 7 in scale of 10 in the red spot are, medicated with Tylenol, ice bag placed in the area. Still ongoing, pain level 4 now.
Mom took infant to local ER due to excessive crying : given Tylenol in ER. Calmed down and discharged.
Received DTaP, Hep A, IPV, MMR on 02/25/2005. Started running fever, vomiting, and rash 03/07/2005 Strawberry tongue 03/09.
No additional AE/no PQC; ROTATEQ  was administered after temperature excursion; This spontaneous report was received from medical assistant and refers to a patient of a not reported age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, first dose, lot #1968393, expiration date: 24-MAY-2024, administered orally for prophylaxis (strength was not provided) following a temperature excursion of 8.9 degree Celsius (C) for 12 hours 20 minutes o seconds and 9.4 C for 8 hours 20 minutes and 0 seconds, it was stated that no previous temperature excursion occurred. No additional adverse event was reported.
Localized redness 12 x 12 cm. No warmth/tenderness/hives/SOB. Dx: localized reaction to shot.