chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Nurse. A 65-year-old female patient received first dose of PREVNAR 13, (Lot Number: X62324, Expiry date: 30Nov2020), intramuscularly at left deltoid on 19Apr2019 at 0.5 ml, single for immunization. Medical history included ongoing diabetes. Concomitant medication included metformin and AMARYL, both for diabetes. The patient also had other concomitant products for diabetes. The nurse was calling on behalf of a patient who received the vaccine and soon after developed cellulitis at the site of injection on 19Apr2019. Nurse stated that the MD thought it may have been administered subcutaneously. Nurse stated, "pneumococcal 13-val conj vac (dipht crm197 protein), cellulitis about a week after the administration, the patient came in with cellulitis at the site of injection. The provider after seeing the patient and completed an event report stating that the arm was sore after the injection and then it progressed over the last week. She said that she had pain immediately after the injection and it progressed and she was seen again on 26Apr2019 with increased pain and redness." Treatment taken in response to adverse events included the patient was prescribed KEFLEX 500 mg. The patient did not do any blood work. The patient's investigations was none. The outcome of cellulitis and redness at the site of injection was unknown, the outcome of arm was sore after the injection was not recovered. Sender's Comments: Based on the information currently available, it cannot be fully excluded that wrong technique in administration with PREVNAR 13 might have played a contributory role in triggering the occurrence of vaccination site cellulitis. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Severe nausea, fever, chills, body aches, severe stomach pain, and head ache. All going on 4 days now
More redness than a normal post-vaccination reaction; This spontaneous case was received on 21-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-04056) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.  On 19-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent;  dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number was 283847 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient was treated with Benadryl(diphenhydramine hydrochloride).  At the time of initial reporting on 21-Oct-2020, the patient had not recovered from the event of redness.  The reporter assessed the case as related to Flucelvax QIV.  The reporter assessed the case as non-serious.  This case is linked to cases 202005363, 202005385 and 202005386 (due to the same reporter).  Company comment: A patient of an unreported age was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed erythema. Reportedly, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related due to plausible chronology.; Reporter's Comments: They reported more redness than a normal post-vaccination reaction.; Sender's Comments: A patient of an unreported age was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed erythema. Reportedly, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related due to plausible chronology.
FULL TRUNK RASH STARTED WITHIN HOURS. ACHES, FEVER CHILLS WITHIN 6-8 HOURS. UPPER RESPIRATORY SYMPTOMS (SEVERE COLD) WITH 24HRS.
Dizziness, Headache, Myalgia, NauseaVomiting, localized pain Narrative:
6x4cm swelling @ site of immunization;2 other children had same rxn;
Got the shot and would you believe, I got shingles the third time/ Suspected vaccination failure; Got the shot and would you believe, I got shingles the third time; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles 2 times, years ago and was painful).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient got the shot and still got shingles for the third time. The patient was suggesting everyone to get the shot as its effective and also stated that, it was a great improvement when he or she got their shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
sore arm; tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and COVID-19 (tested positive for COVID) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037*20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Diabetes mellitus. Concomitant products included METFORMIN and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for Diabetes mellitus, CHLORTHALIDONE, LOSARTAN and VITAMIN B&C for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (tested positive for COVID). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 22-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were provided.
Severe arm pain, fatigue, myalgis. Nausea. Headache. Elevated blood pressure
Mother noticed that child's cheeks were puffy and red about noon. By 4pm, child had "hives" on her back. TC to ER and instructed to give Benadryl. No difficulty breathing or swallowing. Seen at clinic on 8/1/02. Hives faint. Cheeks were normal.
extremely restless sleep, persistent mild nausea, minor headache, generally feeling run down and unwell. It's been a little over 24 hours since I got the injection. Symptoms started about 7 hours after injection. Advil helps a bit for nausea and headache
Strong pain in arm of shot, red and hot to the touch. Can?t lift arm move than 45 degrees or pick up things. Muscle aches and joint aches all over. Low running fever, headache. Same reaction with both first and second dose of Shingrix.
2 days post vaccine (Zostavax) patient states she has a raised bump on her left buttock. States it has a black dot in center and is about the size of a dime. Not sure if it was itchy. Went to medical officer. Rx for Acyclovir - provider was unsure if bump was shingles.
felt nauseated; had stomach pain; cannot keep her food down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "felt nauseated"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "had stomach pain"; FEEDING DISORDER (non-serious), outcome "unknown", described as "cannot keep her food down".  Additional information: Patient was already received the Pfizer covid-19 vaccine shot and the booster shot. She mentioned that after a couple of months of having the booster shot she experienced events. She wanted to know if that was part of the long term side effects of the covid-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine EUA  I had the Qovid-19 virus back in March of 2020 and symptoms such as fever, chills, fatigue, muscle and body aches.  approximately 5-6 hours after receiving the vaccine i felt most of those same symptoms but on a much lesser scale.  all of those symptoms went away after 36 hours.  I spoke to some of my friends that took the vaccine the same day i took it and in general most of the friends that previously had the virus had similiar symptions again while those that never had the virus did not have any reraction to the vaccine.
flare up of COPD; cough; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (flare up of COPD) and COUGH (cough) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.  Concurrent medical conditions included COPD.  On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (flare up of COPD) and COUGH (cough). The patient was treated with AZITHROMYCIN (Z-PAK) for COPD exacerbation, at an unspecified dose and frequency; PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED COLD & SINUS) for COPD exacerbation, at an unspecified dose and frequency and BROMAZEPAM (NIQUIL) for Cough, at an unspecified dose and frequency. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (flare up of COPD) and COUGH (cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Oxygen saturation: 81 (Low) oxygen went down to 81..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 19-Mar-2021, the patient went to get the second dose but was refused due to the treatment medication she had taken for flare up of COPD. Her doctor did physical on 11-Mar-2021 and said he was okay with her getting the shot. Concomitant medications were not provided.
Sore arm; COVID-19 symptom; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and COVID-19 (COVID-19 symptom) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (BUPRENORPHINE/NALOXONE) for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and COVID-19 (COVID-19 symptom). At the time of the report, PAIN IN EXTREMITY (Sore arm) and COVID-19 (COVID-19 symptom) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Patient has a past medical history of quarantine with COVID-19 symptoms since her boyfriend who was full diagnosed with COVID-19. Patient stated that they both quarantine prior to getting the vaccine. Patient stated that all the symptoms related COVID-19 was cleared up before starting the new job.   This case was linked to MOD-2021-337397 (Patient Link).; Sender's Comments: This case concerns a 32 year-old, female subject,  with a non significant clinical history  who experienced the unexpected events  of PAIN IN EXTREMITY and COVID-19. The events occurred approximately unknown time after the first dose of vaccine.   The rechallenge was unknown The events were considered related to the study drug per the reporter's assessment The benefit-risk relationship of the vaccine is not affected by this report
Patient here for seventh grade immunizations. Mom had chosen for daughter to receive TDaP, MCV4, and HPV. Twin brother also here, and received the same vaccinations prior to his sister. Patient did well after receiving the vaccinations. After a few minutes of sitting in the clinic room, patients eyes rolled back, her head fell back, body started shaking and her arms started contracting. EMS was called and nurse was able to arouse patient prior to ambulance arrival. Mom stated patient had not eaten anything yet and has never had a reaction after receiving vaccinations before. BP 110/62. Blood sugar and vitals checked by EMS. Patient was also given crackers and water and stated she felt ok after being checked out by
tinnitus Received a second shot of the  Pfizer vaccine shipped to Hospital. Next day had fever , noise and ringing (both). Fever disappeared after 3 days but noise and high pitched ringing remained and is still an issue as of today. Saw PCP, they were not sure if it is related and could not identify a cause.  It seems moderate but affect ability to concentrate at work and read.
Pt had short nap around 5PM on 30MAY92; Awoke & had small amt of supper was playing & fell over & started convulsing; parents took pt to ER; sz activity lasted approx 2 mins; t103 @ hosp;
Patient described immediate pain, numbness, and weakness through entire left arm. Patient stated it was improving over period of  about 10 minutes from injection time. Patient stated she needed to go home. Offered patient to stay. Declined paramedic intervention. Encouraged patient to visit physician.
I couldn't even walk; had dizziness; Tiredness; Chills; Fever; Muscle pain; Joint Pain; I have stick to my stomach.; I was so sick and so weak.; It hit me like mouth break; I was so sick and so weak.; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0177 expiration date: unknown), via an unspecified route of administration on 30Jun2021 15:00 (at the age of 74-year-old) as dose 1, single for covid-19 immunization. Medical history included hypertension, covid-19 in Mar2021 (had covid, back in March of this year). Concomitant medications included calcium, losartan, clonidine, hydrochlorothiazide triamterene (TRIAMTERENE HCTZ), vitamin d3, turmeric (curcuma longa rhizome). Patient did not take any other vaccination shot prior 4 weeks or during the covid vaccination period. The patient stated that when she got her shot, she got it at 15 O clock in the afternoon and 21 O Clock till next, she was fine, at 9 O Clock in the next morning, it hit her like mouth break. She was so sick and so weak. She could not even walk, her husband had to help her walk, she was feeling as if, she had dizziness, It was further stated that she had all the symptoms basically, she had stick to her stomach, had tiredness and had muscle pain, chills, joint pain and fever. She was supposed to be get-ting a shot on 21Jul2021 (reported as on the 21st of this month) and she was scared to get it, so she wanted somebody to tell her, that because she was having covid already, they were giving one shot. On an unknown date, before vaccination, the patient underwent lab test and was found to have covid-19. She wanted to know if one shot is sufficient or should she get another shot. Patient took Tylenol as treatment. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Dizziness and lightheadedness, turned into neck pain, nerve pain down right and left arm, back pain, loose hip joints, hip pain, cervical headaches
Bad headache,, Dizzy (vertigo), low grade fever (100), approximately 18 hours after injection. Tylenol dulled headache.  Fever subsided by 6pm.  Approx 55 hours after shot, raised welt at injection site after shower.
This spontaneous report was received from a Registered Nurse regarding unspecified number of patient of unknown demographics. There was no information about concurrent condition and historical medication. Since 01-JUN-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K11562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse, the grandmother of a 10 month old female patient who received a first dose of Prevnar in her left leg on 9/13/2005. On the same day, the patient also received a first dose of Hib titer vaccine (haemophilus B conjugate vaccine ( diphtheria crm 197 protein conjugate) in the right leg. Later that day, the patient developed erythema, warmth and tenderness at the injection site in the left leg and crying. On 9/14/2005, the patient experienced a decreased appetite. The patients concurrent illnesses included ear disorder ( reported as fluid in right ear) and tympanic membrane perforation (reported as ruptured right ear drum (possibly due to airplane flight. Indication for Prevnar was immunization. On  9/13/2005, the product was administered in the left leg. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant therapy included Hib titer vaccine (haemophilus B conjugate vaccine ( diphtheria crm 197 protein conjugate) injection, Amoxicillin suspension and Ciprofloxacin ear drops. On 9/13/2005, at approximately 2:30pm, the patient received a dose of Prevnar. Later that day at 7:00pm, the patient developed injection site erythema, injection site tenderness, and it was noted that the left leg was slightly warm to the touch. The patient started crying and was inconsolable. Treatment included Tylenol. On 9/14/2005, it was reported that the patient would not eat her breakfast (decreased appetite) although she drank an 8 ounce bottle of formula. As of 9/14/2005, the crying, injection site erythema and tenderness had resolved, but the outcome of the injection site warmth is unknown. The decreased appetite was reported as not recovered. No additional information was available at the time of this report.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On 25-FEB-2015, RECOMBIVAX HB of lot # J007943, expiry date 05-FEB-2016 and lot number J007946, with expiry date 24-MAR-2016 was improperly exposed to 21.72F for 40 minutes for 1 cycle. On unspecified date after this, in approximately 2015, an unspecified number of patients may have received this improperly stored RECOMBIVAX HB. There were no known adverse effects. The vaccine was however, given via the correct route as per the prescribing information. The outcome of the incorrect product storage was unknown. This is one of the several reports received from the same source. Additional information has been requested.
acute anaphylactic react w/in 5 mins of flu vax; needed EPI, 02, Kenalog & DPH to recover;
Shortness of breath/Trouble breathing; Rash; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Shortness of breath/Trouble breathing) and RASH (Rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 DYSPNOEA (Shortness of breath/Trouble breathing) and RASH (Rash). The patient was treated with EPINEPHRINE for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath/Trouble breathing) and RASH (Rash) 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.   Patient was asking if she should take the second shot with the reaction as bad as it was.   No concomitant medications were reported.
Within 30 min of receiving PNEUMOVAX and FLUZONE in (L) deltoid he has swelling/pain. 2 days later he had redness/swelling of arm.