chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On 26th December 2017, the patient received SHINGRIX (subcutaneous). On 26th December 2017, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The GlaxoSmithKline (GSK) medical liaison reported adverse event that, he heard from one of his account pharmacists told him that another pharmacist administered the SHINGRIX vaccine to a patient. The pharmacist claimed that he administered the vaccine to a patient via intramuscularly. However, the patient complained about pain, redness and swelling at the injection site. Patient said that the pharmacist gave her the vaccine subcutaneously in the back of her arm instead of the deltoid muscle in the front. This led to possible intramuscular formulation administered by other route. The field representative did not have the pharmacy address of his reporting pharmacist but he had the address where the pharmacist works as an educator and name of pharmacist that administered the vaccine. These events were just brought to the attention of the pharmacist who reported it and the field employee. The reporter stated that, there was a lawsuit going on involving the pharmacist who administered the vaccine and the patient. The reporter did not have any additional information regarding the event or lawsuit.
Vaccine was administered to the patient under 18 years of age. No post-vaccine reaction was noted. Patient was given the second dose on 3/26/21 lot number 043L20A. Again, no post-vaccine reaction was noted.
pt recv vax;had a sz 1-2 mins;to hosp er where pt had another  brief sz w/ a rectal T 101;
Caller reporting AE for expired dose of MMR II administered to a patient on 07-OCT-2020; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 07-OCT-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of 0.5 millilters (mL) (strength, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number R027999, which have been verified to be valid, expiration date reported and validated as 01-OCT-2020) as prophylaxis (expired product administered).
The only time I get the flu is when I take that shot; Initial information received from on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an Adult  patient  with unknown gender who experienced the only time i get the flu is when i take that shot while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine (batch no and expiry date unknown), frequency, route, strength, dose was unknown) for Prophylactic vaccination   On an unknown date the patient developed a non-serious the only time i get the flu is when i take that shot (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event the only time i get the flu is when i take that shot.
This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On 26-JUN-2017, the patient was administered one expired dose of VAQTA (dose, route of administration, and site of administration were not reported), lot # M037096, expiration date 17-JUN-2017; for prophylaxis. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
The report had been received from a registered nurse. The report concerns a 12 years old male patient. Concomitant medications, concurrent diseases and medical history were not reported. On 28-Aug-2012, the patient received FLUMIST but the child pulled back while the nurse was trying to administer FLUMIST. A minimal amount of the FLUMIST was sprayed into his eye. He was not revaccinated with FLUMIST. The outcome of the event of FLUMIST sprayed in eye is unknown. The event was considered to be non-serious by the reporter. The reporter and the company physician both considered the causality between the event and the suspect product to be unrelated. Summary of follow-up information received by AstraZeneca/MedImmune 29-Oct-2012 from Health Care professional: Ethnic origin updated. Corrected report 06-Nov-2012: Reporter entered as Health Care professional and case became medically confirmed. Additional reporter added. Corrected report 06-Dec-2012: Coding of event 'FLUMIST sprayed in eye' correct from inappropriate route of vaccination to drug administration error, narrative updated. Corrected report on 11-Apr-2014: The case has been updated with full data due to term additions for FLUMIST /Q/Laiv. For reference, source document can be found at case 2012SE70762.
Headache  10/18-10/20, Chills 10/18-10/19, Shakes 10/18, Cold and cramping in extremities 10/18-10/20, Abdominal pain 10/18-10/20, Nausea 10/18-10/20, Fatigue 10/18-10/19, Pain and swelling throughout underarm near injection site 10/18-10/20, Blood pressure spike 10/18
PT had abrupt onset of cellulitis surrounding area of vaccine admin site 2 days after injection.
Rash on left arm: 3 erythematous macular lesions on left arm, no induration, one lesion on the anterior and superior upper arm is large stretching from distal to axilla to proximal to elbow.    Treated with Zyrtec and Benadryl Outcome: skin is almost back to normal after 7 days, slight redness still remaining on day 7.
patients received improperly stored vaccines; No adverse effects; This spontaneous report was received from a physician referring to a currently 19 years old female patient. The patient's pertinent medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, vaccine dosage detail and route of administration were not reported; lot# R017630, expiration date: 18-DEC-2019) and with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccine dosage detail and route of administration were not reported; lot# R023503, expiration date: 16-AUG-2020, and lot# R009410, expiration date: 29-MAR-2020). Both vaccines were reconstituted with properly stored sterile diluent (STERILE DILUENT).  Administered doses of vaccines were exposed to a temperature excursion between -14 degrees Celsius to -10 degrees Celsius (-11 degrees Celsius) for 80 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  The case is linked to case# US-009507513-1905USA002947 due to the same patient. ; Sender's Comments:  US-009507513-1905USA002947:
Months after receiving the last vaccine, I started feeling ill: fatigue, body aches, congestion, cough. I learned that I had been exposed to a COVID positive person, so I took a home test and it showed I was positive.  I stayed home until the 7th day after the onset of symptoms,  Then I wore a mask when out of the house for about 6 days more.  My symptoms did not disappear completely for about 2.5 weeks after the symptoms started.  I received no prescription medications.  I used over the counter decongestant, antihistamine and Tylenol to lessen the symptoms.
Swelling, redness and warmth from just above shoulder down to elbow and around arm circumferentially.
leg problem more extensive after the 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (leg problem more extensive after the 3rd dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 013M20A and 039K209) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (leg problem more extensive after the 3rd dose) (seriousness criterion hospitalization). The patient was hospitalized on sometime in October 2021 due to LIMB DISCOMFORT. At the time of the report, LIMB DISCOMFORT (leg problem more extensive after the 3rd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Magnetic resonance imaging: normal (normal) MRI normal.         No concomitant medications reported. No treatment information was provided.  Patient again experienced the same leg problem this time more extensive than the 1st one.  The patient was admitted in the hospital for the night.  Company's comment: This case concerns a 77 year old, male patient, with no medical history reported who experienced serious unexpected event of limb discomfort after third dose of mRNA-1273. The event occurred 24 days after third dose of mRNA-1273. The re-challenge for the third dose is not applicable as further dose is not expected. The benefit-risk relationship of Spikevax in not affected by this report.   This case was linked to MOD-2021-350735 (Patient Link).; Sender's Comments: This case concerns a 77 year old, male patient, with no medical history reported who experienced serious unexpected event of limb discomfort after third dose of mRNA-1273. The event occurred 24 days after third dose of mRNA-1273. The re-challenge for the third dose is not applicable as further dose is not expected. The benefit-risk relationship of Spikevax in not affected by this report.
Given Meningococcal Conjugate . Had 2 doses previously on 09/01/2015 and 02/28/2019
Information has been received from a physician concerning a 18 month old male who on 12Apr04 (previously reported as 28Jan05) was vaccinated SC in the left arm with a dose of varicella virus vaccine live (lot 647527/1183N). Concomitant vaccination that day included an IM dose of Hib conj hep B vaccine (lot 646188/0450N) in the right thigh and an IM dose of poliovirus vaccine inactivated (Ipol) (lot E0706) in the left thigh. It was reported that on 10Aug04 (previously reported as 28Jan05) the pt was vaccinated with an SC dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot647671/1188N). On 04May05 (previously reported as 07Feb05) the pt developed breakthrough varicella with 40 plus lesions on his torso, thighs, scalp and legs. The pt's rash was described as vesicular on his torso and scalp. The doctor stated previously that on 09Feb05 it became angry/turned bright red. It was also reported that the pt experienced five days of a fever. Unspecified medical attention was sought. It was reported that while on therapy the pt's adverse events improved. It was previously reported that on 15Feb05 the pt was considered to be recovered. There was no product quality complaint involved. Additional information is not expected.
Information has been received from the pregnancy registry for GARDASIL via a nurse practitioner, concerning a 22 year old female with a history of asthma who on 25-APR-2008 was vaccinated with the first dose of GARDASIL, 0.5 ml, IM, (Lot#659962/1740U).  The patient sought unspecified medical attention at the office and had a confirmed pregnancy test.  Her last menstrual period was reported as 22-MAR-2008, and her due date is 27-DEC-2008.  No other symptoms have been noted.  Follow-up information has been received from the nurse practitioner, for GARDASIL, a Pregnancy Registry product.  On 25-APR-2008 the patient had urine beta-human chorionic gonadotropin test (ECG) performed which was negative.  The reporter noted that the last contact with patient was on 14-MAY-2008, when she called to report pregnancy, 8 weeks gestation.  And the patient experienced scant pink vaginal discharge.  The patient did not return phone calls on 16, 19, 22-MAY-2008, nor to card sent on 22-MAY-2008.  The estimated date of delivery was 28-DEC-2008.  The pregnancy outcome was unknown.  No further information is available.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was reported.     On 14-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
LOW ABDOMINAL PAIN; LOW BACK PAIN NEAR SPINE; LOW ABDOMINAL PRESSURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, copd, hypertension (htn), alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy and there was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 09:30 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-MAR-2021, Laboratory data included: PCR (NR: not provided) Negative. On 31-MAR-2021 21:30, the subject experienced low abdominal pain. On 31-MAR-2021 21:30, the subject experienced low back pain near spine. On 31-MAR-2021 21:30, the subject experienced low abdominal pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low abdominal pain, low back pain near spine, and low abdominal pressure. This report was non-serious.
Spontaneous rapid heart rate for 15 minutes. Rested. Heart rate returned to normal.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.84. Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Extremely swollen lymph node over left collar bone; fatigue; soreness; odd sensation in the entire olfactory; appetite disappear; smell and taste will not go away; nauseous; taste something that was like the peanut sauced used in chicken satay; This is a spontaneous report from a contactable consumer(patient). A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in left arm as dose 1, single on 05Mar2021 15:45 (at the age of 46-year-old) for covid-19 immunisation. Medical history included known allergies with sensitive to acai berries and topical vitamin E, pressure urticaria (patient was also conceived and born a war, which had chemical warfare use) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 05Mar2021 16:00, the patient experienced extremely swollen lymph node over left collar bone, fatigue, soreness, odd sensation in the entire olfactory, appetite disappear, smell and taste will not go away and nauseous. Patient reported other than the usual fatigue and soreness, she experienced an odd sensation in the entire olfactory and now, unless she purposefully smelling or tasting something else and she constantly smell and taste something that was like the peanut sauced used in chicken satay. The scent and taste started within 30 minutes of the shot, which was on 05Mar2021 (on Friday). It was now Tuesday (on 09Mar2021) and the smell and taste will not go away. It made her appetite to disappear and, if she tried to eat more than a few bites, she got nauseous as if she was force feeding herself. Patient asked did her sense of smell and taste forever changed. Patient did not receive treatment for adverse events. At the time of this report, the outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
third time a flare up had hit since I took the shot/Suspected Vaccination Failure; third time a flare up had hit; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: third time a flare up had hit since I took the shot/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: third time a flare up had hit). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that checked with doctor first, if you had nerve issues and already the shingle shot caused you to get the shingles.  The reporter further stated that It did him/her. This was the third time a shingles flared up had hit since he/she took the shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
Pt reported rapid heart rate to EMT at 1410. EMT assessed pt. HR: 82 and no SOB. Pt reported hx of hypertension, allergies to PCN, and severe allergic reaction to flue vaccine 2 years ago. Pt offered adult dose of diphenhydramine. Pt refused diphenhydramine. Pt offered EMS. Pt denied EMS. Pt advised to wait 15 extra minutes. At 1417 pt reported dry throat and feeling hot. Flushing was observed by RN. Pt was moved outside. Pt was offered EMS for a second time. Pt agreed to EMS. EMS was activated at 1420. EMS arrived at 1430 and assumed care. Pt left vaccination site at 1435 and transported to ER.
Fever, pain, inconsolable crying for 3 days. Pain in legs at site. unable to crawl. 2 hours screaming and each day fitfulness, sweating heavily. 12/14/07-records received for DOS 5/20/02-6/20/05-include well and sick visits.Fever times 2 days, cold symptoms with frequent stools on 9/29/02-Congested, fever vomited on 1/12/03-. Vomiting and increased fatigue on 2/13/03. Achieving milestones 6/20/03. Fever vomiting and shaking 6/26/03. Drooling, fever runny nose congested 10/14/03-upper respiratory infection.
Today, the injection site is warm to the touch; slightly swollen and a rash has appeared above and below the injection site and is quite itchy.  Otherwise, feeling fine
given before 90 days after monoclonal antibody. patient got Regen-cov on 9/14/21. Immunization provider was rushed and multitasking and fellow employee asked for a booster. Provider recommended waiting until end of the day when it was less busy, but employee wanted before noon. Provider did not use paper screening questions and forgot to verbally ask about mab treatment. Discovered when entering dose in patient's chart that they had a mab before 90 days ago.
The patient felt an immediate cholinergic cascade, like he was going to pass out.  Then his muscles tensed slightly, his eyes rolled back in his head, and he panicked and asked where he was.  He appeared to have had a 3-5 second seizure.  It took him 20-30 minutes to recover to a point where he could stand up without feeling like he would pass out.