chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave pt FLUVIRIN vaccine, pt was told to have a seat but he stood up. The mom suddenly said pt is seizing or passing out. Pt went unconscious, then became conscious and wanted to know what happened to him his mother was crying. I saw the pt turned red as he passed out the first time, then he fainted again, pt was not jerking. We called 911 paramedics came took his blood pressure, and they said pt was cold to the touch, blood pressure was 90/60 I believe. Pt looked pale and felt weak. Paramedics asked pt has he had any hx of seizures mom and pt said no. But pt did say when he donates blood he faints. There was a drop of blood after giving the pt the vaccine. Pt refuses to go to the hospital. They left the store with the paramedics.
Poor reaction to Flulaval Influenza vaccine - chills, fever, body aches, nausea.
a large lump that is sore and hot to the touch; a large lump that is sore and hot to the touch/lump pain; a large lump that is sore and hot to the touch; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 08:00 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included Lupus. Patient didn't have COVID prior vaccination. Concomitant medications included cyanocobalamin (B-12); bupropion hydrochloride (WELLBUTRIN); levocetirizine dihydrochloride (XYZAL); lisinopril, all taken for an unspecified indication, start and stop date were not reported. No other vaccines were administered in four weeks. One week after shot she woke up with a large lump that was sore and hot to the touch. 24 hours later the lump pain and the heat were still there. Adverse events start from 06Feb2021 09:00 AM. No treatment was received for the events. The outcome of the events was not recovered. COVID was not tested post vaccination.  Information on the lot/batch number has been requested.
Temperature of 103 degrees for 3 days. Stayed in bed. Took TYLENOL to keep temperature below 103 degrees when able to get out of bed. Missed 2 days of work. Felt "run-down" for next several days.
Headache, Arthralgia, Fatigue Narrative: missed work following second dose due to above symptoms
Child passed out post receiving immunization. Fell and bumped head. Initial assessment: child alert, pale, diaphoretic, no change in level of consciousness. Observed for 15-20 mins post incident, given juice. No complaints of nausea and vomiting or headache. Symptoms resolved. Since immunization, child complained of intermittent headaches not seem by physician.
On day 9 developed redness, itching, swelling, hardness, heat & pain at injection site
Pt vaccinated with MMR developed fever 103 x 2 days, rash x 3 days.
Pain in same spot as shingles pain one year ago. No lesions but same pain and location as one year ago. Dr. treating as last year with anti viral med and pain med.
Information has been received from a health care professional concerning a 34 year old female who on 9/20/99 was vaccinated IM in the left deltoid with the first dose of Hep B vaccine. Subsequently, the pt experienced a rash in the elbow vicinity of the injection arm. The rash began approximately 7 days post vax. The pt sought unspecified medical treatment. On an unspecified date the pt recovered.  No additional information is available.
Low Grade Fever (~99.0 degrees F) for about 8 hours following vaccination. Noticed low grade fever same day as vaccine.
It was reported that an 18 y.o. female student received a Menomune A/C/Y/W-135 vax, administered SC in her left arm at 13:30 on 9/27/01. At 16:15 on 9/28/01 the PT developed widespread "rash" all over entire body, complained of itching, eyes were red, c/o nausea and vomiting, c/o swelling in fingers and joints. PT took Benadryl through night. Referred to MD for evaluation.
This spontaneous report was received from a Registered Nurse (RN) referring to multiple, unspecified patients (demographics not reported).  Medical history and concomitant medications were not provided. Between 13-DEC-2016 and 06-JAN-2017, multiple, unspecified patients received improperly stored VARIVAX. Lot numbers involved were: M028553 expiration 07-JUN-2018, M030138 expiration 15-JUN-2018, M036272 expiration 17-JUN-2018 and M034586 expiration 27-JUL-2018. Temperature: >14 degrees Fahrenheit to < or = to 46 degrees Fahrenheit range. Time frame: 2 hours, 36 minutes. No adverse effects were reported. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of local reaction in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 9th February 2019, the patient received SHINGRIX. On 9th February 2019, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In February 2019, the patient experienced local reaction, injection site pain and injection site swelling. In February 2019, the outcome of the local reaction was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site swelling and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the local reaction, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in lower back to upper hip area, due to patient's size, which led to vaccine administered at inappropriate site. The patient had horrible local reaction that lasted almost a week, really big area at the site of injection (size of a tennis ball or more), painful in the area. The patient received vaccine at a friend's house, friend was nurse practitioner.
No adverse event; Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medications were reported. 113 Bivalent doses administered after the BUD to patients 12 and up. 51 doses from Lot AS7140C and  60 doses from Lot AS7148B. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided.
Itching all over body. BP 141/99 (pulse 93), O2 sat 99%. Given Benadryl 25 mg PO.
Rashes open sores, fatigue, panic attacks, depression, unclear thinking, breathing issues, autoimmune issues
Increased Migraines , Decreased hearing, Abdominal pain, chills, headache, loose stool.
Pt vaccinated with TD within hours after immunization, developed hives on arm where inject given plus face. Also, lips & tongue swelling & wheezing, as well as hearing loss. Recovered in 5 days. Had rash & swelling at inject site with DTP.
Onset of child symptoms on 8/28/21, loss of taste and smell 8/30/21, positive covid test 8/31/21.
Information has been received from a Nurse Practitioner concerning a female who in approximately August 2007, was vaccinated with Zostavax (Oka/Merck). The Nurse Practitioner reported that in approximately August 2007, the patient experienced an aching pain at the injection site. There was no redness at the site. The patient's aching pain at the injection site persisted. Additional information has been requested.
lost a lot of blood, there was excess bleeding at the injection site; This is a spontaneous report from a contactable consumer (wife). A 73-year-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: E19126, Expiration date: unknown) via an unspecified route of administration on 23Jan2021 (at the age of 73-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jan2021, patient experienced lost a lot of blood, there was excess bleeding at the injection site. Reporter called for her husband reporting on the Covid 19 vaccine and who wants to know if he should get a third dose of the vaccine. Reported that when he received the 2nd dose the patient lost a lot of blood, there was excess bleeding at the injection site. Because of this, she was questioning if he needs a third dose. Reporter stated that the tech put the needle in and afterward states that he was the 3rd patient that had blood spew out of the injection site. No other information provided for this statement as the reporter declined to complete the report. It was explained the bleeding lasted about an hour, it was not a lot but shot right out of the puncture, where the jab was at the injection site. There was no investigation assessment provided. The outcome of event was recovered on 23Jan2021.  Information on Lot/Batch number was available. Additional information has been requested.
suspected vaccination failure/ both shots I have the shingles now/had the shot and I have the shingles; got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had both shots of Shingles and now had the shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Tinnitus started 3 days after first dose of Moderna vaccine!  It has now been over 4 weeks and the tinnitus is still constant! Never had tinnitus before vaccine!!!!
This spontaneous report was received from a physician via two company representatives from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 04-SEP-2014, the patient was vaccinated with an improperly stored dose of GARDASIL 5 mg/0.5 ml injection, lot # J014219, expiration date 05-OCT-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two temperature excursions (dates unspecified) lasting for 168 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius) and the another lasting for 24 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.555555556 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date). No concomitant medications were reported. No treatment medications were reported. The patient received half dose of Moderna vaccine. The vial had not undergone any temperature excursions. The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.
A report was received from a health care professional on 10/31/03, concerning a 67 year old female vaccinee who inadvertently received 2 doses of Fluvirin, on on 10/28/03 and another on 10/31/03. The vaccinee did not experience any adverse reaction at the time of the report.  There was insufficient information to determine the reporter's causality assessment. Update 1, 12/10/2003: A follow up report was received from a health care professional which indicated that the vaccinee's vital signs were monitored every 8 hours for 2 days after she inadvertently received 2 doses of Fluvirin. There were no problems, changes or adverse reactions noted. No follow up pending.
5 days after immunizations, pt developed polyneuropathy with abnormal sensation in a stocking-glove distribution of hands and feet that is still present. She also developed a tight sensation over the abdomen that has persisted to appt day of 11/18 . Unclear if related but did occur within 1 week of immunization.
Advised parent of error.Will call in Am to check on patient reaction.Will give HepB at 2 mo check.
headache; sinus infection; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SINUSITIS (sinus infection) and OROPHARYNGEAL PAIN (sore throat). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN BAMBINI) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SINUSITIS (sinus infection), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
chills, body aches, nausea, extreme fatigue at exactly 24 hours after shot.   I felt exactly like my worst covid days in December 2020. At exactly 48 hours it was like someone flipped a switch and I felt fine.
half of the vaccine dose ran down patient's arm; half of the vaccine dose ran down patient's arm; half of the vaccine dose ran down patient's arm; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number G9JA7, expiry date 15th April 2023) for prophylaxis.   On 29th December 2021, the patient received the 2nd dose of Shingrix. On 29th December 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were provided as follows: The reporter was an office manager. The reporter stated that when a medical assistant was administering a dose of Shingrix to the patient, the patient pulled away and almost half of the vaccine dose ran down the patient's arm, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. At the time of the report, a repeat dose had not been given. The reporter consented to follow up.
Bell's palsy; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-JUN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related conditions by a pharmacist. At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated. Subsequently (date not reported), the patient was treated by a physician for Bell's palsy. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event Bell's palsy was determined to be medically significant event.
She is a 74-year female with history of morbid obesity, OA on chronic opioids, T2DM, CKD 3, HTN, and hypothyroidism who presents with 10 days of worsening fatigue and trouble ambulating.   She reports that she started feeling unwell about 10 days ago with a sore throat and pain radiated to her left ear.  She had trouble swallowing due to the pain and was generally tired, thinking she had strep infection or ear infection.  Her sore throat resolved as did her ear pain, however her fatigue worsened and had trouble walking due to weakness.  Felt like she had trouble functioning at home, soshe presented to the ED.   In the ED, she is hemodynamically stable, satting low 90s on room air.  Labs are significant for  mild hyponatremia 133 and bump in creatinine 1.84 (previously 1.44).  Found to be Covid positive, and CXR with possible right lower lobe infiltrate.   Currently, reports feeling tired with poor appetite and body aches though no shortness of breath, chest pain, nausea.  She has been eating foods that taste good to her, not following diabetic diet and sugars have stayed appropriate.  Denies any sick contacts or leaving the house.  Of note had her  Covid vaccine (J&J)  3/22 in her house, and does not know where she contracted Covid.
Thirst; dehydration; This is a spontaneous report from a non-contactable consumer. This report was received via a sales representative. An adult male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previous received the first dose of bnt162b2 in Dec2020 for covid-19 immunization. The patient experienced thirst and dehydration on Jan2021. The outcome of the events was recovered in Jan2021 at the time of last observation. No treatment received for the events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
the Moderna vaccine was pulled the morning of the event the pt was given a vaccine given expired best by use date BUD of 01/20/2023 expired by three days Moderna was contacted and they state that the vaccine is still good patient involved was contacted by management.
Patient is 21 y/o male presenting to pharmacy for COVID vaccination, received vaccine at 1500, shortly after administration of vaccine (roughly 1503), patient experienced brief tonic/clonic seizure, total time of seizure less than 20 seconds, seizure resolved spontaneously. EMT's were dispatched to location, ER visit/hospitalization deemed unnecessary. Patient stayed at the pharmacy for the remainder of the 30 minute observation period with no significant events. Patient and parents mentioned history of seizure after vaccination, though specific product could not be recalled. Patient has no formal diagnosis of seizure disorder, which was confirmed by medical testing completed in childhood, and has no history of antiepileptic medication.
Information has been received from a physician concerning a 60 year old male, with unknown pertinent medical history and unknown drug reactions, allergies, who in 10/25/2006 or Nov 2005, was vaccinated route unknown with a dose of Pneumococcal 23v polysaccharide vaccine (lot unknown). In January 2006, the patient experienced Streptococcus Pneuomiae and was hospitalized for 0-3 days. It was reported that the patient was treated with antibiotics while in the hospital. The patients present status was reported as recovered. No product quality complaint was involved. The patients experience was considered to be an other important medical event by the physician (OMIC). Additional information has been requested.