chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt returned to clinic (11/08/18) 2 days after receiving vaccines. Pt has been having severe arm pain within 6 hr after PNEUMOVAX and flu shot. Pain is unbearable, per the pt. She can't raise her arm (left). She has fever 100.5. Feeling body aches and severe HA. She has nausea and can barely eat. She is keeping liquids down. She is having chills and sweating. No notable sick contacts. No muscle weakness, paralysis, tingling. Discussed complications of vaccine reactions. Treatment: ICE for 20 min Q2-3 hrs while awake Elevation of extremity Ibuprofen 400-600 mg Q6hrs PRN pain or swelling Prednisone 40 mg given in office. Continue 40 mg Daily for 1 more day, then 20 mg daily for 3 days. Zyrtec 10 mg daily Zantac 150 mg BID Outcome: Pt feels slightly better today (11/09/18). Discussed her progress by phone.
ASYMPTOMATIC COVID-19; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ADHD (Attention deficit hyperactivity disorder) and allergy and other pre-existing medical conditions included: Patient was not hospitalized. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: unknown) 0.5 ml, 1 total administered on 16-MAR-2021 at 13:30 on left arm for prophylactic vaccination. Age at time of vaccination 58 years old. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate 20 mg within 2 weeks of Covid-19 treatment. It was unknown if the patient experienced any adverse reactions following the administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect vaccine Moderna (elasomeran) (dose number in series 2) (form of admin, route of admin not reported, batch number: 003F214 expiry: unknown) dose was not reported, administered on 27-OCT-2021 at 18:30 on left arm for prophylactic vaccination.  On 31-MAY-2022, the patient tested positive for asymptomatic covid-19 (dose number in series 2).  On 01-JUN-2022, the patient was prescribed by the physician Paxlovid (nirmatrelvir/ritonavir) (route of admin not reported, lot number FY9909, expiry: unknown) 3 tablets, twice daily for 5 days for Covid-19 treatment. The patient took Paxlovid as prescribed till 06-JUN-2022.  On 07-Jun-2022, the patient retested for Covid-19 using home antigen rapid test which was positive. The patient do not have any symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from asymptomatic covid-19. This report was non-serious.
Pt recv vax on unknown day; post vax pt exp muscular pain & joint pain-severe 1 wk
Patient presented to medical clinic with papules extending from vaccination site onto his chest and beneath his eyes bilaterally. He had received smallpox vaccination 2 weeks prior. He had nausea/fever since Friday (2 days prior to doctor's visit). Started on SEPTRA and sent for optometry, emergency room eval. Vaccinia virus diagnosed. Patient quarantined in barracks and followed in clinic.
The patient was given her 3rd dose of moderna a booster dose on 11/10/2021. The family returned a second consent and a 4th dose of moderna a booster done was administered on 11/20/2021
Erythema, induration of right upper arm and extending to shoulder. Pt with cervical adenopathy and eosinophilia.
Swollen upper left lip. Chills and slight fever approx 12 hours after injection.
Patient received both pneumo and flu vaccine in her right arm. 1 hour later her arm began hurting and by night it was really sore and she had a lump size of egg that was warm, red and raised. After 24 hours she  felt a little fuzzy cognitively and now a week later still has a half dollar sized lump, at one time the lump was 4x6 inches long.
oculorespiratory syndrome; little respiratory distress; red swollen eyes; red swollen eyes; Initial information received on 13-Jan-2023 regarding an unsolicited valid serious case from other health professional.  This case involves a 5-year-old female patient who experienced oculorespiratory syndrome after receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 06-Jan-2023, the patient received suspect influenza quadrival A-B vaccine at a dose of 0.5 ml total (lot UT7731MA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization.  On an unknown date the patient developed a serious oculorespiratory syndrome (oculorespiratory syndrome), little respiratory distress (respiratory distress), red swollen eyes (eye swelling, ocular hyperaemia) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Symptoms were resolving.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event oculorespiratory syndrome.  Seriousness criteria: Medically significant; Sender's Comments: Sanofi company comment dated 17-Jan-2023: This case involves a 5-year-old female patient who experienced oculorespiratory syndrome after receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV]. Additional information regarding condition at the time of vaccination, concomitant medication, medical history, lab tests would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
He was found down in cardiac arrest- EMS called CPR done and taken to Emergency room, unsuccessful CPR, patient died
Was sitting in chair. Stood up. Fell on floor. Said he thinks he fell asleep.  Did not remember falling.
Initial information received on 20-Nov-2018 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This case involves a 55 years old male patient who experienced muscle pain, sore throat almost like he has acid reflux and feels the need to keep clearing his throat, chronic fatigue and fibromyalgia, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Immune system disorder. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious muscle pain (myalgia), sore throat almost like he has acid reflux and feels the need to keep clearing his throat (throat irritation), chronic fatigue (fatigue) and fibromyalgia, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This case is accessed as serious due to medically significant event. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. Relevant tests were not reported. Final diagnosis was fibromyalgia. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sender's Comments: This case involves a 55 years old patient who experienced fibromyalgia with muscle pain, sore throat almost like he has acid reflux, chronic fatigue post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown and fibromyalgia is not expected following FLUZONE HD. Additionally, vaccine was administered out of recommended age leading to overdose. Patient has ongoing Immune system disorder. Further information regarding patient's medical history, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based upon the reported information, the role of the vaccines cannot be assessed.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-NOV-2015, the patient was vaccinated with an improperly stored doses of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2015 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot was administered) (dose, route of administration and location were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
had got his first Pfizer Vaccine this past Friday and then he ended up testing positive on Tuesday for COVID.; had got his first Pfizer Vaccine this past Friday and then he ended up testing positive on Tuesday for COVID.; This is a spontaneous report from a contactable consumer. This consumer (patient father) reported for a patient that: An unspecified age of male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown, Expiry Date: Unknown), via an unspecified route of administration, administered on unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date,  the patient got his first Pfizer Vaccine this past Friday and then he ended up testing positive on Tuesday for COVID. He had scheduled appointment on May 21st to get his second dose. Since the vaccination, the patient had been tested for COVID-19 with SARS-CoV-2 test and resulted positive on unknown date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
When I put a magnet at the injection stop, it sticks and I can feel the pull in my arm.
RASH, HEAT AT INJECTION SITE, PAIN AND STIFFNESS IN ARM.  BLURRED VISION STARTING ABOUT 24 HOURS AFTER INJECTION, INABILITY TO FOCUS  AND FIND FOCAL POINT. CONTINUED TO HAVE BLURRED VISION AND INABILITY FOCUSING.
Extreme pain in vaccinated arm with extremely limited range of motion. Pain and limited motion lasted seven days. Ice and ADVIL first day. No relief. Warm compresses and CELEBREX relieved.
Patient had dialysis on the morning of 11/4, received the covid vaccine and then went to a dermatologic office for a skin check. While he was getting checked he became unresponsive. CPR was started, patient came to the ER and ACLS care was given. Patient expired, Time of death was 13:17.
Swelling/redness in left upper arm at injection site. Sent to Urgent Care for evaluation.
Today and yesterday she took an antibiotic she was prescribed for a yeast infections.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Mar2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced today and yesterday she took an antibiotic she was prescribed for a yeast infections on 15Apr2021, the report received as, today and yesterday she took an antibiotic she was prescribed for a yeast infections. It is called Terconazole cream. She is wondering if it will affect her getting the second vaccine. She has not gotten the second vaccine yet. Therapeutic measures were taken as a result of today and yesterday she took an antibiotic she was prescribed for a yeast infections with Terconazole cream taken from 19Apr2021 and ongoing. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Telephone call from the client reporting redness, swelling and discomfort in her upper left arm, in the area where she received the vaccines. Recommended using cold packs and come to the clinic so the PHN could evaluated. Presented with redness below the injection site of the flu and pneumococcal vaccine. The flu vaccine was given above the Pneumococcal vaccine. Noticed the reaction last night. C/O increased discomfort in the area last night and needed to take pain medication. Also took ibuprofen. Reports the area to have been swollen last night. Reports after applying the cold pack before the visit, the swelling has gone down. Redness noted 5 inches x 3 1/2 inches. Redness pattern is irregular. Redness was located more on the anterior part of upper arm. Very slight redness noted in the armpit area. PHN did not feel any swollen lymph. Slight warm to touch. Continue cold packs to the area today 10/12/2005. Switch to heat packs tomorrow, continue taking ibuprofen. Observe for increased redness. Contact PHN this afternoon with concerns. PHN to contact client tomorrow.
A report has been received from a pharmacist concerning a subject of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. It was reported that patient received 2 doses. The outcome of the event of received 2 doses is unknown. The report was considered to be non-serious. Corrected report 13-Nov-2015: Relation to patient added. Reporter information added.
104.5 degree fever, chills and shaking, all started suddenly 7 hours after vaccination (around 10pm on 3/26). Fever was attenuated with extra strength Tylenol. Fever came back the following day with a max temperature of 101.5 (1pm on 3/27). Took Tylenol again and the temperature returned to normal (99.1). Temperature  rose to 100.2 the following day (2pm on 3/28) and returned to normal (98.6) after Tylenol. Throughout all of these events, there was stiffness in the upper arm where the vaccine was injected.
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAB (Twinrix) (batch number 5B22F, expiry date 27th April 2021) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix  (received 1st dose on an unknown date ).   On 29th October 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 29th October 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The nurse reported a patient received an expired dose of Twinrix which expired on 27th April 2021, which led to expired vaccine used. The reporter consented to follow-up via email.
Developed headache, chills within 10 hours after receiving second shot. Developed high grade fever within 24 hours, peak 102.5 F. Temperature started dropping a little bit within 48 hours, but still feeling very ill. Could not fall asleep for two consecutive nights. Had to take Tylenol twice to reduce the pain and fever on the third day. Temperature was brought back to normal on the fourth day. Had to take a sick leave.
Information has been received from a healthcare worker (immunization official) referring to a 5 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 12-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K026387(expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
1) Injection site exhibited extreme pain, soreness and tenderness approx 24 hrs after injection {Thur 4/29 ~10am} a) Area was very difficult to sleep on and even ice pack caused severe discomfort.  Only the specific Deltoid area was painful.  Neither shoulder nor bicep were impacted. b) Pain started to subside approx 12am Fri 4/30 {~40hrs after injection}. c) Approx 5pm Fri 4/30, bicep began to get itchy and exhibit redness with white bordering it. d) As of today, Sat 5/1 1pm, bicep area is still very red, slightly itchy and hot to touch.  2) 24 hours after injection, experienced extreme fatigue. a) Slept on-&-off during ~24 period between Thurs 4/29 ~10am through Fri 4/30 ~5am. b) Fatigue/feverish feeling appeared to subside after experiencing sweating episodes after 12am Fri 4/30.  {similar to hot flashes after effects}
Child experienced chest pain at school the day after the vaccination around lunch time and told his mother about it after school and child was still experiencing chest pain after school when arriving home .  mother report s the child still mentioned the chest pain this morning --child did fine at school today and has not complained since arriving home from school today .   It appears that all symptoms have now subsided
Information has been received from a Licensed Practical Nurse (L.P.N.) referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 14-MAY-2015 the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD (lot # L004007, expiration date 05-AUG-2016; dose and route not reported). No adverse effect was reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 25May2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa" (unspecified if ongoing), notes: known allergies: Aspirin, sulfa, mariscos; "mariscos" (unspecified if ongoing), notes: known allergies: Aspirin, sulfa, mariscos. There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Allergy", notes: known allergies: Aspirin, sulfa, mariscos. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022 at 23:00, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine. Patient did not take other medication in 2 weeks. Patient was treated with anti-viral Paxlovid for COVID-19 from 09Jun2022 to 10Jun2022 and had adverse events Urticaria, vomiting, diarrhea on 09Jun2022 11:00 PM. Outcome of the events was unknown and did not receive treatment for the events.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed a red rash in area below the injection site, patient reports no inflammation or swelling.
pt recvd vax & exp rash;MD questioned whether the pt would be able to receive a 2nd dose;No further details were provided;
Headache for weeks now Joint pain/swelling for weeks now Muscle aches  for days Stomach upset for two weeks  Nausea for last week
Day after nickel size welt right leg. Warm to touch, next day size of plum, next day size of orange.
Redness, swelling "whelp", itching, soreness, headache per patient.  Left arm.
Pt. received the Influenza Vaccine in October. I am unaware of which kind. She was a patient in our ambulance. She relays symptoms related to Guillain-Barre Syndrome which I know is an adverse reaction.
Two IPV vaccines given at same time. One was contained in Pediarix and one was a single dose.
Pain in neck; Pain in neck and arm including wrist; Pain in neck and arm including wrist; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Sep2021 12:45 (Lot number: 30145BA) at the age of 53 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes. Concomitant medication(s) included: INFLUENZA VACCINE, start date: 18Sep2021, stop date: 18Sep2021.  The following information was reported: NECK PAIN (non-serious) with onset 26Sep2021 11:00, outcome "recovering", described as "Pain in neck"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Sep2021 11:00, outcome "recovering" and all described as "Pain in neck and arm including wrist". Therapeutic measures were not taken as a result of neck pain, arthralgia, pain in extremity.  Additional information: Prior to vaccination, patient was diagnosed with COVID and Since the vaccination, patient has not been tested for COVID-19. case was assessed as non serious and patient was not Hospitalized.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
Soreness in left shoulder- and down arm. Pain is not constant but occurs with arm movement especially when dressing. Also pain when patient sleeps on that arm. Pt's trying gentle arm exercise.
Delayed event: 2 weeks later sudden throbbing pain in left anterior hip joint area while walking & sitting. Lasted about 20 min =/- relieved somewhat when sitting. Went away with no other interventions.  5-6 days later  happened on right hip joint area, same duration, but less intense.  Also went away and has not returned.   No  arthritis  or other muskuloskeletal issues, , and never had this type of event before then (or since). Was not doing any new activity  at the time or weeks prior that would have resulted in this event.
PT STATED: RASH ON STOMACH, CHEST, LEFT INNER THIGH OF RIGHT LEG. PT STATED FEELING WEAK, TIRED, ITCHY.