chrisvoncsefalvay/vaers-outcomes huggingface dataset:
passed out; sick to stomach; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant) and stomach discomfort. On an unknown date, the outcome of the passed out and stomach discomfort were unknown.   It was unknown if the reporter considered the passed out and stomach discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was getting the second shot of shingles vaccine the next day of reporting and was really nervous because he/she woke up during the night after getting the first shot and got really sick to the stomach and actually passed out in the bathroom the night of the shot. The patient stated that he/she was praying that would be the case for his/her second dose. The follow-up would not be possible as no contact details were available. This case has been linked to US2022AMR014021, response to same post.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR014021:Response to same post
Patient admitted to hospital on 3/2/23 with moderate pericardial effusion after 2 months of gradual back pain, SOB, intermittent fevers. Exudative on pericardial fluid analysis. Peds Infectious Diseases consulted and believed postviral pericarditis or pericarditis secondary to mRNA vaccination.
Left arm (injection site) swollen, red, hard, warm, tender. Area affected was 2X2 inches in oval shape. 2/4/2020 developed swollen area under Left armpit. Highest temp 99.9°. Seen by HCP who diagnosed cellulitis and prescribed Keflex 2000 mg/day
Got infection in left arm 1 week after injection; Hit too touch painful and had to get VQ scan to see if u had a blood clot; This is a spontaneous report from non-contactable consumer (patient). A 29-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Jun2021 15:30 (Batch/Lot number was not reported) at the age of 29 years as single dose for covid-19 immunisation. Medical history included Factor 5 linden and known allergies: Ceclor product, sulfur, cat scan dye. The patient had no concomitant medications. The patient previously took cefaclor (CECLOR) and sulfur and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient got infection in left arm 1 week after injection. Hit too touch painful and had to get VQ scan to see if patient had a blood clot. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient had to go on antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Lower extremity deep vein thromboses, pulmonary thromboses, cerebral thromboses and hemorrhage, death
Chest pains beginning mid morning after light activity (walking) and lasting until the evening (10am-6pm) including at least two instances of a gripping sensation in the chest. The sharp pain was evident in the front and back of the chest especially during inhalation. Some tiredness and shortness of breath was also experienced. Pain seemed to resolve itself.
Patient started having shakiness 10 minutes post vaccination (2nd dose). Patient sister stated that she had administered 200mg of Levetiracetam and 32.4mg of phenobarbital to patient 5 minutes ago after vaccination. She also stated that patient has history of shakiness, last episode being last week
Pt stated she had left shoulder pain, was treated by Orthopaedic for SIRVA.
pt exp crankiness, wants to be held since vax-does not want to eat-tugging @ rt ear-sleep decrease-starting to have cold sx over a period of 2-3 days;t101-102, vomited, change in sleep habits, diarrhea, won't eat;
Erythema/redness 8x9 cm. T 97.6. Symptoms started 3-4 hrs after injection. Post-nasal drip with nasal congestion.
After the second shot I had another period that was normal flow for two days and then EXTREMELY heavy flow for four days which sent me to the hospital for a blood transfusion.; EXTREMELY heavy flow for four days; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Number: er8730), dose 2 via an unspecified route of administration, administered in Arm Right on 24Mar2021 18:00 as 2nd dose, single for covid-19 immunisation. Medical history included menopausal, MS (multiple sclerosis), hasimotos, autoimune liver disease, known allergies to Mango. Concomitant medications included fingolimod hydrochloride (GILENYA); ursodiol (URSODIOL); atorvastatin calcium (LIPITOR) and blood pressure. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 05Mar2021 18:30 for COVID-19 Immunization. The patient has been menopausal for 9 years.  After the first shot I had a period that was very heavy flow for two days and normal flow for three days. After the second shot I had another period that was normal flow for two days and then EXTREMELY heavy flow for four days which sent me to the hospital for a blood transfusion. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The adverse event result in emergency room/department or urgent care, hospitalization. The patient received treatment for the adverse event included blood transfusion, tranexamic acid. The outcome of the events was resolved in 2021.
Swollen lymph nodes in left underarm Persistent pruritus without urticaria on legs (esp. thighs) Infrequent but recurring pruritus with urticaria on both forearms
Patient reported to clinic on 05/17/2022 at 4:30 for left swollen cervical lymph node, with tenderness on left posterior neck for one day. He states he went to the ER Monday 05/16/2022 had a CT scan and states no abnormalities on imaging. States could be possible infection, no abx given, no blood work obtain in ER. Patient states he was given Ultram 50mg for pain PRN in ER which "helps a little". Patient states he has an appt with PCP 05/19/2022. Assessment performed by nurse in clinic 05/17/2022 no neurological abnormalities noted. Encouraged patient to go to ER if worsening of symptoms. Recommend alternating Ibuprofen and Ultram and using ice for pain. Call with questions or concerns.
Patient started with heaviness in her chest, problems with vision, humming sensation in arms and chest. While lying in bed the patient got chills but not shaking, feeling of sweating but no sweat and also a slight headache. The patient has contacted her doctor she has not seen him. 04/06/10 A 51-year-old female patient was vaccinated with 0.5 ml of S-OIV Fluvirin (Influenza virus vaccine, batch no. 10073803) I.M. on 29 OCt 2009. Later on the same day, the patient started feeling anxious and jittery, and experienced a headache towards the back of the head. The symptoms steadily progressed at night, with the patient feeling anxious, panicky, a loss of appetite, and internal trembling feeling and heart palpitations. A persistent, frontal headache, accompanied by eye pain was also noted. No adverse effect was reported. Follow up information received from consumer on 25 Mar 2010: After vaccination, the patient was unable to eat, sleep or carry on normal activities as it was hard to focus on anything with terrible feeling. Trembling, headache, weird feeling in eyes and generalized anxiety were terrible. The patient felt detached from family and co-workers. The patient was fearful and depressed about the symptoms and their persistence. The patient visited to a doctor who prescribed Xanax but it gave only very minimal and short-term relief. The patient lost about 7 pounds in the course of a week or so. The patient re-visited to the physician and treatment was switched with Klonopin. The symptoms reduced and the patient was again able to carry on normal activities, eat and be functional at work. The patient remained on Klonopin at the time of report. The patient still had occasional internal trembling sensations especially upon awakening, and an overall sense of anxiety that would comes and goes.
Pt recvd MMR vax on 18JUL90; on 26JUL90 pt devel t103.2 & higher; Also exp agitation, & devel rash; Treated in ER;
Information has been received from a certified medical assistant concerning a 17 month old white male with no medical history, no history of chicken pox and no allergies who on 06-Mar-2003 was vaccinated in the right thigh with a 0.5 ml dose of varicella virus vaccine live (lot # 43824/0870M). On 06-Mar-2003 the patient was also vaccinated in the left deltoid with a first dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #43715/0838M). There was no other concomitant medication. At the time of vaccination the patient was ill with atopic dermatitis. On 15-Aug-2003 the patient developed clustered, painful vesicular lesions on a red base. There were three patches located on the right dermatome lesion, the right leg and the right lumbar spin (?L4). On 20- Aug-2003 the patient was seen in the office. The patient was diagnosed with herpes zoster and treated with acyclovir (Zovirax) ointment. No prescription drug was required. It was also reported that no rash occurred at the site of the injection or elsewhere within 42 days of the vaccination. No direct flourescent antibody was done and no specimen was collected for PCR. A photo was taken. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Patient called to report raised hot area after vaccination. Came up about 2 inches below vaccination site.
Day two: woke up with severe ringing in right ear, fullness, and crackling with certain movement.  Contacted ENT to report event who confirmed he has similar cases of other patients reporting tinnitus after vaccine.
Patient test positive for COVID at the nursing home where she lives on 8/4/21.  Received casirivimab and imdevimab monocolonal antibodies on the same day.  Pt arrived unresponsive at the ER 8/8/21 and expired.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates approximately in November 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M033334, expiration date 11-AUG-2018, lot # M029233, expiration date 09-AUG-2018 and lot # M020926, expiration date 11-AUG-2018 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of RECOMBIVAX HB were stored in the temperature of 47.7 degrees Fahrenheit for 45 minutes on 18-NOV-2016, then in the temperature of 47.5 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 5.5 hours (1 cycle) on 19-NOV-2016, then in the temperature of 29.7 degrees Fahrenheit for 11 hours (1 cycle) and in the temperature of 33.4 degrees Fahrenheit for 15 minutes (1 cycle) on 20-NOV-2016. Data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough case admission after 2 vaccines Pfizer 4/29/21 Lot3 Ew0172;  Pfizer 5/9/21 Lot# Ew0183
Fever, chills, aches 18 hours after the shot. Swollen lymph node 24 hours after shot
Tinnitus and hearing loss of sudden onset. Still ongoing. Diagnosed after audiology consult. Complete hearing test and consultation with ENT and no etiology was determined. Symptoms occurred within 4 months of receiving vaccine. Considering possible delayed autoimmune process from vaccine.
Development of fever to 104 degrees F with some irritability. Admitted to local hospital for observation. Medical treatment limited to acetaminophen. Pt discharged to home the following day.
mild fever (101), chills, muscle aches, headache, fatigue, nausea. Tylenol to reduce fever, and rest. Symptoms gradually improving after 24 hours
Mild erythema and edema to Left deltoid. Prescribed over the counter Motrin 400 mg every 6-8 hours as needed.
Headache; her arm is a little sore, but not excruciating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EN6204, Expiration Date: 30Jun2021) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "allergic", notes: 50 years ago. Vaccination history included: Bnt162b2 (First vaccine dose received on 21Feb2021, LOT: EL9267 Expiration: 31May2021 Left Arm), administration date: 21Feb2021, when the patient was 71 years old, for Covid-19 immunisation, reaction(s): "no adverse event". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Mar2021, outcome "recovering", described as "her arm is a little sore, but not excruciating"; HEADACHE (non-serious) with onset 16Mar2021, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of pain in extremity, headache.  Additional information: Caller stated that she is calling because she had her second dose of the shot and she has a headache, asks is she allowed to take Tylenol. Caller stated that she has no fever, her arm is a little sore, but not excruciating. Stated that she rarely gets headaches, this is the first one she has had in a while. Caller stated that her husband told her to take Tylenol. States the nurse didn't say anything to her. Stated her husband was told to move his arm and she wasn't told to move her arm even, stated she guesses it depends on who gives the shot what instructions are given. Caller stated that she has never had a hangover before in her life, it is a constant headache, no fever. She stated the more she slept the better it felt. Caller stated she is sure if she is allowed to take Tylenol, it would work but she didn't want to affect vaccination. She stated that she knows before the vaccine it is not allowed but she doesn't know about after. And also stated as she is talking her headache is going away.  No follow-up attempts are possible. No further information is expected.
Headache, Fever, NauseaVomiting RIB PAIN Narrative:
About 5 minutes after her vaccination, patient said she didn't feel well and then fainted.  She woke up quickly and felt better after she rested and had some orange juice.
Patient had an itchy rash with hives that started about 30 hours after the vaccine was administered.  She initially took diphenhydram,ine and cetirizine but ended up going to the ER.  At the ER she was given an injection of dexamethasone and sent home with a methylprednisolone dose pack.
Developed shingles. Symptoms  began May 5th, skin lesions on May 10th
Unknown Adverse Event; This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2015-2016 season) (batch number DX4SN, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2015-2016 season. On an unknown date, less than 4 months after receiving Fluarix Quadrivalent 2015-2016 season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Fluarix Quadrivalent 2015-2016 season.  Additional details were provided as follows: The reporter did not provide age, age at vaccination, gender or any patient details. The age group was selected as adult as the patient was an employee. The patient developed an unknown adverse event in 2015 after receiving Fluarix. The reporter did not provide any further information.
Felt fine until about nine hours after the shot. Had been sitting at computer for at least six hours straight (and probably smoking more pot than I should have), felt dizzy and short of breath, got up, ended up losing consciousness on the living room floor. Woke up a few minutes later and put myself to bed; felt fatigue, aches, chills, and like I might have been running a mild fever. Slept unusually well; woke up this morning feeling perfectly fine. Not particularly concerned but felt like I should report it.
This spontaneous report as received from a registered nurse refers to an unspecified amount of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant medications were reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from an office manager; reporting on a 17 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated by the medical assistant with an adult dose of VAQTA 50/1.0 U/ml, lot # N016805 and expiration date 04-SEP-2018, for prophylaxis (route of administration was not reported). No adverse effect was reported. No further information was obtained.
Break thru Varicella, Previous Varivax administered 4/13/1999.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 31Aug2023 to 05Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, redness to arm, HA, nausea increased joint pain, swollen arm, and lymph nodes in neck, chills.
Currently 36 weeks pregnant due November 23, 2022. Got the worst migraine of my life starting around 1130pm the night of vaccine which woke me from sleeping and came with neck pain and nausea. Attempted Tylenol, Reglan, sleep, ice, hydration, massage, chiropractor, caffeine, all with minimal relief
pt recvd vax on 11MAR93 & MOC noted a hard nodule @ inject site; pt was seen by MD & it was noted that pt had a sterile abscess of 1 x 1.5 cm & induration @ inject site; By 29APR93 pt had recovered; No further details were provided;
Patient complained of arm soreness bilaterally. Rt side soreness worse than Lt. Patient took Ibuprofen and said it wore off at 10pm 7/3/18. She then states she had feeling of weakness, nausea, increased heart rate and SOB "like a panic attack". She did not seek treatment. She took more ibuprofen and went to bed. She felt better in AM except residual arm pain to Rt side which consists of pain, stiffness and "shooting pains" requiring the use of ibuprofen still on 7/9/18. She then contacted the health dept and was encouraged to contact her primary care physician.
Approximately 6 hours after getting the Pfizer vaccine, 5 itchy hives on the left side of my face happened. The physical hives lasted for 1 hour. The area remained itchy for about 24 hours. Bad dizziness 22 hours later which lasted for 4 hours. 99.6 fever 31 hours after vaccine administered.
Body Ache, breathing difficulty with burning sensation, intermittent low grade fever. Treatment rest, fluids, regular perspiration.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient called and stated that her arm was really red and itchy for several days. Then she thought that it seemed like a piece of "metal" came out of her arm, but that it flew away quickly, so she really could'nt tell. She said she is fine now. She didn't feel like its a vaccine issue, but maybe more of a malfunction in the needle.
Booster; I took the Johnson & Johnson shot earlier this year in May I took the Pfizer booster shot Dec2021; feeling not good; diarrhea; pain in my bones; chills; no smell; no taste; sinus congestion; major coughing; upper respiratory problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson & johnson (Dose:1), administration date: May2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Dec2021, outcome "unknown", described as "I took the Johnson & Johnson shot earlier this year in May I took the Pfizer booster shot Dec2021"; MALAISE (non-serious) with onset Dec2021, outcome "not recovered", described as "feeling not good"; DIARRHOEA (non-serious) with onset Dec2021, outcome "not recovered", described as "diarrhea"; BONE PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "pain in my bones"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "chills"; ANOSMIA (non-serious) with onset Dec2021, outcome "not recovered", described as "no smell"; AGEUSIA (non-serious) with onset Dec2021, outcome "not recovered", described as "no taste"; SINUS CONGESTION (non-serious) with onset Dec2021, outcome "not recovered", described as "sinus congestion"; COUGH (non-serious) with onset Dec2021, outcome "not recovered", described as "major coughing"; RESPIRATORY DISORDER (non-serious) with onset Dec2021, outcome "not recovered", described as "upper respiratory problem".  The lot number for bnt162b2 was not provided and will be requested during follow up.