chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ag positive 23Apr; Ag positive 23Apr; Sx chills 22Apr; Fevers; Cough; Body aches; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 23Apr2022, outcome "unknown" and all described as "Ag positive 23Apr''; PAIN (non-serious) with onset 22Apr2022, outcome "unknown", described as "Body aches"; COUGH (non-serious) with onset 22Apr2022, outcome "unknown"; PYREXIA (non-serious) with onset 22Apr2022, outcome "unknown", described as "Fevers"; CHILLS (non-serious) with onset 22Apr2022, outcome "unknown", described as "Sx chills 22Apr"; The events "ag positive 23apr", "sx chills 22apr", "fevers", "cough" and "body aches" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Positive, notes: COVID test name post vaccination: Home Ag. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure, chills, pyrexia, cough, pain.  Clinical Course: It was unknown if the patient had COVID Prior Vaccination. The patient had COVID Tested Post Vaccination. The COVID Test Type Post Vaccination was unknown. The COVID test name post vaccination was Home Ag.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information in the case the plausible casual relation between the reported events and suspect drug BNT162b2 cannot be excluded.
Transverse myelitis after 2nd dose, currently in hospital; First dose 4/1/2022 - Second dose 4/11/2022; This case was reported by a consumer via call center representative and described the occurrence of myelitis transverse in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 11th April 2022, the patient received the 2nd dose of Shingrix. On 11th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 28th April 2022, the patient experienced myelitis transverse (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the myelitis transverse and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the myelitis transverse to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR094025   Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: The patient had transverse myelitis 17 days after second dose of Shingrix. The patient had stroke after 1st dose of vaccine and also found atrial fibrillation. The patient visit to doctor physically once a year and twice a year after the patient turn 65 year. The patient was in hospital. Additional Supportive Information: The patient received the 2nd dose of Shingrix early, which led to shortening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094025:Same reporter
Initial report received from a health care professional in the USA on 09 May 2007. A 48 year old, female patient (with a medical history of no known allergies, hypertension and depression) developed fatigue, weakness, "flu like symptoms", body aches, redness around the injection site, edema (large amount) in the entire left arm and pain and tingling from the injection site down the arm to the fingers, one day after she received Adacel (lot number C2731AA) intramuscularly in the left deltoid on 03 May 2007. She did not have any laboratory or diagnostic tests done. She did not have any illnesses at the time of the vaccination. At the time of the report, she had not recovered. Same reporter as cases 2007-01632 and 2007-01633.
KILLED BONE MARROW; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, shot killed patients bone marrow and had to get a transplant. As per reporter "JJ shot killed my bone marrow. Had to get a transplant."  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of killed bone marrow was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220306933-Covid-19 vaccine ad26.cov2.s-Killed bone marrow. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
On Oct 9 Received PNEUMOVAX 23 at 10:34 a.m. was fine all day then suddenly at 6pm, my arm went numb all the way to fingers, with extreme pain. Was driving at the time. Was difficult to talk. An hour later was too dizzy to stand. Took BENADRYL, sat for 2 hours, then a friend drove me home. Arm had a huge knot around shot, and on under side of arm also. Deep red rash all down my arm. Severe pain continued all night. Saw doc next morning. Used warm compress, redness localized to 3 inches round shot. Pain and swelling still present now, 54 hours later. Arm now itches, but I have regained strength in it.
This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 10:00 (Batch/Lot Number: EN 6201) as SINGLE DOSE for covid-19 immunization. Medical history included cardiac failure congestive, atrial fibrillation and prolonged issues from having Covid 19. Concomitant medication(s) included high blood pressure medications and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient was allergic to morphine, hydrocodon, lorcet, reglan, cortisone, Diflucan and Mobic. Patient did not receive other vaccine in four weeks. On 17Feb2021, the patient experienced large sore red golf ball size knot at injection site, nausea, chills, headache, intermittent chest pains, achiness all over like the flu. The knot was still there as of 18feb2021 at 03:456pm and was still very sore and still very large. Patient did not received treatment for adverse events. The outcome of the events was not resolved.
Info has been received from a female pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). Subsequently, the pt developed a knot the size of a golf ball, warmth and tenderness at the injection site for 3 to 4 days. Medical attention was not sought. Additional info has been requested.
Since then vaccine 2 booster made no difference in pain levels.; Since then vaccine 2 & booster made no difference in pain levels; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Oct2021 (Lot number: 320306D) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "cant walk without assistance", start date: 03Feb2021 (ongoing), notes: Seriousness criteria: Persistent/significant disability/incapacity, important medical event, AE required visit to: Physician offices, AE outcome: Not recovered, Treatment: Yes, If yes, Details: Biowave machine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Time (24hrs): 03:00 pm, Anatomical site of injection: Upper left arm, Route of administration: Intramuscular, Batch/Lot: EL9261), administration date: 28Jan2021, when the patient was 79 years old, for Covid-19 Immunization; Bnt162b2 (Dose number: 2, Time: 03:00 pm, Anatomical site of injection: Upper left arm, Batch/Lot: EN6200), administration date: 02Mar2021, when the patient was 79 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "Since then vaccine 2 & booster made no difference in pain levels"; ARTHRALGIA (non-serious), outcome "unknown", described as "Since then vaccine 2 booster made no difference in pain levels.".   Additional information: 5 days after first vaccine of Pfizer, she woke in extreme knee pain. 05Feb2021- she have walked with a cane walker ever/since. In pain whenever she stand or mobilize. See a knee surgon (name-withheld) regularly. Have had digital photos and now bone scan Scheduled. Prescribed hydromorphine. Use Advil 600mg daily go to physical therapy 2x week for 3 months. Not effective. Ongoing. No change for 10 months. Followed 5 days of vaccine. Since then vaccine 2 booster made no difference in pain levels.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.
5 mins after injection right arm felt numb from elbow down. No pain no swelling. Pt states numbness was intermittent.
Shortly after patient received vaccination, I was flagged by spouse as patient became nonresponsive and experienced acute loss of consciousness.  No fall or external trauma. Consciousness regained however patient was A&O x 2/3 with pallor and incoherent speech. EMT was contacted and pt was assessed. Pt declined transport to hospital and was further monitored in pharmacy prior to departure.
Within 15 minutes I got a rash around the site that was gone within 40 minutes, later the evening of the vaccine i began to feel itching at the site. At 0400 the next morning I work up with pain in my arm , swelling and redness.  Over the following 24 hours the swelling got larger, warm to touch and painful to touch. I have used pain meds and ice to the area. It is a very large area on my arm .
Patient received pfizer vaccine on 2/12/21, 3/11/21 and 9/28/21. Presented to ER on 7/7/22. COVID positive on 7/7/22. 77-year-old female with past medical history significant for anxiety, arthritis, COPD on 3 L home oxygen at night, hypertension, pulmonary hypertension, spinal stenosis admitted for shortness of breaths and covered infection.  CT angio ruled out PE, small bilateral pleural effusion.  Also superimposed COPD exacerbation.  Started on empiric antibiotic ceftriaxone azithromycin and steroids.  Pt improved with above measures and  Blood cultures remained negative.    Oxygen weaned down to RA.  Saturating well.  Hemodynamically stable.Pt didn't require oxygen on 6MWT. Pt became medically stable and will be discharged home with tapering dose of steroids. Discharged on 7/11/22
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-May-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Internal review on 26-Jul-2021 resulted in updates to the pregnancy information. On 15-Jul-2021: Follow up received on included no new information.
About 1 week after the covid 19 vaccine, he had 4  episodes of syncope
Numbness in feet and hands Restlessness/Ticks/Twitches of Body Motion Sickness with slight movements/vertigo Tunneling Vertigo/Feelings of Passing Out  Extreme Nausea/Lack of Appetite  Flushed Face Painful sinuses Insomnia  Rapid Heartbeat Heart Palpitations Random Heart Rate Spikes Shortness of Breath  Nausea/Rapid Heartbeat/Weakness after a meal Super Thirsty Feeling of disassociation from body/floating swollen back of neck, tender to the touch, at base of skull. Touching causes very bad nausea Burning sinuses Tingling teeth
arm was really sore; could barely move it; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date unknown) for prophylaxis.   On 27th July 2021, the patient received the 2nd dose of Shingrix. In July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient stated her left arm was really sore and she could barely move arm, for the first two days after receiving 2nd dose of Shingrix. The reporter stated that, the patient had a bit more mobility in the left arm after the first two days, but mobility was still very restricted and remained same. The patient tried routinely stretching the left arm and using a heating pad to relive the pain and restricted mobility, to no available. The reporter consented to follow-up.
He had heavy inflammation and pain/irritation. A hard lump developed at the injection site that is still there to this day. It constantly causes irritation and scratching on his left thigh.
Client presented to the vaccination site on 11/11/2021. The client notified that he completed the series  on 08/21/2021. RN submitted a medical consult via phone call to agency Operations Leads, requesting to proceed with the COVID vaccine Janssen. Per Agency guidance, approval to proceed with COVID vaccine Janssen was obtained from medical consult team via phone call from agency Operations  . Client received COVID vaccine Janssen Lot#1822809 on 11/11/21. The client did not report any symptoms during the 15 min minute observation period. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site in a steady gait.
Flu like symptoms; Swollen hard ball at injection site; her skin peeled off where the hard ball was.; tenderness at the site of injection; This is a spontaneous report from a contactable consumer or other non hcp. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 29Jan2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included juvenile rheumatoid arthritis, ongoing familial mediterranean fever. Adverse events following prior vaccinations did not occur as an adult, but as a child. She got the small pox vaccine. She was 4 years old. She still has a scar from the vaccine. It was shortly after this they stopped administering the vaccine. Concomitant medication(s) included methotrexate (METHOTREXATE) taken for juvenile idiopathic arthritis taken for juvenile idiopathic arthritis; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for juvenile idiopathic arthritis,; colchicine (COLCHICINE) taken for familial mediterranean fever. She stated she was a counselor, she has a health care license, but confirmed she is not an HCP. On 31Jan2021, a couple of days after her second dose she noticed she had a really hard swollen hard ball, which she later clarified was located on her arm at the site of injection. It was hot. She was thinking at first it was normal. She called her doctor about it. Her doctor had suggested an antibiotic, but the caller stated she does not like antibiotics so she waited on taking it. Eventually this swollen hard ball went down. However, her skin peeled off where the hard ball was. Then a day or two later either 03Feb2021 or 04Feb2021, she started to experience flu like symptoms. She wanted to know if this was normal. She confirmed the swollen hard ball had gone away. However, now there was tenderness there. Her skin was dry and peeled off. The tenderness and dry skin where skin peeled off is getting better. She confirmed she did not take any antibiotic. No other vaccine in four weeks in four weeks was given to patient. The outcome of injection site swelling was reported as recovered, flu like symptoms as not recovered, skin exfoliation and tenderness as recovering,   Information on the lot/batch number has been requested.
I got my flu shot last year and was sick for over a week after; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved a patient of an unknown age and gender who get the Sickness (Illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient got the flu shot last year and was sick for over a week after (Illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of Illness.  There will be no information available on the batch number for this case.
1 day after: Extremely sore arm with redness and swelling - enough to cause sleeplessness; 3 days after: Shingles rash at site of previous shingles outbreak (2013) - treated with lidocaine.
pt states has had the flu vax a/ w/o any reaction;  this time approx 48 hrs p/recvd vax devel rash w/swelling on ankles, thighs, wrists, & neck; seen by MD;
FLU-LIKE SYMPTOMS: HEAD AND MUSCLE ACHES, SORE THROAT, FEVER, CHILLS
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy (from the neck down) and Handicap. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include pain medication.  pain medication prescribed for neuropathy.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information include:Reporter details updated
Redness and Swelling on left arm infection site Treated with Motrin and ice. Unable to be seen in office mom sent pictures through phone. Area 4 days later without swelling slightly pink.
Pt presented w/ redness that was hot to the touch, swelling, and rash spreading from deltoid to chest. Pt could not raise arm due to stiffness and stated he had experienced fever the night before but did not have fever at the time he was seen. Pt was given antibiotics and 48 hours quarters.
only the liquid portion of PENTACEL was administered to a pt with no adverse event; only the liquid portion of PENTACEL was administered to a pt with no adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 10 months old female patient who to whom only the liquid portion of pentacel was administered with no adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  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 DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (dose, formulation, strength: unknown) lot U7130AA via unknown route in unknown administration site as prophylactic immunisation.  On an unknown date the patient developed a non-serious event "only the liquid portion of pentacel was administered to a pt with no adverse event" (product preparation error) (single component of a two-component product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.