chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies were not reported. On 06-JUN-2008, the patient was vaccinated with COMVAX Lot #656510/0222u and expiration date: 09-OCT-2009 (dose and route of administration were not reported) and with RECOMBIVAX HB Lot #0490u (dose, route of administration, expiration date were not reported) both for prophylaxis (overdose). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Nausea, headache, chills, fatigue, diarrhea, wheezing
Fever, headache, sore throat began the day after dose 2. Persistent fevers x 5 days with negative strep, influenza, or blood culture results. Low-grade fever after first dose.
Patient developed red, raised, itchy rash on face, neck and chest. It developed within 24 hours of vaccination starting on the face area then spreading to neck and chest. Patient still had rash 7 days after onset.
Swollen right arm axilla area, reported enlarged "lymph node" on right clavicle area.
Patient states had pneumonia shot on 10/28/04. Later that day developed redness, swelling, surrounding area where shot was given. Was told to take Tylenol and apply ice. Lasted for six days.
Vesicular pruritic rash full body started 5 days after Varivax 2 was given
Given flu TIV on 10-25-11. On 10-30-11 developed fever, temp. unknown, and increased skin rash. Pt has sickle cell disease and had slight rash at vaccine admin. 10-31-11 went to ER and put on KEFLEX. Seen in our office 11-1-11 and put on steroid and KEFLEX dose increased.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 at 09:30 as dose 1, single (Lot number: EN6199), in left arm, on 03Apr2021 at 09:00 as dose 2, single (Lot number: ER8737), in left arm and on 06Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Mar2015. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: The patient took Pfizer Paxlovid anti-viral as Covid-19. The treatment started since 13May2022 to 18May2022 with lot number lot number= FY5656. The other medication took in 2 weeks product Lupin Losartan started on 01Mar2015.  No follow-up attempts are possible. No further information is expected.
15 min after vaccine administered I experienced ringing in my ears, dizziness, fast heart rate and leg weakness.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
He was fussy all afternoon and had low grade temp as is common.   At 3 am, he woke to feed and while taking bottle, had a seizure which lasted about 5 minutes. 911 was called, evaluated him and he was fine at that point. They suggested he be taken by family car. As family was getting ready to go, he began with another seizure and this one continued on and off for about an hour or more, requiring midazolam other other medications, and then he had respiratory depression and required intubation.  I know GM well and she called me a little after 5am where he was awaiting transport to hospital. I went to see him there and he was stable and intubated, breathing above vent.
Received 1st Moderna Vaccine on July 3, July 7 started having light chest pains, over the following days, chest pains increased, July 18, 2021 chest pains increased to severe. Went to Hospital ER, received aspirin  and numerous blood test and was admitted into hospital for further testing. Testing revealed inflammation of the chest cavity around the heart. Discharged day later, advised to rest to allow inflammation to decrease.
joint ( knees) aches Fever (100.2)-spiked at 3:00 pm day of shot.  Tylenol seemed to control it. *Itchy, rised, red rash around injection site-- noticed at 10;00 pm day of shot.  After 3 days fading, but still visible.*  Began Tylenol--2 tablets at 12:00 noon.  Took last dose at 6:00 pm the next day.
After my vaccine, I had a fever and my leg started to swell up. I also had pain in my right arm, injection site. I also had a covid test because of how I was feeling and the test was negative.  I had an u/s of my right leg to check for blood clots. An x-ray of the chest was also performed. I also have had a bad cough since my vaccine which I can not get rid off.  I am still not feeling 100% from the vaccine, still tired, fatigued and diarrhea.   I do not have my lot #, but I will call back when I get that information.
Chest tightness; Difficulty urinating; Sleeplessness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness), DYSURIA (Difficulty urinating) and INSOMNIA (Sleeplessness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced CHEST DISCOMFORT (Chest tightness), DYSURIA (Difficulty urinating) and INSOMNIA (Sleeplessness). At the time of the report, CHEST DISCOMFORT (Chest tightness), DYSURIA (Difficulty urinating) and INSOMNIA (Sleeplessness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The batch number of suspect drug was reported as 026C21A or 026L21A.  No concomitant medication was reported. No treatment information was reported.
Member was beign observed after admistration of second covid vaccine. 10 minutes into observation member approached the desk and asked for water to take benadryl. Member was asked why he was taking it and he explained that his throat felt "puffy". He expalined that this happened to him with his first vaccine. He was evaluated and was told to take benadryl with the second vaccine if this was to occur again. Dr. was consulted and advised to take the medication. Pateint was observed for an additional 15 minutes. His vitals were all stable. At time of discharge member states that the "puffiness" has improved. Member had mother in the car waiting to escort him home.
Again, about two weeks later, the hip joint pain returned; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Again, about two weeks later, the hip joint pain returned) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 02SL20A) for COVID-19 vaccination.     No medication history information was provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN and ATENOLOL for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Again, about two weeks later, the hip joint pain returned). At the time of the report, ARTHRALGIA (Again, about two weeks later, the hip joint pain returned) had resolved.            Concomitant medication includes Olm ned flesh hctz 40-25.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Additional information received and reporters information added, patient demographics added, concomitant medications added.
I experienced general fatigue, headache, slight nauseas, a little bit of achiness, and general brain fog.
(3/11/15) within a few hours of receiving vaccination, developed headache, pain at site of injection and general fatigue and chills. Subsided by 3/12/15. Took TYLENOL and rested.
discoloration of fingertips and toes, blue/black discoloration of both hands, hands ice cold; feet and leg edema and discoloration; mental fogginess. Started day of second vaccination and continues still.
A couple of days after vaccine, I experienced more blood in my nose that was fresh and kind of clump-like as the day progressed. But I called the Dr and the doctor doesn't think it is sinus related. I switched nasal sprays - got off the Zyrtec and Flonase - and I got on Nasacort and I was better with the nasal issue when I did that. Then in the past, I have had discomfort on the left side of my ribs - on and  off - but the last week to week and a half it has been pretty consistent. For the rib issue, I'm taking a med for that  - Naproxen. That med may have helped a little but I do still feel like I have something that is not right on that side of my body. It did not alleviate it completely.  April 7, I have had a bad leg cramp when I woke up and each morning since it felt like I was going to cramp up and they felt painful when I was sitting for a long period of time or when I was laying down getting ready to fall asleep. For the leg cramps, I am taking leg exercising and trying to get more Potassium in my diet. I saw a dr yesterday and he doesn't think they are related to the vaccine.
no adverse event, moderna confirmed 216K22A was viable until 2/23/23 despite beyond use date of 1/22/23
Feeling of having a stroke. Started at 7:30 PM on 07/22/2021 and still experiencing feeling on 07/23/2021. One side of mouth abnormal. (drooping)  Unable to sleep.
SHORTNESS OF BREATH, NAUSEA, VOMITING, DIARRHEA, HEADACHE, BACK PAIN, AND DIZZINESS
Had numbness and tingling in her face, neck and cheeks; Had numbness and tingling in her face, neck and cheeks; Had achiness for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Had numbness and tingling in her face, neck and cheeks), PARAESTHESIA (Had numbness and tingling in her face, neck and cheeks) and PAIN (Had achiness for a couple of days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Had numbness and tingling in her face, neck and cheeks), PARAESTHESIA (Had numbness and tingling in her face, neck and cheeks) and PAIN (Had achiness for a couple of days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Had numbness and tingling in her face, neck and cheeks) and PARAESTHESIA (Had numbness and tingling in her face, neck and cheeks) had resolved and PAIN (Had achiness for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.   This case was linked to MOD-2021-314631 (Patient Link).
Immediate pain at injection site. Subsided after 2 days. On the 3rd & 4th mornings, woke up to severe pain in the upper arm and shoulder. Pain subsided after being upright for a few minutes. On the 5th morning, woke up in severe pain which worsened and peaked in about two weeks. This was accompanied by weakness and atrophy of the infaspinatus muscle. The pain subsided over the next few months, but the weakness remained. An MRI and EMG led to diagnosis of Parsonage Turner Syndrome. Currently in physical therapy wi
began 4APR98 w/varicella-numerous pox on all body parts;T100;
Friday Evening, (7 PM) after the Thursday PM injection, I experienced extreme chills and all over body aches.  I took 2 Coricidin pills and went to bed at 9:30 PM.  After 12 hrs. of sleep, I woke up feeling better and have not experienced a return of symptoms.
Prolonged scream shrill-high pitched of 3 hrs duration; could not be comforted; temp not elevated beyond 101+ ax;
After having a booster shot, that day had uneven eye dialation; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (After having a booster shot, that day had uneven eye dialation) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE DISORDER (After having a booster shot, that day had uneven eye dialation). At the time of the report, EYE DISORDER (After having a booster shot, that day had uneven eye dialation) outcome was unknown.            Concomitant medications were not reported.  No treatment information was provided by the reporter.
pt recvd vax; large local rxn, entire upper arm swollen, 3x5 cm area of induration;
Severe dizziness, starting 5 hours after 2nd dose. It occurred at 9:30pm, so I went to bed. Woke up at 11pm, 1.5 hours later, and dizziness was gone.
No adverse effects; patient was administered improperly stored PROQUAD; This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 29-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number: R008206, expiration date: 16-SEP-2019) (dose and route of administration were not provided). The vaccine was stored in temperatures between 6 and 14 degrees (13 degrees) Fahrenheit for 7 hours and 15 to 46 degrees (34 degrees) Fahrenheit for 1 hour. Digital data lodger was not involved.  No adverse effects were reported.
BLACK AND BLUE INJECTION SITE; BAD HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced black and blue injection site. On 2021, the subject experienced bad headache. On 2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad headache, muscle ache and black and blue injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210429847.
so the first two time that I had the tooth problem; so the first two time that I had the tooth problem; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing), notes: Patient was on high risk, Patient have diabetes and hypertension (Intent : History); "diabetes" (ongoing), notes: Patient was on high risk, Patient have diabetes and hypertension (Intent : History). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Patient got the Pfizer vaccine from the beginning /the first two time that patient had the tooth problem, patient thought it was dental related.), for Covid-19 immunization, reaction(s): "I had the tooth problem", "Tooth ache". The following information was reported: TOOTHACHE (non-serious), TOOTH DISORDER (non-serious), outcome "unknown" and all described as "so the first two time that I had the tooth problem". The event "so the first two time that i had the tooth problem" required physician office visit. Therapeutic measures were taken as a result of toothache, tooth disorder.  Additional information: This report was not related to a study or programme. The first two time that patient had the tooth problem, patient thought it was dental related. Patient went to the dentist, they gave the pain medicine blah-blah. Patient received second booster on 26Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a 61 y.o. male patient of DO with history of MS, DVT, obesity presented to Hospital with generalized weakness and cough. Problem based management in the hospital is as follows:   Covid-19 Virus Infection Acute hypoxic respiratory failure, resolved Generalized weakness, POA, due to COVID-19 infection Date of onset of symptoms: 9/6/23 Symptoms present on admission: cough and fatigue Date of covid positive test: 9/8/23 Vaccination status: vaccinated Imaging: chest xray - Small to mild effusion in the left lung base with atelectasis.  Slight atelectasis in right lung base.  Oxygen requirements on admission: NA Current oxygen requirements: Room air.  Medical therapy: Was on dexamethasone and remdesivir, completed remdesivir.  Discharged on dexamethasone taper Consultants following: ID - appreciate recommendations Anticipated special isolation end date: 9/18/23 Continue aggressive pulmonary toilet - incentive spirometry, acapella, out of bed, deep breathing PT/OT/UM consulted for disposition planning   History of pulmonary embolism/DVT Continued Xarelto   History of multiple sclerosis Follows at multiple sclerosis clinic On Ocrelizumab infusions   CKD stage III Creatinine 1.5, baseline is about 1.4 Avoid nephrotoxic agents Monitor renal function   Hypertension Continued Coreg   Chronic pain syndrome Continued Cymbalta and gabapentin   Obesity BMI 35.57 kg per metered squared
Narrative: 91 y/o male present to ER on 1/16/22 reporting of worsening cough, dyspnea and weakness. Close contact recently had COVID. Admitted due Covid infection and elevate troponin. Treated with remdesivir and dexamethasone. Complications during admission included suspected CPAP, sepsis, thrombocytosis and lactic acidosis. Discharge on 1/24/2022. PMH includes, SVT, CAD, and Afib.
patient got the flu; Initial information was received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves patient [age and gender unspecified] who got the flu (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (non-serious) within 30 days following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
muscle soreness  only with the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blister (In february2023, received 1st dose and it broke up in pox, refer case US2023106949).   In JUL-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced muscle soreness (Verbatim: muscle soreness  only with the 2nd dose). The outcome of the muscle soreness was resolved.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.     It was unknown if the company considered the muscle soreness to be related to Shingrix.   Linked case(s) involving the same patient:  US2023106949   Additional Information: Receipt date: 07-AUG-2023 The patient self-reported this case. The patient received the 2nd dose of Shingrix vaccine 10 days ago from reporting, last week of July 2023. The reporter reported that he did not have pox reaction and had muscle soreness only with the 2nd dose. Not all information was available, reporter did not provide injection site or lot numbers or expiration dates for neither one of the doses. The reporter did consent to follow up with healthcare professional.; Sender's Comments:  US-GSK-US2023106949:case created 2 doses
No adverse event. Person was accidentally given 1 ml dose. They were monitored for 15 minutes without issues.
Vaccines were administered following a temperature excursion; there were no adverse reactions; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose number, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003602: US-009507513-2110USA003601: US-009507513-2110USA003604: US-009507513-2110USA003605: US-009507513-2110USA003600: US-009507513-2109USA001290: US-009507513-2110USA003599:
Uncontrollable shaking, vomiting, diarrhea, chills alternating with feeling hot, joint and muscle aches, fatigue, fast heartbeat, bad headache.  Shaking and vomiting stopped after a couple of hours, other symptoms have persisted for 3 days, but are improving.  This did not happen with previous covid vaccines.  Im wondering if it should not be given with the flu shot.