chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.
May 4, 2021 patient came to pharmacy stating she had a reaction the day after receiving her second dose.  She described it as itchy, painful, swollen and red at the injection site.  She insisted it be reported.  She also had a severe headache and stomach upset.  Her injection site as of May 4, 2021 is getting better.
Patient presented to the ED with complaints of dyspnea and diarrhea. Patient was positive on 12/03/21 for COVID-19 and had augmentin/doxycycline. patient also received a round of antibody infusion on 12/09/21.  Patient was found to have o2 saturation of 83% on RA. Patient endorsed she has mild COPD and does not wear oxygen or even have an inhaler at home. Patient endorsed she has had a nonproductive cough and occasional wheezing but non on assessment. Patient was placed on 3LNC with o2 saturation remaining around 92%. Patient also endorsed diarrhea and stated she usually goes more than 3 times a day and denied any blood in stool. Patient endorsed some nausea and decreased appetite but denied any abdominal pain or emesis. Patient endorsed sore throat, loss of taste/smell, myalgias, light-headedness with ambulation and she had one episode of fever on Monday but has not had any issues recently. Patient also did endorse red rash on palm on hands and bilateral lower extremities from mid-shin to feet. Patient endorsed that she thinks they started on Wednesday but isn't sure. Patient also did endorse bilateral lower extremity edema. Patient endorsed that sometimes she has pain with ambulation. Patient endorsed that left lower extremity swelling is larger than right lower extremity. Patient did not have any calf tenderness on examination.   She was treated with Remdesivir and Decadron and is on room air on day of discharge.  Elevated Cr, uncertain if AKI or CKD, but Cr has been stable. Trial of albumin given Patient and her daughter opt to go home instead of Rehab  Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Severe shoulder pain initially felt pain at site, Later in shoulder, "Cracking" from site, then joint persistent pain scan at 3 weeks, Cracking subsided, 6-800 mg ibuprofen for 3 X  1 day.
Information has been received from a physician concerning a pediatric patient who was vaccinated with a 0.5ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Subsequently, following vaccination, the patient developed a stiff neck. It was unspecified if medical attention was sought. It was reported that the patient still has a stiff neck at the time of this report. No product quality complaint was involved. No further information is available.
liquid from the injection site was dripping through the arm; liquid from the injection site was dripping through the arm; A spontaneous report was received from a pharmacist concerning, a female patient (HCP) of unspecified age who received Moderna (mRNA-1273) vaccine and experienced an adverse event of liquid from the injection site was dripping through the arm (Vaccination site discharge and Underdose).   The patient's medical history was not reported.   Concomitant product use was not provided by the reporter.    On 19 Feb 2021 morning, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.   On 19 Feb 2021 morning, after receiving the vaccine, the patient raised the arm and saw that liquid from the injection site was dripping through the arm. The reporter wanted to know how to proceed and if the dose could be repeated. Reporter did not have much information about patient.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event of liquid from the injection site was dripping through the arm was considered as Resolved on 19 Feb 2021.; Reporter's Comments: This case concerns a female patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot # unknown), reporting Vaccination site discharge and Underdose without any associated adverse events. Event considered as resolved.
Neuro exam non focal. Etiology unclear however low concern for a demyelinating polyneuropathy, myopathy, or other acute CNS process at this point. UA positive for UTI which could be contributing
Patient was seen in drive through testing site with a positive covid test after being fully vaccinated. C/O cough, SOB, Fatigue, Muscle body aches, loss of taste, congestion, runny nose
Upset stomach; I had tenderness in injection site arm; Tiredness/Fatigue; Headache.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), VACCINATION SITE PAIN (I had tenderness in injection site arm), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headache.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. URV12F1A, 029120A and 025J202A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), VACCINATION SITE PAIN (I had tenderness in injection site arm), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headache.). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), VACCINATION SITE PAIN (I had tenderness in injection site arm), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headache.) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient reported that they experienced tenderness in injection site arm, tiredness, fatigue, upset stomach and headache. Reportedly, the symptoms were ongoing.   This case was linked to MOD-2021-016567 (Patient Link).
The heated spot was hot, tender, and about 5 inches; heated spot was hot, tender, and about 5 inches; Tenderness and pressure/top left side of her head heated up; Head sore/tender on the side of  head; The top left side of head heated up and was sore/Severe migraine; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE, FEELING HOT, INFLAMMATION, HEAD DISCOMFORT, and HEADACHE in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced MIGRAINE. On 20-Jan-2021, the patient experienced FEELING HOT, INFLAMMATION, HEAD DISCOMFORT, and HEADACHE. On 19-Jan-2021, MIGRAINE had resolved. On 20-Jan-2021, FEELING HOT, INFLAMMATION, HEAD DISCOMFORT, and HEADACHE had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment included Advil. This case was linked to MOD21-026177 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up information received 27-APR-2021 on  contains non-significant information; Sender's Comments:  MOD21-026177:
Large red welt (approx 20 cm) wit itching and pain starting 10 days after vaccine, starting to improve 6 days later
Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced some itching with the first dose, but with the second dose she experienced more severe itching and the her lips began to swell. Subsequently, the patient recovered. The physician indicated that he was planning to vaccinate the patient with the third dose, but planned to have an EPI pen with him just in case the patient had an anaphylactic reaction. Additional information has been requested.
Hives throughout my body began  5 days after my injection and lasted for 3 nights.
About 20 minutes after receiving vaccine, started to get a rash on chest and neck and began to have itchy feelings. After about 25 minutes, chest started to feel tight and breathing difficulty. Used Xopenex (Albuterol rescue inhaler, two puffs). 30 minutes after vaccine told nurse at vaccination clinic that I was getting itchier and asked for Benadryl. Received 50mg benadryl intramuscular shot in left arm approx 35 minutes after vaccine. Just a few minutes later throat started to feel tight and kept on coughing. They administered epi in left arm intramuscular. I believe they said it was 0.5 (maybe 5?). A few minutes after that the tightness started to improve and they had called EMS. While in ambulance, it started to get more itchy again, neck and chest and down arms. In ambulance they gave through IV some type of steroid and pepcid. No more medication was given at hospital, monitored for heart and breathing  for approx 2 hours. Discharged home with 5 days of prednisone and benadryl as needed.
Information was received on 26-MAY-2017 regarding a case in litigation concerning a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2015 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JUN-2016 the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir (VALTREX) and aluminum sulfate tetradecahydrate, calcium acetate monohydrate (PEDIBORO) compresses for management of the painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
can't get enough sleep; developed a bad rash on my back, developed a bad rash on my side; have periodic muscle pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (can't get enough sleep), RASH (developed a bad rash on my back, developed a bad rash on my side) and MYALGIA (have periodic muscle pains) 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 16-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced SLEEP DISORDER (can't get enough sleep), RASH (developed a bad rash on my back, developed a bad rash on my side) and MYALGIA (have periodic muscle pains). At the time of the report, SLEEP DISORDER (can't get enough sleep), RASH (developed a bad rash on my back, developed a bad rash on my side) and MYALGIA (have periodic muscle pains) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.
patient vomited 9/2 and lost vision; then on 9/9 presented with emergent need for VPS; on day of procedure testing showed covid positive
Sharp chest pains, shortness of breath.; Sharp chest pains, shortness of breath.; This is a spontaneous report from a contactable consumer (patient reported on himself). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN0199, Pfizer NTEC), via an unspecified route of administration, administered in left arm on Mar2021 07:00, as 1st dose, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: RE8734, Pfizer NTEC), via an unspecified route of administration, administered in left arm on Mar2021 07:00 (at the age of 51-years-old), as 2nd dose, single for covid-19 immunization. The most recent COVID-19 vaccine was administered in the hospital. Medical history included abdominal discomfort from an unknown date. Concomitant medication(s) included omeprazole (PROTONIX [OMEPRAZOLE]), pseudoephedrine hydrochloride (SUDAFED 12 HOUR), glucosamine (GLUCOSAMINE), l-arginine (arginine), ascorbic acid (VITAMIN C ACID) and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously took PCN (penicillin nos). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. In Mar2021, the patient experienced sharp chest pains and shortness of breath. The patient did not receive any treatment. The clinical outcome for the events was not recovered.
Severe joint pain for multiple days, headache, arm where injection was given warm and very sore
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 13-month-old female patient who received KINRIX (batch number KJ924, expiry date 22nd October 2014). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX.
Patient came in today for her second dose.  When asked how she did after the first dose, she reported having chest pain and palpitations 2 to 3 days after receiving her first dose on 11/2/21. She used the word tachycardia. She mentioned that she had never had tachycardia before. She reports her palpitations lasting for 10 minutes at a time, usually in the mornings for 6-8 days. She did not seek medical care or take any medication for the events. After the 6-8 days, she reported having palpitation episodes a couple of times a day but not as severe. The most recent palpitation episode was 2 days ago. Vaccination was deferred until it is clear if symptoms are related to pericarditis/myocarditis and if so, if symptoms resolved. Advised patient to seek medical care. The patient may have visited an ER. Her primary care physician was contacted via internal messaging system.
Within 10 minutes my right wrist started to swell, then my ears started ringing, then skin on arms started turning reddish/purple..... after about 20 minutes my throat felt like it was closing in, felt lightheaded.... after 30 minutes it was hard to breath, heart racing and felt nauseous and itchy all over.  Pharmacist called the paramedics and they checked my vitals which were fine except high blood pressure (not normal for me) I refused hospital treatment and all allergic reactions subsided within 2 hours.  After that I was extremely tired and ran a low fever for 2 days and had a patch of hives on my right thigh that was not there before the shot.
Chest pressure, heart racing, and feeling of breathlessness.    Occurred after first one and passed it off as anxiety but when it happened this time I was concerned it was side effect as not having any added stress or anxiety.
Note, the last two digits of the lot number is unclear on my vax card - looks like 1A.  Perfectly healthy, athletic.  3 weeks after vax shot 2 I developed acute stiffness and pain in my neck.  Could barely move head without pain.  Went to doctor and was given muscle relaxer and anti-inflammatory and sent to PT.  Have been in PT ever since, with gradual modest improvement.  XRAYs suggested mild/moderate arthirtis in neck.  I also developed numbness in my hands and feet, particular when sleeping. This lasted a few weeks and has gone away.  Next a week or two later I began to get stiff at night or when sitting in a chair -- in both hips and in left knee.  I had no such problems before.  This condition improves if I take anti-inflamatories and i feel fine, but if I stop, the stiffness comes back in a day or two.  Never had these problems before, all started right after shot number 2.
TRANSIENT ISCHEMIC ATTACK (TIA)/STROKE; FELT LIKE GOING TO DIE; This spontaneous report received from a patient concerned a 57-year-old Asian and not Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's concurrent conditions included blood pressure, and numbness. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 042142114, and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 to left arm for prophylactic vaccination.  On 15-APR-2021 the patient called paramedics due to right side felt numb. Paramedics diagnosed her wrong as having a panic attack. On 17-apr-2021, the patient started feeling numb and disoriented and close to midnight she felt like going to pass out. She also felt right side was not working and she called paramedics again and was taken to emergency room. Her blood pressure was at 172/111 and she was shaking a little. She underwent the laboratory test magnetic resonance imaging (MRI), computed tomography scan, magnetic resonance angiogram and blood work was performed. On 18-Apr-2021, At 17:00, the patient  was informed that she was moved to another hospital since she was diagnosed with and she was diagnosed with transient ischemic attack (TIA)/Stroke. The patient described that her side was still numb so they performed magnetic resonance angiogram (MRA). No Damage was found hence she was discharged from the hospital on 20-Apr-2021. The patient was hospitalized for 4 days. The patient was prescribed with amlodipine for blood pressure and clopidogrel bisulfate for a blood thinner. Patient reports continuing to "feel a little numb" intermittently. She describes the initial symptoms as "feeling like I was going to die". She stresses that she "has never been to an emergency room in her life". The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from transient ischemic attack (tia)/stroke, and the outcome of felt like going to die was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20210453183-COVID-19 VACCINE AD26.COV2.S-transient ischemic attack (tia)/stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Dad brought in daughter for vaccinations. He agreed to have her receive: MMR, Hep B, Flu, Polio, and Tdap. I inadvertently drew up and administered Dtap instead of Tdap vaccine, after administering all 5 vaccines, I then discovered the error and immediately notified my nursing supervisor. After reviewing protocol, I went and spoke with dad and daughter. I advised them of the error, and that the dose doesn't require repeat vaccination. Dad and daughter both verbalized understanding and they were both ok with it.
Period arrived out of cycle and was considerably heavier than usual.; Considerably heavier than usual.; Passed more (and larger) clots than usual and bled much more than usual. This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0161) via an unspecified route of administration in the left arm on 18Apr2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. The patient had known allergies to Ni (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), withania somnifera (ashwagandha) (MANUFACTURER UNKNOWN and omega 3 (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. On 29Apr2021 at 07:45, the patient experienced period arrived out of cycle and was considerably heavier than usual. Patient passed more (and larger) clots than usual and bled much more than usual. In a single day, she used more feminine products than in a usual cycle, and still bled through three times much. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period arrived out of cycle and was considerably heavier than usual, passed more (and larger) clots than usual and bled much more than usual was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.