chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recv vax on unknown day;  within 24 hr post vax pt exp chorea form movements; tx=Ativan
Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a health professional. Additional information received on 12-Nov-2018 from a health professional. This case is linked to cases 2018SA314537 and 2018SA314539 (same reporter). This case involves a 5 months old patient who was administered just the Dtap and polio portion of PENTACEL (batch number, EXP date, route and site of administration were not reported) on 08-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that patient received only liquid portion of PENTACEL. It was not reported if the patient experienced any adverse event or not. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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 female patient received bnt162b2 (BNT162B2), administration date 31Aug2021 (Lot number: FC3182) at the age of 40 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Liver disease" (unspecified if ongoing). Family history included: "Marfan syndrome" (unspecified if ongoing), notes: son does have a genetic disorder. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot: FC3180), administration date: 10Aug2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Heart is like pounding weird; l never had that feeling in my chest/felt it really very thumping; pounding on my chest felt like four times"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; CHILLS (non-serious), outcome "unknown", described as "Chills"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I just I felt weird". Therapeutic measures were not taken as a result of palpitations, nausea, chills, feeling abnormal. Additional Information: The patient son does have a genetic disorder (never been diagnosed with yet, so I don't know. He has a thing called Marfan syndrome (Further clarification was unknown). The patient stated event that never had that before. The patient received vaccine because she wanted to go and visit son in the hospital that just got heart surgery. The patient did not receive any prior vaccine. The patient stated that she doesn't like if she need to see a doctor for heart or what's going on you know what was mean like never had that feeling in chest before so after vaccination, both of them, it's after the second shot that's when heart started doing that. The patient stated that she cannot explain how she felt, she 'felt like' she was on drugs. The patient confused why her heart felt like that and she just do not know if maybe it was like heart problems in my family and it was making it effect more or what. The patient stated that after second dose felt it really very thumping and then this next time was yesterday, just felt it again just when was sitting the first time was lying down so was 3rd she believe of September and then yesterday which was 8th. No follow-up attempts are possible. No further information is expected.
Patient developed a 6cm x 12cm area of erythema, slight induration and warmth to touch on left thigh. She was treated with ice and observation Keflex 500 BID x 10 D if increased symptom. From mailed correspondence received on Aug 27 2001, it was reported, reviewed, no additional information at this time. This case is closed.
hard at the injection site; body aches; exhaustion; sore at the injection site; red at the injection site/injection site was red; swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard at the injection site), MYALGIA (body aches), FATIGUE (exhaustion), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE INDURATION (hard at the injection site), MYALGIA (body aches), FATIGUE (exhaustion), VACCINATION SITE PAIN (sore at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) and VACCINATION SITE SWELLING (swollen at the injection site). On 14-May-2021, MYALGIA (body aches) had resolved. On 16-May-2021, VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE SWELLING (swollen at the injection site) had resolved. On 18-Jun-2021, FATIGUE (exhaustion) and VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information were reported by the reporter.  Treatment information included massage.   This case was linked to MOD-2021-231152 (Patient Link).
severe thrombocytopenia; Latent autoimmune diabetes of adults; This is a literature report.  A 74-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type-2 Diabetes" (ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus. The following information was reported: THROMBOCYTOPENIA (hospitalization, medically significant, life threatening), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "severe thrombocytopenia"; LATENT AUTOIMMUNE DIABETES IN ADULTS (hospitalization), outcome "unknown", described as "Latent autoimmune diabetes of adults". The patient underwent the following laboratory tests and procedures: Antibody test: confirmed LADA, notes: Progressively rising; Anti-GAD antibody: Unknown results; Blood glucose: remained elevated, notes: after discharge from the hospital; Unknown results. Therapeutic measures were taken as a result of thrombocytopenia, latent autoimmune diabetes in adults.; Sender's Comments: Based on the available information in the case, the causal association between the events thrombocytopenia, latent autoimmune diabetes in adults and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
A few hours after receiving the vaccine I had muscle soreness onset in L deltoid near site of injection. A few hours after that I had moderate soreness in L deltoid, down L arm (bicep/tricep), and up into L pec and trap. I had difficulty abducting L arm to 90 deg but was not hindered in normal movements. Approaching midnight that day the soreness was improving and by mid next day it was limited to L deltoid upon palpation. After 2-3 days soreness resolved. No other adverse effects noted.   I have had very minor muscle soreness to a few vaccinations before, but not this bad. In those cases it has been limited to site of injection (deltoid) and less severe. Usually I don't notice anything after injections and I've never had any other adverse effects.
Developed Shingles on the middle of my back. After getting in to see my Dr. I was prescribed acyclovir 400 MG tablet Commonly known as: ZOVIRAX on 4/16/2021. I am currently on day 4 of the medication.
INJECTION SITE (LEFT DELTOID) PAINFUL KNOT THE SIZE OF A HALF DOLLAR. WAS WARM TO TOUCH. STAYED SAME FOR 1 WEEK, THEN GOT SMALLER. PRESENTLY CAN FEEL KNOT TO BE 1 INCH BY 1/2INCH WIDE.
Severe headache; Diarrhea started and it still has not gone away; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) and DIARRHOEA (Diarrhea started and it still has not gone away) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and TRAZODONE for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DIARRHOEA (Diarrhea started and it still has not gone away). On 19-Jan-2021, the patient experienced HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) and DIARRHOEA (Diarrhea started and it still has not gone away) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Stool analysis: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Tylenol 1000mg (four times a day), Imodium   This case was linked to MOD-2021-016483.
Called over to patient by observer. Patient c/o feeling near syncope. She was pale, diaphoretic, and bradycardic to 58. Patient reports history of previous near syncope/syncopal events with blood draw and immunizations. She reports no adverse reaction to the first dose.
RIGHT ARM PAIN Narrative: 32 yo male with PMH: cleft palate, OSA, pes planus, LBP and knee pain reported that his R arm (where he received the covid19 vaccine) hurt for 4 days and self-resolved. Pt received his first dose of covid19 vaccine on 2/11/2021. ADR was reported on 3/4/2021 when he came back for his second dose of covid19. Bot vaccines were administered without complications.
The patient had severe pain in her lower back and had to be seen by the doctor. It happened the day after she got the vaccine and continued for about a month after.
SHOOTING PAINS IN LEFT LEG AND FOOT; FELT ACHY FROM HER NECK AND AT THE SCAPULAR REGION; FELT VERY WEAK; PERIPHERAL NEUROPATHY EXACERBATED; NOTALGIA PARESTHETICA; COULD BARELY WALK; BRAIN FOG; STIFFNESS ON LEFT SIDE; TENDERNESS ON HER LEFT SIDE; This spontaneous report was received from an 87-year-old. The patient's height, and weight were not reported. The patient's concurrent conditions included peripheral neuropathy, allergies to an extensive list of medications (unspecified), and sleeping problem (not specified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805029, and expiry: unknown) dose was not reported, 1 total, administered on right arm on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included diltiazem hydrochloride, spironolactone used for unknown indications; and zolpidem for an unspecified sleeping problem. On 13-MAR-2021, right after vaccination, the patient felt very weak, the left side of her body was very stiff and she felt achy which originated from her neck and at the scapular region. The patient could barely walk at that time and also experienced itchiness and brain fog. The patient also had tenderness on her left side and was tender to touch. She felt that the vaccine exacerbated her condition of peripheral neuropathy. On 31-MAR-2021, the patient visited her dermatologist who stated that the reason for chronic itching was due to notalgia paresthetica. On an unspecified date, grip tests were done. On an unspecified date, the patient saw her primary care physician (PCP) and neurologist and they both stated that the patient was pretty strong during her grip tests on the left and right side. The patient stated that the PCP and neurologist were not too concerned that the adverse event could be due to the vaccine and hence, she reported her symptoms via call. The patient stated that the itchiness and the tenderness on her left side had gone away. The patient felt better at the time of reporting however, she continued to experience residual stiffness on her left side and nerve discomfort. The patient stated that she still felt achy at times and that there was shooting pains in her left leg and foot that bothered her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from notalgia paresthetica, and tenderness on her left side, was recovering from stiffness on left side, peripheral neuropathy exacerbated, and felt achy from her neck and at the scapular region, had not recovered from shooting pains in left leg and foot, and the outcome of could barely walk, brain fog and felt very weak was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210838529-COVID-19 VACCINE AD26.COV2.S-peripheral neuropathy exacerbated. 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.
Patient got a covid-19 after first dose of the Pfizer vaccine; Patient got a Pfizer vaccine on April 2021 and a Moderna vaccine on June 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient got a Pfizer vaccine on April 2021 and a Moderna vaccine on June 2021) and COVID-19 (Patient got a covid-19 after first dose of the Pfizer vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient got a Pfizer vaccine on April 2021 and a Moderna vaccine on June 2021). On an unknown date, the patient experienced COVID-19 (Patient got a covid-19 after first dose of the Pfizer vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient got a Pfizer vaccine on April 2021 and a Moderna vaccine on June 2021) had resolved and COVID-19 (Patient got a covid-19 after first dose of the Pfizer vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was received by the patient  No Treatment was received by the patient.
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (reporting for herself).  A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date not reported), via an unspecified route of administration on 23Dec2020 as a single dose for covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient reported that she received her first dose on "23Dec and on 27Dec tested positive for Covid". The clinical outcome of the events tested positive for Covid was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (4 days in this case). However, a causal relationship between event "tested positive for Covid " (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded.
The COVID-19 vaccine administered through a vaccine administrator, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
chronic pain; nauseous; headache; dizzy; everything was foggy; swelling; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, osteoarthritis, rheumatoid arthritis, obese, high blood pressure, diabetes type 2, and co-morbidities.  The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. . The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAY-2021, the subject experienced dizzy. On 15-MAY-2021, the subject experienced everything was foggy. On 15-MAY-2021, the subject experienced swelling. On 15-MAY-2021, the subject experienced nauseous. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced chronic pain. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache, and swelling, and the outcome of dizzy, nauseous, everything was foggy and chronic pain was not reported. This report was non-serious. This report was non-serious. This case, involving the same patient is linked to 20190513035 and 20191219543.
This spontaneous report was received from a licensed practiced nurse refers to a 8 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies included sterile diluent (MRK INJ). On 10-APR-2018, the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N023969 and expiration date: 28-FEB-2018) subcutaneously at the temperature from -14 degree Celsius (C) to -10 C (-14 C) for 1 hour. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of the report received from the same reporter. Sender's Comments: US-009507513-1804USA006162: US-009507513-1804USA006161.
Extreme mental fatigue; Forgetfulness; Metallic taste in mouth; Metallic smell in nose; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 12:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and non-steroidal anti-inflammatory drug allergy (NSAID). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN), progesterone (PROGESTIN)/ estrogen nos (MANUFACTURER UNKNOWN) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR) all for unspecified indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 13:00 the patient experienced extreme mental fatigue, forgetfulness, metallic taste in mouth and metallic smell in nose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were 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 extreme mental fatigue, forgetfulness, metallic taste in mouth and metallic smell in nose were unknown.  No follow-up attempts are needed. No further information is expected.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild
itching of upper extremities followed by urticaria upper extremities & face;DPH given;