chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was inadvertently administered only the DTap-IPV component of the Pentacel without reconstituting with HIB/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (MI) (reference number- 00609599) and transmitted to Sanofi on 20-May-2021.  This case involves a 6 months old male patient who was inadvertently administered 0.5 mL only of DTap-IPV component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [ third dose, batch number: UJ382AAA and expiry date: 10-Jan-2021 via an intramuscular route at thigh (left or right thigh not reported) administration site] as the product was not first mixed with the Hib component (product preparation issue) on 28-Apr-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day).  Reporter want to know if the DTAP and Polio portion are still valid or if some other protocol needs to be followed at this point. Healthcare professional also asked if there were any special safety issues to look out for if only the DTap-IPV portion of the Pentacel vaccine was administered, without the Hib.   At the time of reporting, no adverse event was reported.  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 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.
bruising at the site; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received the 1st dose of the Pfizer Covid-19 Vaccine and had bruising at the site. She was on a blood thinner and we did not mention that before the shot. When she goes for the 2nd shot, I would like to know if she should stop taking Zoral Blood thinner before the shot. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Chest pain, heavy pounding heartbeat, palpitations from June 11th through July 7th,  Vaccinated with Pfizer on June 1st and 22nd.
Weakness of both lower extremities. Neutropenia. Fever/diarrhea 6/14/17. Mother believes his symptoms are associated with vaccines.
neck lump; cough; rash; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (neck lump), COUGH (cough), RASH (rash), PYREXIA (fever) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (neck lump), COUGH (cough), RASH (rash), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (neck lump), COUGH (cough), RASH (rash), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No treatment medication provided. No concomitant medication provided.   This case was linked to MOD-2021-176266 (Patient Link).
Woke up at 1:26am to use the bathroom and get a drink, I used the bathroom and got a drink from the kitchen and while walking back to bed I blacked out, hit the floor, woke up instantly and went to lie down. Felt exhausted and shaky but went back to sleep. No other side effects today.
This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 as dose number unknown, single (Lot number: EN6198) at the age of 67 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Acute sinus infection with positive Covid result" (unspecified if ongoing), notes: Acute sinus infection with positive, Covid result. Concomitant medication(s) included: PRAVASTATIN, start date: 02Jan2006, stop date: 11May2022 (lot: 35802170003, also reported as APOTEX); OMEPRAZOLE, start date: 03Jan2005, stop date: 15May2022(lot: 36036227450003, also reported as Dr. Private); VITAMIN D NOS, start date: 02Jan2012 (lot: 108180, also reported as Unknown Molecular Products); MAGNESIUM, start date: 01Jan2020 (lot: 250180, also reported as 250180). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: On 01Jun2022 the product quality group reported investigation results. It was concluded that: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6198 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6198, fill lot EN5330, and the formulated drug product lot EN5319. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Drug ineffective and Covid-19 cannot be completely excluded.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot# L013429, expiry date 21-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
FEVER, CHILLS, HEADACHE, MUSCLE AND ARM PAIN, FATIGUE, BODY ACHES
5 days after being administered the 2nd in a series of Gardasil developed hives requiring Benadryl and a visit to local ER. No facial edema, difficulty breathing or SOB occurred
Tested positive for COVID yesterday with home COVID test. Was exposed to daughter, who also tested positive.  Symtpoms started Friday night with vomiting then coughing.  Not sleeping, exhausted.  No vomiting but will sometimes have dry heaves from coughing.  Is a dry cough.  Also has a runny nose. Drinking fluids.
9 days after vaccine, red area around injection site followed by slightly pruritic maculopapular rash neck, arms, legs but most prominent on trunk.
Information has been received from a health professional concerning a male who on 02-JUL-2001 was vaccinated with a dose of Varivax (Oka/Merck) (Lot # 635792/1893K). Subsequently the patient experienced rash illness. Vaccine failure was noted. This was MD documented/evaluated. Follow up information indicated that no further information was available. No additional information is expected.
Started Friday, Jan. 22, 6:00PM until now 3:45PM Monday, Jan. 25. Red splotches of rash all over the body especially between ankles and knees. Chills and fever (as high as 103 degree). Middle  two fingers tingling and sometimes turning white.  Involuntary tearing of right eye. Diarrhea. Taking Tylenol for fever and benadryl I still have all the symptoms as of writing. Blood and urine sample were taken at er; results negative
Swelling of lips and face, no airway compromise. IM Epinephrine, swelling decreased. Pt stated similar reaction to flu shot. Patient did not disclose previous allergic reaction in vaccine questionnaire or verbally. Pt stated lip and botox injection sites were areas of swelling.
Submandibular lymphadenopathy, severe bilateral temporomandibular joint pain started 4/19/2021. Patient went to urgent care and received cephalexin without improvement.  Patient saw me 4/27/2021 and we are trying pain control with naproxen and hydrocodone?acetaminophen as needed for pain.  Labs below were drawn.
DOSE 3 (BOOSTER), SINGLE; Tested positive for COVID after a total of 3 doses of Pfizer COVID-19 vaccine had been administered; Tested positive for COVID after a total of 3 doses of Pfizer COVID-19 vaccine had been administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Dec2021, outcome "unknown" and all described as "Tested positive for COVID after a total of 3 doses of Pfizer COVID-19 vaccine had been administered"; IMMUNISATION (medically significant), outcome "unknown", described as "DOSE 3 (BOOSTER), SINGLE". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Dec2021) positive. Clinical course: The reporter mentioned that she had two patients who got their Pfizer COVID-19 vaccine including their booster, then tested positive on COVID after that.  Tested positive for COVID after a total of 3 doses of Pfizer COVID-19 vaccine had been administered. The reported event from date/to date/outcome are all unknown; but she thinks the test may have been taken today, 09Dec2021 and she believes it was a home test. She also reported that the patient reported no symptoms, only a positive result for COVID on that test. As far as caller is aware there has not been any further testing or anything done. The reporter has no information to provide regarding any further testing/investigations, treatment or medical interventions performed relative to this event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101759070 same reporter, product, events; different patients
Pain at the ball of the shoulder. States cannoT use leFt arm. Nausea
pt recv vax 26MAR97 & AP97 pt to hosp w/inc creatinine levels & nephrotic synd;14APR97 pt was dx w/systemic lupus erythematous per biopsy & serological testing;tx w/pulse steroids & mid-MAY97 pt hosp;pt dx w/chickenpox;
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of raised red bump at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in September 2011 the subject received a dose of FLULAVAL (unknown route, unknown deltoid). On an unspecified date in September 2011, the same week after vaccination with FLULAVAL, the subject experienced raise red bump at injection site. The bump covered most of the deltoid. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported 3 subjects who experienced raised red bump at injection site after vaccination with FLULAVAL. This is case 2 of 3 (see case IDs A0947997A, A0948000A for details of the other reports). The healthcare professional had reported the cases to VAERS.
1 hour had redness, developed flu like sx but no fever. Seen in clinic yesterday, +mild cellulitis at site of injection.
complicated history. Intermittent numbness of right arm after shot for 2 days. Developed fever, sore throat, cervical adenopathy, fatigue and abdominal pain 5 days later. Felt to have mono like illness with elevated LFTs though EBV and CMV titers negative. Was also noted to have elevated TSH and low T4 at the time. Concern now is that she continues with generalized fatigue and weakness and a white ring at the site of the hep B vaccine. She has seen several specialists and is slowly improving though not back to baseline. She just recently was able to return to school half days. The issue of macrophagic myofasciitis has been raised given her symptoms and persistent white ring on her arm at the site of the hep B vaccine.
Administered vaccine according to normal procedure. Patient reported she felt pain in her arm/shoulder. PCP called to advise of the adverse effect and that patient will be fine
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jun2022 at 10:00 as dose 4 (booster), single (Lot number: fj4991) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No Known allergies and other medication in 2weeks reported as No. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Negative, notes: negative test from first infection; (02Oct2022) Positive, notes: positive covid test result 7 days after negative test from first infection. (8 days after end of Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Anti-viral Paxlovid COVID 19 Treatment started on 20Sep2022 and stopped on 24Sep2022 with Lot number 2815071.
A few hours, post vax, pt began aching all over, vomiting, fever and hypersensitivity.
Under my Chin and Neck turned scarlet red.  A rash or hives covered my chest.  On the left side of my neck hives or a rash developed and crossed my shoulder down to the injection sight on my left arm.
51-year-old male Moderna vaccine First dose in February 2021 and second dose in March 2021. No side effects with the exception of fatigue for one day and sore arm.  On November 14 I received my Moderna booster??????.  Once again no reaction but a sore arm for one day.  On November 22 I broke out all over my body in hives.  Went to my primary care physician the following day. I was put on a regimen of prednisone.   Thanksgiving morning I woke up feeling worse with difficulty breathing. I then went to the emergency room at my local hospital. I was put on an IV and administered 60 mg of prednisone along with Pepcid. I was discharged later that day.  Once the prednisone regimen was over I was hoping this would end. It did not. I?ve then went to an allergist who does believe this is booster related. She advised me to take one Zyrtec and one Pepcid daily for the next few weeks.  They are far from over. My left hand occasionally resembles somebody drawling red lines on it. In addition, after a shower it can really come out.???  I get weird warm sensations that cross under my nose and elsewhere on my face.  Everyday is another rash/urticaria either on my torso,forehead,etc  ??
Tingling all over, aches all over, warm then later got fever chills and shaking rigors but better next day.
All other symptoms, like headache, muscle pain, dizziness, were gone 1 week after the shot (this is the second shot). But starting from 2 weeks after the shot, I started to have tinnitus in my right ear, then my left ear. The ear ringing is high pitched. Its magnitude will increase along with the background noise. It's affecting my sleep and mood a lot.
stroke; light headed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CML (CML Leukemia though she's in remission now) in 1999 and Surgery (Open eye surgery (2 & half year ago)). Concurrent medical conditions included Prediabetes, Blood pressure (Taking medication for blood pressure) and Renal disorder NOS (Taking medication for her kidneys). Concomitant products included METOPROLOL for BP, ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and life threatening). On 05-Apr-2021, the patient experienced DIZZINESS (light headed). The patient was hospitalized from 20-Mar-2021 to 23-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) had resolved and DIZZINESS (light headed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However,  patient's past medical history of CML, hypertension, Hyperlipidemia may contribute to this event. Further information is requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However,  patient's past medical history of CML, hypertension, Hyperlipidemia may contribute to this event. Further information is requested.
pt recv flu vax & redness, swelling to elbow site warm, fever, malaise;
This child had a 8 x 8 cm erythema and induration surrounding her DTaP injection.
Muscle fasciculations in chest, abdomen, hands, arms, and face; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 11:45 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history included exercise induced asthma, migraines, anxiety, depression, obsessive-compulsive disorder (OCD), chronic left ankle pain, hypertension, seborrheic dermatitis and sulfonamide allergy (allergy to sulfa drugs in bulk). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included montelukast (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN), ethinylestradiol; norethisterone (ALYACEN) and hydrochlorothiazide (HYDROCHLOROTH); all taken from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 15:30, the patient experienced muscle fasciculations in chest, abdomen, hands, arms, and face. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle fasciculations in chest, abdomen, hands, arms, and face was recovered on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
anaphylaxis; angioedema; hives; This case was reported by a physician via call center representative and described the occurrence of anaphylaxis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), angioedema (serious criteria GSK medically significant) and hives. On an unknown date, the outcome of the anaphylaxis, angioedema and hives were unknown.   It was unknown if the reporter considered the anaphylaxis, angioedema and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The doctor reported that she had a patient that received the second injection of the Shingrix series and the patient experienced anaphylaxis, hives and angioedema. The symptoms continued over the next several days. The case came through as a CRM, this is all that was reported. The reporter consent to follow up.
Pt developed shingles rash that he says he found this morning after receiving the vaccination yesterday.  Not painful, not itchy, lies in T10/T11 dermatome along the left lower abdomen.