chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented to Emergency Department with urticaria at site of flu vaccine given 2 days prior. Symptoms started 1 hour prior to arrival to ED. While in ED,  spread to right thigh.  Also had 2 days of rhinorrhea. No fevers.  No GI symptoms.  No respiratory symptoms. Observed in ED. No signs of anaphylaxis observed.
Within minutes post vax, the pt developed an injection site reaction characterized by pain, redness, and swelling. The physician prescribed applications of ice and antihistamines.
Pain, soreness, tenderness, reduced movement. Time course has been 9 days and persists. Redness at injection site.
This is a spontaneous report from a contactable health care professional via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose. The patient's medical history and concomitant medications were not reported. On 23May2016 the patient experienced injection site soreness and came in to the doctor and the injection site was red, swollen, itchy and warm to touch and at the point of time, the doctor diagnosed the patient with a soft tissue infection. Outcome was unknown. The doctor stated that the events occurred because of PREVNAR 13.
SO the immediate reaction that I had was irritation at the site of the injection and when I moved my arm it hurt. But then the headaches started after the vaccine, about a week after my 2nd dose, so the first week of April. Well let's see, I changed PCD's and so I believe it would have been on May 7th 2021 that the DR gave me a two week prescription for an antibiotic to see if it was a sinus infection. I had headaches every day except for the last five days of the medication. I went back and they gave me medication that is Butalbital/Acetaminophen/Caffeine/Codeine and that did absolutely nothing for the headaches. So, I went back again on the 22nd of June and he gave me a Toradol shot which helped for a couple days and then on the 1st of July I had an MRI and the 13th of July I saw a new pain DR and he prescribed me new medications which are Topiramate 25mg, Tizanidine 4MG. My cardiologist which I told you, on the 16th of July my Verapamil was increased to 240MG as well. SO that's what I have been trying to get some relief, and I am getting a little bit of relief but no answers or real help in order to have something work.
This spontaneous report has been received from a Pharmacist via Pfizer, concerning to a 74 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, lot # and expiration date were not reported) for prophylaxis. It was mentioned that the patient had an allergy to PNEUMOVAX 23. No further information was provided. The causality between vaccination with PNEUMOVAX 23 and the hypersensitivity was assessed as related. Additional information is not expected as no contact details were given.
Severe generalized pruritus, likely delayed hypersensitivity; Severe generalized pruritus, likely delayed hypersensitivity; This is a spontaneous report from a contactable physician (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 10Jan2021 at 08:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included seasonal allergies. Patient has no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Jan2021, the patient experienced severe generalized pruritus, likely delayed hypersensitivity. Patient was given antihistamines and topical agents for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Throat swollen, blood pressure increase, pt contacted doctor, was advised to take Benadryl.
Red, indurated lesion in dermal layer with sore vesicles at epidermal level. Pronounced local reaction (thickness).
Diaphoretic, weak one hr after injection. BP 146/90, P 114, O2 Sat 100% RA, T 97.9 - MD called, had her lie down on (R) side, monitored VS and called 911 - sent to ED.
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24 year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and 4 months after vaccination developed meningococcal meningitis and sepsis, year reported as 2009 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
mom states pt lt arm red & swollen around inj site;instructed to use warm compresses & given APAP;p/having warm compresses to arm, arm was swollen more;pt taken to MD & tx w/med;pt exp urticarial rxn;-allerg rxn to DTAP;
Covid Arm. A raised, red, itchy patch near the injection site. It is 4" high by 3" wide. This is day 3.  Seems to be dissipating some. It is responding to Benadryl, cold compresses, and topical application of cortizone cream at the site.
Pt developed numbness on left side of her body (face, arm, leg) after receiving vaccine in left arm,  Pt was sent to ER to be further evaluated
This spontaneous report as received from a pharmacist refers to a 60 year old female patient without history of drug reactions or allergies. On 24-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # was reported as "L017165" and exp. date 13-AUG-2016, dose of 0.65 ml, subcutaneous. On the same date "reported as immediately after receiving ZOSTAVAX", the patient developed swelling, redness, "soreness" and "hot" at the injection site. The pharmacist informed the patient to take BENADRYL and ibuprofen (manufacturer unknown). No lab diagnostics studies were performed. At the time of this report, the outcome of the events was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Patient stated redness, slight SOA with first vaccine dose. Hesitant about 2nd dose. 2nd dose given in observation area. Supervisor notified. Fluids provided to patient. Patient was observed 30 minutes per protocol for allergies. At 11:20 c/o slight dizziness, crackers and water provided. At 1130 patient states heart is racing; P88. Patient states this also happens when taking effexor. Refused ambulance; taken to car by EMS personnel. Patient's mother was present in observation area.
swelling of lower lip; numbness of the lower lip; swelling of tongue; numbness of the tongue; Heaviness of the right leg; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swelling of lower lip), HYPOAESTHESIA ORAL (numbness of the lower lip), SWOLLEN TONGUE (swelling of tongue), HYPOAESTHESIA ORAL (numbness of the tongue) and LIMB DISCOMFORT (Heaviness of the right leg) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 immunisation.     The patient's past medical history included Kidney transplant. Concurrent medical conditions included Drug allergy (Allergic to lisinopril, Haldol). Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), ARIPIPRAZOLE (ABILIFY), HYDRALAZINE, CALCIUM CARBONATE, GRAMICIDIN, NEOMYCIN SULFATE, NYSTATIN, TRIAMCINOLONE ACETONIDE (KENALOG COMP. MED MYCOSTATIN), MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), FAMOTIDINE (PEPCID AC), PREDNISONE, BELATACEPT (NULOJIX), TRAMADOL, SODIUM BICARBONATE, CALCITRIOL (ROCALTROL), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), PARACETAMOL (TYLENOL), DOCUSATE SODIUM, SENNOSIDE A+B (SENOKOT S) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced LIP SWELLING (swelling of lower lip), HYPOAESTHESIA ORAL (numbness of the lower lip), SWOLLEN TONGUE (swelling of tongue), HYPOAESTHESIA ORAL (numbness of the tongue) and LIMB DISCOMFORT (Heaviness of the right leg). At the time of the report, LIP SWELLING (swelling of lower lip), HYPOAESTHESIA ORAL (numbness of the lower lip), SWOLLEN TONGUE (swelling of tongue), HYPOAESTHESIA ORAL (numbness of the tongue) and LIMB DISCOMFORT (Heaviness of the right leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was provided by the reporter as immunosuppressants, fibroid pills. Treatment information was provided as paracetamol.
could raise arm to the side; now it hurts; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT ( could raise arm to the side) and PAIN IN EXTREMITY (now it hurts) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Swollen lymph nodes (swelling in the lymph node (left arm) after receiving the first dose of the Moderna Covid19 vaccine.) and Mammogram (negative.). Concomitant products included ALENDRONATE SODIUM and OMEPRAZOLE for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced LIMB DISCOMFORT ( could raise arm to the side) and PAIN IN EXTREMITY (now it hurts). At the time of the report, LIMB DISCOMFORT ( could raise arm to the side) and PAIN IN EXTREMITY (now it hurts) outcome was unknown. Not Provided          This case was linked to MOD-2021-065472 (E2B Linked Report).; Sender's Comments:  MOD-2021-065472:First Dose Case
2 1/2 wks p/vax swollen lymph glands sinus infect stiff neck; 28FEB94 testicular swelling cont arthralgia & stiffness consulted physician; sx cont as of 11MAR94; wife dx as having mumps;
a 5 year old male patient was given Flublok inadvertently/ No AE; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a consumer.  This case is linked to case 2020SA273273.  This case involves a 5 year old male patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2005, expiry date: 21-May-2021), via an unknown route and administration site inadvertently, on 25-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications were unknown.  It was a case of an actual medication error due to the inappropriate age at vaccine administration (latency on same day).  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Dime-sized whelp on left arm, right at injection site, immediately, child was given Benadryl PO. Within 5 minutes it was quarter-sized red area and the whelp stayed the same.
Information has been received from a nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 02-SEP-2015, the patient was inadvertently vaccinated with expired PROQUAD (Merck) (lot # K002483, expiration date 18-AUG-2015, strength, dose and route unknown). No adverse events were reported. Additional information has been requested.
This spontaneous report as received from a nurse via a field representative refers to a female patient of unknown age. Information about concurrent conditions and medical history was not provided. Approximately in 2012, reported as two years ago patient was vaccinated with two doses of CERVARIX (strength, route, dose, lot, batch # and expiration date not reported) and one dose of GARDASIL (strength, route, dose, lot, batch # and expiration date not reported). Concomitant therapies were not reported. No adverse event reported at time of intake. Adverse event taking as CERVAIRX was not part of the GARDASIL prescribing information. The outcome of the event was unknown. Additional information is not expected because the nurse did not want to be contacted.
Narrative:  COVID infection following COVID vaccine series 01/25, Pfizer, dose #1 02/16, Pfizer, dose #2 08/31 pt cc: cough, fatigue, fever, headache,  rhinorrhea exposure: unknown 09/02 COVID swab, result: detected 09/02 SARS- COV-2 LINEAGE result: AY .25 09.02 SARS-COV-2 CLADE result: 21 J (DETLA) clinically resolved
Weakness and nerve pain in left arm (injection arm), shoulder, top of back and chest.  Pain would be acute at times and lasted for approximately one month.
About 3 days after the vaccine my daughter mentioned to me that I was not breathing right. It was harder to breathe and I could not even take a shower that I would be out of breath. My daughter checked my pulsox and it was 85. I couldn't really walk or do anything so my daughter  transported me to ER and lots of labs were done so since my D Dimer was too high they did a CT scan and it showed some blood clots in my lungs. They admitted me because they were concerned with the location of one of them. They did some heart tests too and put me on Eloquis and then sent me home. I stayed for 2 days. Then they scheduled me FUs with a heart doctor and a pulmonologist.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a seven-year-old male. Neither relevant medical nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. The patient received expired FLUMIST on either 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Patient developed bright red macule about 3 in. diameter at the site which was itchy and also developed generalized hives.  Both noted about 3 days after imm. given.  He was also on Amoxicillin at the time for a sinusitis and I think the hives were due to an allergic reaction to the Amox.
Itchy rash, eventually spreading to most of the body (all except hand,feet,stomach,lower back.) Began on upper chest and upper back, spreading to neck, face, forehead. LIDEX(fluocinonide) used sparingly. Rash totally covered these areas and lasted approximately 10days-2 weeks, leaving scaly skin. Dry eyes, very dry mouth.  Rash spread to upper arms, thighs (both were less dense than other areas, less itching) Finally spread to lower arms and lower legs.  All rashes and itchiness cleared approximately 4 weeks after first rash appeared (or 5 weeks anfter 2nd dose) Size and color or hands differed after 2nd dose (uncertain dates for this obser For approximately 2 weeks, left hand noticably fuller and redder than right.
It started itching/sometimes it itches; Then red/it's been red ever since; Now my wrist and hand is bothering me; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It started itching/sometimes it itches), ERYTHEMA (Then red/it's been red ever since) and PAIN IN EXTREMITY (Now my wrist and hand is bothering me) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (It started itching/sometimes it itches), ERYTHEMA (Then red/it's been red ever since) and PAIN IN EXTREMITY (Now my wrist and hand is bothering me). The patient was treated with ALCOHOL at an unspecified dose and frequency. At the time of the report, PRURITUS (It started itching/sometimes it itches), ERYTHEMA (Then red/it's been red ever since) and PAIN IN EXTREMITY (Now my wrist and hand is bothering me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication, cholesterol medication, thyroid medication, and neuropathy medication.   Other treatment received included massage.
Patient was administered varicella vaccine that had unknowingly been in a temperature excursion too warm.
forgot about the scheduled second dose appointment on 25May2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (forgot about the scheduled second dose appointment on 25May2021) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (forgot about the scheduled second dose appointment on 25May2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (forgot about the scheduled second dose appointment on 25May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
when administering the vaccination, pt was held by father who at first had a firm grip on him. When the vaccine entered pt's leg he jumped and the needle came out and scraped his leg forming a small gash on the lower left thigh. sight was cleansed and bandages applied. Pt was examined by Dr. and she gave them some antibiotic cream to put on the site.
Delayed reaction with her throat closing up.; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Delayed reaction with her throat closing up.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (Delayed reaction with her throat closing up.). At the time of the report, THROAT TIGHTNESS (Delayed reaction with her throat closing up.) outcome was unknown.            No concomitant medications were reported. Treatment medication was not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Pt developed a papular and vesicular rash over his trunk, neck, head and later, on extremities about 1 week after vaccine. On exam, crusted lesions were noticed. (Pt came to office approx. 5 days after onset of rash).
Had stroke after the 1st and 2nd dose of the Moderna COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had stroke after the 1st and 2nd dose of the Moderna COVID 19 vaccine) in a male patient of an unknown age 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 23-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had stroke after the 1st and 2nd dose of the Moderna COVID 19 vaccine) (seriousness criterion medically significant). The patient was treated with ROSUVASTATIN for Adverse event, at an unspecified dose and frequency; LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Adverse event, at an unspecified dose and frequency; EVOLOCUMAB (REPATHA) for Adverse event, at an unspecified dose and frequency and APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Had stroke after the 1st and 2nd dose of the Moderna COVID 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Company comment: This case concerns a male patient with unknown age with no reported medical history, who experienced Serious ( Medically Significant )  , unlexpected , ADR event of Cerebrovascualr accident which occurred on July 23 , 2021 t with the 1st dose of mRNA -1273 vaccine ( Moderna Covid 19 vaccine ).  Time to onset  is unknown since the vaccination date was not reported. The re-challenge for this case is not applicable since the outcome of the event was  unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-391796 (Patient Link).; Sender's Comments: This case concerns a male patient with unknown age with no reported medical history, who experienced Serious ( Medically Significant )  , unlexpected , ADR event of Cerebrovascualr accident which occurred on July 23 , 2021 t with the 1st dose of mRNA -1273 vaccine ( Moderna Covid 19 vaccine ).  Time to onset  is unknown since the vaccination date was not reported. The re-challenge for this case is not applicable since the outcome of the event was  unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.