chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 10-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006064: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Vomiting and diarrhea started day after vaccination. Vomiting with each bottle feed, diarrhea was non-bloody and 3-4 x per day. Symptoms lasted for 5 days.
Pfizer was diluted with 0.8ml of diluent instead of 1.8ml.
Around 4-5 hours after the vaccine was given, the patient's arm was red and warm to the touch.  I then became swollen and painful.  She was given benadryl 50 mg and tylenol 500 mg 9 hours after the vaccine was given.
2-3 days of fever up to 105 degrees, decrease oral intake, decrease urine output.
the vaccine was administered into the shoulder joint. Patient has reported shoulder pain/ Nurse administered Prevnar 13 in the shoulder joint instead of deltoid muscle; the vaccine was administered into the shoulder joint. Patient has reported shoulder pain/ Nurse administered Prevnar 13 in the shoulder joint instead of deltoid muscle; This is a spontaneous report from a contactable Physician via Sales Representative. A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), on unspecified date in 2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The nurse administered Prevnar 13 to the patient last week and believed that the vaccine was administered into the shoulder joint. The patient had reported shoulder pain. The nurse administered Prevnar 13 in the shoulder joint instead of deltoid muscle. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Lt upper thigh at injection site, redness, and slightly raised area, 8 cm around. Slightly warm to touch. No S/S of pain. Instructed pt's mom to apply cool compress a notify us/MD immediately if it gets worse.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site gets hot), LIMB DISCOMFORT (couldn't lift arm), VACCINATION SITE PRURITUS (lots of itching at injection site - like a mosquito bite), VACCINATION SITE ERYTHEMA (arm got red) and VACCINATION SITE SWELLING (arm got swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-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 LIMB DISCOMFORT (couldn't lift arm) and VACCINATION SITE PAIN (arm hurt). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site gets hot), VACCINATION SITE PRURITUS (lots of itching at injection site - like a mosquito bite), VACCINATION SITE ERYTHEMA (arm got red) and VACCINATION SITE SWELLING (arm got swollen). On 22-Mar-2021, LIMB DISCOMFORT (couldn't lift arm) and VACCINATION SITE PAIN (arm hurt) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site gets hot), VACCINATION SITE PRURITUS (lots of itching at injection site - like a mosquito bite), VACCINATION SITE ERYTHEMA (arm got red) and VACCINATION SITE SWELLING (arm got swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment details were provided.
At the time of my vaccine I was 30 weeks pregnant. My expected date of delivery is 5/18/21 and I have had no issues/complications with this pregnancy.   I received my vaccine on 3/9  at 4:00 PM, and stayed to be monitored for  30 minutes due to my pregnancy, After the vaccine, Per the clinics recommendation, I drank lots of fluids the rest of the day. Several hours later I noticed I had a minor headache. I Consulted with my OBGYN and took 650mg of Tylenol before going to bed. By midnight when I layed down(and throughout the remainder of the night - till about 7am) I had moderate body aches - especially in my legs. I also felt feverish with chills and at times sweating, but had no actual fever. I checked on three sperate occasions between 12AM and 7AM. I was unable to sleep that night.   The following day (3/10) I felt tired, had some lingering body aches (though not as bad as the night before) and a minor headache that would come and go throughout the day. I also had minor arm pain at the injection site - nothing different then a flu shot. continued to drink lots of fluids and took  Tyelnol as needed.   When I woke up on 3/11, I felt perfectly fine. No headache, body aches, arm pain, etc.
Swelling, rash on upper arm. Also a rash on legs and slight rash on arms. Symptoms clearing after 1st day.
Nausea, lethargy, body aches, head ache, along with redness/soreness/significant swelling at injection site.
This literature-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION, COVID-19 and DRUG INEFFECTIVE in a 22-year-old female patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart transplant rejection (Recent episode of rejection 6 mths prior treatedwith methylprednisolone, rituximab, thymoglobulin, plasmapheresis, and IVIG) and Heart transplant in 2013. Concurrent medical conditions included Non-ischemic cardiomyopathy and Immunosuppression. Concomitant products included SIROLIMUS, TACROLIMUS and PREDNISONE for Immunosuppression.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (Breakthrough infection) (seriousness criterion hospitalization), COVID-19 (COVID-19) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of drug effect) (seriousness criterion hospitalization). The patient was treated with REMDESIVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINE BREAKTHROUGH INFECTION (Breakthrough infection), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINE BREAKTHROUGH INFECTION (Breakthrough infection), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) to be possibly related.    Patient was admitted to the hospital with nausea, vomiting, cough and shortness of breath. Was not hypoxic during admission.  Company Comment: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.   This case was linked to MOD-2021-279918 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received by safety on 06-Aug-2021 included an email from the with FTA and abstract containing no new information.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.
was seen in Emergency Dept 3/22/07 with increased redness and warmth at injection site approx 8 x 9 cm-no lymph node involvement
The patient was brought to the local hospital on 02/21/2022 via EMS d/t being found unresponsive.  The patient is a residential facility patient who was found to be covid positive and was a DNI/DNR with limited interventions.  The patient expired on 02/21/2022.
Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; This spontaneous case was received on 30-Sep-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-02593) and concerned a patient of an unknown age and gender.   The patient's medical history and concomitant medications were not reported.    On an unknown date in Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, route of administration and anatomical location: not reported). The batch number reported was 279838.     On the same day, a few hours after receiving Flucelvax QIV, the patient experienced warmth, pain and edema at injection site.   At the time of initial reporting on 30-Sep-2020, the outcome of events was not reported.   The reporter did not provide a causality assessment.  This case is linked to cases 202004826, 202004883, 202004884 and 202004885 (the same reporter).  Company comment:The patient developed vaccination site warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 09-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000862: US-009507513-1906USA011674:
flushed face; Face swollen; felt funny; face warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushed face), SWELLING FACE (Face swollen), MALAISE (felt funny) and FEELING HOT (face warm to the touch) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A--A) for COVID-19 vaccination.     No medical history information were reported.  Concomitant products included LATANOPROST for Eye drop instillation, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FLUSHING (flushed face), SWELLING FACE (Face swollen), MALAISE (felt funny) and FEELING HOT (face warm to the touch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Mar-2021, FLUSHING (flushed face), SWELLING FACE (Face swollen), MALAISE (felt funny) and FEELING HOT (face warm to the touch) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were Tylenol provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: - contact information was updated .
Received covid vaccine from outside source - reported by patient ACUTE RESPIRATORY FAILURE 11/25/2021 PNEUMONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/25/2021 PNEUMONIA HYPOXIA 11/25/2021 PNEUMONIA
Not reported to doctor until last immunization; arthralgia, muscle atrophy, tremor, Parkinson's. Slow to onset, 2 days, post injection of opposite sides arthralgia and declined progress to neuro specialist. Sees rheumotologist and neurologist.
large local allergic reaction; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The patient developed a large local allergic reaction to Shingrix dose.  The reporter was concerned about administering the second dose of Shingrix. The reporter declined to provide credentials and disconnected the chat before he/she was able to get any additional information about the adverse event. The reporter did not consent to follow-up.
2 pts exp large local rxn from same vial of medication;discontinue use of vial;
Patient was given 2nd dose of Moderna. Patient is under 18 years of age.
a large area of redness, itching, and swelling at the injection site; a large area of redness, itching, and swelling at the injection site; a large area of redness, itching, and swelling at the injection site; This spontaneous report was received from a nurse, referring to a 21 years old female patient. The patient's concomitant vaccine included tetanus toxoid. The patient had no pertinent medical history. The patient had no known drug allergies prior to this adverse event. Information about the patient's concurrent conditions was not reported.  On 13-APR-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T017179, expiration date 26-OCT-2021; route was reported as injection) in the right arm for hepatitis A prophylaxis.  On the same date, the patient experienced a large area of redness, itching, and swelling at the injection site. The patient was treated with cetirizine hydrochloride (ZYRTEC) 10 mg, diphenhydramine hydrochloride (BENADRYL) as needed (prn) and hydrocortisone prn, topically. There was no lab diagnostics/studies performed. On 13-APR-2021, 19-APR-2021, the patient had sought medical attention. The patient was better each day post-injection. In April 2021, the patient recovered. The causality assessment between hepatitis a vaccine, inactivated (VAQTA) and all events was not reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T017179; expirationdate: 26-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
About 3 weeks after the vaccine my right arm felt like I tore my rotators cuff, bicep tendon and elbow.  That lasted for about 2-3 months.  Also, I developed a miscommunication between my brain and my heart which led me to a cardiologist.  Which lead me to wearing a monitor, stress test and an echocardiogram. Which was very costly to me. As the vaccine wore off after 5-6 months so did the symptoms.  Because of the way I felt I didnt get the second  shot after the 3 week period.
Developed a rash the night after receiving the vaccine. Seen at urgent care the next day, diagnosed as hives. Based on pictures, rash did appear to look like coalescing hives on torso. Rash got a little better, but then seemed to spread again to include face, arms and legs. When I saw him 3 days after the symptoms started, the rash consisted of circular lesions with erythematous borders and central clearing of varying sizes present on torso, arms, legs, neck. Erythematous areas do blanch and some areas are coalescing. Sparing palms/soles. The rash was itchy, but not painful and he was taking BENADRYL for it. No fever, joint pain, mucosal involvement, etc.
Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced COVID-19 (Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired). On 25-Sep-2021, COVID-19 (Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired) had resolved.            Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.  The patient suffered from covid19 after vaccination, the symptoms were exhaustion for a month as well as feeling tired, fever for a day when she first discovered she had COVID-19, could hardly move her body and had an awful taste in her mouth.  Company Comment: This case concerns a 73-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19. The event occurred after receiving the second dose of Spikevax, which administration date is unknown. The rechallenge is not applicable since no additional dose will be administered. The benefit-risk relation of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 73-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19. The event occurred after receiving the second dose of Spikevax, which administration date is unknown. The rechallenge is not applicable since no additional dose will be administered. The benefit-risk relation of Spikevax is not affected by this report.
Throat swelling; tightening; difficulty breathing/swallowing and hot/flushing/sweating all over body. The ER gave me Epinephrine; Benadryl; Fluids.
Employee given TB screening with Tetanus injected instead of PPD. Local reaction on left forearm around 9 x 6 cm swelling and erythema with small raised lesion in center, 1 cm diameter. Complained of pain at site. No treatment given.
PEDIARIX and HEP B given on the same day. No symptoms, signs or treatment.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 11-SEP-2013, the patient was vaccinated with M-M-R II (lot # J005575, expiry: 16-DEC-2015), 0.5 ml, subcutaneously for a negative titer. The dates of the doses of M-M-R II administered during the patient's pediatric series of M-M-R II were unspecified. The outcome of negative titer was unknown.  Additional information has been requested.