chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received pneumococcal and influenza vaccines on 10/12/2020. Patient reported receiving PCV 13 last year without difficulty.  Patient reported she developed red/painful/warm rash on the interior portion of her left arm near the pneumococcal immunization site first noticed the morning after the vaccination (10/13/2020).  She reported no fever, no vomiting, and no skin breakdown or hives but stated  that she was experiencing  intolerable nausea.  She requested and was prescribed  medication to treat the nausea.
Red area (L) deltoid, somewhat tender. Motrin/ Tylenol PM.
No adverse event-- administration error- the patient should have received Pfizer (first dose of COVID vaccine unknown), at our clinic for 2nd dose
1st diagnosed with covid/ COVID 19 Treatment; 1st diagnosed with covid/ 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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 13:00 as dose 1, single (Lot number: en6206), in right arm, on 26Mar2021 at 13:00 as dose 2, single (Lot number: er8730), in right arm and on 12Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 30145ba) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Apr2018. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "1st diagnosed with Covid/ COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Serious: No, Seriousness Criteria-Results in death: No, Seriousness Criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. Reaction(s)/Event(s): Reaction/event as reported by primary source: 12 days after being diagnosed, I started having sore throat, congestion, headache, fever, same symptoms as when I was 1st diagnosed with COVID. Date of start of reaction/event: 17May2022. Outcome of reaction/event at the time of last observation: Recovering/Resolving, Hospitalization Prolonged: No Treatment Received: No. Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: COVID-19 Treatment Date of last administration: 13May2022, adverse event start time: 12:00 AM Active Substance Information: Active Drug substance names: COVID 19 Treatment.     No follow-up attempts are needed. No further information is expected.
p/vax pt devel low fever & local redness & swelling 6/8/99; adm to hosp for cellulitis of lt upper arm 6/10/99 Am;
Started developing paresthesias in bottom of feet 2 days after 2nd Pfizer vaccine. That progressed ascending up to legs and arms over the course of 3 weeks. She went to the hospital and was diagnosed with Gullain-Barre syndrome based on the CSF studies and MRI imaging.
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021; expired dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.  No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 29-Oct-2021. Many doses were administered from expired lots due to confusion with the expiration date printed in the carton.
There were no side effects from the 1st dose. This was my second dose. I woke up at about 0350 shivering  with flu like body ache. This lasted throughout the day following the second dose. The next evening, after going to bed, I began to fell chills again and woke up multiple times sweating profusely. By about 0900 on 1/28, I felt pretty much back to normal.
hives, lip swelling, dyspnea starting 90 minutes after influenza vaccine. 12/23/2008 MR received for DOS 11/25-26/2008 with DX: Allergic Reaction. Pt presented with itching, urticaria, SOB, throat & tongue swelling and swelling of face.  Diffues rash noted on PE. Chest tightness resolved. Tx with Benadryl, steroids with improvement. Observed o/n and d/c.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a patient who was a child. On 27-OCT-2014, the patient received intramuscular AFLURIA batch number not reported) at 0.5 ml. The AFLURIA pre-filled syringe that was administered to the patient underwent temperature excursion of 68 degree F for 48 hours. No adverse events were reported. Outcome was not reported. Reporter's comments: The reporter assessed the events as non-serious. Linked case: 2014046068 (same reporter).
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 07May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 26Nov2021 as dose 2, single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (11Jun2022) Positive, notes: Rebound Covid antigen test positivity (negative to positive conversion). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events COVID-19 and Drug ineffective cannot be completely excluded.
2 days p/vax h/a, fever, nausea, weakness, fatigue approx 1 wk p/vax; swelling @ wrist, hands, knees; resolved p/Naprein; reoccurrence approx 10 days p/vax-same problems;
12/03/2021 received vaccine 10am and started developing symptoms around 10pm that night.  Fever, chills, dizziness, body aches--left arm very soar--swelling at the injection site.  12/04/2021 got out of bed, very dizzy in the morning--fainted, had bloody nose in addition to the other symptoms.  By 6pm, started to feel better.  Next day was okay.
The day after felt normal aches and tired. On Tuesday my calves and  right leg started to hurt. I woke up on Wed felt as if right leg was numb and begin to had headache. i left work went to ER had Blood Work, Ultrasound (right leg). I went home  on Sunday I don't take my Claritin felt fine. On that Monday 4/19 I did take Claritin my right leg started back hurting. Since Tues 4/20 I haven't taken allergy medication my right leg doesn't feel weird.
approx 5x7cm red raised swollen area over site of inj w/in 12-24hr of inj;c/o pain & tender to touch;also c/o abd pain;treated w/antihistamine;
itchy maculopapular rash that started on elbows/bilateral upper extremities; spread to neck, torso, back, abdomen and thighs. going on 2 weeks now.
her left side of the cheek was very hot and swollen; her left side of the cheek was very hot and swollen; left arm was hurting; This is a spontaneous report received via Medical Information Team. A contactable consumer (patient) reported a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1,  via an unspecified route of administration on 16Mar2021 (Batch/lot number: not reported) as 1st dose, single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that her left side of the cheek was very hot and swollen (feeling hot & swelling face), but went away after 1 hour. She was asking if she should be concerned and if she should get the second dose. The patient also reported that her left arm was hurting (pain in extremity). The outcome for the event left side of the cheek was very hot and swollen was recovered while pain in extremity was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I had a small  bump and minor discomfort the day I received the vaccine. The next day it was gone. Eight days later I developed a bright red circular rash around the injection site it lasted for about 2 days and I had a telehealth appointment visit about it. It was rather large.
The subject is a female with the date of birth of 10/18/2000, who expired due to cancer while enrolled in a comparative post marketing safety study of Daptacel (Diphtheria and Tetanus toxoids and Acellular pertussis vaccine absorbed) administered with other recommended vaccines according to standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received the study vaccine on 5/13/2003. Other vaccines administered on that day included a dose of IPOL, lot number W01972, a dose of hepatitis A vaccine, lot number 0498N, a dose of MMR/measles, mumps and rubella vaccine, lot number 0858M, and a dose of VZV, lot number 0485N, manufacturer unknown. The routes and sited of administration were not provided. The subject suffered from a germ cell tumor. The tumor was resected and radiotherapy and chemotherapy were started. The subject was in palliative care when she expired 398 days post immunization. The subject did have a history of renal failure and pancytopenia. Autopsy information is pending. The event of cancer was reported by the investigator as unrelated to the study vaccine. 3/7/06 Multiple d/c summaries received which state patient had abdominal teratoma w/metastasis/ss
she had arthritis on her leg; swelling on her feet; she hasn't been well at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (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: ARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "she had arthritis on her leg"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swelling on her feet"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "she hasn't been well at all".  Additional Information: It was reported that, the patient and her daughter received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 11Aug2021. They were originally scheduled to receive the 2nd dose on 01Sep2021, but they were not able to go. The patient said she had arthritis on her leg and swelling on her feet. She said she had not been well at all. She wanted to know how long she could still get the 2nd dose after missing her schedule.  Follow-up attempts completed. No further information is expected.
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot# and expiration date were not reported) and then received a second dose of ZOSTAVAX on an unknown date (extra dose administered). Concomitant drug was not reported. No adverse effects were reported. Additional information has been requested.
Flu; Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a female patient (unknown age) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My wife is always wary about the flu shot because she swears it has given her the flu at least twice. I have to remind her that it cannot possibly cause the flu and that she usually gets the shot at the height of the flu season."  It is unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
She was afraid to take her second injection Will not take second dose; heaviness in chest; burning in chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (heaviness in chest), CHEST PAIN (burning in chest) and INTENTIONAL PRODUCT USE ISSUE (She was afraid to take her second injection Will not take second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CHEST DISCOMFORT (heaviness in chest) and CHEST PAIN (burning in chest). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (She was afraid to take her second injection Will not take second dose). At the time of the report, CHEST DISCOMFORT (heaviness in chest), CHEST PAIN (burning in chest) and INTENTIONAL PRODUCT USE ISSUE (She was afraid to take her second injection Will not take second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Electrocardiogram: normal Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Throat numbness, difficulty swallowing. Given Benadryl 25 mg PO. BP 136/85 (pulse 134), O2 sat 96%. F/u BP 127/92 (pulse 131), O2 sat 98%. MD rec'd ED, patient declined.
This spontaneous report was received from a licensed practical nurse and refers to a 6 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-00950713-1608USA012794:
Had analphylaxis reaction 5 minutes after recieving COVID vaccine at 0916.  She was having wheezing, tightness of throat, and difficulty breathing, nausea.  She was treated with Albuterol inhaler followed by self injecting epipen at 0925  with improvement subsequent respiratory distress   She was given supplememental oxygen and code team was called and arrived within 3 minutes.  IVs started and given  IV benadryl 50 mg and IV solumedrol 125mg @0941.  She continue to be in respiratory distress and 2nd dose of epipen at 0946 was administered.   She continue to revert back to anaphylaxsis,  She was adminstered 3rd epi injection at 0958 am administered by the paramedics and transported to Hospital.
Child has had explosive yellow watery diarrhea since 4/25 - saw N.P. 4/29/04.  Getting better.  No other symptoms.
Patient experienced itching evening of 021/16/2005 and believes itching began prior to her taking first dose of oral typhoid around 9:00 P.M. ? Approximately 10:00 P.M. Patient went into bathroom and noticed she had full body rash on trunk, legs,and arms. Rash was red, raised, and bumpy. Face was reddened. No respiratory involvement. Patient took Claritin and  Allegra with relief. Thinks rash may be due to Hep A. Pt states she ate but for dinner that evening at Depot Restaurant, had a tuna dish, Pt reported she has lots of allergies (certain drugs, food, and animals). Patient has Epi Pen kit at home. Advised client to take a dose of Claritin prior to her taking 2nd dose of oral typhoid this evening as a precautionary measure to contact MD and health department if additional symptoms develop or rash reoccurs. Will follow up with client on 02/22/2005. 02/22/2005 telephone call to patient, Rash is much better and pt had no difficulty taking additional dose of typhoid. Patient states she will premedicate with Benadryl prior to taking booster Hep A vaccination in 6-12months. D. Shneider, RN. MTO502
Patient reports intermittent generalized skin rash with blisters, "welts", and associated intermittent itching and "pins and needles" sensation. Occurs 4-5x per day and began 3 days after she received her first dose of Pfizer COVID-19 vaccine. Mainly occurs on her extremities and back but she also notices it on her face. Also reports her menstrual cycle is 2 days late and it is usually regular and always on time.
Shortly after receiving vaccination for yellow fever, polio, hepatitis A, and typhiod, I departed the clinic and lost conciousness while driving home. I was involved in a single vehicle accident as a result. Fortunately, I suffered no injuries.
Warmness about 2/3 above and below injection site; Dots and redness about 2/3 above and below injection site; Swelling about 2/3 above and below injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warmness about 2/3 above and below injection site), VACCINATION SITE ERYTHEMA (Dots and redness about 2/3 above and below injection site) and VACCINATION SITE SWELLING (Swelling about 2/3 above and below injection site) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles (Got vaccinated).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warmness about 2/3 above and below injection site), VACCINATION SITE ERYTHEMA (Dots and redness about 2/3 above and below injection site) and VACCINATION SITE SWELLING (Swelling about 2/3 above and below injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness about 2/3 above and below injection site), VACCINATION SITE ERYTHEMA (Dots and redness about 2/3 above and below injection site) and VACCINATION SITE SWELLING (Swelling about 2/3 above and below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was unknown
Cough; Fever; Fatigue; Headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced COUGH (Cough), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COUGH (Cough), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information was not provided.
No side effects or adverse reactions reported; expired VARIVAX given to a patient today, 7/31/2020; This spontaneous report was received from a medical assistant regarding a 16 years old male patient. Concomitant medications included hepatitis A virus vaccine (unspecified), meningococcal A and tetanus (+) diphtheria (+) pertussis (Tdap). The patient's pertinent medical history and drug reactions/allergies were not reported.  On 31-JUL-2020, an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml (lot R020673 and expiration date: 18-JUL-2020; strength, frequency, anatomical location were not reported) was given to the patient subcutaneously in right arm for prophylaxis (updating immunizations for school) (expired vaccine used). The patient didn't seek medical attention. No treatment was received. No side effects or adverse reactions reported.
This spontaneous report as received from a nurse refers to a 6 months 9 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
The next morning at 06:30 AM fever, chills, headache, weakness but it wasn't as severe as the first two but I did miss work. No doctor needed and I recovered that evening.