chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to an 84 year old female patient. No concurrent or historical conditions were reported. It was reported that the patient received the last year a dose of PREVNAR vaccine. On 24-SEP-2015, the patient was vaccinated with a booster dose of PNEUMOVAX 23 (lot # K009874, expiration date 19-MAR-2016), unknown dose, intramuscular on unspecified arm. The same day, the patient received as well an unspecified flu vaccine which was given in the same arm as the PNEUMOVAX 23. Concomitant medication included Simvastatin (manufacturer unknown) and "Lodapine". On 24-SEP-2015, the patient developed the initial reaction of bruising and swelling in her arm she received PNEUMOVAX 23, later the patient went to the pharmacy on 29-SEP-2015, with the swelling in the lower part of her arm showing some improvement. The patient sought medical attention with her sister who is a Nurse practitioner, she was treated with BENADRYL, TYLENOL and ice on the area. The outcome of bruising in her arm was reported as recovering/resolving. The reporter considered bruising and swelling in her arm was related to PNEUMOVAX 23. Additional information has been requested.
Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 51 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Experienced paresthesia bilaterally within one week of injection. Occurred a second time a week to 10 days later and last episode was to date 6 weeks after vaccine.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were provided.  No treatment medication was provided.  Nurse was providing information for 35 patients. A vial at their clinic was punctured 30 times. 10 patients were affected. Given the process in place at the vaccination clinic  and stated that it is not possible to identify the 10 patients who received the compromised vaccine. In addition to the information described above the Nurse Practitioner reports that 35 patients potentially were involved. The Nurse is calling with the names of the first 35 patients involved. All doses given are booster doses.
Patient developed acute chest pain consistent with myopericarditis requiring hospitalization 72 hours post 2nd dose of Moderna vaccination.  COVID testing negative.
Felt light headed and very tired day after second dose was received. Did not experience this after first dose 4 months ago. I had to go to bed and slept all afternoon.....very unusual! But I was fine the next day.
COVID vaccine breakthrough case. Pfizer 1/22/21 EL9261, 2/12/21 EL9267, and boosted 12/8/21 33130BA
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-076498 (E2B Linked Report).; Sender's Comments:  MOD-2021-076498:sister's case
Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of ROTATEQ, orally (lot#, expiration date and dose not provided). It was unspecified how many doses of ROTATEQ the patient had received. The patient experienced several intetinal cramping after the administration of ROTATEQ. The physician described severe intestinal cramping as the patient was doubled over with head on knees. The outcome of severe intestinal cramps was unknown. Additional information has been requested.
I began vomitting 12 hours after the shot which quit after 2 times.  But today, 4 days after my shot in the morning , my left side of my stomach is bloated filled with gas and I am burping.  Also I have stabbing pain  and now liquid diarreha and I cant go to sleepbecause of the pain.
Approximately 45 minutes post vax, pt started to develop hives that eventually covered the entire body. Pt experienced swelling and itching of soft palate of mouth and difficulty breathing. Pt treated with Benadryl and Primatene. Hives resolved  14 hours post vax and swelling resolved 48 hours post vax.
11-year-old patient received a dose; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-JUNE-2022 Reporter's comment: Medical doctor reported that a 11 year old patient received Kinrix. Consented to follow up. Additional supportive information: 11 years old patient received Kinrix, which led to inappropriate age at vaccine administration
polycystic condition; This is a spontaneous report from a Pfizer sponsored. A contactable consumer (patient's husband) reported for a female patient (reporter's wife) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE both for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported by the reporter that before he was originally part of the original trial of Pfizer covid-19 vaccine and now his wife is part of the booster trial. He stated that he is confused in regards with Pfizer's general plan. He pointed to the 3rd dose/booster if they can get it because they were informed that after 12 months getting the 2nd dose, they will be receiving the 3rd dose but up to now they didn't receive it. Name withheld is aggravated already in regard to what happened and he stated that he wants to go to the media to inform people about Pfizer's general plan because he had diabetes and his wife had a polycystic condition. On an unspecified date, the patient experienced polycystic condition. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient under 18 years of age has been vaccinated; A spontaneous report was received from a pharmacist concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history and relevant concomitant medications were not reported.   On 11 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (lot number 025J20A) intramuscularly for prophylaxis of COVID-19 infection.The patient was underage at the time the vaccine was provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (vaccine was administrated for 17-years old patient) for mRNA-1273, lot # 026L20A.  There were no reported AEs associated with this case of product administered to patient of inappropriate age. The reported event is unlisted and company causality was assessed s not applicable.
Flu like symptoms; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Pain at injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Prostate cancer (Stage 1). Concomitant products included SILODOSIN for Prostate cancer.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Pain at injection site). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at a dose of UNK dosage form. On 16-Jan-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and VACCINATION SITE PAIN (Pain at injection site) had not resolved.        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.
Pt woke up in middle of night on 5/14/15 with temp to 102 and severe body aches.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 48-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
face red and burning for two days after; eyes burning- these symptoms  started ten minutes after received second dose Dr on site advised to wait an extra 30 minutes.  That same evening started to have stuffiness and pain to ears,  eyes burning; severe muscle aches, both to arm where received shot largely to shoulder area and throughout body (mostly shoulders and back), which has continued for more than a week after; overall feeling like flu and fever.   Only had this reaction to second vaccine.
Intense pain at injection site along with swelling, redness, limited mobility and hot to touch. Then a few hours later, fever in excess of 101 degrees F, intense body aches, fatigue, malaise, dehydration. All lasting in excess of 5 days with a gradual increase of pain at injection site, resolving over a week after injection.
Information has been received from a registered nurse concerning a 15 month old Caucasian male patient with an acute ear infection and positive green rhinorrhea, who on 11/19/02 was vaccinated SC into the right thigh with a dose of MMR (second generation) (lot #642182/0774M). Concomitant vaccination included a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (lot # 643305/0692M). Concomitant therapy included amoxiclllin for the treatment of the patient's acute ear infection and positive green rhinorrhea. On 11/27/02 the patient developed a localized, pinpoint rash that the physician documented as a measles-like rash and a temperature of 103 degrees F. The rash was described as a possible antibiotic reaction or a possible reaction to the MMR (second generation). The reporter indicated that there were no other symptoms and that the patient was eating and drinking. The patient was cranky and the rash worsened over the next several days spreading all over the trunk, face, hair and mouth. On 11/30/02 the patient returned to the doctors office. It was also reported that the patient had developed an upper respiratory infection. It was reported that the patient was negative for roseola and Kawasaki. The reporter indicates that the patient's experience resulted in persistent or significant incapacity. It was reported that the patient recovered from this experiences. Additional information is not expected.
Day 8 rash at vaccination site, swollen, hot, itchy, lasted for three days
pt recv vax 23OCT96 930AM;devel itching on way out to car p/flu vax;2 hr later eyes were swollen, flushed & h/a & itched on face & shoulders;itching eyes for 3 days, other sx lasted throughout the afternoon of 23OCT96;pt took DPH
2/26/07 Fever 104 x 1 day, c/o lower abdominal pain, lower back stiffness, nasal congestion, residual cough from previous sinusitis 2/17/07; completed Augmentin 3 days ago; treated with Tamiflu x 5 days.
Dizzying from day 4,  Feel kind of falling down while in certain body position.  Maintain blood pressure 140/90, Doubt Cervical Vertebra and apply treatment, but Dizzy still there until today May 08th.
Patient stated she had her 2nd Moderna vaccine on Saturday 3/27 and she had fever, aches and pains and then later on a knot with a 3 in X 4 in swollen rash on her upper left arm
This spontaneous report as received from a registered nurse refers to a 16 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-FEB-2017, the patient was vaccinated with the improperly stored (between 6 and 14 degrees Fahrenheit for 30 minutes) dose of VARIVAX (for prophylaxis, lot # L050561 with expiration date of 14-DEC-2017 or lot # M019841 with expiration date of 20-APR-2018; dose and route of administration were not reported) that was reconstituted with the properly stored sterile diluent. No adverse effects and no previous temperature excursion were reported. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009837:
her daughter's friend's mother also lost her menstrual period after getting the 2nd dose of the Moderna vaccine but she got it back; This spontaneous case was reported by a nurse and describes the occurrence of MENSTRUATION IRREGULAR (her daughter's friend's mother also lost her menstrual period after getting the 2nd dose of the Moderna vaccine but she got it back) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (her daughter's friend's mother also lost her menstrual period after getting the 2nd dose of the Moderna vaccine but she got it back). At the time of the report, MENSTRUATION IRREGULAR (her daughter's friend's mother also lost her menstrual period after getting the 2nd dose of the Moderna vaccine but she got it back) had resolved.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720346, US-MODERNATX, INC.-MOD-2023-720425 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720346:Reporter case US-MODERNATX, INC.-MOD-2023-720425:daughter's friend's mother
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug allergies were not reported. On 12-MAY-2015, the patient was vaccinated subcutaneously with a dose of VARIVAX (Merck) (lot # K011804 and expiration date 21-AUG-2016). The reporter stated that the administered dose of VARIVAX (Merck) was improperly stored. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
fever of 102, headache, joint pains, nausea, vomiting, diarrhea, runny & congested nose, back pain by kidneys, swollen lymph nodes
Sore arm, very high fever (103), chills, aches tired. Symptoms subsided after 36 hours. Tinnitus noticeable and worsened within a month. Tinnitus continues.
Her thigh where the flu vaccine was administered began to swell to an abnormal size.  The welt was roughly 5-6" in diamater, taking up her entire thigh from hip to knee.  It was surrounded by a red ring, was extremely hot to the touch, extremely hard, and extremely uncomfortable for my daughter.
Inappropriate schedule of drug administration; no adverse effect Information has been received from a physician concerning a 6 month old female who on approximately 27-JUL2--6 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). It was unknown if medical attention was sought. At the time of this report no adverse reaction was noted. Additional information has been requested.
This was my second dose of the Moderna vaccine.  I had no reactions other than a slightly sore shoulder after the first dose. After the second it was exactly the same until about 5 days after when I developed an itchy, swollen, hot, rash on my arm around the injection site.  Now on day 2 it has roughly doubled in size, and is incredibly annoying! I am using ice blocks and calamine lotion to try and reduce the itching and heat its giving off.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing), notes: other medical history: Type 2 Diabetes, PCOS, androgenic alopecia; "PCOS" (unspecified if ongoing), notes: other medical history: Type 2 Diabetes, PCOS, androgenic alopecia; "androgenic alopecia" (unspecified if ongoing), notes: other medical history: Type 2 Diabetes, PCOS, androgenic alopecia. Concomitant medication(s) included: OZEMPIC, start date: 26Apr2021, stop date: 26May2021; METFORMIN ER, start date: 26May2021, stop date: 26May2022; FAMOTIDINE, start date: 26May2021, stop date: 26May2022; VIT D [COLECALCIFEROL], start date: 01Sep2021, stop date: 26May2022; SPIRONOLACTONE, start date: 01Mar2022, stop date: 26May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022 at 12:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative on rapid test; Negative, notes: then negative again on Day 8; Positive, notes: Tested positive on rapid test in afternoon. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details: product COVID 19 Treatment, treatment start date 16May2022,stop date 21May2022, indication treatment of COVID-19. Other medication in 2weeks: Yes, other medication in 2weeks product Multivitamin, started on 26May2021, stopped on 6May2022. Adverse event type 2 Diabetes, PCOS, androgenic alopecia started on: 26May2022 at 12:00 AM, If patient recovered: Not Recovered, If treatment ae: No, known allergies: No. Other medical history: Type 2 Diabetes, PCOS, androgenic alopecia. Patient was not a pregnant at time of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed soreness, erythema and soft tissue swelling (mild, seems more dermal) that lasted over 4 days. It is improving.
Vaccine administered 2 days outside of the 31 day window after thawing.  Patient was informed and advised to receive first Pfizer covid dose again without a wait period or have vaccine already administered as her first dose. Patient was interested in receiving first dose of Covid Pfizer vaccine again.  She returned to clinic to receive dose again.
Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatigue, pain a swelling a injection site.