chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RIGHT-SIDE ABDOMINAL PAIN; DIARRHEA; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: Clindamycin and Bactrim allergy, and concurrent conditions included: high cholesterol, and osteoporosis, and other pre-existing medical conditions included: The patient was not pregnant at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 11-MAR-2021 09:15 for covid-19 prophylaxis. Age at time of vaccination 69 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received non-company suspect vaccine included: Spikevax (elasomeran) (dose number in series 2) (form of admin, route of admin, and were not reported, batch number: 022C21A expiry: UNKNOWN) dose was not reported, administered at left arm on 17-NOV-2021 10:00 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Spikevax (elasomeran) (dose number in series 2) The patient additionally received non-company suspect vaccine included: Spikevax (elasomeran) (dose number in series 3) (form of admin, route of admin, and were not reported, batch number: 057F22A expiry: UNKNOWN) dose was not reported, administered at left arm on 23-DEC-2022 11:15 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine. Concomitant medications included atorvastatin.  On unspecified date in DEC-2022, the patient had suspected covid-19 infection (dose number in series 3) for which patient was treated with non-company suspect Paxlovid (form of admin, route of admin were not reported, batch number: 2707493 and expiry: unknown) dose was not reported, administered on 29-DEC-2022 for treatment of COVID-19.  On 29-DEC-2022 18:30, the patient experienced right-side abdominal pain, and diarrhea (dose number in series 3) commencing 3 hours after initial dose of Paxlovid and was continuing at the time of reporting, 24 hours post first dose. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable, and action taken with paxlovid was not reported. The patient had not recovered from diarrhea, and right-side abdominal pain, and the outcome of covid-19 infection and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
light headed when he stood up, taken to EMS room for observation and was discharged in stable condition
Injection given to high up my arm near my shoulder, had intense pain.  When got home pain worsens and took ibuprofen and used ice pack considered going to ER but thought may subside as just got the injection and that the paperwork said pain at site expected.  So I continued self care rest, ice and ibuprofen at home until my stomach hurt.  However it progressively worsened and I was not able to have full function of my arm had painful range of motion. I could not turn my steering wheel or take off my shirt or fix my hair without pain with numbness and tingling going down my arm.  I called to complain to Clinic as I did not want another person to suffer the consequences that I have and I spoke with someone at clinic to complain and she instructed me to not wait until MD appt 3/6 but get immediate medical attention.
Initial unsolicited misuse report received from a nurse on 29 January 2016. This case involves a 26-year-old female patient who was vaccinated with an intramuscular dose TENIVAC (batch number U4669AA, expiration date 10 January 2016), in the right thigh, an intramuscular dose of ACTHIB (batch number UI278AA, expiry date 29-MAY-2016) in right deltoid, an intramuscular dose IPOL (batch number K1649-1, expiry date 15 November 2016) in left deltoid, HEP B in right thigh, PREVNAR 13 (batch number M35763) in right deltoid all on 28 January 2016. The patient did not had illness at time of vaccination. Patient had history of cancer, bone marrow transplant. Concomitant medications were not reported. On 28 January 2016, few hours "same day at evening" following the vaccination, the patient developed nausea and vomiting. It was also an expired vaccine used case, as Tenivac was an expired product. Lab data was reported as none. Corrective treatment was reported as unknown. Outcome of event was not recovered. List of documents held by sender: none.
Second Moderna COVID vaccine received on 1/25/21. Reports L arm injection site red, warm, painful and itchy hives to B arms and B legs started on 1/27/21. Also states she has "different feeling" when swallowing. Sent on 1/28/21.
Vomiting: diarrhea: Malaise: unusual crying -  Information has been received from a mother concrning her sone in approximately 1995 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 616251/0750B at the approximate age of 16 months. The patient's mother reported that her son received mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation about 5 years ago and she stated I remember that  he cried and creamed for hours after.  She reported that he vomited and had diarrhea and a general malaisa for the following week.  Unspecified medical  attention was sought.  Additonal information has been requested.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The pharmacist stated that several times she would only be able to draw up approximately 0.6 mL of reconstituted dose of ZOSTAVAX, injection (route, lot number and exp.date not provided) which would be administered to patients because of foaming issues air bubbles were needed to be pushed out of the needle tip - the reported stated that a small amount of product was loss during this step and therefore a full amount of recommended 0.65 mL dose had not been administered to an unspecified number of unspecified patients. No adverse effect was reported. The outcome of event was unknown. The product quality complaint (PQC) was filed. No further information is available.
NUMBNESS and TINGLING ON MY LOWER LEGS INITIALLY AND GRADUALLY  UP MY BUTTOCKS . SOME MILD NUMBNESS ON LEFT SIDE OF FACE.  Now mostly on my left lower extremity from feet to buttocks.
day p/vax pt devel fever 104 w/sinus & chest congestion,migraine h/a & dec appetite & cough;saw MD who felt vax related;started on Cipro;cont w/fever @ noc;pt also vomits
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. The medical assistant reported that, on 17-MAR-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot # and expiration date were not provided) and, on 25-MAR-2015, received the second dose of GARDASIL (dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
expired Pentacel was given to patient / no AE; Initial information received on 10-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years 1 months old male patient who was vaccinated with an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ100AB) (Expiry date 13-Jun-2020) via unknown route in unknown administration site on 09-Jul-2020 for Prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
Has not received the second dose (13Jan2021 was first dose); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the second dose (13Jan2021 was first dose)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 26-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose (13Jan2021 was first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose (13Jan2021 was first dose)) 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 medication was not provided.  Treatment information was not provided.
mom states child has felt warm for the last two days but today is warmer;on child's rt arm there are little bumps that are itchy;states put DPH cream on but didn't help;states right arm is red & warm to touch;now has congestion & dry cough
Post vax of DTAP, HIB, IPV and Prevnar, the baby cried very hard. The MA left the room and within a couple of minutes, the mother came out of the exam room carrying a limp, pale and cyanotic infant. The doctor witnessed the event and estimated that the baby did not breathe for 15 seconds but responded to back rubbing. After the baby resumed breathing, she had another shorter spell. The baby was observed overnight in the hospital and did well.
The pt experienced night chills, no fever, chest congestion, dry cough. Sweats lasted 2 days. Took Advil regularly. A little better now.
swollen arm/Swelling of feet; menstrual bleeding 5 days after the second dose which is out of their menstruation cycle; difficulty to focus which is impairing their ability to work; cannot stand very long; swollen ankles and feet; continuous periods with clots of blood; weakness; headache comes and goes, pretty much everyday; general fatigue; muscular pain and weakness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm/Swelling of feet), MENSTRUATION IRREGULAR (menstrual bleeding 5 days after the second dose which is out of their menstruation cycle), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to focus which is impairing their ability to work), DYSSTASIA (cannot stand very long) and JOINT SWELLING (swollen ankles and feet) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M208 and 024M208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm/Swelling of feet), MENSTRUATION IRREGULAR (menstrual bleeding 5 days after the second dose which is out of their menstruation cycle), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to focus which is impairing their ability to work), DYSSTASIA (cannot stand very long), JOINT SWELLING (swollen ankles and feet), HEAVY MENSTRUAL BLEEDING (continuous periods with clots of blood), ASTHENIA (weakness), HEADACHE (headache comes and goes, pretty much everyday), FATIGUE (general fatigue) and MYALGIA (muscular pain and weakness). The patient was treated with IRON (IRON COMPOUND) at a dose of 1 dosage form; PARACETAMOL at a dose of 1 dosage form and ETHINYLESTRADIOL, NORGESTIMATE (ESTARYLLA) at a dose of 1 dosage form. On 11-Mar-2021, PERIPHERAL SWELLING (swollen arm/Swelling of feet) outcome was unknown. At the time of the report, MENSTRUATION IRREGULAR (menstrual bleeding 5 days after the second dose which is out of their menstruation cycle), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to focus which is impairing their ability to work), DYSSTASIA (cannot stand very long), JOINT SWELLING (swollen ankles and feet), HEAVY MENSTRUAL BLEEDING (continuous periods with clots of blood), ASTHENIA (weakness), HEADACHE (headache comes and goes, pretty much everyday), FATIGUE (general fatigue) and MYALGIA (muscular pain and weakness) outcome was unknown.            Concomitant medication was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
I received the Moderna vaccine and had several side effect from it; mild chest pains in the middle of my chest; fatigue; headache; body ache; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I received the Moderna vaccine and had several side effect from it), CHEST PAIN (mild chest pains in the middle of my chest), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (body ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I received the Moderna vaccine and had several side effect from it), CHEST PAIN (mild chest pains in the middle of my chest), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (body ache) and CHILLS (chills). At the time of the report, VACCINATION COMPLICATION (I received the Moderna vaccine and had several side effect from it), CHEST PAIN (mild chest pains in the middle of my chest), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (body ache) and CHILLS (chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment medication was not reported.
patient had been feeling ill (malaise) due to getting a flu shot; fatigue; Initial information received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves a 62 years old female patient (90.7 kg) had been feeling ill (malaise) due to getting a flu shot and fatigue after receiving Influenza Vaccine and while treated with Treprostinil Sodium.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included Amlodipine (amlodipine besilate).   On 23-May-2022, the patient started taking Treprostinil Sodium 54 µg (9 breaths) via inhalational route four times a day (QID) (lot number- 2102260, Expiry date:  30-Nov-2023) (with an unknown formulation, dose ) for Secondary pulmonary arterial hypertension.  On 00-000-2022, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown formulation, route, expiry date, lot number, administration site) for immunization.  In Nov-2022, the patient had been feeling ill (malaise) due to getting a flu shot (malaise) (latency: unknown) following the administration of Influenza Vaccine and first dose intake of Treprostinil Sodium.  In 2022, the patient developed an event of fatigue (latency: unknown) following the administration of Influenza Vaccine and first dose intake of Treprostinil Sodium.  Action taken with Influenza Vaccine not applicable and Treprostinil Sodium was unknown.  It was not reported if the patient received a corrective treatment for the events (fatigue, patient had been feeling ill (malaise) due to getting a flu).  Outcome: Unknown
This spontaneous report was received from a registered nurse (R.N.) concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route, Lot No. and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hemorageic stroke, died next day on 03/12/21   My mother became noticeably and increasing confused, quiet and forgetful after the first dose.  Immediately after the second dose, she became confused and shakey.  On the third day  after the second shot, she was disoriented and unable to communicate sufficiently.  She was rushed to a local hospital, where she was diagnosed with a brain bleed.  She was transported immediately to a hospital, where she was given a catscan and it showed unreparable damage to the right side of her brain, she never regained consciousness and died the next day.
Less than 5 minutes after patient received the vaccine, he began to feel lightheaded and his vision became narrow. He leaned against the pharmacy counter and lost consciousness. He hit his head on the counter, bumped into the nearby display, and hit his head on the floor. Customer standing nearby called 911. Attended to patient and he was unconscious, shaking, and his eyes were open. A few seconds later, he regained consciousness, but immediately became unconscious again. Tried feeling for a pulse but he regained consciousness a few seconds later for good. He asked what happened, but remembers that his vision became narrow. Patient was alert/oriented x3. Brought him to a nearby chair and gave him some water and a Poptart and told him to wait for EMS to arrive. It was a hot day and he had only had a bagel/some water before work that morning. He let EMS check him out but refused transport to the hospital. Tried reaching out to patient the morning after x2 but his phone mailbox was full.
Left arm swelling and redness 12x20 cm. Redness, warmth, tenderness.
No adverse effects reported; the patient inadvertently received an expired dose of PROQUAD; This spontaneous report was received from the medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.      On 08-MAY-2019, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # N021730, expiration date on 06-FEB-2019 (formulation, strength, dose, frequency, route of administration, anatomical location, and indication were not reported). No adverse effects were reported.
Low grade fever; Chills; Nausea; Really super super bad dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), CHILLS (Chills), NAUSEA (Nausea) and DIZZINESS (Really super super bad dizziness) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PYREXIA (Low grade fever), CHILLS (Chills), NAUSEA (Nausea) and DIZZINESS (Really super super bad dizziness). At the time of the report, PYREXIA (Low grade fever), CHILLS (Chills), NAUSEA (Nausea) and DIZZINESS (Really super super bad dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
During her observational 15 minutes, patient was having dizziness and blurred vision. Patient had a loss of consciousness for 30 seconds. After regaining, patient was alert and oriented. Patient was given water and asked to sit for 15 minutes.
Patient had previously been able to talk and feed himself, his son witnessed him having an acute seizure and patient became unresponsive with a rightward fixed gaze, pt has had no previous noted seizures before this time, there have been a number of witnessed seizures since including witnessed by this RN, the wife had asked me if there was any possibility that this could be a longer term side effect of the vaccines he had received in April & May, I had mentioned this to the intensivist MD at that time and he responded"no, I have to go, I have another call" with no further explanation, This patient was on the ICU for quite some time, he is now on another floor, has not recovered and apparently the plan is for him to go home on hospice if he makes it through the night.
Hives distributed only on injected arm.  Duration has been at least 45 hours.  Spots are about 5-7mm diameter and in groups of 4 to 8.
This spontaneous report as received from a consumer refers to a 4 month old female patient. On 15-OCT-2013 the patient was vaccinated with a dose of VARIVAX (lot number reported as J003709; expiration date, dose and route of administration were not provided). The patient's mother reported that the patient was vaccinated at 4 months old. No adverse effect reported. The outcome of event is unknown. Additional information is not expected.
I have woken up in the middle of the night three times with a terrible headache. I attributed it to possible dehydration even though I was hydrated. The issue occurred sporadically over three weeks after the vaccine.
History of egg allergies-he fell down-without cause-slight rash on his belly-monitored for 15/20 mins-gave OJ-feeling better. Mother advised to follow-up with pediatrician if symptoms continue.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (exact dose, expiration date, therapy type and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Numbness in both arms and both legs ( started 3/1/2021 and still have it) Pain in left arm (started 3/1/2021 and still have it ) pain in Right side of chest ( started 3/6/2021 and has subsided) dropping things that are in my hands ( started 3/6/2021 and still happening every so often). Went to hospital on 3/6/2021 and had a follow up with PCP on 3/10/2021. Neurologist appointment scheduled 3/24/2021.
Swollen lymph nodes, anxiety, confusion, fever and chills for 2 days and still has symptoms.