chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A healthcare professional reported the occurence of limb swelling in a five-year-old female who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The subject's medical history, concurrent conditions, and concurrent medications were not provided.  The subject had no adverse experiences following receipt of four previous diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed injections.  On an unspecified date, the subject received her fifth injection of Infanrix.  On 05/15/2002, post-immunization, the subject developed limb swelling and was seen by a physician.  The event was reported to have resolved on 05/21/2002 and was considered by the reporter to be related to Infanrix administration.
Sore arm; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 06Apr2021 at 14:00 (at the age of 52-years-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 started on an unknown date. The patient had no known allergies. The patient did not receive any other medication in two weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 18:00, the patient experienced sore arm and fatigue. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm and fatigue was recovering at the time of this report.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment of product data and narrative as Dose Description updated to DOSE 1, SINGLE, Dose Number added as 1.
felt dizzy whenever she would bend over; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (felt dizzy whenever she would bend over) and PYREXIA (fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (fever). On 29-Apr-2021, the patient experienced DIZZINESS POSTURAL (felt dizzy whenever she would bend over). On 29-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, DIZZINESS POSTURAL (felt dizzy whenever she would bend over) had not resolved.            Concomitant medications were not provided. Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Injection site swelled to an inch by two inch rectangle. It was raised, hot, red, and very sore. This started a few hours later. I took Benadryl Sunday night. This seemed to help the swelling, redness, and size. It lasted until the following Wednesday. My arm is still sore. Starting Tuesday I became very fatigued, muscle aches everywhere brought to tears, and  anxiety became high to panic attacks. This is still going on.  I take Percocet for breakthrough pain for other illnesses. I took this Wednesday, Thursday, and today.  I am in more extreme pain than I should be.
Summary:  - Patient was seen at our Covid vaccine clinic on 10/10/2023. - She were scheduled to receive the Moderna Covid 12 year + vaccine. - However, she was mistakenly administered the Moderna 6 month - 11 year vaccine, which is half the dose. - The error was not identified until after they had left the office. - Dr. immediately contacted her mother to inform her of the mistake.  Follow-up Actions:  - On the morning of 10/11/2023, I contacted the medical team at Moderna, the CDC, and a nurse at Public Health. - All resources concurred that the appropriate course of action is for her to receive a full dose of the correct Moderna 12+ vaccine with no minimum wait time. - Dr. will discuss the vaccination schedule with her mother to determine her preference.  Reporting and Office Actions:  - A VAERS report for an incorrect vaccine administration has been filed. - The Medical Assistant responsible for the incorrect vaccine administration has been counseled and subjected to a written reprimand. - As an office, we are implementing updated procedures to ensure such errors do not occur in the future.
Numbness on the left side of face and ear. Lasted only about 4 hours from about 5pm to about 9pm.
No Adverse event; gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No Adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .3 milliliter. On 02-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.).    No concomitant medication details was reported. It was reported that HCP travelled and used to giving the Pfizer, which was 0.3mL. No treatment medication details was reported.   This case was linked to MOD-2022-668652.   Reporter did not allow further contact
First Moderna Covid-19 vaccine on 29 AUG 2021 and second dose on 26 OCT 2021; Injection site sore after the first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site sore after the first vaccination) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Covid-19 vaccine on 29 AUG 2021 and second dose on 26 OCT 2021) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced VACCINATION SITE PAIN (Injection site sore after the first vaccination). On 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Covid-19 vaccine on 29 AUG 2021 and second dose on 26 OCT 2021). On 26-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Covid-19 vaccine on 29 AUG 2021 and second dose on 26 OCT 2021) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site sore after the first vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report was received from a nurse practitioner and refers to a multiple patients of unknown age and gender. There was no information about the patients' concomitant therapies, concurrent conditions or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot # M022924 with an expiration date 24-JAN-2018, 0.5 ml, intramuscularly for prophylaxis (anatomical location was not reported). There was no adverse effect reported. Administered doses of VAQTA experienced the temperature excursion between 0 and 2 degrees Celsius for 37 hours. A digital data logger was involved. There was no previous temperature excursion. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005226:
Acute vertigo with vomiting started on April 2 at 12:30 in the afternoon. The vertigo and vomiting continued until zofran was prescribed at which point the nausea stopped when I did not move in the bed. Vertigo was constant for April 12th. On April 8th I saw my PCP. She prescribed continued my zofran prescription  and added Xanax and meclazine. On April 13th I had a tachycardia event with 114 bpm for 10 minutes. The vagus maneuver worked on my 3rd attempt and my bpm resumed at 70 bpm. I am still experiencing slight vertigo. My gait is not yet steady and I cannot drive because to turn my head brings on dizziness. I am scheduled for my second vaccine Thursday April 22 at 1:00. Needless to say-I am very anxious about taking it. But my cardiologist, ENT and PCP all recommend that I finish getting vaccinated.
Pt c/o anxiety and dizziness post vaccination. Treatment reassurance, q5min vital signs monitoring. Outcome: stable vital signs.
Information has been received from a registered nurse and a physician referring to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 11-FEB-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot# J005693, expire date 07-MAY-2015, dose, route, anatomical location were not reported) (incorrect product storage). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
At 04:00 pm, excessive fatigue. I was taking my mom shopping and I had to stop and take her home. Just excessive fatigue. 3/26/ 21-  I woke up at 01:00 am with chills; freezing and infrequent tremors. I had a bad headache. Body aches. 04:00 am started feeling nausea. I contacted Dr to see what I could take. Got a reply email that recommended not to take anything. I toughed it out and I was in bed all day. I finally ate at 05:00 pm that day for the first time. The nausea  and chills subsided with the mild food. But headache and achy body persisted. On 3/27, mild headache and mild body aches - I was a 2 out of 10 for pain.  It continued to get better. I have joint pain in the winter when it is cold but I don't have any of that when it's warm. But I'm having joint point this summer. Which is weird and not usual. My joints have never hurt in summer time and spring before but have been this year.  My left shoulder is frozen out of the blue at the injection site. It hurts. Have been having foot pain. Shooting pain in my right heal. Communications via email to Dr and Dr said to do heat and ice and sent me exercises to do with feet and shoulder. The shoulder still hurts but it is slowly getting better. I have been seeing Naturopath for  hormone/menopause and I have been taking the hormonal supplements a month before the shot.
Patient presented with complaints of weakness and tingling in arms and legs. She became progressively weak and required intubation. She was diagnosed with GBS. Intubated, ended up trached, required Pheresis. Developed pneumonia, anemia. No definate etiology for the GBS was noted, except that patient reports having a flu shot in October--not sure exact date. The MICU team felt the GBS was due to the flu shot.
Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003956 is a spontaneous case report initially received on 05-Oct-2022 (reference number: USBAV22-1628) and concerns a patient of unknown demographics (second out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On 12-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L037921 and expiration date of 31-MAY-2017 (strength and dose were not reported). No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 88 y.o. Admit Date: 7/31/2022  9:54 AM Discharge Date:  8/6/2022 Admitting Physician:  Discharge Physician:   Discharge Diagnosis: Principal Problem:   Cerebellar stroke Active Problems:   Internal carotid artery stenosis, left   Primary hypertension   Vertigo   DM type 2 (diabetes mellitus, type 2)       HPI:    Patient is a 88 y.o. male with a history below admitted for Vertigo. Pt came in with complaints of nausea, vomiting, starting 5am. Noticed room appeared to be spinning. Worse with movement. Vomitus was bilious. No abdominal pain / tenderness. Recent covid infection, but no longer symptomatic and only had mild course. No suspicious foods or recent sick contacts. No fever / chills, no diarrhea / constipation. Discussed with er. Will admit      Hospital Course: No notes on file He was initially admitted to the coverage unit after he tested positive for COV ID?19 infection. He was initially diagnosed with this medical condition last July 8. Osseous already completed his quadrant. He was transferred to neurology floor. He had  MRI of the head that shows an acute infarct in the right cerebellum measuring 1.5 cm. Carotid ultrasound was done and it showed a possible greater than 70% stenosis of the left ICA. Permissive hypertension was observed. He was seen by PT, OT, ST. He was started on aspirin. He was seen by neurology. His condition improved he was also seen by possible surgery and further review of the don't think patient has significant stenosis. He is currently doing better. He'll be discharged to rehabilitation center today. He will follow up with vascular surgery in 6 months. Discharge was held for a day as he was complaining with leg pain. Venous doppler did not show DVT and there was popliteal cyst. He is doing better and will be discharged to rehab today.                 Physical Exam on the Date of Discharge: Physical exam:  General Appearance: alert, NAD  Neck: no JVD, no LN enlargement  Lungs: clear, no wheezing   Heart: RRR, S1 S2 heard  Abdomen / GI: soft, non-tender, no ascites  Extremities / musculoskeletal:  edema, no synovitis   Skin: no rash, dry skin  Neuro: follows commands, moves extremities with right leg weakness           Consults:   IP CONSULT TO SOCIAL WORK IP CONSULT TO VASCULAR SURGERY IP CONSULT TO NEUROLOGY   Significant Diagnostic Studies:    Mri head as above     Disposition:  SNF   Discharge Condition:  good
got sick; felt really bad; headaches; achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), FEELING ABNORMAL (felt really bad), HEADACHE (headaches) and PAIN (achy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick), FEELING ABNORMAL (felt really bad), HEADACHE (headaches) and PAIN (achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (got sick), FEELING ABNORMAL (felt really bad), HEADACHE (headaches) and PAIN (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications reported were Unknown medicine for bipolar disorder.
Site: Pain at Injection Site-Mild, Systemic: Shakiness-Medium, Additional Details: patient's wife called to report he was having some shakiness the day after his vaccine. General shakiness of the body. Arm was "a little" sore. No previous history of this with previous covid shots
I experienced chest pain and was advised to go the ER by the BCBS "Ask the Nurse" line. I went to the ER and the doctors performed a baseline EKG because they wanted to make sure that I didn't have a heart attack. The recommendation was to follow-up with a Cardiologist and a Urologist but my PCP disagreed with them because I did not have a heart attack because my heart was fine.
This spontaneous report as received from a female patient of unknown age concerning herself via Pfizer (other company number 2014073846). 10 years ago, in approximately March 2004 the patient was vaccinated with PNEUMOVAX 23 (lot number, dose, route and strength were not reported). Then the patient received a booster vaccine (manufacturer unknown) 2 years ago in approximately March 2012. Diagnosed with pneumonia this last week (in March 2014). The patient experienced cough, fever, wheezing. The patient was asked that why would she get pneumonia when she received the pneumonia vaccine. The outcome and action taken were not provided. Additional information has been requested.
She recieved the Gardasil series, which ended in June of 2008. In the first weeks of September 2008, she began to suffer from her tongue becoming paralyzed. On September 23rd, 2008 she woke up and could no longer walk. Her legs had become so weak and then paralyzed. She was hospitalized and now cannot walk, her arms are now becoming weak, and her speech has slowed and has stuttering.
This is a spontaneous report from a contactable physician via a Pfizer sale representative. A patient of unspecified age ethnicity and gender received a single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient referred to emergency room with redness and swelling in arm, from shoulder down to the elbow, following a dose of pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date. The outcome of the events was unknown. The reporter stated that the events took place after use of product. No follow-up attempts possible. No further information expected.
Dizzy & diaphoretic 10 min p/ vax,BP 100/60, P 82, 5 min p/ laying down BP126/80, P 82, left clinic w/ no other c/o
She said that with the first 2 shots she got "fever and chills, not a real deal; She said that with the first 2 shots she got "fever and chills, not a real deal; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (She said that with the first 2 shots she got "fever and chills, not a real deal) and CHILLS (She said that with the first 2 shots she got "fever and chills, not a real deal) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history  was reported.  Concomitant products included ESTRADIOL BENZOATE (ESTRADIOL [ESTRADIOL BENZOATE]) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (She said that with the first 2 shots she got "fever and chills, not a real deal) and CHILLS (She said that with the first 2 shots she got "fever and chills, not a real deal). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (She said that with the first 2 shots she got "fever and chills, not a real deal) and CHILLS (She said that with the first 2 shots she got "fever and chills, not a real deal) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       some supplements as regular medication was reported. 7 months later patient received the 2nd dose and the booster shot  on the 03Dec2021.   This case was linked to MOD-2021-404471, MOD-2021-404472 (Patient Link).