chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)) 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 (Patient received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)).    No concomitant medications were provided. No treatment medications were reported.  This case was reported for 18th patient of 27 adult patients.
Few drops of the dose dripped out as the nurse was administering; vaccine pen was faulty; Received another dose as a result; A spontaneous report was received from a health care professional, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported the patient had received the product and a few drops of the dose dripped out during administration and subsequently received another dose with no associated adverse events.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number:004M20A ) for prophylaxis of COVID-19 infection.  On 04-FEB-2021, during vaccine administration, the vaccine pen was faulty and a few drops of the dose dripped out as the nurse was administering. The patient received another dose as a result. There was no reported adverse events with the product administration error.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, few drops of the dose dripped out as the nurse was administering and received another dose as a result, was considered resolved.; Reporter's Comments: This report refers to a case of vaccine underdose, syringe issue, and extra dose administered for mRNA-1273, lot # 004M20A with no associated AEs.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) for the first and second time were 212, 34, and R; 828,29 and R; The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) for the third time were 24, 49 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Left arm red and itchy use ice pack and Ibuprofen prn, can use Benadryl cream, for itch.
5 Days after PENTACEL -> rotavirus given pt with fussiness, lighter colored stools and hypoglycemia. Mother of child attributes to vaccines. Reviewed with her GI specialist who recommends continuing vaccine schedule. I spoke with her GI specialist who reviewed the UC record and thinks her labs are the best they've looked. She recommends continuing vaccine series. MOC desires the VAERS report be completed. Patient was seen along with father and mother. Patient is a 6 month old female with history of cholestasis and hypoglycemia. To summarize, she presented to Hospital Ed on 10/6/2018 with a bilirubin of 18/10. She was found to be hypoglycemic. During her hospitalization from 10/6/2018 to 10/19/2018, she underwent a large workup including evaluation by endocrine, evaluation by ID, evaluation by metabolics, and liver biopsy. No underlying cause of her cholestasis and hypoglycemia has been found to date. She underwent surgical GT placement on 11/29/18. In the last month she had been doing great. Jaundice is gone and direct bili is normal as is GGT. No longer itching. Having colored stools. Gaining weight and height. During the day she goes about 2 hours inbetween bottles before her sugar drops below 60. Overnight gets continuous feeds. Once forgot to hook up and after 5 hours had sugar of 30-irratable but still mentating. No bleeding or bruising. No fevers. Developing normally. Recently received PENTACEL and rotavirus vaccine. Had some alcoholic stools and diarrhea-maybe unrelated to vaccine.
Mother states she noticed redness and swelling this AM 07/17/2003.  Left arm (70mmx 70mm).  Mother using cold compresses at site.  Denies any other symptoms.
2 days of fever without other symptoms. Riding in car seat and had seizure. Given Diastat 2.5mg. 911 EMS when arrived pt post-ictal.
This spontaneous report as received from an other health professional refers to a patient of unknown age. On 08-SEP-2014 0.5 ml VARIVAX (Merck) (lot# unspecified) that underwent a temperature excursion was administered to the patient via subcutaneous. No adverse effect was reported. This is one of two reports from the same reporter. The other report is 1409USA004711. Additional information has been requested.
This spontaneous report as received from a medical assistant. On 23-JUN-2014, the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneously, Lot # J005726 and expiration date verified as 08-MAY-2014 (reported as 08-APR-2014) that underwent a temperature excursion. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected, because all pertinent information has been received.
Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous report from a contactable other HCP (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) via an unspecified route of administration on 18Dec2020 18:30 at single dose in left arm for COVID-19 immunisation. She received the second dose (lot number: El1283) in right arm on 08Jan2021. Medical history included Idiopathic anaphylaxis and was allergic to penicillin, had COVID-19 from May2020 to an unknown date. Concomitant medication included unspecified birth control pills. The patient experienced anaphalaxis on 19Dec2020 06:00 AM. She talked with her doctor lips swelling and face. Treatment received for events lips swelling and face. But her question is she had an IGG antibody test and it was negative. She had COVID in May2020 and have been tracking her antibodies. She wanted to know 'does this antibody test show the same antibodies?' She had negative after the two vaccines. The patient is not pregnant. Events outcome was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
after receiving the complete scheme of Shingrix relief on general neuralgia; Pain; This non-serious case was reported by a physician via call center representative and described the occurrence of unexpected therapeutic effect in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included trigeminal neuralgia and pain. Concomitant products included carbamazepine.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: after receiving the complete scheme of Shingrix relief on general neuralgia) and pain (Verbatim: Pain). The outcome of the unexpected therapeutic effect was unknown and the outcome of the pain was not resolved.   It was unknown if the reporter considered the unexpected therapeutic effect and pain to be related to Shingrix.     It was unknown if the company considered the unexpected therapeutic effect and pain to be related to Shingrix.   Additional Information: GSK receipt date: 05-SEP-2023 This case was reported by husband on behalf of his wife.  The patient suffered from Trigeminal Neuralgia and her pain subsided after her second dose of Shingrix in 2021 (Unexpected Benefits). The pain had returned after two years, however, patient was happy to be pain free for approximately two years. This case was identified as duplicate of case US2023121047. All future correspondence would be added in this case, which stands as case of record for this patient and the case US2023121047 would be deleted. The reporter did not consent to follow-up.
The first dose of the vaccine was given to me on April 2, 2021.  The second dose was given to me on April 30, 2021 (at 9:00am).  On May 4, 2021, at approximately 9:00pm, I noticed that my heart skipped a beat several times beginning at this hour.  The following day, it happened several times again throughout the day.  Then it continued to happen multiple times a day on most days lasting for approximately until mid-August 2021.  Beginning in late July I had begun taking magnesium citrate supplements to try to abate the heart palpitations.  By mid-August until today's date, the palpitations seemed to have now gone away.
Pt in for covid vaccine. Immediately after pts dose pt stated he began to feel like his arm was on fire. Pt stated his ears were ringing and he became diaphoretic. Pt aslo  states he feels like he loss vision for about 30 seconds. Pt had small amount of emesis as well. Vitals 110/67 hr 70 rr 20 temp 97.8 oxygen 98%. After about 5 minutes pt stated he felt so much better. Pt monitored for 30 minutes by nurse vitals q5 min. Last vitals 120/72 hr 72 respiratory rate 18 oxygen 98% t 97.8. Pt left facility accompanied by family. Educated to follow up with PCP.
Pt. states that he received his second dose of moderna on 2/5/21 to his left arm at 9 am. Pt. states that he had to wait 15 minutes and started getting a light headache around 09:45 am. Then two hours later he developed a worsened headache, dizziness, and nausea. Pt. told manager that he was not feeling well around 1:00 pm. Pt. states that he left work a little bit after 1 pm.  Pt. states that he took ibuprofen for headache. Pt. states that he did not get relief of symptoms after taking ibuprofen. Reported in VAERS by provider/reported in PURE. Pt. instructed to follow up with pcp. Pt. understands/agrees with plan. Questions/concerns addressed.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and fender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 22Jan2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received their Pfizer vaccine on 22Jan2021. The patient then tested positive for COVID on Monday, 25Jan2021. The patient was to receive a monoclonal antibody infusion, bamlanivimab. Patient had to wait 90 days to get the Pfizer vaccine. Pharmacist asked after that 90 days was up, should the patient get the second dose, or start the series over. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
This female received a flu vaccine at pharmacy on 12/28/13. She developed back pain, weakness, foot drop and presented herself to the emergency room on 12/31/13. She was evaluated and on 1/2/14, she was felt to have a transverse myelitis and was transferred to another hospital. There she underwent exhausted workup and was felt to have an acute transverse myelitis secondary to the flu vaccine, which is a very rare complication. She was subsequently transferred to my care at Nursing and Rehabilitation Center for subacute therapies and at that time, she was admitted with transverse myelitis, neurogenic bladder, paraplegia, urinary retention with Foley catheter and obstipation. She underwent physical therapies and has not improved. I am trying to get her into the transverse myelitis clinic at another facility as an outpatient. Patient is diagnosed with acute transverse myelitis secondary to flu vaccine with other diagnoses as noted above. She is unfortunately going to be completely and totally disabled starting 12/31/13, through the rest of her life due to this unfortunate illness. I am going to enclose records that I have from the other facilities.
tiredness; leg and shoulder ache; leg and shoulder ache; a little headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (first dose), for COVID-19 Immunisation.  The following information was reported: FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "tiredness"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 10Mar2021, outcome "unknown" and all described as "leg and shoulder ache"; HEADACHE (non-serious) with onset 10Mar2021, outcome "unknown", described as "a little headache".  Additional information: The patient was asking how could there be side effects after the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within minutes of receiving the vaccine, he, vomited and then fainted twice.  His blood pressure plummeted  (60/40)  and required the on site EMT medics to intervene with a 800 cc saline IV and Zophran medication.  He responded well to the treatment and was able to be release  45 minutes after the IV started.
pt recv vax 16OCT96 & 21DEC96 started having a sore throat;2 days later pt had chills, congestion, fatigue but not fever;
a new allergy to milk; a possible allergy alert to ROTATEQ in the patient chart due to the milk allergy; This spontaneous report was received from a pediatrician and refers to a 6-month-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unspecified date in 2021, at 2 months old, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, dose/frequency reported as 1st dose, lot # 1741377, expiration date: 07-MAR-2022 (exact dose was not reported) for prophylaxis. At 4 months old, she received her second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, dose/frequency reported as 2nd dose, lot # 1707591, expiration date 11-MAR-2022 (exact dose was not reported) for the same indication.  On an unknown date in 2021, the patient experienced a new allergy to milk (milk allergy). The reporter stated, that they received a possible allergy alert to rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (allergy to vaccine) in the patient's chart due to the milk allergy and the third dose of vaccine which was scheduled on 06-OCT-2021 was held. They were going to schedule the patient for the third dose soon so that she would still be 6-months-old at the time of the 3rd dose. It was confirmed that the patient did not have any other adverse events that occurred with the previous 2 doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  The outcome of allergy to milk and allergy to vaccine was unknown.  The causality assessment between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided, however a possible allergy alert to rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was considered to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (body aches) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced BACK PAIN (body aches) and PYREXIA (low grade fever). At the time of the report, BACK PAIN (body aches) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 99.6f High.         No concomitant was provided. Patient treatment information was not provided.; Reporter'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.
pt devel local rxn poss abscess @ inject site & systemic effects (aching, low temp & nausea); 2 other also recvd inject from this lot on 30NOV92; it is too ealry to tell it they will have a reaction;
I experienced chills, fever and body aches. My temperature went up to 103.1 about 10 hours after I received my injection. I took Tylenol and it was reduced to 101 by the next morning. I felt bad for the rest of the day and took one more dose of Tylenol. My shot was on Wednesday afternoon and I felt better by Friday morning.
Patient received DTaP, Hib and MMR on 9/18/07; mom noticed rash on 9/22/07 at approximately 730pm - Head to toe.
On 3/15/2023 started having runny nose and cough and low grade fever prompted a Covid test the next day. By 3/17/2023 prescribed PAXLOVID.
The patient came to his scheduled appointment after 6 months for the follow-up of diabetes mellitus, hypercholesterolemia, and coronary artery disease. He was a new patient to this clinic in June 2010 and this is his first follow-up visit. He was given injections of a flu shot and a pneumonia vaccine by the nursing staff after confirming that he never had any drug reaction to those vaccinations in the past. After the injections, however, he became very nauseated and threw-up clear bile stained gastric juice a couple of times and his heart rate slowed down to 39 beats per minute and blood pressure temporarily dropped to 80/50 and he was passing in and out. 911 call was made and he was transported to the triage room where he started recovering. His blood pressure began coming up and heart rate recovered to 80 times a minute and pulse oximetry remained above 90 all the way. He was still nauseated when the paramedics arrived and he was taken to the local emergency room. He reportedly brought bottles of FLOMAX and VICODIN and he had gallbladder surgery 3 months ago according to the nursing notes. He was very nauseated and he was passing in and out when this provider hurried up to the examining room and his blood pressure was as low as 80/50 and heart rate slowed down as low as 39 beats per minute on the machine. Initial heart rate was 104 and blood pressure 118/77 and after he was taken to the triage room his heart rate started picking up to over 80 beats per minute and blood pressure started rising and pulse oximetry was 96% saturation on room air. Lungs: Clear to auscultations bilaterally. Heart: Regular with normal S1 and S2. He was still having nausea and vomiting when the emergency transport team arrived and he was throwing up bile stained clear gastric juice. He had an urinalysis drawn earlier this afternoon and blood tests were done on May 15, 2010. TSH 2.072. PSA 5.89. A1c 6.66. Glucose 130, blood urea nitrogen 16, creatinine 0.87, sodium 142, potassium 5.2. Normal hepatic enzymes. Total cholesterol 180, HDL 43, LDL 103, triglycerides 209. CBC normal. Assessment: 1. Probable drug reaction with shock and bradycardia. 2. Diabetes mellitus, under good control. 3. Hypercholesterolemia, under fairly good control. 4. Coronary artery disease. 5. Elevated PSA. Plan: 1. EKG was done also and that showed normal sinus rhythm with minimal voltage criteria for left ventricular hypertrophy. 2. He was taken to the local emergency department by emergency transport team.
I was recently diagnosed with Graves Disease. I first indication of symptoms was increased heart rate when my dental hygienist took my blood pressure and heart rate and said my heart rate was extremely high and asked if I was ok.  That was on 5/10, two weeks after my first dose.  I am unsure exactly when the increased heart rate began, but on 5/10 at the dentist is when I was first made aware of it.  I got my 2nd dose on 5/15, and 3 days later I broke out in hives and have had hives every days since, which I am able to manage with Allegra.  In June I started getting hand tremors, and my right eye was bulging. Both symptoms have persisted since.  I also lost 12 pounds between May and July while eating regularly.  When I learned that all these symptoms were indicative of a thyroid issue, I requested my doctor test my TSH, The results indicated hyperthyroidism. On 9/8/2021 I saw an Endocrinologist who gave me a preliminary diagnosis with me Graves Disease. On  10/1/2021 I completed blood work which showed above range T3, T4, TSI, and Thryroid Peroxidase Antibodies.  I also visited an Opthamologist today (10/6/2021) who confirmed Thyroid Eye Disease.
Spoke with pt. the day after she received the vaccines. States appx. 4-5 hours after vaccine administration, experienced rash, chest pain, trouble breathing. Took oral benadryl.  Did not use epipen, did not see provider. At the time I spoke with the pt., she stated her symptoms had resolved.  Also followed up with pt. 4 days later, stated no further symptoms.
Patient experienced nausea, paleness, and sweating. Used an ice pack. Called 911. Paramedics arrived and assessed patient inside and then moved patient outside for further assessment. Called patient after leaving the pharmacy and his wife stated that he was doing fine and back to normal.