chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 50-year-old female with a history of hypothyroidism, seasonal allergy, bee sting allergy and possible vaccination of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) as a child who in the beginning of July 2007 had a negative rubeola titer. She was vaccinated subcutaneously in the left arm with a 0.5 milliliter dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 656038/0204U). Concomitant medication included SYNTHROID and ALLEGRA-D. On 24-JUL-2007, the patient experienced a large red area at the injection site of the left arm that became walnut size, swollen, and raised. The patient sought medical attention and was treated with TYLENOL, ibuprofen, ice or warm packs as needed. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up information concerning a 50-year-old female states that patient had no pre-existing allergies, birth defects or medical conditions (patient previously reported to have a history of hypothyroidism, seasonal allergy, bee sting allergy). On 23-JUL-2007, the patient was vaccinated at 10 in the morning with a first dose (previously reported as having a prior possible vaccination) of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# "DQ4U)", previously reported as 656038/0204U). There was no illness at the time of vaccination. On 23-Jul-2007, (previously reported as 24-Jul-2007) at 6 PM the patient had a local reaction. The injection site was the size of a "walnut" and the entire arm was swollen, red, and hot. She was treated with ice and BENADRYL. There were no signs or symptoms of drainage or infection. On 15-Aug-2007, the patient still had a local hard area present around 3 centimeters, however it was reported that the patient recovered on 15-Aug-2007. Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 07-AUG-2016, the patient was vaccinated with a dose of PNEUMVOAX 23 (dose, lot # and expiration date not reported) intramuscularly. On 21-AUG-2016, the patient was administered second dose of PNEUMOVAX 23 in error. No adverse effects were reported. Additional information has been requested.
Patient was administered the vaccine with no complaints. Patient and mother left the vaccination room and proceeded to the candy aisle. After finding some candy they went to the register, once at the register the patient suddenly fainted and hit her head on the floor. I responded to the situation and brought the Epi-pen, EMS instructed us to not use the Epi-pen. Patient soon regained conciousness and then was taken to the hospital by EMS.
Rash less than 12 hours. Benadryl 2.5 ml (12.5mg/5ml) TID Ranitidine 15 mg BID
12/28/16 vomiting and diarrhea (once & done); 12/28/16 2:00 PM general ill feeling all day (nausea and stomach pain); 12/29/16 vomiting again (2 hours); chills, and then feeling hot; most of day; 12/31/16 tingling in hands and feet(off and on for about 10 days); Eyes hurting and blurry vision(off and on and is still occuring).
The patient for started to develop symptoms approximately 7 days prior to admission.  Symptoms started  on Tuesday, August 10, 2021 and she was admitted to the hospital on 8/17/2021.    The patient did not particularly perceive any shortness of breath., but she had been coughing frequently and overall felt very weak.  The patient received the first dose of the Covid vaccine on 8/7/2021 and notes the next day she developed fever, body aches.  She did visit the ED on 8/15/2021 and tested positive for Covid, but was discharged to home.  Upon  this admission, the patient was found to have COVID-19 pneumonia with some mild hypoxia.  The patient was requiring 2 L/min via nasal cannula to maintain sats greater than 88%.  The patient underwent CTA of the chest which was negative for any PE.  Throughout the hospitalization the patient required slightly increased oxygen needs.  The patient ultimately required a heated high flow nasal cannula at 8 L/min max.  This was ultimately weaned down to room air at the time of discharge.  The patient did have a home oxygen study that showed she required oxygen with any ambulation.  During the hospitalization, the patient was treated with remdesivir, dexamethasone, CCP the patient felt well on the day of discharge.
Patient received a flu shot on 8/26/11 and had a seizure the following day at 4:35 AM. No prior history of seizures. Patient was hospitalized for four days and seems to be fine now.
A patient received PENTACEL and VAXELIS at the same time; This non-serious spontaneous safety report, with reference number 2023SA223707 was received by a partner on 20-JUL-2023 and forwarded to company on 23-JUL-2023 from a health professional.   Due to the nature of the event, the causality between the events "A patient received PENTACEL and VAXELIS at the same time" and Vaxelis was not applicable.  Further information is expected.   Significant follow-up information was received by company on 14-AUG-2023, from an HCP. The case is maintained as non-serious.  The causal relationship between Vaxelis and the reported event " A patient received PENTACEL and VAXELIS at the same time "was assessed as Not applicable due to the nature of the event.  No further information is expected.
Initially developed arm soreness about 3-4 hours post vaccination.   8 hours post vaccination developed chills, fatigue, nausea, low grade temperature.   Very restless night sleeping.    The following morning symptoms continued until 12pm, then started to feel better. That evening (day1 post- vaccination) developed non-itchy maculopapular rash on trunk, thighs and upper arms.   Rash lasted that for 24 hrs.   Injection site was red, warm and sore for many days post-vaccination.
she is one week behind on the second dose of GARDASIL 9.; The caller reported being one week behind due to the clinic not having the available supply for GARDASIL 9.; The caller reported being one week behind due to the clinic not having the available supply for GARDASIL 9.; No AE/PQC reported; This spontaneous report was received from a female patient concerning herself. No concurrent condition, medical history, or concomitant therapy was reported.  On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. She was one week behind on the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) due to the clinic not having the available supply for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product supply issue, circumstance or information capable of leading to medication error and inappropriate schedule of product administration). She refused to provide any additional information regarding the adverse event (AE) for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No AE was reported.
temperature excursion; This case was reported by a pharmacist via sales rep and described the occurrence of product storage error in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced product storage error. On an unknown date, the outcome of the product storage error was unknown.   It was unknown if the reporter considered the product storage error to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: On 27th September 2021 the retail pharmacy called medical information to obtain temperature excursion data because theirwholesaler had contacted them to inform them that there had been a temperature excursion. Wholesaler asked pharmacy to quarantine the product.  The product had already been administered to 3 individuals.  On 27th September 2021 the pharmacy did not yet have the specifics of the temperature excursion. They did not yet know whether the product had been stored above or below refrigerated temperatures nor did they know for how long. On 4th October 2021 GSK employee (Director for GSK, retail) learned the specific details of the temperature excursion.  The product was shipped from GSK to the wholesaler ia but the shipment was lost and was sitting on a loading dock unrefrigerated for 2 weeks.  The wholesaler then put the FLUARIX product back in the refrigerator and subsequently shipped it to the pharmacy. The pharmacy correctly stored the product in the refrigerator and unknowingly administered 1 dose each to 3 individual patients. This is 1 of the 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208518:same reporter US-GLAXOSMITHKLINE-US2021AMR208519:same reporter
Patient states in evening her leg starts to vibrate and tingle that prevents her from going to the gym. Reaction started the evening of immunization.
20MAY92 1 day old pt accidentally recvd 2 doses of Engerix 2 hrs apart; no adverse events reported;
Patient was given the incorrect vaccine. Patient should had received Fluad instead received Moderna Bivalent Booster. Patient already received last month November Pfizer Booster
chronic hives, dermatographia, angiodema, etc. Has been almost three weeks so far with no improvement.
The following side effects occurred after receiving a booster of the COVID 19 vaccine, but not during the first two shots. Approximately 12 hours after the injection, there was nausea. Fatigue, headache, and eye soreness were experienced the second day after the injection. In the afternoon of that day, shortness of breath occurred. Intense anxiety and agitation were experience on the third day after injection.
Patient developed hives, redness and swelling of her right upper arm around the vaccine site on 1/21/2016.  She had itching.  Mother treated with Zyrtec and Zantac.  Hives resolved and returned again on 1/25/16-1/26/16.  Mother called the pediatric office and was advised to treat with Benadryl. This seemed to help the hives and itching.  Rash remained- residual hives, swelling and induration.  On 1/27/16 she developed headache, nausea and stomach ache.  She had reflux but no vomiting.  She was tired and had chills but no fever.  She was seen in the doctors office on 1/29/16.  She was mildly ill appearing on exam.  Tired.  Non-focal exam.  Right upper arm with induration and a serpiginous rash and resolving hives.  No discrete wheal and flare.  Patient was treated with supportive care.
Patient presented to pharmacy on approximately 2:20pm 8/20/2018 reporting the following symptoms: fever of 101, redness, flu like symptoms, and asthma-like (cough) feelings on 8/17/18 till Sunday 8/19/2018. Patient still feels fatigued and has a cough as of 8/20/2018.
Approximately 48 hours after vaccination, infant carried to ER for lethargy. Diagnosed with encephalopathy and seizures. Did not require ventilation. All infectious studies negative. Fever developed in hospital. Neurology and Infection DT - involved. Initially paced on Phenobarb then Tegretol. Initially thought to be viral. Per 60 day follow up: Pt has not recovered. Still having seizures . On Togretol. Spastic Diplegia, hypotonia. Overall improving, but very slowly. Follow up on 11/04/2003: "Vaccine recipient did not recover from the adverse events.  Cortical blindness; Developmental delay; Spastic quadriplyis, Seizures."  Nurse follow up on 07/08/04 states: "Mild URI, no fevers"
sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included GVHD and Stem cell transplant. Concomitant products included PREDNISONE, IBRUTINIB, AMOXICILLIN, ACYCLOVIR [ACICLOVIR], COLECALCIFEROL (VIT D [COLECALCIFEROL]) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   This case was linked to MOD-2021-026779 (Patient Link).
RAPID HEART RATE, NAUSEA, UNCONTROLLED TREMBLING, NUMBNESS TO FACE AND HANDS. HIVES.
DTaP GIVEN RATHER THAN Tdap. NO ADVERSE EFFECTS AT TIME OF ADMINISTRATION OR ON FOLLOW UP.
Pt reports "heat and soreness " at injection site. Pt requested Benadryl at this time. Vitals stable. Pt given 12.5 mg of Benadryl and reported relief in symptoms.
Information has been received from a registered nurse concerning a mother who called in to report that her 5 year old daughter, with a drug hypersensitivity to amoxicillin and ZITHROMAX, was vaccinated intramuscularly with a pediatric dose of VAQTA (lot# 654814/0786F) on 06-MAR-2007. There was no concomitant medication. On the evening of 06-MAR-2007, the patient began experiencing vomiting and a stomach ache. The patient's vomiting and stomach ache persisted. Additional information has been requested. 02/11/2010 Follow-up information from the nurse was received which indicated that the patient siblings also developed stomach aches and vomiting and some neighbors also developed these symptoms. The nurse believed that the symptoms were something going through the neightborhood and unrelated. RECOMBIVAX HB. Additional information ahs been received from the registered nurse who reported that the patient's other siblings and neighbors had stomach aches and vomiting. The reporter felt that the patient's events were not related to therapy with RECOMBIVAX HB and that is was "probably a viral infection." No further information is expected.
About 15 mins after getting the vaccine became lightheaded, dizzy and was pale. Did not faint.
metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not 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 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Fevers, chills, nausea, migraine headache, diarrhea, malaise, myalgia
An area of diffuse erythema and local increased temp was noted when her clothing was removed that evening, but we are not sure as to when it began. It was located approximately 2 fingerbreadths inferior to the injection sight. No systemic fever, but we empirically gave TYLENOL upon return home (around 6 pm) that day. The next morning (today) the area of erythema had increased and swelling was evident and the area was tender to touch. Dimensions today are 2 1/2 inches x 1 3/4 inches. She still does not feel febrile to touch x still with local increased temp over the area in question. O/w, appears to be at baseline. Although she is diabetic and elderly, we doubt cellulitis, since the skin abnormality developed away from the area of trauma from the injection. She had blood drawn from that arm before the immunization near the antecubital area, but no erythema is there or at the site of tourniquet application.
About a day after the vaccine, had a sun-burn like rash for about 1 week, went away on it's on. Resembled a rug burn.
Left preauricular swelling and tenderness. States symptoms began 2-3 hours post injection.  No difficulty swallowing, opening mouth, breathing. No specific treatment required.
pt came in to receive first Pfizer booster dose after receiving two Covid doses. Pt?s last Covid dose was on 11/24/2021. Pt did not attest to being immunocompromised. According to the CDC guidelines this pt should have received their first booster dose 5 months after their previous dose, therefore receiving their booster dose 12 days too early.
Started feeling faint and dizzy more often about 2 weeks after the vaccine. After almost fainting at work, the paramedics came to find out it was due to a dangerously high  blood pressure of 180/110.
A report has been received from a Health Professional concerning a 43 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced headache, joint pain, and body aches which started on 14-Oct-2013. The outcome of the event of headache, joint pain and body aches is unknown. The report was considered to be non-serious.
Neck tightness 2 hours post vaccine. Treated with Motrin then went away.
weakness in his legs; nerves on fire; anxiety reaction; flu like symptoms; tension headache; brain fog / "feels like I am fighting something off"; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), TENSION HEADACHE (tension headache), FEELING ABNORMAL (brain fog / "feels like I am fighting something off"), MUSCULAR WEAKNESS (weakness in his legs) and NEURALGIA (nerves on fire) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), TENSION HEADACHE (tension headache) and FEELING ABNORMAL (brain fog / "feels like I am fighting something off"). On 06-Jun-2021, the patient experienced MUSCULAR WEAKNESS (weakness in his legs), NEURALGIA (nerves on fire) and ANXIETY (anxiety reaction). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), TENSION HEADACHE (tension headache), FEELING ABNORMAL (brain fog / "feels like I am fighting something off"), MUSCULAR WEAKNESS (weakness in his legs), NEURALGIA (nerves on fire) and ANXIETY (anxiety reaction) outcome was unknown.            No concomitant medications were provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-258049 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: follow up received and contains reporter contact details.
Arrhythmias; Cardiac issues; This is a spontaneous report received from contactable reporter(s) (Physician).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "Arrhythmias"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Cardiac issues". The events took place 2-3 weeks after the patient received the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for the reported events of arrhythmias and cardiac disorder due to temporal relationship. However, there is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and post vaccination, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.
patient is 13 years old. based on patient age she was not eligible for vaccine. she received .3 ml of the pfizer vaccine, 6 months after her initial vaccine.
This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported) for prophylaxis that were improperly stored (Incorrect product storage). The storage temperature was 9C and time frame was 1 hour. No adverse effects was reported. This is one of the three report received from the same reporter. Additional information has been requested.