chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse in a physician's office and a registered nurse in a county health department, for the Pregnancy Registry for GARDASIL, concerning a 21 year old female with a history of gestational diabetes with her first child and no drug reactions/ allergies who on 05-Feb-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 661954/1496X) in the physician's office. There was no concomitant medication. It was reported that the patient did not have a pregnancy test prior to the vaccination. Subsequently, the patient discovered that she was pregnant. The patient's last menstrual period was 03-Jan-2009, her estimated delivery date is on 10-oct-2009. On 05-Mar-2009, the patient had a prenatal ultrasound performed in the physicians office that reported her estimated date of confinement (EDC) to be 19-Oct-2009. The nurse also reported that along with the prenatal lab work the patient had preformed, she also underwent a 1 hour glucose test that she failed. She then underwent a 3 hour glucose tolerance test that was normal. The patient was referred to a county health department. Additional information has been requested.
Subsequent to receiving vax pt developed a papular vesicular rash on her trunk, neck and ears. Pt was treated with Benadryl, Aveeno and oatmeal baths.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 13-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
I got the shot in Wednesday and then Saturday I was sitting there watching TV when suddenly I realized I could not hear a thing in my left ear. I went to see the dr. and they gave me 30 decibels of steroid injections in my ear drum.
Swelling tenderness at site without erythema or fluctuance. About 5 cm diameter.
Loss of energy; Loss of energy; Headache; very tired; arm sore; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 12:05 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient previously administered first of BNT162B2 on13Jan2021 for covid-19 immunisation and experienced Headache, loss of taste, very tired, arm sore. The patient experienced headache, very tired, arm sore, loss of energy on 03Feb2021 and patient again experienced loss of energy on 04Feb2021. The patient did not received any treatment for the events. The outcome of the events arm sore was reported as unknown and other events was reported as Recovered.   Information of Lot/ Batch number have been requested.
Pfizer vaccine administered after being stored at a regular freezer temps longer than recommended. Dose determined invalid, client contacted and recommended repeat dose.
Pt received pneumonia vaccine 0.5 IM L deltoid at around 10am. Returned at 3:20 T 96.6-tenderness at injection site area slightly red, some edema noted, warm to touch. Ibuprofen 600mg po-ice cap applied. Heat for comfort later tonight F/U in am or return PRN. 11pm Kenalog 40mg IM, Benadryl 50mg IM MD. Discharged 9/12/02.
Breakthrough COVID infection. Tested positive 07/26/2022. Symptoms of shortness of breath and fatigue . Unsure onset of symptoms.
Painful inflammation; Blister like bumps; Blister like bumps; Sore behind neck head area and in fold of right arm.; Sore behind neck head area and in fold of right arm.; Sore behind neck head area and in fold of right arm.; This is a spontaneous report from a contactable consumer, the parent. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3183) via an unspecified route of administration in the left arm on 28Aug2021 at 10:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. Concomitant medications taken within two weeks of vaccination were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fa6780) via an unspecified route of administration in the left arm on 04Aug2021 at 10:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Aug2021, the patient experienced painful inflammation and blister like bumps and sore behind neck head area and in fold of right arm. Those were the areas where the reporters son had eczema. Therapeutic measures taken included treatment with self medication with prescription products. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient was tested for COVID-19. On 03Sep2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events painful inflammation, blister like bumps, sore behind neck head area and in fold of right arm were not resolved at the time of this report.
Patient reported dizziness 15 mins following COVID vaccine. Assessed by EMS & Dr. At 1545, BP#1 138/97 P 97 R 20 O2 Sat 97% RA. At 1600, BP#2 141/86 P 92 R 20 O2 Sat 97% RA. Pt reported no improvement at 30 min post vaccine and now c/o new symptoms: nausea, gen. itchiness, lump in throat Dr and EMS with patient. Pt stated she experienced dizziness with 1st dose of COVID vaccine on 03/09/2021. Pt transported by Rescue at 4:15PM.
cellulitis; itch at the injection site; red, raised and warm spot; ears ringing; body aches; Blood pressure was extremely high; feel ill; arm has a throbbing sensation; swelling in  lymph nodes under the armpit area; nausea; chills; low grade temperature; Severe  headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing) and PAIN (body aches) 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 information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing), PAIN (body aches), HYPERTENSION (Blood pressure was extremely high), ILLNESS (feel ill), PAIN (arm has a throbbing sensation), LYMPHADENOPATHY (swelling in  lymph nodes under the armpit area), NAUSEA (nausea), CHILLS (chills), PYREXIA (low grade temperature) and HEADACHE (Severe  headache). At the time of the report, VACCINATION SITE CELLULITIS (cellulitis), INJECTION SITE HYPERSENSITIVITY (itch at the injection site), INJECTION SITE HYPERSENSITIVITY (red, raised and warm spot), TINNITUS (ears ringing), PAIN (body aches), HYPERTENSION (Blood pressure was extremely high), ILLNESS (feel ill), PAIN (arm has a throbbing sensation), LYMPHADENOPATHY (swelling in  lymph nodes under the armpit area), NAUSEA (nausea), CHILLS (chills), PYREXIA (low grade temperature) and HEADACHE (Severe  headache) outcome was unknown. off and on wet sensation    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 154/95 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took medication for the events, antibiotic and oral steroids. Later on, when the conditions magnified several doses of IBU and Tylenol were also taken.    Reporter did not allow further contact
SHINGRIX #1 6/8/18. Admitted 7/10/18 DOE, mod pericardial effusion. Discharged 7/12/18 on diuretics. Readmitted 7/15/18 for emergent pericardial window (surgical emergent pericardiocentesis for tamponade). SHINGRIX #2 9/10/18. SOB, increased LE edema 11/6/18, 11/28/18. Admitted 11/30/18 pericardiocentesis drained 400cc fluid. Discharged 12/4/18. S/P tamponade.
This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (breathing problems), AMNESIA (I lost my memory) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 08-MAY-2021 and 2nd Primary monovalent dose on 09-AUG-2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS7140C, 052E21A and 027C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced DYSPNOEA (breathing problems) and AMNESIA (I lost my memory). On 09-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 08-MAY-2021 and 2nd Primary monovalent dose on 09-AUG-2021). The patient was treated with OXYGEN at an unspecified dose and frequency. At the time of the report, DYSPNOEA (breathing problems) and AMNESIA (I lost my memory) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 08-MAY-2021 and 2nd Primary monovalent dose on 09-AUG-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported.    It was reported that after each shot, he went to the hospital with breathing problems. He went to Emergency room 3 times. He was using oxygen all the time now. Patient had lost his memory.
Nausea, cramping in uterus, back ache, fatigue- I thought I was pregnant. I got my period one week early. On 4/30, I fainted in the morning.
very sore arm; sick; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness and pain in arm. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the sickness and pain in arm to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had the shingles vaccine and the flue shot at the same time.The nurse said it was ok. The patient was sick for two days also had very sore arm. The patient did not recommended it.
Patient received moderna vaccine on 3/17/21 and 4/14/21. Found to be COVID positive on 7/24/22. Presented to the ed for cough and shortness of breath found to have covid 19 pneumonia. Vitals remarkable for hypotension and requiring high flow nasal canual to maintain saturations. Labs remakrable for leukocytosis, elevated bnp and positive covid. CXR remarkable for left pleural effusion vs chronic pleural thickening. CT chest angio remarkable for ascending thoracic aneurysm, left pleural effusion, ascites. Started on remdesivir, dexamethasone, vanc and zosyn. Nephro and onc consulted.    Patient is now s/p dexamethasone, remdesivir and antibiotic treatment for bacterial pneumonia. Discharged on 8/8/22
Information was received from a patient's mother regarding her 9 years old son who on 12SEP2012, was vaccinated with his first dose of GARDASIL, 0.5ml intramuscularly. It was reported that 3 days after receiving GARDASIL, he experienced dizziness, headaches, fever, and vomiting. The patient has also had loss of appetite and has lost 8 pounds. The patient had been to physician's office five times and had also gone to hospital emergency room and was given ZOLFRAN and sent home. It was reported the patient has had extensive blood work and blue titer test meningitis (results not reported). At the time of this report it was noted that the patient has not recovered. Additional information has been requested.
Pt received anthrax left arm at 1030 and flu-vaccine at 1300. By 1900 hours he developed pruritic red rash, initially beginning on his arm, and then progressing overnight to also iclude face, trunk, back, palms. Also asscoiated with mild fever, but no other systemic symptoms. On exam the next day he had multiple 1-2cm red, indurated lesions on his upper arms, forehead, palms, trunck, back. The remainder of his exam was normal. Pt was treated with course of prednisone and antihistamines and rash eventually resolved several days later.
Developed visual loss  to 20/800, double vision, oscillopsia, ataxia, dysarthria Symptoms started with difficulty with speech and loss of depth perception on 04/10/2021 (7 days after COVID vaccine shot)  Trial treatment with Solu Medrol 1 gm 5 days and Gammaglobulin 0.4 mg /kg for 5 days. No significant improvement except vision went from 20/800 to 20/400
Symptoms within first 24 hrs of receiving vaccine: warmth, pain at injection site, headache, muscle pain, tiredness, fever, nausea, weakness, tiredness, chills.   Symptoms continued for next 24 - 48 hrs: warmth, pain at injection site, muscle pain, itching, baseball size strawberry color appearance on arm around the injection site
This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of M-M-R II (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA005342: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005387: US-009507513-1705USA005389: US-009507513-1705USA005390.
Patient presented to outlying hospital on 3/31 for a 4 day history of nausea, vomiting, and confusion. Blood pressure in the 200s. Admitted for hypertensive urgency, renal failure, encephalopathy. By 4/3, patient was agitated and unable to recognize anyone but his mother. Fever 102.1. Intubated on 4/5 as he continued to worsen and responded only to painful stimuli. Patient transferred on 4/5. MRI demonstrated mutlifocal bilateral cerebral infarcts with vasogenic edema. Small infarct in the left cerebellar hemisphere. All workups so far have been negative. TEE being performed 4/20 to evaluate possible cardiac embolic source.  Providers are unsure of etiology of infarcts and edema. Reporting per infectious disease physician's request.
Revive 1st shot 2 day before period was suppose to start. Not 8 days later no period; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROPRANOLOL. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 08Apr2022, outcome "not recovered", described as "Revive 1st shot 2 day before period was suppose to start. Not 8 days later no period". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation delayed. Additional information: No other vaccine was given in four weeks. Other medication which patient received in two weeks was Propranolol. Received 1st shot 2 days before period was supposed to start. Not 8 days later no period. She was not pregnant have taken 5 tests all were negative. Doctor think this is just a skipped period. Have never had a missed period except when pregnant. This effects women's mental health, and patient feel that they have a right to know. Especially has a health care worker who had to be vaccinated. Adverse events start time: 12:00 AM. Patient did not have Covid prior vaccination. Patient was not tested for Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received on 24 April 2007 from a healthcare professional. A seven-month-old female patient had received a second dose, left thigh, intramuscular injection of Daptacel, lot number C2552AA; a second dose, left thigh, intramuscular injection of IPOL, lot number 20324 (not a valid manufacturer lot number); a second dose, right thigh injection of Comvax, lot number 0999-F; a second dose, right thigh injection of Prevnar, lot number B08668; on 21 March 2007. On the same day that the patient was vaccinated, she developed a fever of 104.4 degrees Farenheit. She was evaluated in an emergency room and discharged. Two days later, she as re-evaluated and subsequently admitted to the hospital for a sepsis workup. The fever resolved, and the patient was discharged following a three day hospitalization. The patient recovered from the event.
Fainted; Profusely sweat; severely sick; dont feel the same; Dizzy; Fatigue; Vomit; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (Patient received unknown medication for high blood pressure).    On 03-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), HYPERHIDROSIS (Profusely sweat), ILLNESS (severely sick), FEELING ABNORMAL (dont feel the same), DIZZINESS (Dizzy), FATIGUE (Fatigue) and VOMITING (Vomit). At the time of the report, SYNCOPE (Fainted), HYPERHIDROSIS (Profusely sweat), ILLNESS (severely sick), FEELING ABNORMAL (dont feel the same), FATIGUE (Fatigue) and VOMITING (Vomit) outcome was unknown and DIZZINESS (Dizzy) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.  Company comment: This spontaneous case concerns a 62-year-old female patient, with medical history of high blood pressure, who experienced the serious (medically significant) unexpected event of syncope, among other non-serious events. No onset date was provided for the event; hence, latency to the first dose of mRNA-1273 vaccine, cannot be assessed. No further clinical information for medical reviewing and no treatment information were provided. The history of high blood pressure and concomitant dizziness could be contributing factors for the event. The benefit-risk relationship of the mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-480584 (Patient Link).; Sender's Comments: This spontaneous case concerns a 62-year-old female patient, with medical history of high blood pressure, who experienced the serious (medically significant) unexpected event of syncope, among other non-serious events. No onset date was provided for the event; hence, latency to the first dose of mRNA-1273 vaccine, cannot be assessed. No further clinical information for medical reviewing and no treatment information were provided. The history of high blood pressure and concomitant dizziness could be contributing factors for the event. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Injection site is red, itchy, water/puffy eyes. Spoke with patient at 11:30 on 01/13/2016 she stated she felt better but still not as well as she would like. Pt scheduled app. to be seen.
incomplete course of vaccinationhad the first shot about 5 years ago but never had the second dose; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date about 5 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received second dose, which led to incomplete course of vaccination. The patient enquired if he/she need to start over.
11/23/09 hives on upper body, neck, head and arms, itching all over on said parts above. 11/24/09 - severe dry mouth at 530 AM - jumped out of bed - could not swallow or breathe needed to swallow lots of water, also severe wheezing. Symptoms recede on 11/27 except for severe head aches.
Patient stated 15 minutes post vaccination she felt tingling bilaterally in her feet. She rested for additional 5 minutes and tingling resolved.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Visual Changes/Disturbances-Severe
Patient was given a shot with vaccine that was left out passed the 12 hour mark.  Patient was contacted, no adverse affects or symptoms reported at this time.
Site of injection is red, hot, swollen 5x5cm, pt had fever x 2 days.