chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; she had an adult patient that had her first dose of a hepatitis b vaccine in 2015 and no additional hep b vaccine since then; This spontaneous report has been received from a registered pharmacist, referring to an adult female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   In 2015, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (reported as it could not be confirmed the name brand of the original vaccine) (route, dose, strength, lot number and expiration date) for prophylaxis and no additional hepatitis b vaccine since then (incomplete course of vaccination). No additional adverse event reported.
Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient experienced blurred vision for 6-7 hours after vaccine administration.
Information has been received from a physician concerning a female who "about a year ago"  in approximately 2007 was vaccinated with a dose of GARDASIL, lot number was not provided.  The physician reported that the patient's mother reported that her daughter experienced severe mood/personality changes "about a week post vaccination"  after receiving GARDASIL.  At the time of the report, the patient's outcome was unknown.  This is one of two patients concerning the same source.  Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Additional Details: Patient had Pfizer 1st dose administered in left deltoid on 03/08/2022 at 7:10pm.  Shortly after patient experience syncope for <10 seconds.  Was alert and oriented, normal blood pressure.  Monitored for 30 minutes, and two blood pressure checks were normal.  Follow up with patient on 03/09/2022 and patient reported no further issues.
pt recvd vax 3NOV93 & 1 wk later exp tingling in arms & fingers, hands were on fire, pins & needles, sore elbows, insomnia, arthralgia, aches; Advil was givne w/some relief; No further details were provided;
This spontaneous report was received from a consumer refers to a 60 year old female patient. No pertinent medical history. No drug reactions or allergies. On 07-NOV-2013, the patient was vaccinated with ZOSTAVAX, subcutaneous injection for prevention of shingles (lot number, strength and dose number not provided). Concomitant therapy reported as COUMADIN (unspecified dose, frequency and manufacturer). On 10-NOV-2013, the patient initially experienced redness and aches at the injection site where she received ZOSTAVAX injection. Since the initial injection, her symptoms have progressed into weakness, discoloration of skin, indentations, white spots and pain in and around the injection site. No treatment was given for the event. Lab diagnostics studies were not performed. Patient sought medical attention through an office visit (unspecified date). At the time of the report, the outcome of the events was reported as not recovered/not resolved. The causal relationship between the events and therapy with ZOSTAVAX was unknown. Additional information has been requested.
Encephalitis. Annual follow up 03/17/04: "It is unknown if pt recovered from adverse events."
This spontaneous report as received from Licensed Practical Nurse refers to a female patient of unknown age. On 19-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (lot # not reported) strength not reported, dose: 0.5 ml, intramuscular. On 03-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (lot# not reported) strength not reported, dose: 0.5 ml, intramuscular. No adverse effect reported. The outcome of event was unknown. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
patient had throat discomfort, benadryl given, epi given, EMS notified, patient declined further evaluation in the EMS and further evaluation in the ER, patient was asymptomatic upon departure of clinic, vitals stable taken by EMS
Immediately after receiving her second Moderna vaccine, patient states that she felt a tightness in her chest.  No shortness of breath noted.  She did not tell anyone at the clinic, but went home to rest.   She states that immediately after vaccine, she began to have cough, chest congestion and tightness.  Two days later, she went to PCP for evaluation.  The Dr diagnosed her with pneumonia and  prescribed treatment of antibiotics, steroids and albuterol.  Per patient, she has gone back to see the Dr four times and  been on treatments continuously.  She was referred to Pulmonologist and was seen on 4/14/21.  She states that the insignificant nodules that were previously in her lungs were more pronounced.  She continues to have cough and chest congestion.  No fever has been noted.  She will follow up with pulmonologist in July 2021.   Patient states that she feels like she still has pneumonia.
My entire left eye socket which was completely swollen; right side face is so swollen, my chin, my cheek; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 08Apr2021 (Lot Number: ER8733) as single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included amlodipine taken for hypertension; lisinopril taken for hypertension. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced right side face was so swollen, her chin, her cheek on 09Apr2021 04:00; allergic reaction on 09Apr2021 04:00; her entire left eye socket which was completely swollen on 13Apr2021 05:00. Clinical course: Patient stated she had two several reactions to the vaccine when she received this, her 2nd shot on 08Apr2021 and she was fine and she went to bed. She woke up 4 o'clock on 09Apr2021 morning and right side face was so swollen, her chin, her cheek, she called provider, who provided the vaccine, her primary care doctor saw her on 10Apr2021 and immediately he told her that probably she had an allergic reaction, so she had taken Benadryl that morning so it's go down and then 11Apr2021 night she went to the bed and she woke up on 13Apr2021 morning her entire left eye socket which was completely swollen, so and again it never happened to her before, so her husband just headed for 1st shot, after he had received information to where she would to call. She headed received that information and when she had her shot so he headed received information to call and she reflected that she had that reaction twice and in her face. Patient took the Benadryl on 09Apr2021 morning, before her whole face my right side swollen and then she took the Benadryl , she didn't take Benadryl on 11Apr2021 when she woke up, here was anything she needed to because she already had the reaction again so she woke up on 13Apr2021 morning at 5 O' Clock in the morning her whole face left eye socket and she was so swollen and it's still swollen it's going to take so long to slow down. Patient stated she still did have some swelling under the left eye, so things got slow down, she not took the Benadryl and so the major swelling gone right under the her eye, it's still pretty swollen, so If she look down take a look, she couldn't see she kind of lost. Patient stated it was still but not red but it was still there, definitely improved, because her eye was actually swollen much so on 13Apr2021 she was, it was improved. As for treatment, patient stated what she did was the 11Apr2021 when her left cheek and chin swollen, she actually took Xyzal which and that was 5 MG and 24 hours tablet. So when she went to primary care doctor on 10Apr2021, she told him that she took Xyzal, he gave her Benadryl because it would be stronger and on 13Apr2021 she took 525 MG Benadryl. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Rash - only left side of body including face, chest, inner arm and thigh. Salmon color macular and small sand paper like lesions coalasced and advance red papules.
Pregnancy: LMP 09/04/2020, DD 06/11/2021; First pregnancy; early in pregnancy experienced PR rash due to unknown virus confirmed NOT COVID-19; I have two prior hospital histories due to complications from regular seasonal flu; got COVID-19 vaccine around 1:30 PM; felt a little dizzy, came home and was so tired stopped working; around 7 or 8 PM suddenly had extreme chills and shivering, by 10PM had fever of 101.4 and called on-call nurse who instructed 1000mg Tylenol every 6 hours and staying hydrated;  3AM diarrhea; 6AM nausea followed by vomiting; continued three doses of Tylenol; fever dropped to 99.8 by 11AM; kept down BRAT foods and sugar water; had extremely intense headache/could not look down; symptoms all faded by 5PM and stopped taking Tylenol. Was not able to do usual activities for another day due to fatigue, nausea and diarrhea. By Sunday March 21, 9AM I felt 100% back to normal.
Swelling of the mouth, tongue, throat, eyes and face; chest pains; shortness of breath; body pain; headaches; sore throat; coughing;
Arm swollen; Arm is hurting; Arm is warm to the touch; Arm is red down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm is hurting), FEELING HOT (Arm is warm to the touch) and ERYTHEMA (Arm is red down to the elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm is hurting), FEELING HOT (Arm is warm to the touch) and ERYTHEMA (Arm is red down to the elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm is hurting), FEELING HOT (Arm is warm to the touch) and ERYTHEMA (Arm is red down to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route, lot# and expiration date were not reported) that were exposed to unsupported temperature conditions. No adverse experience had been observed or reported by any of the patients who received these improperly-stored doses. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient felt heart racing, shaky, and flushed  a few minutes after COVID shot number 1. VS 186/98  HR 97 RR 16 Temp 36.5  No SOB or throat tightness. Patient sat for 15 minutes after vital signs. Given water. Felt much better. BP 145/94 HR 87 RR 14. No more shaking of hands. Discharged from clinic and recommend to report for next shot and let them know to monitor for 30 minutes.
Patient describes ringing in bil ears, beginning 1 to 1.5 days post injection of second dose of Moderna.  He also c/o a burning, itchy feeling on bil legs.  He has not taken anything for these symptoms.  No relieving factors.
No adverse event; Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes; Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes), PRODUCT TEMPERATURE EXCURSION ISSUE (Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) in an adolescent patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes), PRODUCT TEMPERATURE EXCURSION ISSUE (Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes).    This case contains information for the 2 of 6 patients described by the reporter.  No concomitant medication was reported.  Reporter stated that they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes in the morning on a day before reporting. She stated that some of the vials were used to administer the vaccine to patients on 25-Sep-2023. There were potentially 6 patients impacted by this. None of the patients have reported any adverse reactions.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742028 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742028:Master case
Asthmatic, own MDI, ALBUTEROL transported to hospital with audible wheezes. S/p o2 2L, nebulizer ALBUTEROL. 11/19/09 TC home, spoke to child and asked mother to call back - child reported she was fine, back to school. 12/1/09 - no call back from parent
i had the usual aches after second dose after 24 hours i felt better but have a swollen lymph node under my arm out of the shoulder where got vaccine.  is this a normal reaction?
Patient reported immediate "uncommon" pain at the injection site. The pain worsened though the night, and patient complained of severe pain in the lower back, legs, ankles and feet throughout the next day. The pain was subsiding by the end of the following day. Patient also complained of general malaise throughout the second and third day post-vaccine. Patient still has substantial pain and discomfort at the injection site on day two post-vaccine
Narrative: Patient received COVID-19 vaccine on 10/29/21. On 10/30/21 patient reported "excruciating back pain" that led to a fall.
This spontaneous report was received from a nurse and refers to a 29 male patients of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot number N005274, expiration date: 03-APR-2018 (dose, dose number, route of administration and injection site were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1805USA001642: US-009507513-1805USA001643: US-009507513-1805USA001644: US-009507513-1805USA001645: US-009507513-1805USA001646: US-009507513-1710USA011550.
5-3-13 Friday at 230 got shots, within an hour felt sore throat and cough cold sx flu h/a felt faint and dizzy achiness heart palpitations felt feverish drank lots water and laid down took BENADRYL and ROBITUSSIN did not eat Fri night or Saturday also was nauseated and having diarrhea. Sunday went to church still sx persist not eating. Monday feeling a little better less feverish feeling did not take temp had palpitations injection site sore - neck sore chest sore, over weekend did not see a medical provider managed to do so.
This spontaneous report was received from the grandmother of the 4 year old male patient who, on 11-NOV-2015, was vaccinated with GARDASIL 9 injection (dose, route, frequency and Lot # were unspecified) (drug administered to a patient of inappropriate age). The patient's concurrent conditions and medical history were not reported. Concomitant therapy was not reported. Additional information is not expected since no contact details were provided.
pt recv vax 27MAy97 mom reports pt fussy & did not sleep for 24hr;saw PMD recommended no more pertussis;pt devel cont crying & screaming lasting 9 to 10hr;no sz activity;took formula dec amounts;
The pt experienced redness, swelling and warmth to the touch to the injection site. The pt complained of itching at the site of injection that evening.
Difficulty swallowing and breathing, gaging, regurgitating after eating, gradual onset worsening by 01/08/2010 resulting in urgent care visit, due to difficulty breathing.  (Note:  maternal granfather of patient suffered vocal cord paralysis after swine flu vaccination in 1976).
26 yo male received second dose of Pfizer Covid -19 vaccine on Thursday, today developed chest pain. Patient has ST elevation in inferior leads, evidence of myocarditis on bedside echo with decreased ejection fraction. Patient also has elevated troponin of 6.03
Administered only the adjuvant portion; Administered only the adjuvant portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA730A, expiry date 30th September 2023) for prophylaxis.   On 22nd August 2022, the patient received the 1st dose of Menveo. On 22nd August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's comment: Health Care Professional reported that a staff member forgot to reconstitute the Menveo and administered only the adjuvant portion of the vaccine to the patient. The reporter consented to follow-up via postal. Additional Supportive Information: The patient received only the adjuvant portion of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
*Was given a Flu vaccination.  He is unaware of the type given.  I selected a type to move forward.    Face feels frozen with a pinching feeling that moves throughout body.
Softball size lump to left leg, hot to touch and tender. Size 5.5 x 6.5 cm.
R05 - Cough R06.00 - Dyspnea on exertion J44.1 - COPD exacerbation (CMS/HCC) D64.9 - Symptomatic anemia Z20.822 - Encounter for screening laboratory testing for COVID-19 virus J44.9 - COPD (chronic obstructive pulmonary disease) (CMS/HCC)
?Moderna COVID-19 Vaccine EUA Fever (101.6 degrees), chills, aches, headache, tired Spoke with MD this evening, was told to wait 72 hours, take medication to reduce fever and go to urgent care if it does not resolve.
I got shingles. I got the shingles shot that should have prevented me from getting the shingles. I went to the doctor and was diagnosed with it.
soreness at site; chills; fever; tiredness; headache; diarrhea; loss of appetite
She contracted Sars-Cov-2 infection 05Feb2021, then she was hospitalized 13Feb2021 to treat the infection; This is a spontaneous report from a Pfizer sponsored program.  A contactable consumer (the patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient contracted Sars-Cov-2 infection 05Feb2021, then she was hospitalized 13Feb2021 to treat the infection. The patient underwent lab tests and procedures which included Sars-Cov-2 infection positive on 05Feb2021. The patient was supposed to have her second dose 14Feb2021 but it was not administered.  The patient was wondering if she needs to take the 1st dose again or if she can still take the 2nd dose of the vaccine. The outcome of the event Sars-Cov-2 infection was unknown. Information on the lot/batch number has been requested.
Patient developed Bell's Palsy left.  3 days after influenza vaccine was given. Follow up on 11/17/2003: "Eye tearing, can close eyes-facial droop on Prednisone.  Follow up in office in 2 weeks."
Daily headaches in the morning when waking up often lasting most of the day.  This has continued up to today 2 months later.  No prior history of recurring headaches.
Given ZOSTAVAX L shoulder, pain next day with decreased strength - could not lift independently above horizon. Slowly improved over 15 months.
COVID-19 symptoms started on 06/28/2022. I had a runny nose, stuffiness, and minor cough, and then on Wednesday that developed into chills during the day and fever at night, body aches and pains, and the congestion and cough got worse. It felt like a head cold to me. I called in sick to work Wednesday and on Thursday I hadn't gotten better and on Friday I took a rapid test and it was positive. I called Doctor and they gave me appointment for telehealth and she put me in contact with the COVID-19 center, I got a blood test, and was sent home with PAXLOVID for 5 days. Symptoms lasted for a good 2 plus weeks before the cough went completely away. I have bad allergies to pollen, cats, and dogs, so it's hard to tell exactly what it was when the cough was just a symptom of my allergies instead of symptoms to COVID-19. I still cough one or twice a day. Last week on Sunday I took another rapid test and it was negative. I went back to work on 07/06/22 and the one thing I noticed was from that was a little congestion at the top of my chest and I was exhausted by the end of my day at work.