chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's palsy; This is a literature report. This reporter reported 3 reports, this is the 2 of 3 reports. This case was split from master case 202101198829 for a patient taking Bnt162b2 and experienced Bell's palsy. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced bell's palsy. First, data reported in the Food and Drug Administration briefings suggest risk of Bell's palsy is greatest within 1 month of a second vaccine dose. The Pfizer briefing notes "from dose 1 through 1 month after dose 2, there were three reports of Bell's palsy in the vaccine group and none in the placebo group". The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101207186 Same article, different patients with same drug;US-PFIZER INC-202101207188 Same article, different patients with same drug
On 12/8 felt a pain in my lower neck that was causing soreness in my lower neck. 12/11 at 4am woke up and got very dizziness and continues through the morning. At times cannot walk without assistance due to light headedness
Headache, Myalgia, Fever, Fatigue, Chills. Narrative:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2015, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Pt. had 5 other vaccines & was alert with no complaints. GARDASIL given last. Pt. very soon afterward slumped forward & was unresponsive. She was breathing but diaphoretic & pale. After 1-2 minutes she opened her eyes but was confused & stated "my heart is racing". BP 105/60 HR 60. She quickly recovered & left the facility about 1/2 hour later to walk back to her dorm. She declined to allow us to call anyone.
Headache, Myalgia, Arthralgia, Fever, inj site pain, redness, swelling x4 days; fever, chills, myalgia, arthralgia, headache x2 days Narrative:
1 Feb 2018 patient states he developed a sore throat with left axillary lymph node tenderness and swelling, states that on 2 Feb he noticed that the left cervical lymph nodes started to become tender and swollen. States that on 3 Feb he felt feverish and had body aches. 4 Feb indicates that he developed a spot type rash across his trunk/back/flanks. Patient was evaluated on 5 Feb due to clinic not open due to work hours. Upon evaluation patient had papulovesicular lesions (40-50 lesions) that all looked to be in the same stage. Injection site looked on par for 2 weeks post smallpox vaccine via scar. Upon noticing this contact state health department who then contacted CDC. Patient has non-viral pustulosis and is being treated with antihistamines and conservatively. No contact precautions other than those previously given to patient for the smallpox vaccine. Patient will follow up if worsening.  Informed to follow up in 2 weeks to see how he is doing. CDC with no concerns unless this becomes worse.
Pt was given 2nd MMR booster 10/22/08.  Developed severe headache 10/28/08.  Has slightly improved but not back to baseline as of 12/10/08.
Approximately 10 minutes after receiving the Moderna vaccine, this writer was called to the patient room by other staff.  The patient was extremely confused and not speaking to anyone.  He was gazing to the left and not making eye contact with this writer, who was loudly talking to the patient.  Multiple attempts were made to get the patient's attention with no success.  The patient then began to involuntarily raise his bent left arm in front of his face and then back down to his side.  In this writer's opinion, the patient was having a silent seizure.  This writer sat with the patient, who became aware approximately 15 seconds later.  He was able to answer questions and was quickly reoriented.  At this point this writer had the staff call 911 for further evaluation.  After answering basic questions appropriately., this writer gathered vital signs on the patient .  The first set of vitals were:   bp 88/48, pulse 60, respirations 14/min, oxygen saturation 93% on room air, temp 98.5.  After small conversation with the patient, another set of vitals were taken:   bp 94/70, pulse 68, respirations 15/min, oxygen saturation 95% on room air, temp 98.8.  We then had the patient drink some water, then had him lie down in the patient room until EMS arrived.  By the time they arrived, the patient was completed reoriented and laughing with office staff.  EMS evaluated the patient and deemed him safe to go home with his friend driving.  This writer walked the patient to the car to assess balance and coordination.  This writer informed the patient and his friend to call 911 if symptoms returned.  The patient agreed.
Received 2nd Pfizer vaccine yesterday (Thurs 2/4). Felt fine for several hours but then began to feel muscle pain, body aches, somewhat nauseous on Thurs. night, continued through Fri. Felt better by Sat. evening.
Child had vomiting and diarrhea for 4 days after receiving Rotateq.
COVID Arm - 5 inch red swollen bump around injection site. Sore, hot and slightly itchy
Deviation from interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from interval) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from interval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Experienced numbness on left side of body 3-4 days after injection. Lasted for over a month. Was not sure if it was due to injection or just the numbness usually experienced post-injury from gun shot.
No adverse symptoms were reported; administered a dose of improperly stored VARIVAX; This spontaneous report as received from a study coordinator referring to a 13-month-old patient of unknown gender. Information about pertinent medical history, concomitant medication, drug reaction or allergy was not provided.      On 14-JUL-2020, the patient were vaccinated with a dose of improperly stored doses varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S007963, expiration date: 02-AUG-2021, but upon internal validation was non-valid lot #; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). The vaccines were reconstituted using a properly stored sterile diluent (lot # and expiration date not reported). It was reported that the vaccines were exposed to a temperature of -14 Celsius degree to -10 Celsius degree (-12.8 Celsius degree) for 46 minutes. There was no previous temperature excursion. Data logger was involved. No adverse symptoms were reported. The outcome of product storage error was unknown.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA000429: US-009507513-2008USA000587:
2 swollen lymph nodes in right breast opposite of where vaccines were given in left arm. 4 months after vaccine was first given on 08/22/2021.
Caller states both her and her mother got their first dose of the Moderna COVID-19 vaccine on 1/27 around 14:50. Since then they have both had a Shingles flare up. Caller wanted to report this effect if necessary. They have both had telehealth care that prescribed antivirals. Caller is unsure of exact medication as she is about to pick hers up from pharmacy. No hospitalizations for this ADR. Refused Info for her mother.  Daughter did not want to provide any info on her mother's behalf for privacy reasons. She provided more info for herself . She would not like anyone to contact her mother as she is frail.
Left arm turned red from elbow to armpit and shoulder. Very painful and itchy. Got worse every day. Got redder - hurt to touch and the itch was unbearable. Lasted 10 days.
This case involves a 62 years old male patient one of the nurses administered the remaining contents of a multidose vial of IPV (VERO) [IPOL] (overdose) and vaccine administered at inappropriate site with no reported adverse event. The patient's medical history, past medical treatments, vaccinations, and family history were not provided. Concomitant medications included HEPATITIS B VACCINE; HIB VACCINE; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE); MENINGOCOCCAL VACCINE B; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13; VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for prophylactic vaccination; and BORTEZOMIB for Multiple myeloma. On 24-Nov-2021, the patient received a dose of suspect IPV (VERO) (lot number: T1E872M and expiry date: 10-Oct-2022) via subcutaneous route via abdomen for prophylactic vaccination. It was a case of actual medication error due to overdose and vaccine administered at inappropriate site (latency: same day). It was reported "Pharmacist clarifies that the exact dose of IPOL administered is unknown; states the nurse said she gave, "several mL's". Pharmacist states the dose could have been up to 4.5 mL. Pharmacist asks what they should monitor for." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Provider ordered 2nd dose of two dose series for HAVRIX. Medical assistant got confused on age and gave adult dose 1.0 ml instead of 0.5 ml. Medical assistant thought that 15 years of age was adult and did not verify with package insert. Age of patient at time of event: 15 years.
Patient states that she has had what she believes to be hives since the day after the shot was given.  They are on her left arm and shoulder.  They get large and them subside.  She is seeing Dr to determine if this could be shot related.
Rash-onset 48 hours later. Rx with topical steroids and hydroxyzine.  Follow-up received - Pt required Dr. office visit M 3/4/10.
Shingles; burning right hip; tingling pain in the right hip; This is a spontaneous report from a contactable physician. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el9264) via an unspecified route of administration in the left arm on 09Feb2021 at 11:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included sulfonamide allergy. Concomitant medications included vitamin D3 2000iu (MANUFACTURER UNKNOWN) and b complex (MANUFACTURER UNKNOWN), both since unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el1283) via an unspecified route of administration in the left arm on 12Jan2021 at 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 vaccine within four weeks prior to the COVID vaccine. On 28Mar2021 at 14:00, the patient experienced burning tingling pain in the right hip. On 04Apr2021, the patient experienced shingles. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcomes of the events burning right hip, tingling pain in the right hip and shingles were recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.
Client (DOB:10/11/1959) received the 2nd dose of Moderna COVID vaccine lot # 021C21A and expiration date 5/26/21 at 2:45pm.  Client reports to patient having an asthma attack at 3pm and using her albuterol inhaler.  At 3:05pm healthcare provider arrives and sees client sitting in wheelchair, alert and oriented.  Client reports she is feeling better but that "mask makes breathing harder". Client reports no symptoms at this time. Vitals at 3:05pm: blood pressure:140/90, pulse:80 and oxygen:97%. Client reports that after she was intubated she now has some issues with her breathing.  Client reports she will be getting dialysis tomorrow.  At 3:10pm client reports she feels "fine" and that she is "sure this is not from the vaccine and that this has happened before." At 3:15pm vitals: blood pressure:140/90, pulse:78, and oxygen:98%.  Healthcare provider recommends client stay until 3:30pm but since client has already been waiting 30 minutes, client reports she is ready to leave.  Healthcare provider reviewed ER precautions. Client was wheeled out at 3:17PM by healthcare provider.  Client is being driven home by daughter.
My arm felt very very sore in the muscle immediately following the shot and increasing over the next 48 hours until it dissipated  - then  7 days later I began feeling itching and soreness at the injection site. When I woke up on day 8 there was a hard itchy spot where the injection site was and just below was a growing firm red area that was both itchy and sore.
Red circle at injection site that feels warm. Swollen lymph nodes extending into left breast and diarrhea.
Information has been received from a nurse practitioner referring to a patient of unkonwn age and gender. Information about patient's concurrent conditions and medical history was not reported. On 25-JUL-2015 the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (dose, route not reported, lot # K005402 with expiration date 07-NOV-2015) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. Additional information is not expected because the physician did not want to be contacted.
Within 10 minutes of getting Hep B vaccine IM Right deltoid, Complained of headache which lasted approximately 1 hour.
A non-serious spontaneous report of "administration of full dose of FLUMIST up one nare to several individuals" was received from a registered nurse subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for these patients. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 10 Mar 2022; Pharmacy gave Moderna Covid-19 vaccine past its 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 days beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 10 Mar 2022) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 10 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 days beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 10 Mar 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that the patient received vaccine past the 30 days beyond use date after the vaccine was placed in the refrigerator on 24-Jan-2022. The pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022. The reporter does not know which dose the patient received and on which arm the patient received the Moderna Covid-19 vaccine. No other adverse events or side effects were reported. Vial did not undergo any temperature excursion.  Treatment medications were not reported.
hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Rash on only one side of both lower legs with some itching. No treatment taken. By 12/18/2009 at 9:00 am rash and itching were decreased. No other complaints. Patient usually takes annual flu shot and has not had a reaction from any flu shots before.
Extreme nausea, fever, aches, vomiting, headache, redness and knots at injection sight, dizziness, sore throat.
Had 1st shot Pfizer vaccine and 5hrs later severe left arm swelling, fever and pain. High heart rate which reported to catch SVT superventricular tachycardia. MEDICAL history blood clots but no history of hypertension or cardiac issues Checked in to ER and observed to treat SVT given meds. Heart rate went down a bit but still have mild high heart rate hoover 110
rebound of Covid/had a positive test; rebound of Covid/had a positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EN6207), in left arm and on 23Apr2021 as dose 2, single (Lot number: EL9262) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Nov2021 as dose 3 (booster), single (Lot number: 052E21A), in left arm and on 04Jun2022 at 10:00 as dose 4 (booster), single (Lot number: 058A22-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "other than menstrual migraine" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "rebound of Covid/had a positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2022) Positive, notes: I received faintly positive tests on 31Aug2022and 01Sep2022; (01Sep2022) Positive, notes: I received faintly positive tests on 31Aug2022and 01Sep2022; (02Sep2022) Negative, notes: followed by a negative test on 02Sep2022; (03Sep2022) Positive, notes: Then I had a positive test on 03Sep2022, followed by onset of symptoms; (07Sep2022) Positive, notes: I am still positive as of today, 07Sep2022, and still experiencing symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: I experienced a rebound of Covid symptoms after recovering from all symptoms and having a negative test. I received faintly positive tests on 31Aug2022 and 01Sep2022, followed by a negative test on 02Sep2022. Then I had a positive test on 03Sep2022, followed by onset of symptoms. I am still positive as of today, 07Sep2022, and still experiencing symptoms.Paxlovid (start date: 26Aug2022, stop date: 31Aug2022)
12hours after vaccine had severe rigors, fever - 101.0, muscle aches and fatigue. Worse then last time. Continued 36 hours after vaccine and after that I felt great but still had swelling in legs (both) from last adverse event of Dose 1.
Patient developed a swollen left leg, with redness and swelling. The parent described it as a red blotchy rash. Patient could not walk on that leg for 4 days. He saw his healthcare provider who prescribed antibiotics and this helped. Patient did have a lack of appetite, fever up to 100 F and body aches.
Patient was administered an expired COVID vaccine on 09/21/2021. Patient did not state having in adverse reaction from expired vaccine.