chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 87-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 15-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805481 was cross linked to original cases 201804863 due to same reporter.
I had serve fatigue and hard pressure headache. I had chills but no fever slight body aches and arm pain.
vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment; vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment; 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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6208), on 12Apr2021 as dose 2, single (Lot number: EW0150) and on 13Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cinnamon, reaction(s): "Known allergies: Cinnamon", notes: Known allergies: Cinnamon. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (18May2022) Negative; (18May2022) Negative; (21May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included no other medication in 2weeks. Treatment for covid-19 included Paxlovid.  No follow-up attempts are possible. No further information is expected.
* Extreme headache, extreme weakness, nausea, vomiting, delirious, tiredness * Benedryl and Tylenol * Four days
This spontaneous report as received from a nurse practitioner refers to a 3 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 29-DEC-2014, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K008680 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Bone crushing pain, horrible headache, extreme fatigue, diarrhea, nausea,  sweats, chills, fatigue
Bruising from shoulder to elbow, no pain at injection site. Incident not reported to our facility until 10/8/2013 nor did see signs or symptoms to report.
Received HPV (#2) and MenB (BEXSERO #2) vaccine on 6-29-16. Played basketball following immunization. Pt arm particularly sore. Woke up the next morning with head turned and flexed to the left side and unable to turn to right side. No fever, chills, and vomiting. Normal mentation. Went to ER. Treated and dismissed. Dx with spasmodic torticollis.
Information has been received from a physician concerning a 16 year old female patient with no known drug allergies who on 19-JAN-2009 was vaccinated with her first dose of GARDASIL (lot number 661703/0651X, site and route not reported). Concomitant medication included "LOVLO" which was a birth control pill. On 19-MAR-2009, the patient went in the office for her second dose of GARDASIL (lot number, site and route not reported) and she reported that in the evening of 19-JAN-2009, when she received the first dose, she experienced nausea and vomiting which lasted for two days. The patient sought unspecified medical attention. Follow-up information was received from the physician who reported that the patient got a headache shortly after receiving vaccine on 19JAN2009 whose lot number was reported as 660616/0570X at this time. That evening she complained of nausea and vomited 3 times. She did feel bad for two days after. The patient did not notify office until 19-MAR-2009 when she came for second dose of GARDASIL. It was noted that the patient recovered. The patient and her mother decided to receive the second dose on 19-MAR-2009 with no pressure. No further information was available.
fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches; headaches; This is a spontaneous report from a contactable physician (reporting for herself).  A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization.  Medical history included hashimoto thyroiditis and hypertension.  Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide (HCTZ), biotin, cyanocobalamin, folic acid (MVI 3), influenza vaccine inact split 3v (FLULAVAL) taken for immunization on 03Dec2020.  On 23Dec2020 12:15, the patient experienced fast heart rate, tingling in feet, mild tightness in the chest, shaking chills, sore arm, body aches and headaches.  The patient underwent lab tests and procedures which included heart rate: fast on 23Dec2020.   There was no treatment given for any of the events.  The outcome of the events was recovered in Dec2020.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Ectropion of left eye. Daughter concerned about eye and possible swelling. No apparent angioedema. Narrative:
9/13/13 1035 pt presented to clinic with induration, redness, warmth to Lt. upper outer arm. Was advised by FNP to apply ice packs through out the day.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer,  took out one to two vials and place in fridge each day as needed.  No treatment medication was provided to the patient.
Extreme Fatigue and light confusion for the rest of the day, and light fatigue the following day
Occasional tingling in arms and legs (hands and feet), slight numbness. It started about a week after the first shot and continues to this day (for about a month now).
On 7/23/08, patient developed hives on both arms and some on the neck, armpit and shoulder.
Information has been received from a health professional concerning a 5 year old male with haemodialysis, end stage renal disease (ESRD), reactive airways disease, hyperplasia, potter's syndrome and allergic reaction to Biaxin and Tetracycline who on 21-AUG-2003 and 28-APR-2006 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included fluticesone propionate (FLOVENT), somatropin, ranitidine HCl (ZANTAC) and vitamins (unspecified). The patient was shown to have seroconverted after the first vaccination, but after yearly antibody tests were performed, it showed no seroconversion after the second vaccination. Additional information has been requested.
Information has been received from a physician concerning a 54 yr old Caucasian male pt with sarcoidosis, thrombocy, and no known drug reactions/allergies, who on 24Oct2005 was vaccinated SC with a first dose pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 24Oct05 the pt developed a local reaction. The left tricep and upper arm of the pt had warmth and erythema. It was reported that the doctor gave the pt a shot of methylprednisone sodium succinate (Solumedrol) and gave cefdinir (Omnicef) (300g) to take for 7 days for cellulitis. The physician also reported that the pt was scheduled for a splenectomy. The pt reported the area affected had increased each day. On 28Oct05 the pt was seen for a follow up visit. The pt felt better. The pt had a temp of 96F. The pt recovered. No product quality complaint was involved. Additional information is not expected.
Full body rash (HIVES) that started on late Monday 11/15/21.   Saw doctor on Wednesday and given 12 day steroid taper pack.
rash on arm; arm tenderness; redness; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 22-SEP-2023, the patient received Arexvy (unknown arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced erythema (Verbatim: redness). On 23-SEP-2023, the patient experienced rash (Verbatim: rash on arm), pain in arm (Verbatim: arm tenderness) and fatigue (Verbatim: fatigue).  The outcome of the rash and pain in arm were unknown and the outcome of the fatigue was resolved (duration 1 day) and the outcome of the erythema was not reported.   It was unknown if the reporter considered the rash, pain in arm, fatigue and erythema to be related to Arexvy.     It was unknown if the company considered the rash, pain in arm, fatigue and erythema to be related to Arexvy.   Additional Information: GSK Receipt date: 28-SEP-2023 The reporter was a patient's wife. The reporter reported that patient received Arexvy and he experienced rash on arm, arm tenderness, and fatigue. Reporter reported that patient's fatigue lasted 1 day, the day after the vaccine. Reporter was unsure if redness resolved as patient could not roll up his sleeve that high at time of call. Reporter declined to provide any further details. The reporter did not consent to follow up.
During a records audit, it was discovered that the 17 year old patient received the Moderna Covid 19 vaccine on date of incident. Patient did not report any side effects or adverse events to this healthcare facility.
Circular 2" x 1 1/4" lot, firm induration at injection site. No visible signs of cellulitis or lymph node involvement. No fever.
This spontaneous report as received from a physician refers an unspecified number of patients of unknown age and gender. On an unspecified dates since 21-Feb-2015, the patients were vaccinated with an improperly stored doses of VAQTA (dose, route, lot # and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Noticed new small fiber neuropathy symptoms in upper right side of mouth after shot. Neuralgia on upper ride side of mouth. Lasted about 2 1/2 weeks. Flare up appears to be dying down. Not sure if it is vaccine related but I was advised to report.
left arm started hurting; she could barely move it; the pain was up to her neck; left arm started hurting; the pain was up to her neck; she could barely move it; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (left arm started hurting), the second episode of PAIN IN EXTREMITY (left arm started hurting), the first episode of HYPOKINESIA (she could barely move it), the second episode of HYPOKINESIA (she could barely move it) and the first episode of NECK PAIN (the pain was up to her neck) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced the first episode of PAIN IN EXTREMITY (left arm started hurting), the first episode of HYPOKINESIA (she could barely move it) and the first episode of NECK PAIN (the pain was up to her neck). On 24-Mar-2021, the patient experienced the second episode of PAIN IN EXTREMITY (left arm started hurting), the second episode of HYPOKINESIA (she could barely move it) and the second episode of NECK PAIN (the pain was up to her neck). At the time of the report, last episode of PAIN IN EXTREMITY (left arm started hurting), the last episode of HYPOKINESIA (she could barely move it) and the last episode of NECK PAIN (the pain was up to her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Myalgia, Arthralgia, Fever, chills, fatigue, injection site pain/arm pain Narrative:  Other Relevant History:
After receiving the FLUZONE HD, patient started to slide down the chair. She look like she was fainting, but it then seemed like she might have had a seizure. Patient regained consciousness quickly and 911 was called. Her HR was high at 120 then down to 89 then 74. BP=89/154 when ambulance got there. She was released from ER. She is doing well. Normal per ER.
dizzy, equilibrium off, nausea from the dizziness/equilibrium issue.  This started 23 hours after injection and lasted 42 hours.  48 hours after injection I started feeling numb and tingly in feet, hands, and tongue.  48 hours later I was feeling numb in my calves.  I was able to walk and move, but it felt like circulation was cut off or those body parts were asleep - without the painful tingly feeling when you move it.  No fever, no chills, body felt heavy and tired after the dizziness wore off.  Didn't feel like myself until Sunday afternoon.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers 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 26-DEC-2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 28-OCT-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, 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. The outcome of the events was considered to be not recovered. Additional information has been requested.
Rash with hives over all of body and swelling of lips. No other problems. Rash within 2 hours of Hep-B and TD. History of hives. Mother gave child Benadryl that night and the next day, hives were going away and no swelling.
I had Covid in December of 2020 and was hospitalized fir 8 days. I received my first Pfizer vaccine on 3/16/21 and my second on 4/6/21. I did have a high fever, body aches and felt sick for 2-3 days after receiving both injections. On 07/20, I was feeling extremely tired with abdominal pains. On 7/21, the abdominal pains got severe and I went to the hospital and was admitted with appendicitis. The appendix was removed on 7/22 and it was gangrenous.
Monday following(12/21/2020)  I woke up with sore throat, headache, body aches, fatigue had a fever of 100.1 Next day  99.5 fever with the same symptoms as Monday .
itching on my neck and it was red and swollen; itching on my neck and it was red and swollen; Itchingn on my neck and it was red and swollen/ face is red and puffy, itching with rash; Face is red and puffy, itching with rash; Face is red and puffy, itching with rash; I have it (rash) underneath my stomach, right underneath injection site; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 13Apr2021 (at the age of 24-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension diagnosed "for about four years". Concomitant medication included nifedipine (PROCARDIA) taken for hypertension. The patient reported that she started having issues about 30 minutes after receiving the vaccine on 13Apr2021. When she got home, she started itching on her neck and it was red and swollen. She told her nurse and was given some Benadryl. The night before report (13Apr2021), she also woke up from itching, and her face was red and puffy, itching with rash. She had the rash underneath her stomach, right underneath injection site. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Expired flu vaccine was given to patient with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who was given expired Influenza Quadrival A-B Vaccine [Fluzone quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),  concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received an expired dose of suspect Influenza Quadrival A-B Vaccine from 2022/2023 season (lot UT7759KA with unknown strength, dose and expiry date) via intramuscular route in unknown administration site as prophylactic vaccination with no reported adverse event (expired product administered) (latency: same day).  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
Developed joint pain in wrists, ankles, hands, and knees associated with a maculo-papular generalized rash of uncertain etiology. RX today 4/20/21 with prednisone.
Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Date of start of drug: 06Jan2021; Date of start of drug: 06Jan2021; This is a spontaneous report from a contactable Other healthcare professional (patient). A 41-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 06Jan2021 09:00 in left arm at single dose for covid-19 immunization.  There were no medical history,  known allergies or concomitant medications in two weeks. There was no other vaccine in four weeks. The patient previously took the first dose of bnt162b2 on 19Dec2020 12:00 PM in left arm (Batch/lot number: EJ1685) for COVID-19 immunization. The patient experienced left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle on 07Jan2021 07:00. The patient underwent lab tests and procedures which included Covid antibody blood test: negative on 23Dec2020. The events did not resulted in emergency room or physician visit. The events was reported as non-serious. There was no treatment for left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle were not resolved.
2-9-15 Discussed Tdap and Flu vaccins with clinet, she was undecided on flu and stated she wanted just Tdap at that visit. I administered a flu vaccine. Not Tdap.
Patient received her first Pfizer vaccine at hospital on 3/15/21. Given her history of anaphylaxis with demerol she was asked to stay for 40 minutes. She is unsure how soon her reaction started but thinks within 20 minutes of getting a shot. Her symptoms started with a sore throat, followed by throat tightness, chest tightness. These symptoms improved a bit with drinking water but didn't go away. She didn't experience tongue swelling or lip tingling like she does with eating certain foods (see below). She took her own benadryl and was better in 15-20 minutes and denies recurrence of symptoms.   Denies dizziness/fatigue, urticaria, conjunctivitis, nasal congestion, wheezing, n/v/d post immunization.
This case was reported by a consumer via another manufacturer and described the occurrence of swelling of lip and face in a female subject of unspecified age who was vaccinated with ROTARIX, GlaxoSmithKline. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced swelling of lip and face, swelling of tongue, swelling of cheek (s) and difficulty breathing. A Merck representative learned of the adverse event on 10 November 2009. The representative was with the subject's mother at the time of reporting and put the reporter on the phone to report the adverse event. The subject's mother reported that the daughter experienced swelling in her lip, face, tongue, and cheeks after receiving ROTARIX. The subject also experienced breathing difficulties after the vaccination. No further information was given at the time of reporting. At the time of reporting the outcome of the events were unspecified.