chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; fever; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EK9231, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 10:30am (at the age of 37-year-old) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccination included first dose of BNT162B2, lot number: EH9899) via an unspecified route of administration, administered in left arm on 12Jan2021 10:30am for COVID-19 Immunization. Patient did not take other vaccine in four weeks. On 02Feb2021 the patient experienced, about 14 hours after 2nd dose, developed a fever of 101.5 and a headache. This lasted about 24 hours but improved, especially with over the counter dose of acetaminophen. Lower fever (100.5) persisted for another 24 hours. All symptoms resolved within 48 hours. Patient did not receive any treatment for AE. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The patient underwent lab tests and procedures which included body temperature: lower fever (100.5) on an unspecified date (Lower fever persisted for another 24 hours), body temperature is 101.5 on 02Feb2021. The outcome of the events was reported as recovered on 04Feb2021.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
mobilized and gave ALL 100 vaccines; excursion; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (excursion) and PRODUCT USE ISSUE (mobilized and gave ALL 100 vaccines) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PRODUCT STORAGE ERROR (excursion). On 08-Jan-2021, the patient experienced PRODUCT USE ISSUE (mobilized and gave ALL 100 vaccines). On 07-Jan-2021, PRODUCT STORAGE ERROR (excursion) outcome was unknown. On 08-Jan-2021, PRODUCT USE ISSUE (mobilized and gave ALL 100 vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were  provided by Reporter
Pt experienced pain upon receiving vaccine, stated more pain than experienced in the past. Within the hour she was experiencing greater pain and marked decrease in range of motion. These symptoms have persisted since the vaccination on 10/11/14. Pain is relieved by IBU 600mg every 12 hours, but discomfort increases when not taking. Range of motion issues stated above are limited to left arm/shoulder.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 22-years-old female patient who received Moderna's COVID-19 vaccine during pregnancy.    Patient's medical history include Allergies, Anxiety  Eczema and consumption of alcohol also one previous pregnancy(normal, Live full term birth), and concomitant medicines taken by the patient, are Zyrtec 10mg QD, PO (Allergy), Zoloft 50mg QD, PO (anxiety), Stool softener 100mg PRN, PO (Constipation) and  Prenatal vitamins.   The blood test, ultrasound and genetic test  were normal.  Pregnancy details: LMP- 10-NOV-2021, Estimated date of consumption- 25-nov-2020, estimated due date : 23-may-2021. G2P1  On 15/Jan/2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the upper arm for prophylaxis of COVID-19 infection.  On 12/Feb/2021 the patient received their second of two planned doses of mRNA-1273 intramuscularly in the upper arm for prophylaxis of COVID-19 infection.   The outcome of the events, exposure during pregnancy is unknown.
patient felt "dizzy" and noted to be pale, assisted to lying position, wheel chaired to extended observation but not admitted, discharged home
Case number PHEH2016US026359 is an initial spontaneous report received from a nurse on 26 Sep 2016. This report refers to a 2 year old patient of an unknown gender. Medical history and concomitant medications were not reported. The patient under the age of 4 years was vaccinated with FLUVIRIN (batch number: 1620201) at a dose of 0.5 ml (intramuscular) on 26 Sep 2016. No adverse event was reported following this maladministration.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.      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.   Date of refrigeration was mentioned as 07-May-2021.  No concomitant medications were reported.  No treatment information was provided.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patients' concurrent conditions and historical conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (concentration, dose, anatomical place of vaccination and route were not reported) which had a lot # reported as "M013067" and an expiration date of 01-APR-2017, a lot # of L019835 with an expiration date of 23-MAR-2017 and a lot # of L040053 with an expiration date of 10-MAY-2017. Information regarding concomitant therapies was not reported. No adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
FIRM, ERYTHEMATOUS, PAINFUL AREA SURROUNDING VACCINE SITE EXTENDING DOWN TO ELBOW. UNABLE TO MOVE UPPER ARM.  STARTED ON AUGMENTIN 875MG BID   RESOLVED 2 DAYS LATER.
Felt achy, headache, earache, neck pain and back pain for 24 hours, no fever, increased sleeping.  Treated with Tylenol.
The day after the Shingrix shot, I had the same symptoms as the flu.  My head began to itch and my scalp began to turn red.  Over the course of 5 months, my forehead, neck, and upper back had a red rash and itched.  Then the rash began to work it's way down my face so that it is now on my cheeks.
Ataxic symptoms, shaking, "bobblehead" mannerisms, "dizzy appearing" per parents starting 3 days after vaccinations.  Self-resolved by 6 days, but then developed fever, decreased activity/appetite by 8 days. "Doesn't look right" per parents.  Mildly tired-appearing but cooperative, interactive and appropriate during most recent follow-up exam (5/2/2009), slightly wide-based gait with some staggering observed; not much better at home per parents.
Information has been received from a physician concerning a 7 month old female who was vaccinated with third 2 ml oral dose of Rotateq. Concomitant vaccinations given at the same time included DTaP, Hib and IPV. Subsequently, the patient experienced intussusception and was hospitalized (length of stay unspecified). A physical examination was performed results not provided. Intussusception was considered to be immediately life-threatening and an other important medical event which required surgery. Additional information has been requested. 8/20/07-records received from facility for DOS 7/1-7/2/07- DX: Intussusception. Incisional Reduction of intussusception lysis of fiber strands, appendectomy. C/O 4 days vomiting and diarrhea with some blood yesterday,
Onset of leg pain began four days after vaccination (vaccination on 2/27 onset of leg pain 3/3).  DVT behind left knee confirmed with ultrasound on 3/8 and started on apixiban 3/9. No history of clots and no activities that would contribute to an elevated risk:  no family history, no recent injuries or surgeries, not sedentary,  nonsmoker, and drink only in moderation.
Menstrual cycle started 10 days earlier than expected, on an otherwise completely rigid cycle. It has never changed ever before.
A report was received from a health care professional concerning 4 vaccinees of unspecified demography who experienced injection site bruising, swelling, warmth and erythema of an unspecified length of time after receiving Fluvirin between 10/10/2003 and 10/16/2003. It was not reported if the vaccinees had recovered. There was insufficient information to determine the reporters Causality assessment. Follow up pending.
generalized rash over entire body 1/99 referred to dermatologist 2/99;Gianotti crosti synd dx by dermatologist;papular acrodermatitis;rash lasted 3-4wk;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported. On or about 27-OCT-2010 and 05-NOV-2010, the patient was inoculated with the ZOSTAVAX (strength, dose, frequency, route, lot # and expiry date were not reported) by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries. On unspecified date, the patient was diagnosed with shingles and/or other zoster-related injuries despite being inoculated with the ZOSTAVAX (vaccination failure), and suffered serious physical, emotional, and economic damages as a result of injuries. On or about 02-DEC-2015, the patient was treated by a healthcare provider for herpes zoster opthalmicus. It was reported that, as a direct and proximate result of cine live ZOSTAVAX, the patient had and would continue to suffer ongoing injuries, including but not limited to mental and physical pain and suffering; extensive medical care and treatment of these injuries. The outcome of the events was unknown. The causality assessment was related. Upon internal review, ophthalmic herpes zoster was determined to be medically significant. Additional information has been requested.
This reaction was to the Dtap vaccine: Severe Flu-like symptoms that lasted about 36 hours (body aches/pains, weakness, tiredness, headache, soreness, slight fever, stomach ache); rash on stomach, chest, and back (didn't itch) that started on 10/23/11 & was gone by the next morning; major swelling at injection site (red lump about 3 inches in diameter & stuck out about 1/2 inch, that didn't go down with icing or ibuprofen); soreness & itching at injection site (this is the last symptom to go away, still slightly swollen on 10/27/11) -- the only treatment I did was take ibuprofen for the pain and swelling & also severe cold medication (pills) when I felt like I had the flu.
Itchy rash developed soon after vaccine administered at site of IPV shot (30 hrs later) no treatment as he was not at clinic when happened.
Patient came to the pharmacy 5/25/21 at 1:20pm to alert us that she had reactions that started 4-5 days after getting her first dose of Pfizer. She reports that her blood sugar increased >400 and >600 4-5 days after the dose. The patient spoke with her Dr and the Dr told her to increase her Lantus and Apidra. The patient also reports getting pain in her right leg that caused trouble walking, bruising on hip that both started 4-5 days after the dose. Patient reports headache, insomnia due to pain and increased blood sugar. Patient reports now sleeping a lot because of exhaustion and having to check her blood sugar every 2 hours and drink lots of water as directed by her Dr. Patient says she finally got her blood sugar down below 120 on Friday 5/21/21.  Patient reports she lost some vision and had blurry vision in her left eye that started 5-6 days after the dose. Patient says her A1C was 5.6 before the Pfizer dose and after the dose her blood sugar was uncontrolled. Patient says her Dr told her to go to the ER if her symptoms continued. Patient also spoke with someone at the CDC and they told her they would follow up with her regarding her symptoms and they will let her know if she should get her second dose.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 06-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Redness & swelling at the injection site 2 days later. Advised to do warm & cool packs & BENADRYL.
Initial report received from a nurse on 30 Dec 2009. The patient (a boy younger than 4 years) was vaccinated with FLUVIRIN (batch no: 102147P1) 0.25 ml on an unknown date. No adverse events were reported.
This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received PREVNAR 13; (lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted stability information during temperature excursions. On an unspecified date, temperature at 72F for 186h was reported and they gave 1 dose to 1 patient. Information on the lot number/batch number was requested.
5/11/03: "Run-down, achey feeling". 5/13/03: "Felt better". 5/14/03: "Pulled muscle" in chest area.
A non-serious spontaneous report of feeling bad, fever and sore throat has been received from a physician concerning an 18-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medication was reported for this patient. On 31-Oct-2010, the patient received FLUMIST. On 05-Nov-2010, five days after vaccination, the patient started feeling bad. On 07-Nov-2010, the patient experienced fever and sore throat. The outcome of the events feeling bad, fever and sore throat was unknown.
on day 8 following the vaccine administration, I developed itching at the vaccination site (L deltoid). On day 9, in the morning I noticed redness, heat, and itching at vaccination site-for an area of about 4" long and 2" wide. Today, the area is slightly less reddened but still very itchy. I have no other signs or symptoms. I was responding daily to V-Safe check ins but the the last text that I received from them was on Wednesday, January 6. I have not been able to contact them to report the change in my signs and symptoms since this reaction has occured after their check-ins with me, stopped. I am a nurse and feel it is improtant for you to know all reactions which I why I am contacting you. I could not find another site or place to report this.  Thank you!
Patient had a lot of redness around the arm and some swelling in the area with a good amount of swelling around the elbow.
Nurses miscommunicated and accidentally gave him 2 COVID boosters instead of a COVID booster and a flu shot.
This started within 10 minutes of receiving my vaccination. First my mouth became completely dry, I had hot flashes, I felt lightheaded, and very nauseated.  I was released from work for the day.  I went home and after a couple hours I began to vomit.  The vomiting was technically 1 episode, however, I stayed in the bathroom for about 45 minutes vomiting intermittently.  About 3  4 hours after the vaccination I began seeing a halo around the lights in the room, shortly after that I began having a really bad headache on the left side of my head.  The next day, I still felt very nauseated so instead of going to work I went to Medical Center. I had a provisional diagnosis of migraine headaches secondary to the H1N1 Vaccine.  I was then told that I needed to follow up with my primary care provider.  I did just that.  My PCP also diagnosed me with migraines.
Information has been received from a physician concerning a 17 month old Caucasian female patient who on 9/25/02 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 642632/0324M). On 3/4/03, the patient experienced initial symptoms of pain and a severe headache. A computed axial tomography scan was normal. On 3/13/03, the patient developed a macular papular rash, no vesicular, along the right side of her face and forehead. Zoster, shingles was diagnosed. Unspecified medical attention was sought. Subsequently, the symptoms resolved. Additional information has been requested.
10 cm wide x 8 cm long area of redness, induration and warmth with a few vesicles (which began today).
Initial misuse report received from a healthcare professional (nurse) on 17 October 2013 and the case was received on 21 March 2014. A patient (gender and date of birth was not reported) had received a dose of FLUZONE vaccine (batch number, route and site of administration was not reported) on an unspecified date. The patient was given regular dose instead of HD. No adverse event was reported. List of documents held by sender: none.
C/o dizzy, lightheaded, shaky. Assess: - LOC, - NIV. VS 132/86, HR 96 Reg, + SOB, Resp 22 reg nonlabored. Within 5 min PT state I feel much better. Only had a muffin earlier. Encourage hydration & nutrition. Resp came down to 16 reg non labored. Daughter with her provided encouragement. Anxious about getting vaccine. Refused to wait 30 min. OK'd to exit. RN
Muscle atrophy; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (ongoing); "HTN" (ongoing); "Weakened Immune System" (unspecified if ongoing); "Pain" (ongoing). Concomitant medication(s) included: AZATHIOPRINE oral taken for colitis ulcerative (ongoing); LYRICA oral taken for pain (ongoing); HCTZ oral taken for hypertension (ongoing); ASACOL oral taken for colitis ulcerative (ongoing). Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: MUSCLE ATROPHY (non-serious) with onset 14Apr2022, outcome "not recovered". The event "muscle atrophy" required physician office visit. Therapeutic measures were not taken as a result of muscle atrophy.  Additional information: The patient provide information regarding the reported adverse event(s) with the use of the product and the Pfizer product had a causal effect to the adverse event. Patient received dose 4, anatomical site of injection was left shoulder. Booster dose due to a weakened immune system. Prior vaccinations (Within 4 Weeks) was none reported. Specific relevant test (For Thromboembolic events with Thrombocytopenia) was none reported. Comments/ Narrative: Has had five vaccine only the 4th had an issue. Spot Muscle Atrophy left an indentation in her arm. Gradually happen over months. Suspect due to injection and damaged the nerve.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt was helped to sit down in chair as soon as she complained of dizziness. Pt felt sweat after receiving vaccine. Vitals stable 110/70 HR 64 Respiration 16 oxygen saturation 99%. Patient sat remained of monitoring time. Left with husband with no issues.
Dizziness, Headache, Fever & Nausea Vomiting Narrative:
my arm hurts; my arm swelled up; scared; pain; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid-19 vaccine with an associated reaction of pain in extremity (received Covid-19 vaccine on an unknown date).   In August 2021, the patient received Shingles vaccine. In August 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm, swelling arm, fear, and pain. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and analgesic, (Pain Medication). On an unknown date, the outcome of the pain in arm, swelling arm, fear, and pain were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, fear, and pain to be related to Shingles vaccine.  Additional details were provided as  the patient self reported the case. The age at vaccination was not reported. The patient received Shingles shot and his/her arm hurt worst than Covid-19 vaccine. The patient's arm swelled up bad and he/she was scared. The patient kept cold ice pack for pain and took some pain medication. The patient enquired if shingles shot a two step vaccine.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Mild
Left deltoid area is very tender to touch and painful to move arm in most any direction. Pain increases during night time hours and is painful to be slept on. Arm is also very weak and becomes more flaccid as the pain increases. Muscle strength in that arm is 1/2 if not less at certain times of the day then it was prior and today marks the 11th day since the vaccine was given. I have been taking ibuprofen at least once if not twice daily which is helpful for a few hours but doesn't eliminate the pain.
Patient felt back pain initially, then was light headed and sweating and clammy She then fainted (did not hit her head) and was unconscious for about 20 seconds. EMT's arrived, and checked her out, Blood pressure, blood glucose and vital signs were normal at that time and they transported her to local hospital. Follow up with blood tests and CAT scan a the hospital were normal per hospital nurse. She was kept over night for observation and following up with echo-cardiogram today. Both the nurse at the hospital and patient's husband said she is feeling fine now, just awaiting ECHO test.