chrisvoncsefalvay/vaers-outcomes huggingface dataset:
maternal vaccine exposure with no reported adverse event; Initial information received on 21-Sep-2023 (with live follow up CSD:22-SEP-2023 processed together) regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 30 years old female patient who was pregnant and exposed to influenza quadrival A-B vaccine [Fluzone Quadrivalent] with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal vaccine exposure with no reported adverse event occurred at 19 weeks of pregnancy and the patient was exposed to influenza quadrival A-B vaccine at 19 weeks of pregnancy, during second pregnancy trimester for influenza quadrival A-B vaccine.  The date of last menstrual period was reported as 09-May-2023. The estimated due date is 13-Feb-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 14-Sep-2023, the patient received a dose 1 of suspect influenza quadrival A-B vaccine Suspension for injection (lot UT80404A) (with an unknown strength, expiry date, dosage) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation).  On 14-SEP-2023 the patient had maternal vaccine exposure with no reported adverse event (exposure during pregnancy) (latency-same day) following the administration of influenza quadrival A-B vaccine.  Relevant prenatal testing was not reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  Additionally, at time of reporting, the pregnancy is still ongoing.
PATIENT RECEIVED MMRV ON 2/26/2014 GRANDMOTHER PHONED 02/29/2014 STATING THE RIGHT THIGH HAD A ROUND RED SWOLLEN AREA. SEEN BY DR., TREATED WITH BENADRYL LIQUID 25MG TWICE A FOR 5 DAYS.
On 5/28/04 right upper arm 3 X 4 cm swollen, warm, red. Compresses, Augmentin.
Information has been received from a physician concerning a female who on an unspecified date in April 2007, was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  "A few months after vaccination" the patient developed a case of zoster.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Pt complained of severe pain in right arm that radiated from deltoid up to shoulder and lateral thorax.
This spontaneous report as received from an other health professional on 20-NOV-2014 refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (Lot # 4387514). The clinic reported the patient had a reaction. The patient developed a hot red swollen rash. The outcome of developed a hot red swollen rash is unknown. The product was noted to be disposed of , however, the rest of the inventory was turned to branch. Additional information has been requested.
Pt presents to clinic on 6/8/00 with pain and swelling on right upper arm and shoulder. Area hard and warm to touch. Measurement of arm is about 2" larger than other arm. Pt was dx'd with localized allergic reaction to DT booster. Treated with Pediapred, Claritin syrup and return to clinic if not improving.
a few red spots; red itchy spots all over their body; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (a few red spots) and PRURITUS (red itchy spots all over their body) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 081P021A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for Blood pressure.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (a few red spots) and PRURITUS (red itchy spots all over their body). The patient was treated with PERMETHRIN at a dose of 1 dosage form and PREDNISONE at a dose of 10 mg. At the time of the report, ERYTHEMA (a few red spots) and PRURITUS (red itchy spots all over their body) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events were Not Applicable.
Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. Since 28-NOV-2016, the patients had been administered improperly stored doses of GARDASIL lot # M014929, expiration date 27-MAY-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse experiences had been reported. The doses of GARDASIL were exposed to a temperature >46°F but <77°F and were out of range for 21 hours. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA003709: US-009507513-1701USA003710: US-009507513-1701USA003711: US-009507513-1701USA003712.
Pt seen 12/18/09 in office - after receiving H1N1 vaccine w/i 15 minutes developed "tingling" like "butterflies" all over body (head to toes), shortness of breath. After 24hrs had baseball cup local ... developed sore throat and fever 5 days later with swollen lymphnodes. Has generalized achiness and malaise.
Soreness at injection site, lethargy, headache, fever, body aches, chills
Approximately 1 minute after receiving injection, patient reports itchiness, throat & lips swelling. EpiPen administered in observation & patient immediately transferred to Emergency Department. In the ER, patient was given famotidine, diphenhydramine & prednisone. @1230 in the ER, patient reports increase in itchiness and lips/throat swelling and feeling of return of symptoms. 2nd dose of epinephrine 0.3 mg administered intramuscularly. Pt was admitted for observation with plans to discharge if symptoms resolve with no return.
7 days p/vax T104, up & down for 2 days, then rash-rxn to measles vax;
approx 5 mins p/vax pt exp lt hand redness, tingling & swelling of fingers; took DPH which relieved itchiness;
zoster related vision loss; zoster related vision loss; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for zoster related vision loss. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered zoster related vision loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of blindness was determined to be medically significant.
Narrative:  pt got COVID-19 pna 2+ months after receiving 2 doses of Moderna COVID-19 Vaccine, pt also w/ (+) COVID-19 Abx test before during and after COVID-19 infxn.
Patient received his second Moderna COVID vaccine (4/18/21). Patient began to feel ill (5/1/21) and presented to the ED (5/2/21) where he had tested positive for COVID-19. He is currently hospitalized and receiving Remdesivir and steroids (Dexamethasone).
severe shortness of breath when exercising / Difficulty breathing; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (severe shortness of breath when exercising / Difficulty breathing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Hiatal hernia in 2018. Concurrent medical conditions included Anaphylaxis, Hypertension (BP was increasing for a few months before, in 2020) since 2000, Clotting disorder since 1999 and Heartburn. Concomitant products included OMEPRAZOLE from 2091 to an unknown date for Heartburn, HYDROCHLOROTHIAZIDE from 2001 to an unknown date and AMLODIPINE from 2017 to an unknown date for Hypertension.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021 at 9:30 AM, the patient experienced DYSPNOEA (severe shortness of breath when exercising / Difficulty breathing). At the time of the report, DYSPNOEA (severe shortness of breath when exercising / Difficulty breathing) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Angiogram pulmonary: abnormal (abnormal) PE, COVID and perocardiis ruled out by pulmonay angiogram.     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.   Lab tests include: ECG and Blood troponins. Patient stated that: Respirations >20 per min.  Patient was sent to a cardiologist for increased BP management. Full workup to exclude infarct, studies included stress echo. Meds increased and BP was lowered, over a few weeks, but the dyspnoea did not improve. Treatment information was not provided. Event Recovered with residual effects - Reduced effort tolerance. Patient also asked about the booster dose.   This case was linked to MOD-2021-297778 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Reporter name,Patient demographics( height, weight, race, ethnic group), Patient's medical history, concomitant medications, date of start of event and  outcome of the event were added.
Pt requested flu vaccine, I administered it and he said he was alright. Then he stated he may sit in waiting area for awhile, as I always instruct patient to do, after being vaccinated. A bit later, a non-pharmacy staff member informed me that a pt had fainted in magazine aisle. I helped pt back to pharmacy waiting area. He informed me that he has a lot anxiety when it comes to needles and every time he receives an injection, he faints. We called 911. The paramedics took pt to ER, and pt was back in his home a few hours later. I called pt the following day. Pt assured me that he was fine, and that he goes through anxiety and fainting episodes every time he has any type of injection. I urged him to inform pharmacists, doctors, etc of this condition before hand, going forward. Pt informed me he is completely fine. Pt did not inform me, or any Walgreens staff member about his anxiety w/injections until after he fainted.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to an approximately 62-year-old female patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in October 2013, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at county health department for prophylaxis. As a result of her receipt or zoster vaccine live (ZOSTAVAX), on an unknown date in March 2014, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
NAUSEA, FATIGUE, MUSCLE ACHE, CHILLS, FEVER, LOSS OF APPETITE, UNABLE TO GET OUT OF BED WITHOUT HELP, UNABLE TO WALK WITHOUT HELP. THIS LASTED FROM THURSDAY UNTIL SUNDAY MORNING.
Patient medical history:  Seizures, Hypertension, Cancer    Allergies:  None Patient received her Moderna Vaccine   at 9:30 a.m. 9:45 a.m. pt complained of dizziness and metallic taste.  Pt instructed to lie down and elevate feet.          VS:  B/P   160/88    HR:   69   O2 sat:  97% room air    (Lying) Pt has no complaints of shortness of breath, rash or difficulty breathing 9:50 a.m.   Pt states dizziness is better. 9:55 a.m.  Pt sat up on the side of the bed.  PT states no dizziness.         VS:   B/P   150/88    HR:   65   O2 sat:   97%  (room air)  10:00 a.m.  Pt stood up to side of bed and complained dizziness had returned. Pt instructed to lie back and elevate feet again.   Dizziness subsided when laying down and sitting on side of the bed. 10:05  Orthostatic Blood Pressure taken:           VS:  Lying -   B/P   160/90   HR:  65   O2 sat:   98%  Sitting -  B/P   160/90   HR:  66    O2 sat:  98%   Standing -  B/P 150/80   HR:  64  O2 sat:  98%   10:10   Patient still complaining of dizziness upon standing.   EMS notified for evaluation. 10:15  EMS arrived.  Pt states dizziness improving when standing. EMS evaluating. 10:25  Pt signed refusal to transport with EMS and stated dizziness had stopped. Pt husband at bedside.  Pt ambulated to vehicle with no further complaints.  4:45 p.m.   Called to follow-up with patient.  No answer.  Left a message to return my call. Will continue to attempt follow-up with patient.
The patient is a 57 year old female who presents to the ED with an allergic reaction. Patient received her COVID vaccine this morning at a vaccine POD at 0708, 5 minutes after receiving the injection she began to feel short of breath, with dry cough and felt tightness in her throat. Patient used her inhaler at that time and then her symptoms improved.  Of note patient also took a Benadryl prior to receiving the vaccine because she has a history of allergies (reports allergy to codeine ). She was evaluated by people at Covid vaccine site and cleared.  She went to work at the clinic where she works as a tech but continued to have tightness in her throat, so a doctor at the facility told her to take another Benadryl. Patient states that an hour after taking the second dose of Benadryl she began to feel drowsy and nauseous.  She had a sip of coffee and try to eat something but then became tremulous and vomited.  She was given epinephrine at work and transferred here for further work-up and management.  On arrival patient reports that she feels back to baseline.  She denies at any time having any rash, pruritus, or angioedema.
This was the second shingles shot given right before the 6 month period ended. I started that evening with the red swollen warm sore arm like the first time and headache. The next day I started with the fever and body aches fever got to 100.8   I knew these were normal side effects and took Advil.  But then the soreness and swelling went to my underarm and I guess lymph nodes under arm.  It is now Tuesday and the injection site is almost normal but my underarm is still sore and swollen
Screaming in pain for multiple hours straight for several days after, refusing to breastfeed for almost 7 hours, diarrhea for more than 10 days
Patient received vaccine on the 11th and on the 12th the vaccine site was erythemic, hard, warm to touch, and tender.
May 28th, 2021 I wore up that morning with extreme pain in my arms and hands and for the next two and half months, the pain spread to my knees, hips, shoulders, and hands.
Heaviness while walking, Fatigue, Headache, Low Grade Fever, Chills, Muscle Pain, Body Aches, Loss of Apetite, Nausea, Odd symptom on day 2 and 3 was heaviness in chest and urge to cough 1-2x after taking a deep breath. On 8/23 around 11pm, had tenderness at 2 precise spots on right forearm; sensation like bruising but no discoloration. Felt like 2 tiny rice grains were in my vein. I had anxiety and couldn't sleep, thinking they were blood clots. Will visit doctor to do ultrasound to rule out blood clot
She had swollen lymph nodes under her left arm.  Area has been decreasing and returned to normal by end of 1 week
Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; arm is swollen; feels hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old-non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 18:00 (at the age of 47-year-old) as a single dose for COVID -19 immunisation. Medical history and concomitant medications were not reported. 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 vaccines within four weeks prior to the COVID vaccine. On 02Apr2021 at 08:00, the patient's left eye was swollen and painful and watery. The patient's arm was swollen and felt hot to touch. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events left eye swollen and painful and watery, arm was swollen and felt hot to the touch were not recovered.   No follow-up attempts are needed; information about lot number cannot be obtained.
pt recvd vax; mom reported fever on 1oct94 & stated that pt had fever of 106-104; not breaking w/ apap;
Patient is a retired physician and my grandfather. I gave him the shot on 1/6/21. Sometime on 1/7/21, Patient started to experience severe arthralgia that started in his left arm and was radiating down from his shoulder area to his wrist continuously throughout the day.   Sometime late 1/7/21 or early 1/8/21, he was experiencing severe arthralgia radiating from the right shoulder down to his wrist. Sometime on 1/10/21, the arthralgia was consistently happening in his hip and back region. Patient has a doctor appointment scheduled for 1/12/21 which was the first appointment available.
Patient reports immediately following vaccination doing fine. She got her errands done that night without any issues. She reports waking up in the middle of the night with a sense of disequilibrium. She reports feeling very dizzy and nauseous. She looked in the mirror and said she was very pale and that is the last thing she remembers. She woke up then on the ground with a small laceration to her forehead. She also then vomited multiple times. She reports no other associated symptoms and felt better the next day.
?In this case, 0.9% NS nebulizer solution was used. I am unable to find the ingredients without having the package of what exactly they used, but the front of the Addipak box states that no bacteriostatic or preservative agents were added. In the case of NS for injection, it sometimes contains various ingredients (differing by manufacturer) for pH control and such, and this is not an issue, so while I can't say for certain without seeing the ingredients on the box, I think that the doses are acceptable and those who received this can move on to their second dose.  To clarify-pediatric Pfizer Covid-19 Pfizer vaccine was reconstituted with NS for inhalation not with supplied NS for parenteral injection.
Patient did not give times, but states that the day after getting the shot, between 12 and 24 hours, he began getting a rash over his whole body.  Slight itch.
Tinnitus - ongoing, low-medium, high pitched buzzing. No action/response needed, Just want to register for the side effect research.
At the end of September after receiving the vaccine I noticed I wasn't feeling well. I went to my endocrinologist; they had done bloodwork and noticed my liver enzymes were up. She called me in and had my bloodwork ran again and the numbers were even higher. She referred me to a gastrointestinal doctor who ran an extensive bloodwork. panel. I had and MRI in early March that I am awaiting the test results.
people who had ringing in their ears as well; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (people who had ringing in their ears as well) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (people who had ringing in their ears as well). At the time of the report, TINNITUS (people who had ringing in their ears as well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment information was reported   This case was linked to MOD21-123774 (E2B Linked Report).; Sender's Comments:  MOD21-123774: