chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles on the upper left leg; upper respiratory infection; This case was reported by a physician via call center representative and described the occurrence of shingles in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date unknown) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th May 2019, 3 days after receiving Shingrix, the patient experienced shingles and upper respiratory tract infection. On an unknown date, the outcome of the shingles and upper respiratory tract infection were not recovered/not resolved.   It was unknown if the reporter considered the shingles and upper respiratory tract infection to be related to Shingrix.  Additional details were provided as follows: The expiry date for Shingrix was not reported. The patient received Shingrix on right arm.  The patient experienced shingles on the upper left leg and also experienced a upper respiratory infection. The outcome reported for all the adverse events in the structured field is "recovering" instead of "not resolved" (outcome uploaded in Agency).
pt recv vax 7AUG96 530PM & later @ dinner pt became quiet & was staring & not responding to voice or touch;mom noticed redness developing on neck, cheek & behind ears;pt to ER -given DPH;allergic rxn;pt also exp itching;swollen red cheeks;
On 6/24/2021, the patient reported pain in the right shoulder and redness around the injection site of the Shingrix vaccine. Patient stated that she only used some topical remedies to help with pain. Patient also stated that she informed her doctor but doctor did not make any recommendations. Pharmacist advised the patient to start taking over-the-counter Advil and contact the doctor if the pain is not better after a few days. Pharmacist also told patient that the pharmacy will be calling her to ask how she is feeling.
Patient reports severe migraine started on 4/16/21 around 9pm. Complains  SOB, sore throat, severe fatigue & body aches started Saturday, April 17th, 2021. Patient was seen in clinic today, 4/21/21. Covid rapid test was negative ,rapid influenza was negative, as well as rapid strep was negative today. Pt found to have a acute otitis media & acute pharyngitis upon examination.
Came into clinic with red, war, swollen area on arm near injection site. Raise applied fluorcidine cream to arm and wrapped, applied ice bag.
An initial erythematous patch in the area of vaccine administration which spread out all over her body and also affecting her oral mucosa with vesicles and ulcers in tonsillar pillars. Associated to subjective fever.
after 2nd shot felt like throat was closing, (has had reaction before with food allergies)EMT assessed and released
This spontaneous report was received from a physician via company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAR-2016, the patient was vaccinated with an improperly stored dose of VAQTA "25U/0.5ml-SD LLok wCap Ped" which had a lot number of L02259 and expiration date on 06-APR-2017 (route of administration and anatomical location were not reported).There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On unspecified date, the VAQTA had two temperature excursions; one of 96 hours and other one of 360 hours. The lowest recorded temperature of 33 F (0.555555556 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a 30 year old female pharmacist, for ZOSTAVAX, a Pregnancy Registry product, concerning herself. The patient had no pertinent medical history. The patient had no drug allergies. On 01-AUG-2013, the patient was accidentally exposed to ZOSTAVAX (lot # not reported) (strength not specified). There were no concomitant medications. It was reported that while she was reconstituting ZOSTAVAX, the ZOSTAVAX accidentally splashed in an unspecified eye of hers. The patient reported that she experienced a little bit of burning of the eye after the splash of the ZOSTAVAX but she stated that her eye no longer burned at the time of reporting. At the time of accidental exposure, the patient was pregnant for 10 weeks. Her LMP and EDD was on approximately 23-MAY-2013 and 27-FEB-2014. The patient reported that she did not have a physician at this time and did not seek medical attention. No treatment was given. Lab diagnostics studies performed were reported as none. Additional information has been requested.
vaccination site erythema; vaccination site swelling; injection site hard to the touch; vaccination site warmth; vaccination site pruritus; lymph nodes that were large and swollen near collar bone; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (vaccination site erythema), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE INDURATION (injection site hard to the touch) and VACCINATION SITE PRURITUS (vaccination site pruritus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L204A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-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 VACCINATION SITE PAIN (arm pain). On 12-Jan-2021, the patient experienced LYMPHADENOPATHY (lymph nodes that were large and swollen near collar bone). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritus). On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site erythema), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE INDURATION (injection site hard to the touch) and VACCINATION SITE WARMTH (vaccination site warmth). On 09-Jan-2021, VACCINATION SITE PAIN (arm pain) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (vaccination site erythema), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE INDURATION (injection site hard to the touch), VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE WARMTH (vaccination site warmth) and LYMPHADENOPATHY (lymph nodes that were large and swollen near collar bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Last night (14JAN2021) before going to bed, she noticed her arm near the injection was itching and red. This morning (15JAN2021) the area became round as a softball, hard to the touch, much bigger, itchy, and hot.  No history of concomitant medications were taken by the patient.   Patient was able to get hold of health department who suggested her using heat, cold and ice in the effected area. She has not started following the suggestion which health department gave.
Fever up to 105 , body aches, chills, headache lasted 24hrs
Patient was given kinrix at 10 months old, though Kinrix is recommended for ages 4-6.
This spontaneous report was received from a registered nurse referring to a 4 year old patient. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On 06-FEB-2017, the patient was vaccinated with an expired dose of PROQUAD (which had the lot # L023113, expiration date 24-DEC-2016) for prophylaxis (dosage information and anatomical site of vaccination were not reported). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Headache, body aches, chills, night sweats, upset stomach, fatigue. Took Tylenol to ease symptoms. It helped a little. Symptoms most intense for 24 hours and are still present but very mild between 24 and 48 hours.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 22-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. No adverse reactions were reported by patient.
About 3 minutes after receiving the shot, I became dizzy.  After 15 minutes, I was still dizzy.  I had a little shortness of breath and it felt like my heart was beating faster but this only lasted a few minutes.  They had me wait an additional 10 minutes and the dizziness was better but not gone completely.  I drove myself home and tried to work from home but was feeling confused.  I took the rest of the day off.  The next day (yesterday) I woke up exhausted.  I took a sick day and slept until noon, which was about 14 hours in total.  When I woke up, I felt okay but had no appetite and did not get out of bed for 5 hours.  When I finally got up, I still felt dizzy.  I ate dinner, watched some TV and went to bed.  I woke up this morning without the fatigue but started to feel dizzy in the shower to the point where I almost lost by balance twice.  I'm trying to work from home today but feel very dizzy and confused.  I couldn't remember my office's phone number.  I'm sweating but my temperature is 97.5.
Breakthrough Case of COVID-19; I never had a fever but I had a bad headache, I had shortness of breathe, I had a really bad cough and my throat hurt so bad that my ears were hurting.  I spoke to my Dr. on 07/12/2022 and he prescribed me the Paxlovid. Took for 5 days and symptoms went away, I went back to work and tested negative, ever since and we have routine testing at work because I work for a nursing home and I tested positive again they took two test and they were both positive and now I am out of work for 5 days. We test twice a week at my job and I have tested every other day at work and all of my test until yesterday has come out negative. I have no symptoms for this new case of COVID-19
The day after, I had the normal fever, flu-like symptoms, and my left ankle/right knee ached pretty badly. Starting Monday 05/17, my right knee was unbearably painful. If I moved it at all away from a ~30 degree angle, my entire leg lit up with the worst pain I've ever felt. Not as bad as if I put pressure on it though, that was even worse. I couldn't walk, couldn't drive, could barely get out of bed for days. I got through that with over the counter pain killers and Biofreezing the knee like crazy.  Starting Friday 05/21 I believe, my knee pain suddenly went away only to be replaced with pain in my left foot. It's not nearly as bad as the knee was, but the entire left side is in constant pain made worse with pressure. I can drive now that my right leg works fine, but still can't walk without some form of assistance. I was reporting all of this in the V-safe health checker, but it apparently doesn't care outside of 7 days. Tempted to put "permanent damage" for Item 21 as the result, but I'm hoping this goes away soon.
Redness, swelling, warmth. Pt went to quick care/prescribed corticosteroids 10/30/16 phone conversation.
I took 2 Tylenol, 1,000 mg and an hour later took 600 mg of ibuprofen. Headache improved but still coming and going throughout the day and was bad enough I wasn?t able to run errands today. I took a mild opiate type RX pain medicine and headache went away at about 5:00 pm, which I haven?t taken any opiates since hospital visit for back injury 12/27/2020 and discharge medication of Percocet #15.
Dramatic increase in ocular eye pressure causing loss of vision.; Dramatic increase in ocular eye pressure causing loss of vision.; This is a spontaneous report from a contactable consumer (reporter himself). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 18Apr2021 15:00 (age at vaccination 74-year-old) as dose1, single for covid-19 immunisation. Medical history included glaucoma. The patient's concomitant medication included eye drops for glaucoma received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced dramatic increase in ocular eye pressure causing loss of vision on 21Apr2021 09:00. The patient lab test included intraocular pressure increased (dramatic increase in ocular eye pressure) on 21Apr2021. The event resulted in the doctor or other healthcare professional office/clinic visit. The patient received treatment for the events was new stronger ophthalmic drops. Since the vaccination, the patient had not tested for COVID-19. The outcome of the events was not resolved.   Follow-up attempts are needed. Information on the lot/batch number has been requested.
Patient describes that 3 days after receiving vaccine that her arm near injection site became hard and red. It has progressively gotten worse and is now itchy. Pt. applying ice and will start BENADRYL 25 mg po q 6 hours.
This spontaneous report was received from a registered nurse and refers to a 1 year old male patient. The patient's medical history included cardiac murmur (reported as resolved). He did not have any pre-existing physician-diagnosed allergy, birth defects or illness at time of vaccination. On 13-SEP-2018, the patient was vaccinated with the first dose of varicella VARIVAX lot # N034551, expiration date: 05-DEC-2019, subcutaneously (SC) in the right thigh (RT); with the first dose of M-M-R II, lot # N023024, expiration date: 23-AUG-2019, SC in the left tight (LT); with the first dose of VAQTA lot # R006210, expiration date: 22-APR-2019, intramuscularly (IM) in RT; and with the fourth dose of PREVNAR 13, lot # T94429 (expiration date not provided), IM, LT. All the vaccines were administered for prophylaxis and purchased with public funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) (product storage error) as recorded from a digital data logger which ocurred at the time of storage in clinical practice. None adverse effects were reported. Also, the patient received an unspecified treatment for the experience. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1901USA002765: US-009507513-1901USA002756: US-009507513-1901USA002755: US-009507513-1901USA002753: US-009507513-1809USA010598.
Bumps on back of my tongue; chills; swelling face/Face and neck puffy; swelling throat; tingling in throat; weakness; Tingling in lower jaw; Mouth was dry; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (swelling face/Face and neck puffy), PHARYNGEAL SWELLING (swelling throat), PHARYNGEAL PARAESTHESIA (tingling in throat), ASTHENIA (weakness) and PARAESTHESIA (Tingling in lower jaw) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney stone and Pulseless electrical activity. Concurrent medical conditions included Drug allergy (Allergic to chlorhexidine, ciprofloxacin, Propofol and sevoflurane.) and Contrast media allergy (Allergic to Iohexol and omnipaque.). Concomitant products included ROSUVASTATIN for Cholesterol, TAMSULOSIN for Prostatic hyperplasia.    On 01-Mar-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SWELLING FACE (swelling face/Face and neck puffy), PHARYNGEAL SWELLING (swelling throat), PHARYNGEAL PARAESTHESIA (tingling in throat), ASTHENIA (weakness), PARAESTHESIA (Tingling in lower jaw), DRY MOUTH (Mouth was dry) and CHILLS (chills). On 11-Mar-2021, the patient experienced TONGUE DISORDER (Bumps on back of my tongue). At the time of the report, SWELLING FACE (swelling face/Face and neck puffy), PHARYNGEAL SWELLING (swelling throat), PHARYNGEAL PARAESTHESIA (tingling in throat), ASTHENIA (weakness), PARAESTHESIA (Tingling in lower jaw), DRY MOUTH (Mouth was dry) and CHILLS (chills) had resolved and TONGUE DISORDER (Bumps on back of my tongue) 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.   Treatment included Benadryl, Pepcid and Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Added patient's demographics, medical history, concomitant medications. Events ( tongue disorder, paresthesia and dry mouth) were added. Event outcome updated to recovered.
5 minutes after injection, I felt tingling in my fingertips and toes. Two and a half hours after injection, I had an insatiable craving for cheese and other dairy products that lasted approximately 12 hours after injection.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-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 FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-114386, MOD-2021-114386 (Patient Link).
Initial unsolicited report received from the literature on 08-AUG-2018. This case was linked with the case 2018SA220375 (same reporter). The following is the abstract from the article: Background: Other than influenza, little is known about the consequences of viral acute respiratory illness (ARI) on pregnant women and fetuses. Our objectives were to determine the frequency of ARI due to respiratory viruses and the associated clinical outcomes during pregnancy. Methods. Pregnant women in their second or third trimester were enrolled if they reported having symptoms of ARI or were healthy within the preceding 2 weeks. Nasopharyngeal secretions were evaluated for respiratory viruses by molecular diagnostic assays. Clinical outcomes were evaluated at enrollment and via a follow-up telephone-based questionnaire 2 weeks later. Results. There were 155 pregnant participants, with 81 ARI cases and 91 healthy controls. Acute lower respiratory tract illness (ALRTI) was identified in 29 cases (36%). Human rhinovirus (HRV), respiratory syncytial virus (RSV), and influenza virus accounted for 75% of virus-positive cases of ALRTI. Cases with ALRTI often reported a longer duration of illness, history of allergies, symptoms of wheezing, shortness of breath, or chest pain, and use of prescription medication. Two cases with ALRTI reported decreased fetal movement; a third case with ALRTI was hospitalized. Conclusions. In over one third of ARI cases, participants had symptoms consistent with ALRTI. Infection with HRV, RSV, or influenza virus was commonly detected in patients with ALRTI. Viral ALRTI during pregnancy appears to be common and is associated with significant morbidity. Keywords. Maternal respiratory viral infection; respiratory tract infection; maternal vaccination; respiratory syncytial virus; influenza; rhinovirus. This case involves an adult female patient (age not reported), who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date, while she was pregnant (exposure during pregnancy). Pregnancy information regarding gestation period at onset, LMP was not reported. Patient's medical history was not reported. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed acute lower respiratory tract illness (ALRTI). Patient presented with uterine contractions and fever. On an unknown date patient was hospitalized. The patient other relevant lab tests and other corrective treatment were not reported. The outcome of all the events were not reported. List of documents held by sender: none. Sender's Comments: This case concerns an adult pregnant female who was vaccinated with INFLUENZA vaccine (unknown manufacturer) and presented with acute lower respiratory tract illness. The time to onset is unknown. More information regarding nature of the event and patient's personal and historical information are not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
Information has been received from a registered nurse concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on 22-AUG-2007 was vaccinated with a first dose of Gardasil (lot# 658556/1060U) 0.5 mL IM.  There was no concomitant medication.  On 22-AUG-2007 the patient experienced dizziness, began to sweat, complained of arm pain, tingling and numbness after receiving the vaccination.  Medical attention was sought.  The patient was instructed to lie flat for 30 minutes as the blood pressure was monitored.  The specific blood pressure readings were unspecified but reported to be within normal limits.  There were no other symptoms or treatments were reported.  On 22-AUG-2007 the patient recovered. Further information was not available.  Additional information has been requested.