chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse. A 51-year-old female patient received PREVNAR 13, in Jun2017 at single dose for immunisation. The patient medical history and concomitant medications were not reported. In Jun2017 the patient experienced arm swelling and limitation of arm movement. The local reaction expanded to the entire arm, including the elbow. The outcome of the events was unknown.
23 y/o F patient calls Vaccine Healthcare Center (14MAR11) with concern re appearance of SPV site (placed RUE on 09OCT09 while deployed)". It doesn't look normal-it still itches and it looks like a bubble." Patient comes to Healthcare Center for eval on 17MAR11 at 10:30AM. She denies changes in size, color or pigmentation since receipt of primary SPV 09OCT09. States that SPV site followed usual 3-4 week evolution after immunization, but "looked like a bubble" once the skin healed. PMH: + sickle cell trait; ASCUS, chlamydia, migraine, PFS. Denies any personal h/o chronic or autoimmune disease- no eczema, psoriasis, SLE, RA, Crohns, etc. Denies prior hospitalizations or surgeries. Allergies: Amoxicillin (unknown reaction), TYLENOL- blacked out once many years ago, but has taken TYLENOL since w/o problems. ACTIVE MEDS: PRN OTC Ibuprofen or TYLENOL for HA's or malaise. No family h/o melanoma, squamous or basal cell CA, auto-immune disease, asthma or psoriasis. F-48, living: OA, HTN, hyperlipidemia, (?) eczema hand; M-45, living: healthy, no asthma, eczema, psoriasis, Lupus, RA etc; Bro-29, living: stomach ulcer; Bro 26, living: healthy. On exam: raised, non-tender, hyperpigmented, round, fibrous papule measuring approximately 1.3 cms x 1 cm in diameter with firm center- not fluid filled or pus filled and w/o erythema or warmth. Appears consistent with keloid. Will refer to Derm for possible biopsy. Patient would like removed for cosmetic reasons.
Tongue, lips, face went numb at around the 5 min mark. Then hands and arms. I was dizzy and weak, had a hard time walking. I noticed my vision was blurred. I couldn't see freckles on my arms that I usually can see. After 40 mins the numbness improved. On the drive home I was swept with head-to-toe numbness for about a min with the feeling like I was going to throw up and chest pain.  The chest pain continued to come and go a few times for the next 10-12 hours. I was very dizzy and very weak. My vision went back to normal about 5 hours later. But I remained dizzy and weak for about a week. I still have dizziness on and off throughout the day that I never had before though.  All those symptoms I feel like are outside of what was expected and concern me but other than that I had symptoms that I expected as well like my arms was sore for maybe 3 hours total the day after, I was tired, and had an elevated temp around 100 degrees.
Pt came in for a adult Hep B vaccine for her work and seen the provider, after she finished seeing the provider I gave her the Adult hep B vaccine and then documented the vaccine at which time I then seen that the pt had already had the 3 required doses of Hep B as a child.
weakness; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and HEADACHE (Headaches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054c21a) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-2021, the patient experienced ASTHENIA (weakness) and HEADACHE (Headaches). At the time of the report, ASTHENIA (weakness) outcome was unknown and HEADACHE (Headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
2 inch area erythema/local reaction at the site of injection; This spontaneous case, initially received on 11-Oct-2018, reported by other healthcare professional (nurse) concerns a patient of an unspecified gender and age.  On an unspecified date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 00844621A (reported as 02844621A), expiry date: 25-Jun-2019] for an unknown indication.   On an unspecified date after vaccination, the patient developed erythema of size 2 inches in area at the site of injection.  At the time of this report, the outcome of the event was not reported.  The reporter assessed this case as non-serious.  This case was linked to case 201804405 owing to the same reporter.  Non-significant case amendment (11-Oct-2018): The sentence 'On an unspecified date after vaccination, the patient developed erythema of size 2 inches' in narrative was changed to 'On an unspecified date after vaccination, the patient developed erythema of size 2 inches in area at the site of injection'.; Reporter's Comments: A patient of unspecified gender and age developed injection site erythema after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related to the suspect vaccine due to site-specific occurrence of the event.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No medical history, concurrent conditions and drug reactions/allergies were reported for the patients. On unknown dates beginning since 11-JAN-2016, the unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L031273 with expiration date 19-NOV-2016, (dose, frequency, route and anatomical site of administration were not reported), which were previously exposed to temperatures outside of the recommended range. No concomitant medications were reported. No adverse experiences had been reported. No product quality complaint was involved. This is one of two reports received from the same source (MARRS # 1602USA006564). Additional information has been requested.
Pfizer vaccine was given with out diluent. Pt notified not to obtain her second booster dose due to receiving a larger dose.
Blistering rash on face, extremities, not on trunk (Tylenol only for fever, plenty of liquids)
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 6:14 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 6:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on 19 Nov 2021. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Patient fainted within five minutes after the vaccines were administered. She recovered in about ten seconds and felt fine but continued to feel dizzy for another hour and a half she received water and rested.
Fever 103, tonic-clonic seizure lasting less than one min. Tylenol given at time of fever.
Right sided Bell's palsy with right facial pain, treated with course of prednisone/valacyclovir followed by gabapentin for persistent pain
Patient's arm was swollen, red, and also had a fever.  She started taking tylenol for the fever.
Hospitalized on 4/14/2021 with respiratory distress - history of COPD
Information has been received from a health professional, for the Pregnancy Registry for GARDASIL concerning a 16 year old female who on 09-JUL-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot # 658094/0524U). On 22-OCT-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot # 658563/1063U). The patient is now about 6 weeks pregnant with an estimated LMP of 12-JAN-2008 and a due date of 18-OCT-2008. The patient had a positive urine pregnancy test. Follow-up information has been received which indicated that on 14-MAR-2008, the patient underwent elective termination. Upon internal review, elective termination was considered to be an other important medical event. Additional information is not expected.
Client c/o scratchy throat, flushed face. O2 sat was 98% on room air. Lungs clear. No stridor or SOB. BP was 204/114. Received Pfizer vaccine about 10min prior to symptom onset. 20ml of Children's Benadryl 50mg given PO. Client evaluated. Symptoms decreased by the time her mom arrived. She was going to stay with her mom. Client was advised to go to ER if symptoms got worse or prolonged. In no apparent distress as she left. BP was 180/104 and O2 sat was 99% on RA.
hazy vision in both eyes; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Apr2021 at 10:00 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not take any concomitant medications. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 12:00 the patient experienced hazy vision in both eyes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hazy vision was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Months after my vaccine, I have developed low oxygen, low blood pressure, shortness of breath.  I have seen many medical professionals and been admitted to the hospital twice.  No one is able to find out why.  I did just discover that I have two leaking valves in my heart.  I am wearing oxygen 24/7 as my oxygen saturation continues to drop into the 80s.  Last night while wearing oxygen at 2.5 liters, my saturation dropped to 81%.
I first noticed I was really itchy when I was sleeping that night. When I got up in the middle of the night I noticed it on my arms, chest, and stomach. There were red bumps and some white bumps. I sprayed something on it. I don't remember what it was. I called my pharmacist and she told me to take Benadryl and Zyrtec. I was taking Zyrtec throughout the day and Benadryl at night. The bumps look red and the rash was in the form of lines. Always on my forearm, and sometimes on my neck, chest, face, and upper legs. When I take Zyrtec it seems to go away after an hour, but it comes back after about 4 hours, but its happening more often. I had a tele-visit with my doctor and he prescribed Urticaria and wanted my to see an allergist. I scheduled that appointment and I will see them in March 2022.
Muscle and joint pain, mild headache, chills, queasieness, low grade fever, raised pink rash about 6" x 2" at injection site, general feeling of malaise and low energy.  Symptoms persisted for about 24 hours except for the rash which lasted several days and began to itch after about 3 days.  Intermittent itching at rash site continue for a couple of weeks even though the rash had faded.  During itching a faint outline of the rash area was visible.
received only diluent portion; received only diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 21st October 2022) for prophylaxis.   On 3rd March 2022, the patient received Menveo. On 3rd March 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient had received only diluent portion of Menveo, without being reconstituted, which led to the inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. Vaccine administration facility is same as primary reporter. This case has been linked to US2022040277, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040277:Same reporter
Patient was given Tdap at time of visit.  Had patient wait in office 20 minutes.  No adverse reaction occurred.  Patients mother informed in detail.
Body aches; Chills; Really bad headache; Really really tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Really bad headache) and FATIGUE (Really really tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023CZ1A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Really bad headache) and FATIGUE (Really really tired). At the time of the report, MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Really bad headache) and FATIGUE (Really really tired) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
fuzzy head; dizzy; fogginess; headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fuzzy head), DIZZINESS (dizzy), FEELING ABNORMAL (fogginess) and HEADACHE (headaches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (fuzzy head), DIZZINESS (dizzy), FEELING ABNORMAL (fogginess) and HEADACHE (headaches). At the time of the report, FEELING ABNORMAL (fuzzy head), DIZZINESS (dizzy), FEELING ABNORMAL (fogginess) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Mental fog; Chills; Dizziness sensation; Headache; Extremely large lymph nodes; Fevers; This is a spontaneous report from a contactable nurse reported for self. This 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 08Jan2021 12:00 PM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The patient had no COVID prior vaccination. The patient had none known allergies. The patient medical history included hypertension/ gastric sleeve 2020. The patient concomitant mediations included metoprolol 100mg once a day. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 18-Dec-2020 12:00 PM at single dose in right arm for COVID-19 immunization. The patient experienced extremely large lymph nodes, chills, fevers, Constant headache and dizziness sensation, mental fog. The events onset date was reported 08-Jan-2021 20:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. The COVID test post vaccination (COVID test type Nasal Swab, COVID test name COVID/flu AB by PCR) resulted Negative on 11-Jan-2021. The patient received no treatment. The outcome of events was recovering. Information on the Lot/batch number has been requested. Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported mental fog and the administration of the suspected vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
08/15/02 10:10 The pt became diaphoretic, pale, lips cyanotic, limbs flaccid a few seconds after receiving vaccine, no loss of consciousness, episode lasted for 30 minutes off and on-was evaluated at ER and by his private doctor. Mother to follow with private doctor.
Muscle pain, shivering, weakness. This is the first day after the vaccination. Had the same reaction with the first dose (effects only lasted 1 day  with the first dose).
Patient is a 75 y.o. female with a history of primary progressive aphasia, frontotemporal dementia, mechanical heart valve on warfarin, HTN, HLD who presents for fall and left hip pain. History is limited secondary to patient's chronic aphasia. Reportedly, she had the dog on a leash which got wrapped around her legs, causing her to fall. No head trauma. Patient initially presented to health center where imaging showed a left intertrochanteric femur fracture. CXR and CT head were obtained as well which showed no acute abnormalities.   Patient was tested for COVID-19 and positive upon admission on 7/2/2022.
This is a spontaneous report from a contactable consumer. An 18-year-old other ethnic group male patient received the first dose of TRUMENBA, intramuscular at 0.5 ml single in the left arm on 28Dec2015. The patient medical history and concomitant medications were not reported. On 28Dec2015, the patient experienced chills, pain. On 29Dec2015 he developed slight pinkness around the sight, slight fever at 99.8 degrees Fahrenheit, headache. Therapeutic measures were taken as a result of headache included ibuprofen. The outcome of the events was not recovered.
Grey phlegm; This spontaneous case was reported by a consumer and describes the occurrence of SPUTUM DISCOLOURED (Grey phlegm) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SPUTUM DISCOLOURED (Grey phlegm). At the time of the report, SPUTUM DISCOLOURED (Grey phlegm) outcome was unknown.            No concomitant medication were reported. No treatment information was reported  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    Reporter did not allow further contact
This spontaneous report as received from a pharmacist refers to a 52 year old male. The patient's medical history, concurrent condition and concomitant therapy were not provided. The pharmacist reported the patient was vaccinated with his first dose of RECOMBIVAX HB lot # K011957, expiration 24-OCT-2016 on 04-FEB-2016. The pharmacist reported that the patient stated, on an unspecified date in "March 2016", he "remembered getting another vaccine at another facility, and he thought it was his second dose of RECOMBIVAX (lot number/expiration date unspecified) but he is not certain". The patient then vaccinated with his first dose RECOMBIVAX HB (M027339, expiration 31-MAY-2018) on an unspecified date in "September 2016". On an unspecified date after the dose the patient received in September 2016, the patient had serologic testing and was found to have 'negative titers'. No additional information was provided. Additional information has been requested.