chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed fever and became dizzy approximately 2 weeks after receiving 2nd Shingrix vaccination. Patient was admitted to hospital 8/11/2018 and subsequently diagnosed with viral meningitis, though no correlation between Shingrix vaccination was identified or suspected. Patient was informed that the actual cause of his condition would probably never be established. Patient recovered after eventually being diagnosed and treated for viral meningitis, and was released on 8/29/18.
Information has been received from a physician concerning a 20 year old female who on an unspecified date was vaccinated with a dose of GARDASIL 0.5 ml IM. Subsequently the patient experienced joint pain. The patient's joint pain persisted. The patient sought unspecified medical attention. Additional information has been requested.
Patient passed out about 5 minutes after receiving the Janssen vaccine. Patient recovered after a few minutes and applied ice pack to left side of face that hit the ground.
Chest pain (severe) and respiratory distress. Treated in the Emergency Room. Unresolved repeated attacks of acute shortness of breath since COVID 19 #2 vaccine. Currently under the care of Pulmonology.
Swollen sore lymph nodes in axilla, neck, thorax for three weeks now.
pt recv vax & exp petechial hemorrhage;A blood test revealed thrombocytopenia;No further details were provided;
Patient noted injection site reaction 10 days post vaccine dose 1. She reports redness around injection site that subsided after 48 hours. Discussed known allergies and precaution to second dose vaccination. After discussion, patient wished to proceed with second dose vaccination but was recommended to enroll and to report any side effects that may occur.
Information has been received from a female pt's mother who is an RN. The child had autism and was vaccinated with MMR II. Subsequently, the pt's mother felt that the child's autism has gotten worse since the vaccination. Unspecified medical attention was sought. Upon internal review, autism was determined to be an "Other Medical Event". Additional information has been requested.  Follow up on 03/28/2001 : "Patient date of birth, age of vaccination, adverse event onset date/time, lot # for vaccine 1 and vaccine administration date/time is not provided."
fever to 105 x 36 hrs w/3 febrile sz, irritable & lethargic;
This is a previously healthy 40 year old female that  patient began having visual disturbances and a severe headache 1 week following her initial dose of the vaccine. Her symptoms progressed and she was evaluated by a retinal specialist 2 -3 weeks later. Examination showed a central retinal vein occlusion in her left eye. She had an OCT, fluorescein angiogram and fundus photos which revealed macular edema and ischemic peripheral retina.  She has needed to have intravitreal injections of aflibercept to control her macular edema and she is being monitored for neovascular complications.  She has had an extensive  systemic workup  which could not identify an underling cause.    This  included a negative hypercoagulable work-up with oncology and a negative autoimmune/inflammatory work-up.  She had an extensive cardiovascular work-up including a negative Zio patch, Echocardiogram with shunt study, and carotid ultrasound.      Infiltrative causes were  been ruled out with an MRI.  It is my impression as a retina surgeon that her retinal vein occlusion was a result of her vaccine given the temporal association and reports of prothrombotic events happening after these vaccines.
Bilateral sural mononeuropathies. Neuropathic pain approximately 2 years after.
Event after second Covid vaccine: mild and periodic headache for first few days. On day 5, dizziness and increased tinnitus. On days 6 and 7,  fatigue, dizziness, brain fog, headache and worsening tinnitus.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 14 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 14 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information has been received from a physician concerning a child who was vaccinated with varicella virus vaccine live. The physician reported that the child had a case of breakthrough  chicken pox earlier this year (2004). The physician reported that the case was mild with less than 50 lesions. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date reported as several years ago, the patient received first dose of VAQTA dosage regimen and route unknown. Physician reports that this information was unknown to physician's staff at the time the patient transferred to physician's office and the patient then received a second dose of VAQTA on 25-NOV-2014 (Inappropriate schedule of vaccine administered). On 30-MAR-2016, the patient received third dose of VAQTA (Extra dose administered). Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two multiple patient reports received from the same reporter. Additional information has been requested.
Pfizer 4/13/21 and 5/11/21. Positive on 1/16/22
7 cm of swelling, 5 cm of redness. No fluid pockets or abscesses. Pt was given MOTRIN, BENADRYL and ice packs.
I received my first Moderna booster for COVID-19 on 11/26/2021. On the morning of 8/21/2022, I woke up with a sore throat. I took a home antigen test and got a negative result. I thought I was okay and that I had just strained my voice recently while yelling at a sporting event. On 8/22/2022, just to be on the safe side, I took another home antigen test before going to work and got a strongly positive result. I stayed home and continued to test positive every day for the next several days, although I felt fine, since the sore throat had resolved pretty quickly. I finally tested negative on 8/27/2022 or 8/28/2022.
This spontaneous report was received from a registered nurse and refers to a 16-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB thimerosal-free, lot # R001530, expiration date 07-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
NO ADVERSE EVENTS FROM THE PEDIATRIC INCORRECT DOSE THAT WAS GIVEN TO THE 14 YEAR OLD PATIENT. PT WAS GETTING THEIR SECOND DOSE AND UPON CHECKING THE  CDC  CARD LOT NUMBER FOR FIRST DOSE WE NOTICED THAT THE FIRST DOSE WAS GIVEN INCORRECTLY.
A non-serious spontaneous report of environmental exposure to seasonal FLUMIST and H1N1 while administering vaccines, flushing and malaise has been received from a registered nurse concerning himself, an 18-year-old male, subsequent to administering FLUMIST and H1N1, Intranasal. Medical history and concomitant medications were not reported. The reporter administered FLUMIST and H1N1, Intranasal from Nov-2009 to Dec-2009. On 09-Nov-2009, the patient reported that he developed flushing and malaise after administering numerous doses of FLUMIST and H1N1 to vaccinees. The outcome of flushing and malaise was not provided. The reporter indicated that his symptoms may have been due to the environmental exposure to FLUMIST and H1N1.
This is a 73 year old female that received her 1st dose with Moderna vaccine on 1/8/21 at approximately 1600.  Within one hour, the patient developed altered mental status and increasing weakness.  She was transported to the hospital by the staff at her Assisted Living Facility for concern of a vaccine reaction. On admission, oxygen saturation was found to be 89% on room air, BP=137/86, HR=94.  Labs were normal, with the exception of WBC=15 (leukocytes normal, chest xray clear, COVID test negative), and a detectable troponin=63.  Head CT negative.  Physical exam was only notable for 'slight superficial erythema over distal right forearm and dorsal hand. No significant edema.' The patient was treated for a possible allergic reaction to vaccine with NS bolus, methylprednisolone 125mg, famotidine 20mg, and aspirin 300mg PR.  She was admitted for monitoring given continued altered mental status/weakness.  The next day, she continued to show no improvement, so a head MRI was ordered.  MRI showed " 1. Numerous acute cerebral and cerebellar infarcts involving both anterior and posterior circulations consistent with a central embolic source. 2.  Minimal right parietal petechial hemorrhage. 3.  Moderate atrophy and moderate nonspecific white matter signal abnormalities compatible with chronic microvascular ischemia  "  Neurology was consulted, who approved the start of aspirin and to continue DVT prophylaxis.  The patient's advanced dementia and timeline preclude other intervention.  The patient's status was DNR/DNI. The patient was discharged on hospice to her assisted living facility on 1/11/21 (with reports of continued somnolence).  It was reported that date of death was 1/24/21.
Pt developed huge swelling of the left arm from shoulder to elbow. No pain, full range of motion present.
Left arm sore, edematous 25 hours after immunization; then became red, warm to touch, itchy from elbow to shoulder. Referred to PCP if not better by tomorrow. Applied cortisone cream and dectin cream with some relief. (Sister had same vaccine last year with no ill effects).
Approximately one month after taking my third GARDASIL shot, I began experiencing hives all over my body. This continued for weeks and has now developed into chronic skin rashes with intense itchiness two years later.
Turning their head is really hard to do; Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored; Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored), HEAD DISCOMFORT (Turning their head is really hard to do) and HEADACHE (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 24-Feb-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 NECK PAIN (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored), HEAD DISCOMFORT (Turning their head is really hard to do) and HEADACHE (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored). At the time of the report, NECK PAIN (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored), HEAD DISCOMFORT (Turning their head is really hard to do) and HEADACHE (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication: high blood pressure medication.   This case was linked to MOD-2021-255326 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The patient was getting ready to exit the office, when he fainted. We stabilized patient, then took him to a room to lay down for 15 minutes for observation.  Patient was then released.
I started experiencing tinnitus after my 2nd Pfizer shot.  With time, it started to improve marginally.  I then got a Moderna booster and the tinnitus is back as bad as it was before.
hot rash at the injection site; hardness at the injection site; swelling at the injection site; red rash at the injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot rash at the injection site), PAIN (sore arm), INJECTION SITE INDURATION (hardness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE ERYTHEMA (red rash at the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PAIN (sore arm). On 07-May-2021, the patient experienced INJECTION SITE WARMTH (hot rash at the injection site), INJECTION SITE INDURATION (hardness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE ERYTHEMA (red rash at the injection site). On 03-May-2021, PAIN (sore arm) had resolved. At the time of the report, INJECTION SITE WARMTH (hot rash at the injection site), INJECTION SITE INDURATION (hardness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE ERYTHEMA (red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Swelling of the left arm, pale skin color, bruising on are and injection site Inflamed veins in left chest, breast, and under arm tenderness Went to the PA on 12/22/2021, blood work and was treated for cellulitis Returned to doctor on 12/28/21 after symptoms worsened and was sent to hospital for tests and was treated for blood clot (DVT) Prescribed Eliquis blood thinner, two weeks of medication and will continue for three months Wearing a compression sleeve on left arm Follow up and recheck for clot around mid-march
Patient advises that she has been experiencing lower back pain, leg painful and swelling on her right  foot, a fogginess that "feels like I'm on a conveyor belt", depression, diarrhea  and fatigue since receiving the vaccine. Patient also advises that she used to be  able to walk her dogs 4 miles a day and now can barely walk them 20 min. Patient  also states that the foot that is painful is also a blueish gray in color.
Red swelling at injection site and redness extending over area 6" long and 3" wide.
tinnitus worsened after vaccination, had tinnitus usually prominent at night when quiet and when sleeping   now constantringing in my ears
Gave the patient a vaccine and it leaked out; syringe leak/product leak; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine leaked out down his arm while being administered.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   During the vaccine administration, the vaccine leaked out down the patient's arm.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine leaked out down his arm while being administered, was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a male patient.  The patient's medical history is not provided.  The patient experienced the unexpected event of vaccine leaked out down his arm during the administration of the first dose of the mRNA-1273 (Lot 011J20A) on 29 Dec2020. This report refers to a case of Product administration error for mRNA-1273, lot # 011J20A.
This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (16 weeks pregnant) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (16 weeks pregnant). The delivery occurred on an unknown date, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (16 weeks pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Internal review on 21-Jul-2021 resulted in updates to the pregnancy information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 14th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th February 2019, less than a day after receiving SHINGRIX, the patient experienced muscle pain, headache and tiredness. On an unknown date, the outcome of the muscle pain, headache and tiredness were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient planned to follow up with his physician on an unknown date. The reporter gave consent to follow up.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient without known drug reactions or allergies. Concurrent conditions included hypertension and hypercholesterolaemia. On 16-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX subcutaneous, 0.65 ml, lot # L002423, expiration date 23-APR-2016 (dose number and anatomical location were unspecified). Concomitant therapies included "a lot of chronic meds" (unspecified). On an unknown date in June 2015, after vaccination, the patient experienced a large, red spot on the arm that was itchy and warm to the touch and measuring approximately 3 inches in diameter around the site of injection. The patient sought medical attention by the pharmacist; no treatment was given for the events and none laboratory diagnostic studies were performed. The outcome of skin warm and rash papular was reported as not recovered. Additional information has been requested.
Severe convulsions and possible seizures. 150.4 degree fever. Heart rate above 150 beats per minute. Shortness of breath. I was unable to catch my breath. Sent to emergency room by ambulance. Was given sodium chloride, acetaminophen and ketorolac. This was over a 6 hour time period.
The injector could not get the shot in,  and kept trying and finally after i heard a pop the shot got in. Injection site is more towards side arm and shoulder. 3 hours after the second shot, I started to experience flu like symptoms, dizzy, achy, arm pain from awful injections, soar arm etc etc. The last 3 days I have experienced all symptoms that they say are normal, plus nerve pain running down my arm and across my chest to my other arm pit. Back pain, neck stiffness and just an overall feeling not good. I am concerned that there is damage from the injector not knowing what she was doing and now I am having a reaction to how she did the shot. Injection site is hot to the touch and bruised. My first vaccine I did experience dizziness and injection site looked like I was stung by a bee, very swollen but not hot to the touch like now. I have been on tylenol, which is doing anything so i switched to ibuprofen for pain, achinesss and overall just not feeling well. I cannot move my arm much, but can use my fingers. Today is day 4 of the same issues and at this point if my arm is not better by next week I will go see the doctor. My doctor has advised to report this, and ice areas and ibuprofen/tylenol. I am concerned I have nerve damage done at this point from whoever was the injector. I am hoping there is a way to find out who did mine. At the end of the appt, the injector did say sorry that was awful and I was so traumatized that I didn't even know what to do or say at the time. It was so bad my husband was getting his phone out to video but as soon as he did, she got it in deep where it was suppose to go????
2 weeks of cough superimposed a chronic cough with mild wheeze & chest tightness. Seemed a little worse after shot. Patient noted walk in cold air on way to vaccine apt seemed to trigger it.
sore throat; pain under his armpit; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and AXILLARY PAIN (pain under his armpit) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included AMLODIPINE BESYLATE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and AXILLARY PAIN (pain under his armpit). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and AXILLARY PAIN (pain under his armpit) outcome was unknown. Not Provided          Treatment medications included aspirin Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079099: