chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ongoing unexplained frequent nausea, lethargy, joint pain, sweating with minimal exercise
Mom states baby extremely fussy, agitation couldn't calm baby for 8-9 hr. Reports baby fever at about 9:20pm cont all next day at the next day although mom didn't check temp reports baby fine by the 3rd day.
This literature marketed report has been received from the authors of a published literature article, and refers to a 10-year-old patient of unknown gender. The patient's concurrent condition included ataxia telangiectasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On an unknown date at age of 18 months, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin where the rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 3085 cells/uL, CD4 count 1091 cells/uL, CD19 count 0 cells/uL (post-rituximab) and natural killer (NK) cell count 560 cells/uL. The authors assessed CD3, CD4 and NK count as normal. The patient was treated with abatacept and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. The patient have slowed in the progression of lesions but and lost rubella in skin on biopsy but subsequently bones were involved At the time of the report, the final outcome of the rubella was unknown but the patient was alive. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA004784, 1902USA003143 1902USA004786, 1902USA004787, 1902USA004788).  Sender's Comments: US-009507513-1902USA003143:
pt developed erythema, edema, warmth, itching, stinging & pain in approx. 4" X 6" area at site of injection /p receiving vaccine. Experienced flu-like symptoms. That include haedache, light-headedness, dizziness, nausea within 3 hrs /p vacc
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This case refers to 60th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician. Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
After receiving the third dose of the Pfizer COVID-19 vaccine the patient suffered dementia. He was able to function normally and was able to drive to the vaccine site. Within one month of receiving his booster (third shot) he deteriorated to the point where he was unable to drive. Indeed, he is unable to remember how to adjust the thermostat in his home or even the remote control for the television. He is incapable of living alone. He is now living with my wife (his daughter) and me (his son-in-law) who watch over and care for him.  He also developed a cancerous tumor in his lung discovered on or about October 2021. The tumor was not there about 9 months earlier.
Feel pain on the stomach, headache, loose of breath and High pulse, causing go on A Emergency yo the Emergency Room.
About 3 hours after the injection, I was hit all of a sudden with extreme fatigue and dizziness. This lasted several hours until a took a 2-3 hour nap after lunch. I felt better enough after the nap to at least get through the rest of the day. However, by around 8 pm I had uncontrollable shaking chills. Could not get warm. Eventually fell asleep, and woke up 3 hours later with fever and severe body aches. My temperature was 101.5, but consider that my normal body temp is a full degree lower than average, so for me this was extremely hot. I felt like my body was radiating heat like a furnace. I was so hot and uncomfortable that I couldn't sleep, and gave up after an hour. I got up and had a Tylenol, tea, and snack (so as to not have the Tylenol on empty stomach). A little before 4 am I finally fell asleep again. When I woke up around 7 am, I didn't feel quite so hot anymore but there were still the body aches. As the morning went on, the aches reduced to just my upper body, neck, and the sore injection arm. I had a headache through the morning and early afternoon, but by late afternoon I was feeling more normal again.
Pt reported having a "burning sensation" in his throat about 11 min post vaccine.  Denied any shortness of breath, swelling of lips or tongue and had no evidence of rash.  He also denied any difficulty swallowing .  He did report tingling and "cold" feeling in his hands.  Pts BP was elevated to 148 / 98 ( both by machine and manually) with HR 87,  He drank some juice, but refused any Benadryl.
Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
On 09/27/2013, patient came into the pharmacy to report that she was experiencing an adverse event in response to her influenza vaccination (FLUZONE-LOT UH899AD) that she received on 09/24/2013. The injection site was warm to touch and red. Dr. (PharmD) advised patient to treat with ibuprofen, Benadryl, and cold compress on injection site. The patient performed these actions. Dr. called the patient on 10/01/2013 to assess whether the problem was resolving. The patient reported that the problem was resolving and that the site was still a slight pink color and that there was no pain associated with the injection site. Dr. advised patient to call the pharmacy if any further problems arise.
In April pt had a bout of uncomplicated diverticulitis--went to ER.  Then May 30th had severe abd pain again--this time to ER again and had perforated diverticulitis.  Required 10 days in hospital.  Now pt still having abd pain.  Dx with "smoldering diverticulitis" as is now required to get a sigmoid colectomy--as this is the treatment for such a condition.  Just wanting to report this as inflammatory conditions have been reported after covid and the vaccine.  Just wanting you to look into this in particular.
09/06/2021 The patient presents with COVID-19 symptoms x1 days. Pt states she tested positive for COVID-19 on 9/3 and c/o subjective fever, body aches, HA, cough, and chest tightness. Pt reports speaking to her PCP who advised her to come to the ED. Pt is vaccinated with J&J in March and denies any other symptoms or complaints.  The onset was 1  days ago.
Info has been received from a health professional concerning a 35 year old pt who on 5/23/00, 6/28/00 and 1/03/01 was vaccinated with a 1st (1960J), 2nd (0488K) and 3rd dose (0488K) respectively of Hep-B. On 3/1/01, the anti-hepatitis B surface antigen titer was negative. It was noted that the pt failed to respond to the 3 injection series. Additional info has been requested.
Unable to reach the patient. Phone was disconnected. Pt was contacted 4 days later by his PCP's medical assistant. Seemed like there were no adverse reactions.
Mild rash across midsection of body (lower breast to groin) and neck. A few additional spots each day for 5-6 days. Mildly raised, some starting to scale after a couple of days, but not going away. Mild itching for a few hours after appearing, but not otherwise bothersome. No medical attention or treatment sought yet; waiting to see if it resolves on its own. All 3 Moderna doses  caused same red, swollen, sore spot several inches in diameter that lasted 4-5 days (and itching, chest pressure, fatigue, headache, body aches for first 2 days), but no rash.
swelling at Injection site; redness at the injection site; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on unknown date. Please refer the case US2020AMR119387).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, headache and nausea. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the headache and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, headache and nausea to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient recently received 2nd dose of shingrix injection.  After vaccination the patient experienced large, size not specified redness and swelling at the injection site.  The swelling and redness had gotten better per patient, but had not completely resolved. She also reported that a few days after getting the injection.  The patient experienced nausea and headache, which had resolved.  The reporter did not consent to follow up.
102.6 fever by PM of 4/6/2021; chills, elevated heart rate (resting HR at 120-130), oxygen levels at 95-96%; redness, swelling and pain at injection site  Fever continued through 4/8/2021 reaching a high of 103.6; chills, elevated heart rate continued but lower to around 110, oxygen levels 96%; redness, swelling and pain at injection site  Redness, swelling and pain at injection site still continued through today, 4/13/2021; large border of bruise on upper arm from injection
feeling "blah"; headache/headache pain at bottom left side of head; a fever; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling "blah"), HEADACHE (headache/headache pain at bottom left side of head), PYREXIA (a fever) and MYALGIA (sore left arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 025B21A and 030A21A) for COVID-19 vaccination. The patient's past medical history included Colon cancer on 04-May-2021, Cancer surgery (Colon Cancer surgery.) on 08-Jun-2021 and Colonoscopy on 04-May-2021. Concurrent medical conditions included Arthritis.Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for Arthritis.On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced FEELING ABNORMAL (feeling "blah"), HEADACHE (headache/headache pain at bottom left side of head), PYREXIA (a fever) and MYALGIA (sore left arm). At the time of the report, FEELING ABNORMAL (feeling "blah"), HEADACHE (headache/headache pain at bottom left side of head), PYREXIA (a fever) and MYALGIA (sore left arm) outcome was unknown. Treatment medications were not provided.This case was linked to MOD-2021-392014 (Patient Link).
feeling symptoms, body numbed; it still burns me; sudden sweating; it's cold, it's not hot; This case was reported by a consumer via interactive digital media and described the occurrence of body numbness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced body numbness, burning sensation, sweating and feeling cold. On an unknown date, the outcome of the body numbness and burning sensation were not recovered/not resolved and the outcome of the sweating and feeling cold were unknown.   It was unknown if the reporter considered the body numbness, burning sensation, sweating and feeling cold to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-Jan-2023 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient wanted to ask that the patient took treatment but still feeling symptoms, they were not very strong but had a piece of body numbed and still had burns.  The patient also had sudden sweating and feeling cold, it was not hot.  The patient was asking what GSK recommend. Additional Supportive Information: The follow up would not possible as no contact details were available.
(The clinic online Epic/MyChart systems shows this as Influenza (FLUARIX) 4V 0.5mL PF 19+ yrs). I received the immunization on Monday 06NOV2017. I've been getting these every year in the fall for the past 5 years. When I got out of bed two days later, on Wednesday 08NOV2017 I had dizziness similar to a bout of vertigo I had in January 2012, and again in January 2013. This is a mild case of that, compared to the two previous instances. Coincidentally, I probably received the influenza vaccination in the days/weeks before those two episodes. In 2012 I was seen at a dizziness and balance center and evaluated. I had the test with the goggles to check for nystagmus (sp) and I did not have that. Rather, I likely had a vestibular virus that "reprogrammed" me. I recall that I was told that I didn't have crystals or "ear rocks". I did not require the canalith repositioning procedure. So I went through vestibular rehabilitation with a lot of walking and eye movements and successfully "learned" my changed inner ear. When I had an episode in January 2013 it was not as severe and I did the rehab myself, with good results in a few weeks. This current episode is the mildest I've ever had and I'm doing a DIY rehab. If it doesn't work I'll contact my doctor.
It has improved his skin. It has improved his immune system greatly.; itching; all of the skin on head has peeled/ The skin on his shoulders have peeled.; This is a spontaneous report from a contactable consumer or other non hcp received from Pfizer sponsored Program.   A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced all of the skin on head has peeled/ the skin on his shoulders have peeled, it has improved his skin. it has improved his immune system greatly and itching on an unspecified date. It was reported: Caller adds that he spoke with a woman at the bank and it happened to a friend of hers. Caller does not have any details to provide. The outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100924204 same reporter/drug/event, different patient
Morning after receiving vaccine, I was nauseous, injection site was very sore, had headache, back of neck hurt, occasional stomach pain and fatigue. Stayed in bed all day until 5:00 p.m. Following morning I feel fine but have a rash on chest and under breasts.
DIFFICULTY BREATHING(LOW OXYGEN); ELEVATED D-DIMER; INABILITY TO MOVE; LOW BODY TEMPERATURE; TINGLY FACE; RED FACE; FELT BAD AND AWFUL; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylaxis reaction, and concurrent conditions included fibromyalgia. The patient did not had previous history of allergy to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1605018,expiry: unknown) dose was not reported,1 total administered on 20-MAR-2021 to the right arm for prophylactic vaccination. No concomitant medications were reported.   On 20-MAR-2021, 20 minutes after vaccination, the patient's felt her face red and tingly and it went away. On 29-APR-2021, nine days after receiving the vaccine, the patient woke up not able to breathe or move and had a temperature of 94 degree F. The patient went to hospital and had low oxygen, an elevated d-dimer and had no evidence of blood clots in CT (computed tomography) scan. The patient was treated in ER (emergency room) with epinephrine, steroids, diphenhydramine (Benadryl) and a unspecified nebulizer and then she could breathe. The patient's physician tested her d-dimer for second time following the patient's visit to the hospital and it was elevated, but not as high. The patient had history of fibromyalgia and mysterious health condition but it was reported that she did not have anything like what she experienced after vaccination and she felt really bad and super awful. The patient was not feeling great, but better and can breathe again at the time of this report; her oxygen level also was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing(low oxygen) on 2021, and red face, was recovering from felt bad and awful, had not recovered from elevated d-dimer, and the outcome of tingly face, inability to move and low body temperature was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210446229- covid-19 vaccine ad26.cov2.s -Difficulty breathing(Oxygen). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Immediately upon receiving injection, blood pressure dropped to 60/40, broke out in hives and red spots, sweating profusely, fainting, ,choking, ad difficulty swallowing. An IV was placed in arm, medication inserted, ambulance took to emergency and oxygen placed on patient.  Stayed in  ER for about three hours.  Was administered steroids, Benadryl and pepcid.  Was sent home and was prescribed to continue taking Prednisone 20 mg, pepcid 20 mg and Benadryl every 6 hours for five days.  Broke out on day two for about thirty minutes and rash went away
Dizziness, fast heart rate, shortness of breath. Went to ER but symptoms subsized completely, so did not stay to see MD.
56 year old patient was given FLuzone HD instead of Fluarix which is appropriate for his age of 56
Heart palpitations; Headache; Dizziness; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 19Apr2021 at 15:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included gluten sensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for an unknown indication, since an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm left on 23Mar2021 at 16:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Apr2021, about an hour after vaccination, the patient experienced heart palpitations and lasted for about 4 hours intermittently. On 19Apr2021, on the same day of vaccination, the patient experienced severe headache and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event heart palpitations was resolved on 19Apr2021. The clinical outcome of the events headache and dizziness was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Probably 39 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Probably 39 days since first dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) 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) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Probably 39 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Probably 39 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.