chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SLEPT UNTIL 8:30 IN MORNING, USUALLY UP BY 6AM; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age and unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: walking pneumonia in OCT-2019. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 02-MAY-2021 for prophylactic vaccination on left arm. The concomitant medications included multivitamin injection, vitamin C, vitamin D3, and zinc to help with immune. On 05-AUG-2021, Laboratory data included: COVID-19 virus test (swab test) (NR: not provided) Positive for covid-19. On 05-AUG-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. On 09-AUG-2021, the patient experienced slept until 8:30 in morning, usually up by 6am. On Wednesday, 04-AUG-2021, the patient was up at corporate for a meeting. The patient was tested for COVID-19 on Thursday, 05-AUG-2021 and the patient was asymptomatic at that time. The test results came back positive on 06-AUG-2021. The patient's colleague who were present for the meeting the previous week were also tested covid-19 positive. The patient thought buffet-style lunch was not the best thing that they did at Headquarters. The patient stated that he was asymptomatic, but his wife wasn't feeling well, from the grandkids who were sick. The patient's wife underwent swab test for covid-19 on 07-AUG-2021 and was tested negative on 08-AUG-2021. The patient further stated that he had symptoms starting night of 08-AUG-2021, symptoms of fevers. Exact temperature was not known. On the day of reporting the patient slept until 8:30 in morning which was unusual since the patient would usually be up by 6:00. A while ago, the patient's brother was tested covid-19 positive. On 08-AUG-2021, the patient had doctor appointment who suggested the patient to monitor the oxygen level and report to him if it dropped below 93%. The patient was waiting for his oxymeter and manometer and was quarantined alone at home. The patient was advised to stay at home for 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and slept until 8:30 in morning, usually up by 6am was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189148.; Sender's Comments: V0: 20210817957-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient was given the Flublok that is for 18 and older rather than the fluzone for pediatrics. No adverse reactions ARNP notified
Patient was dizzy and fell down hitting his head while leaving the vaccine room  to the waiting area. He looked nauseas, but was breathing .
On 3/8/21, I had the vaccine. During that week I had sore muscles in my neck, upper arm shoulder and back I also had weakness in my legs. The pain is constant and is always somewhere in my body. In late March, I contacted my PCP, and asked if I should get the second shot. On 5/5/21, I had a doctor's visit where physical therapy was ordered for the pain. It was primarily for my shoulders and neck. On 7/7, I went to another doctor, and he discontinued alendronate thinking the soreness was a side effect from that. For 4 months I was off but no difference. 8/21, I went back to the doctor. I was told to double up on over-the-counter medication but that did not help. On 8/26, an MRI was ordered. The MRI showed mild arthritis in my neck. I was then referred to physicians rheumatology. On 10/4, I went for my first visit to another primary care doctor. Several lab tests were ordered. The results did not show abnormal inflammation. Today, I saw an NP who is treating the soreness and pain as polymyalgia. She has prescribed a high dose prednisone which I will taper off. I am severely restricted with what I can do. It interferes with my walking, standing, sleeping. The pain is currently at a 7.
Patient was administered a dose of Janssen on 9/22/2021 that had expired on 9/21/2021.
Patient was seen for his 7 year old physical. He had a history of obstructive sleep apnea, but was getting better. Flumist was given at that time 11/4/08. Since 11/4/08- patient had onset of prolonged congestion, restart of snoring and reemergence of sleep apnea.
MODERNA COVID-19 VACCINE EUA  Patient reports approximately 24 hours after receiving vaccine , he came in from a doctor's appointment and remembers opening the door and then woke up in the floor and there was blood on the floor. Patient had no other adverse reactions other than soreness in his arm. No follow-up treatment required per patient.
I have had a cough that has gotten deeper that has a lot of phlegm that causes nasal irritation and throat irritation my doctor thinks I have a sinus infection and prescribed prednisone and an amoxiclav.
I developed a severe reaction to the booster, fever, chills, body aches, headache, nausea lasting 48 hours.
Patient received her 1st Shingrix vaccine on 10/07/2023. She began to experience spots on/in her mouth and chin the morning of 10/10/2023. The bumps are red with white in the middle. The patient was concerned of the appearance of these spots. She was not sure if it was the vaccine causing her to experience this reaction or not. The patient was advised to seek additional medical attention to determine the cause of her skin reaction.
Patient was inadvertently given a fourth booster. Patient resident a booster prior on 12/14/21. No adverse reaction. Logging due to fourth dose error.
arm was tender day after vaccination. no other symptoms till lastnite vaccination site was a little itchy woke up this morning (1/18/2021) swollen the size of a mango hot to the touch and tender again. contacted doctor and pharmacist both recommended benadryl and ibuprofen and to monitor 24/36 hours
Initial report was received on 08 December 2008 from a consumer (patient's mother). A 4-month-old male with a history of being 33 weeks premature at birth and a milk protein intolerance had received a first dose of PENTACEL (lot number C3199AA) intramuscularly in the right thigh, an initial dose of ROTATEQ (manufacturer Merck, lot number 1886U) orally and an initial dose of PREVNAR (manufacturer Wyeth, lot number C68312) intramuscularly in the left thigh on 07 October 2008. The patient's mother reported that on 07 October 2008 the patient slept for 48 hours post vaccination. Then the patient was wide awake for five to six days with periods of up to 12 hours awake at a time. The patient had a doctor's visit (date not reported). The patient's recovery status was unknown at the time of the report. Documents held by sender: None.
Within 5 minutes of shot tingling noted in left arm down to fingers, spreading across shoulders to right arm and hand as well as tip of tongue, lasting for about 16 hours. Within 5 hours nausea, diarrhea were moderate. Fever noted as well after about 5 hours with mild generalized soreness increasing steadily, highest temp before medication intervention was 102.8, with severe bone pain throughout whole body. Fever has not been below 100.0 since it started despite consistent medication, light clothing. Bone pain is moderate with medication and severe without. Headache is noted to be mild with medication and moderate without. Swelling at site of injection is about 2 inches currently with maximum swelling noted to be 3 inches (with other swelling noted in the arm around the knot) causing skin tightness and moderate itching, swelling noted in armpit lymph nodes, which are also painful.
This spontaneous report was received from the medical assistant refers to a 4 years old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included sterile diluent (MRK) used to reconstitute the PROQUAD was properly stored. On 04-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A 12-years-old patient of an unspecified ethnicity and gender received the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced malaise and fever on an unspecified date with outcome of unknown. Events took place after use of product. No follow-up attempts are possible. No further information is expected.
One day following vaccination arm became swollen and red. Patient called pharmacy on 9/22 and was advised to take BENADRYL. Patient indicated on follow-up phone call that all symptoms were resolved.
Site: Pain at Injection Site-Medium, Additional Details: Patient reported pain on left arm that radiates to neck when she coughs. Arm hurts throughout the day. pain continued after 3 days from injection. adviced patient to see pcp.
approx 15min p/vax pt suddenly became limp, fell asleep & difficult to arouse;pt would respond to vigorous stimulation but then go back to deep stupor;
4 inch long redness area that spread about 4 inches horizontally also.  patient was also very tired and arm hurt.
Positive COVID-19 test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID-19 test) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID-19 test). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID-19 test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19. On an unknown date, SARS-CoV-2 test: positive (Positive) POSITIVE and negative (Negative) NEGATIVE.     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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Updated the lab test COVID-19 , tested positive on Jan 15, two weeks later he tested positive again and a few days after that he tested negative
Information has been received from a 79 year old female consumer with a history of lymphoma and no known allergies who "about five months ago" in approximately October 2007, was vaccinated with a 0.65mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included COUMADIN, BENICAR, SYNTHROID, TAMBOCOR, PROTONIX and vitamins (unspecified). Subsequently, "several months ago" the patient experienced a burning, itchy rash on her breasts and stomach. Unspecified medical attention was sought. There was no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician concerning a 79 year old female consumer with a history of lymphoma and no known allergies who "about five months ago" in approximately October 2007, was vaccinated with a 0.65ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included COUMADIN, BENICAR, SYNTHROID, TAMBOCOR, PROTONIX and vitamins (unspecified). Following some period of time (several months ago) the patient developed a burning, itchy rash on her breasts and stomach. Medical attention was sought. The event persisted and even biopsy was non-diagnostic. The patient was unclear of the time it took after the ZOSTAVAX for the rash to appear. The relationship of the rash to the ZOSTAVAX remained undeterminate. There was no product quality complaint involved. Additional information has been requested.
Pt received vaccine, and waited required 15 minutes without incident. While proceeding to registration for 2nd dose appointment, pt exhibited signs/symptoms of seizure activity. Pt became non-responsive and slumped in wheelchair while twitching in extremities, cycling between rigidity and limpness. Mother reported seizure activity (common) controlled by medication taken that AM. O2RA: 94, Pulse: 84, BP: 184/100. RN and Nurse Manager maintained airway (neck position) while awaiting EMS. EMS arrived in 15 minutes, administered IM anticonvulsant, transport to ER with family present.
I received a deep pain in my inner thighs and on my lower left side of my stomach; I received a deep pain in my inner thighs and on my lower left side of my stomach; It was a burning and stinging sensation all the night of the vaccine; It was a burning and stinging sensation all the night of the vaccine; The next day I had large lumps underneath my skin which lasted for about 1 month; The lumps then turned to bruises that are still visible; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 12:45 (Lot number: FJ1614) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Chronic Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: PAIN IN EXTREMITY (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 14Jan2022 16:00, outcome "recovered with sequelae" and all described as "I received a deep pain in my inner thighs and on my lower left side of my stomach"; BURNING SENSATION (non-serious), PAIN (non-serious) all with onset 14Jan2022 16:00, outcome "recovered with sequelae" and all described as "It was a burning and stinging sensation all the night of the vaccine"; SKIN MASS (non-serious) with onset 14Jan2022 16:00, outcome "recovered with sequelae", described as "The next day I had large lumps underneath my skin which lasted for about 1 month"; CONTUSION (non-serious) with onset 14Jan2022 16:00, outcome "recovered with sequelae", described as "The lumps then turned to bruises that are still visible". The events "i received a deep pain in my inner thighs and on my lower left side of my stomach", "i received a deep pain in my inner thighs and on my lower left side of my stomach", "it was a burning and stinging sensation all the night of the vaccine", "it was a burning and stinging sensation all the night of the vaccine", "the next day i had large lumps underneath my skin which lasted for about 1 month" and "the lumps then turned to bruises that are still visible" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, abdominal pain upper, burning sensation, pain, skin mass, contusion.  Additional information: Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient received ultrasounds treatment for the AE, Patient did not had Covid prior vaccination. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Pt said on the evening he received vaccine his fingers on left hand were stiff, had difficulty playing his guitar 3 or 4 days later pain was marked-a deep aching pain from left shoulder to left little and ring fingers which persist to, pt has history GERD so taking Ibuprofen with Prilosec was recommended.  He is taking Aleve with Prilosec and Ibuprofen 200 mcg every 8 hours to cover.  Pain is moderately alleviated but not resolved.
husband developed Parkinson's after his shingles shot; This case was reported by a consumer via media and described the occurrence of parkinson's disease in a male 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 parkinson's disease (serious criteria GSK medically significant). On an unknown date, the outcome of the parkinson's disease was unknown.   It was unknown if the reporter considered the parkinson's disease to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The reporter said that do not take the vaccine as her husband developed Parkinson's after his shingles shot. No contact details were available.
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 68-year-old female 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 medications were reported. No treatment medications were reported.  The reporter stated that their facility was not able to download the digital data logger, they had been put on hold at the moment. They would need to treat this issue as a temperature excursion. There had been no power outages that would have impacted the Moderna vaccine. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
pt recv vax OCT96 & exp high fever & flu sx;11FEB97 MD confirmed on 5DEC96 pt exp cough, aches, & chills;
Indurated, red area noticed on injection site on day 9 which became larger & extremely itchy.  Took 8 days to slowly resolve
Patient with bilateral Meniere's disease noted significant hearing fluctuation AU, dizziness and vertigo after first dose of vaccine which resolved spontaneously. No symptoms after second dose.
The patient was given her second dose of Pfizer COVID vaccine 2 weeks after her first dose.
Patient received the Flu shot and the next day had a small rash on her abdomen. The rash grew to cover her entire torso and chest. She has seen several physicians and is being treated for pityriasis rosea. Treated with steroids and other topical medication.
I don't know exactly when they started. but I woke up at 1:30 AM on April 8, 2021 with chills, uncontrollable shaking, diarrhea, nausea, muscle fatigue, but no fever
Fever, swelling 8 inches at (L) deltoid, red "patchy" areas at left arm. Nausea, chills, body achiness and weakness. Limited mobility of (L) arm. Slight chest tightness. Denies difficulty swallowing or breathing.
The day after my mom shot she woke up from a nap and had long term and short term memory loss.  She couldn't remember what happened the week before including the fact her daughter was pregnant.  She could remember what happened minutes before and my father had to call the paramedics to get her to go the hospital.   Blood pressure was elevated so a stroke was what they thought.  As of today none of the stroke tests show any signs of stroke
I have had severe pelvic pain that started around 2-3 weeks after the 2nd dose of the Covid Vaccine, Moderna.  It feels like cysts are rupturing around once a week.  Previously, before the vaccine, I had 1 to 2 cysts rupture per year.  Now after the vaccine, I've had around 1 rupture per week.  I have discussed this with both my family physician (08/02/2021) and my OBGYN (11/01/2021).  I'm not sure that this because of my age or not, but seems to coincide with the 2nd dosage of the vaccine.  I've now had bloodwork done that shows that I am not premenopauseal as of yet, so I wanted to record this severe issue and would like to know more information on this before allowing my daugther to be vaccinated.  This severe pain is causing issues for a day or two each week and is interrupting my work schedule and quality of life.  I will continue to visit the doctor or hospital unitl this is resolved.  I was told to go back to my OBGYN again when a cyst ruptures.  At this point, they are rupturing weekly and outside of office hours.  I will have an ultrasound completed once a rupture happens during the workday.  I would really appreciate any support or information on if this is vaccine related.  I am holding off on having my duaghter vaccinated until we have a better understanding of the vaccine and more data surrounding pelvic pain and female issues.
Patient's monovalent COVID 19 vaccine was not diluted correctly. I spoke with patient's mother to inform her of this. I educated her regarding possible side effects of the vaccine and the possibility of restarting the series. Mother reported that patient was acting normally and was not experiencing any side effects. Mother felt reassured and stated she will keep her appointment in December for COVID dose.