chrisvoncsefalvay/vaers-outcomes huggingface dataset:
there was 1 dose of VARIVAX administered while it was out of recommended storage range; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 26-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 milliliter (ml), lot # S032356, expiration date 14-OCT-2021; strength, frequency and route of administration were not reported) for prophylaxis, while it was out of recommended storage range (product storage error). Current temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees for 1.5 hours and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 20.5 hours. There was no previous temperature excursion. Data logger was involved.
Severe pain, muscle soreness, difficulty with mobility, weakness due to pain. Difficulty with ADL's. Treated with prednisone (continues to present), initially hydroxychloroquine, then methotrexate added. As soon as prednisone dc'd in January 2022, symptoms flared. Now on Sulfasalazine 1500 mg bid and prednisone 2.5 mg daily. Seeing a Rheumatologist.
At approximately two and half hours after dose extreme headache every hour for 1min. Took Ibuprophen. Night sweats, no chill or fever. Following morning  headache continued. Took Ibuprophen. Very congested but that may have been from the allergy from the pollen. Sore arm with slight bump. Very fatigue after 5:30  pm. Woke up to another bout of night sweats, 3"x1-1/2" rash bump 1 inch below injection site.  Very tender left armpit extending to left outside breast.  Will continue to monitor site and will report to physician if symptom continue to worsen. Pictures were taken on my phone  for comparison.
10 hours afterwards had sudden extreme fatigue followed by hard chills and headache, body aches, feeling of nausea without diarrhea or vomiting, fever, profuse sweating , vertigo, loss of appetite, hard sleep for 20  consecutive hours only waking briefly to use bathroom. Was able to get out of bed after 38 hours. Took ibuprophen, After 42 hours I felt OK again.
Positive covid-19 test post 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive covid-19 test post 1st dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No historical conditions were reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive covid-19 test post 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive covid-19 test post 1st dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided.
Vaccine administered at 0939. At 0945 patient passed out in the observation area.  Nursing staff responded to the situation. Patient woke up within one minute. VS  upon regaining consciousness were as follows: BP-98/74, HR-74, O2 -98. Pt and his  parents verify that he has had fainting spells in the past when getting a vaccine  or seeing blood. Pt confirms this has happened at least 5 times in the past. Pt  moved to a more private observation area. Pt given water and sat under  observation for several minutes when he reported feeling unwell again and asked  to lay down.  Vital signs taken again at this time (0955) and were as follows BP  - 94/55, HR - 50, 02-98.
Fever-99-not measured at home, on 8/14/03. Myalgias.
The patient had 2 previous Shingrix doses, and we administered an additional, third dose .
Patient reported previous severe allergy to shellfish, redness itchiness, swelling around neck. About 15 minutes after vaccine patient developed noticeable redness and itching on shoulders, chest, neck area. Patient reported no previous reaction to vaccines, patient denied feeling any lightheadness or difficulty breathing. Patient asked if it was okay to take a diphenhydramine tablet to help with redness and itchiness. Patient took diphenhydramine at 1:45, remained in waiting area another 15 minutes (30 minutes total after vaccine). At 2:00 pm patient said she felt fine, redness hadn't spread, no breathing difficulty, patient went home.
swollen lymph nodes at left color bone area (Acute onset supraclavicular lymphadenopathy)
Information has been received from a physician concerning a male with coronary disease who "about two months ago (approx October 2007), was vaccinated with Zostavax. Concomitant therapy included a "Statin". The patient developed rhabdomolysis. Laboratory and diagnostics studies were not reported. It was reported that no medical attention was sought by the patient. A product quality complaint was not reported. Rhabdomyolysis was considered by the reporting physician to be life threatening. Additional information has been requested.
Information has been received concerning a 36 month old Native American/Alaskan female pt who was vaccinated with a 1st, 2nd and 3rd dose of Haemophilus b conjugate vaccine on 9/30/1994, 12/29/1994, and 8/31/1995, respectively. Subsequently, the pt developed pneumonia and unspecified blood work showed Haemophilus type b due to vaccine failure (consider to be other medical events).  Other business partner numbers include MA2000-0450.  This is a corrected report.  Suspicion of vaccine failure has been added as an adverse event.  Follow up information states: "Additional information has been received from a published abstract titled "Haemophilus influenzae invasive disease among children aged <5 years--epidemiology in the United States.  1994-1999" from the 34th National Immunization Conference on Vaccine Preventable Diseases (WAES # 00102472); abstract is attached."
0910 - Pt. reports smelling something "funny," numbness around mouth, mild pain in RLQ abdomen. Pt. received Pfizer vaccine at 0907 in rt. deltoid muscle IM. Pt. O2sat 99%, heart rate 112, BP 128/88. Pt. remains in vaccination room with nurse at this time. Pt. denies SOA, chest pain, any swelling in face/mouth/throat. Pt. denies desire for eval. in ED at this time. 0915 - O2sat 98%, heart rate now down to 78, pt. reports "feeling better," but admits feelings of anxiousness and history of anxiety and panic attacks. Pt. reports he feels that is what happened (panic attack.) Pts. wife at side. Discussed adverse reactions. Benadryl 25 mg PO discussed and admin. at this time.  0918 - Pt. ambulatory to waiting room with wife, stable condition. Instructed pt. to wait until 0930 before leaving the clinic. Wife will drive pt. home. Reviewed if additional S&S or worsening symptoms including SOA, chest pain, swelling of throat/mouth, call 911 or go to nearest ED. Understanding verb. 0930 - Pt. denies SOA, chest pain, swelling in mouth/throat, no abd. pain. Pt. reports he is starting to feel tired. Reviewed precautions and S&S to report to ED. Pt. and wife verb. understanding. Pt. ambulatory out of clinic in stable condition accompanied by Wife.
I have new onset painful, burning and itching toes after going for a 30 min walk. Small blisters on toes as well.
Full Body Rash/Itching  Dermatologist prescribed Triamcinolone .1% Cream which I used for 10 days.
Fever of 103.0 F, body aches, general malaise, irritation and burning in eyes, excessive pain in left arm (vaccine site), slight redness at site of Zoster vaccine.
Strep pneumonia bacteremia. 60 day follow-up dated 9/28/00 provided no additional data.
Took flu shot at 11:30 AM Nov. 1, 2012. Taken to Emergency Room at 4:30 p.m. Nov 1, 2012. Could not breath. Chills.
Became lethargic a few hrs post vaccine, but felt better after ibuprofen.  Woke up at 2:00 AM feeling nauseous, with a fever of 105 degrees.  Able to keep fever at 102 with ibuprofen, but would shoot up to 104-105 when meds wore off - high fever, moderate lethargy, anorexia and muscle aches continued for about 24 hrs. Next day, fever had decreased to 101ish all day, felt quite a bit better, developed a productive cough.  Next day, no fever, felt good but tired more easily, coughing.  Back to school the next day - has had a mild productive, then dry cough for a week so far.
The patient had an unknown HPV vaccination history/ patient did not remember which HPV vaccine she was administered; Indication: positive hpv 16/ The patient had two pap smears in 2019 which were positive for HPV 16 and 18/ the patient had a pap  smear a week ago which came back positive for HPV 16; The patient had a bunch of abnormal pap smears, positive for HPV, most were benign, since 2007 and reported the patient, kind of cleared the HPV infection; This spontaneous report was received from a medical assistant, concerning a 36-year-old female patient. The patient's concomitant medication included ethinyl estradiol (+) ferrous fumarate (+) norethindrone acetate (TILIA FE). The patient's drug reactions or allergies included nuts. The patient did not have any pertinent medical history.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) ( for positive human papilloma virus (HPV) 16 (strength, formulation, dose schedule, anatomical sites of injection, route of administration, lot number and expiration date were not reported). Furthermore, the patient reported that, she did not remember which HPV vaccination she had or how many doses she was administrated (product origin unknown).  On an unknown date in 2007, the patient experienced a bunch of abnormal pap smears, positive for HPV (papilloma viral infection). On an unknown date in 2019, the patient had two pap smears which were positive for HPV 16 and 18 (drug ineffective for unapproved indication). On approximately 19-MAY-2020, the patient had a pap smear which came back positive for HPV 16. According to the medical assistant, medical assistant reported the patient did not seek for medical attention and had not received any treatment;  however it was reported that, she may need a colonoscopy.  The outcome of papilloma viral infection was reported as not recovered. Despite this, it was reported that, the patient kind of cleared the HPV infection. The outcome of drug ineffective for unapproved indication was reported as not resolved.   The causality assessment between the suspect vaccines and all the aforementioned events was not reported.
Pt vaccinated with DTP/OPV began to vomit soon after immunization developed hyponatremia & seizure admitted to hospital for correction of hyponatremia for 24 hrs.
both of his arm are red; shaky; Warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (both of his arm are red), NERVOUSNESS (shaky) and VACCINATION SITE WARMTH (Warm) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 05-Mar-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (both of his arm are red), NERVOUSNESS (shaky) and VACCINATION SITE WARMTH (Warm). At the time of the report, ERYTHEMA (both of his arm are red), NERVOUSNESS (shaky) and VACCINATION SITE WARMTH (Warm) outcome was unknown.       No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Action taken with mRNA-1273 in response to the events was not reported.
The patient began experiencing dizziness and lightheadedness while shopping after getting her covid vaccine.  She felt fine immediately after the shot and during her 15 minute observation time.  While shopping after she began feeling dizzy and was given water, a cool towel, and sat down.  When I arrived she was breathing heavily and had trouble speaking.  Her color was good.  Her initial blood pressure was 139/80, pulse 89.  After 15 minutes of rest her blood pressure was 126/109, pulse 90.  She reported she hadn't eaten lunch so we offered her food or juice.  She chose to eat some nuts and dried cherries she purchased and reported that she felt better.  The EMS arrived, gave her a workup,  and she eventually left on her own.
This literature marketed report has been received from authors of the published article, referring to a 21 month old male patient with aluminum allergy. He received standard 2 - and 4-month immunizations without any reactions. At 6 months of age, he received a PENTACEL and ENGERIX injection in the left leg. Several days later, a golf ball-sized, firm lesion appeared in the left thigh. The lesion became fluctuant and was subsequently incised, producing a culture which was sterile with a negative Gram stain. Seven days later, a small lesion reappeared in the same area that eventually self-drained purulent fluid. His next series of immunizations were administered at 1 year of age, on 19-OCT-2015, including the first dose of VAQTA (dose, lot# and expiration date unknown) in the right thigh for prophylaxis. Concomitant therapies included FLUZONE and M-M-R II. Following the immunizations he developed a similar lesion on his right thigh at the site of a VAQTA immunization. An incision and drainage procedure was performed, from which purulence was obtained but a culture was sterile and a Gram stain was negative. A third golf ball-sized lesion developed on the right thigh after receiving his next PENTACEL immunization 5 months later (on 01-APR-2016), and a fourth abscess appeared on 16-MAY-2017 in the left leg after another dose of VAQTA (also reported as "13 months later following a ENGERIX immunization"). He remained afebrile during all episodes, with no erythema or significant discomfort. He did not receive any antimicrobial therapy for the lesions. The outcome of the events was reported as recovered. The reporter considered the events to be related to aluminum-adjuvant based vaccine VAQTA.
Lethargy & tiredness, post-nasal drip and sinus congestion, felt generally listless.
Systemic: Body Aches Generalized-Severe, Systemic: difficulty walking-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Weakness-Severe, Additional Details: being seen by pcp/emergency md
1)Shingles developed on right side lower body 10 days after 2nd dose covid vaccine.  First symptom was discomfort & mild pain.  A week letter a rash emerged so I went to Dr & was diagnosed. It?s been 4 weeks & still recovering.   2) A second effect I?m beginning to notice is that my RA which has been under control for several years now through anti-inflammatory diet, is starting to act up.  Pain in fingers - primarily pinky fingers  with swelling at joints. Both hands. First time experiencing any symptoms on right hand.  And I have never had the characteristic bumps at the joints until now. I haven?t yet mentioned this symptom to my dr. It I was overshadowed by the extreme pain from shingles.
I had tremors on my arms would shake, my back you know I had weird shaking; I had tremors on my arms would shake, my back you know I had weird shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "I had covid, 17Dec", start date: 17Dec2020 (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (Dose number 1, lot number EN6201), administration date: 23Feb2021, for COVID-19 immunization, reaction(s): "lost control of my bladder".  The following information was reported: TREMOR (non-serious), TREMOR (non-serious) all with onset Mar2021, outcome "recovered" and all described as "I had tremors on my arms would shake, my back you know I had weird shaking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, tremor.  Additional information: When probed for concern the consumer stated, "I had covid, 17Dec, my system started and then about 90 days later I had the Pfizer and then had Pfizer again and its been a while since it is been over two weeks what I had covid. I had lost control of my bladder not completely but enough so that I had to change my pajamas bottoms quite often. When I had first Pfizer shot about day and half I had the same problem. The second Pfizer shot that I had, I took Tylenol before and Tylenol after and then two Tylenol before bedtime. I did have tremors with the second Pfizer shot and I thought I still tell you that because my doctor often said that incontinence is not symptom of covid but it might was. So I tell you that. No it was just after the shot. I had covid symptoms started in December 17th and lasted for about 2 or 3 weeks I guess. I have experience of covid. I am 77 years old. My experience of covid is incontinence not all the time but particularly night and when I have first Pfizer shot about 3 months later after the day and half the covid symptoms came back including the incontinence and then for second shot I had tremors on my arms would shake, my back you know I had weird shaking. I'm all right now, there is no problem right now."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortly after receiving injection, my arm was very achey.  Took 600mg ibuprofen that evening, woke up the next morning with same pain.  Weeks later, it still hurts.  Can't raise my arm, twist to put on jacket, sleep on arm, lift any weight.  Disrupts my sleep several times a night.  Experience lots of pain while driving.  Can't hold my kids with that arm. I know, wa wa wa, I am a baby, but it really hurts!
passed out 4 hours after i received shot and did not remember even thinking about going to sleep. I woke up and was sweating, cold, headache, body aches, dizzy, feeling ok, then feeling terrible going thru the cycle again and again.  The above scenario has been going on since around 12pm the last day I received the shot.
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 61-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 medication was provided.  It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at this time. It was reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
Case PHEH2016US023443 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 57 year old patient of unknown gender. Past medical history and concomitant medications were not reported. the patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
No fever but chills; Hot flashes; Severe body aches; Sore throat; Heavy lungs; Headache; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 14Apr2021 at 17:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 17:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient also took previously paracetamol (TYLENOL) on an unknown date and experienced drug allergy. On 15Apr2021, the patient experienced no fever but chills, hot flashes, severe body aches, sore throat, heavy lungs, headache and extreme fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, hot flashes, severe body aches, sore throat, heavy lungs, headache and extreme fatigue were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Urticaria related to heat and exercise appeared a few days after bivalent booster shot.
(3) syncopal episodes following vaccination, one of which resulted in a fall with direct injury to the base of neck, head, and right flank. Pt reported chest pain prior to syncope.
Headache, Myalgia, Arthralgia, 3 days Narrative:  Other Relevant History: