chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose given SQ instead of IM; erythematous reaction from elbow to shoulder; hot; painful; This case was reported by a physician via sales rep and described the occurrence of localized erythema in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, less than a day after receiving Shingrix, the patient experienced localized erythema, skin warm, pain localized and intramuscular formulation administered by other route. The patient was treated with meloxicam. On an unknown date, the outcome of the localized erythema, skin warm and pain localized were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the localized erythema, skin warm and pain localized to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: The patient received 2nd dose of Shingrix via subcutaneous (SC) instead of intramuscular (IM) by pharmacy tech.  An erythematous reaction developed within hours from elbow to shoulder that was hot and painful, it worsened over 5 days and took 3 weeks to resolve.  Oral meloxicam was used to alleviate symptoms.  No hospitalization was required.  No loss of work.  Additional Supportive Information: The patient received Shingrix via subcutaneous instead of intramuscularly, which led to intramuscular formulation administered by other route.
This case was reported by a pharmacist via call center representative and described the occurrence of dry mouth in a adult female patient who received FLUARIX QUADRIVALENT (batch number 4ZY53, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced dry mouth. The patient was treated with BENADRYL. On an unknown date, the outcome of the dry mouth was recovered/resolved. It was unknown if the reporter considered the dry mouth to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported via chat. The age at vaccination was not reported. The patient experienced dry or cotton mouth that was resolved after a dose of BENADRYL. The reporter also said that the employee health nurse at her facility felt that they were having more reactions to the vaccine than normal. The reporter did not have patient's date of birth. No further details available about the statement more reactions to the vaccine than normal. This case was linked with the case US2018GSK175707, reported by the same reporter.
Two days after receiving my vaccine I woke up with generalized joint pain.  I always have morning stiffness from my OA but this was pain.  I also found that I had fatigue and ongoing shaking chills without fever.  This continued throughout the week; I had little appetite but continued my regimen of medication except the gabapentin as I was so weak I didn't feel I should take that.  I also stopped taking my Tramadol ER that I had started one month before my vaccine for the same reason.  That Saturday, March 6, I went to the emergency room seeking treatment for these ongoing symptoms.  They did preliminary screening test including a Covid test which was neg.  The only positive was a + urine c/s which was treated with an antibiotic.   I have continued with low energy levels to this day with some improvement with Physical Therapy.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: EP7534), on 20Apr2021 as dose 2, single (Lot number: ER8733), in right arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient received Paxlovid from 01Jul2022 to 06Jul2022 as treatment of COVID-19.
CHIEF COMPLAINT:   Pt c/o SOB, cough, fever, N&V x 5 days. Pt received covid booster 2 wks ago.  On arrival EMS  states spo2 85% RA,  on15L Non rebreather to 96% spo2.   HISTORY OF PRESENT ILLNESS:     52-year-old male with a history of type 2 diabetes, obesity presenting for the evaluation of shortness of breath.  Patient reports 5 days of progressively worsening shortness of breath.  He reports a dry cough.  He reports fever.  Denies chest pain or palpitations.  Denies cardiac history.  No known COVID-19 exposures.  Additionally reporting several episodes of watery diarrhea over the past 2 days.  He is fully vaccinated and boosted against COVID-19.  No leg swelling.
Redness, swelling 8 cm diameter (R) arm deltoid treatment with KEFLEX.
Information had been received on 01-MAY-2017 from a nurse who reported that an unspecified patient was given GARDASIL (dosage, lot#/expiration not reported) on an unspecified day in June 2013 when the patient was seven years old. Nurse reported that GARDASIL 9 (lot# M013636, expiration 15-FEB-2018) was administered to the patient today, 01-MAY-2017. No adverse effects reported. No further information provided. Additional information has been requested.
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SB21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 01-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported.  No treatment information provided.   This case was linked to MOD-2021-101584 (Patient Link).
feeling dizzy; wasn't steady on his feet; slight headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy), GAIT DISTURBANCE (wasn't steady on his feet), HEADACHE (slight headache) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Defibrillator/pacemaker insertion and Heart disease, unspecified (He is a heart disease patient , has a pace maker and defibrillator.).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (feeling dizzy), GAIT DISTURBANCE (wasn't steady on his feet), HEADACHE (slight headache) and PYREXIA (fever). At the time of the report, DIZZINESS (feeling dizzy), GAIT DISTURBANCE (wasn't steady on his feet), HEADACHE (slight headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not provided. Treatment information was not provided.
FAINTED FOR LESS THAN 30 SECONDS , FALLEN ON THE FLOOR , SCRATCH ON RIGHT SIDE OF THE HEAD , SMALL AMOUNT OF BLEEDING, PATIENT REFUSED TO CLEAN AND REFUSED TO CALL 911 FOR MEDICAL TREATMENT.
PATIENT REPORTED HAVING AN LOCALIZED ACUTE ITCHING AND BURNING AT THE INJECTION SITE. UPON INSPECTION THERE WAS A LARGE CIRCULAR ERYTHEMA OF ONE INCH BY 2 INCHES AREA. PATIENT ALSO REPORTED THAT BENADRYL HELPED WITH ITCHING, AND WHEN SEEN ON 10/12/2010 THE PAIN HAS ALREADY SUBSIDED.
Light headed  within a few hours Soreness at injection sight left arm Pain and tenseness - sinuses and around eyes  - increased in the evening and through the night  lessoned in the morning Pain and tenseness - lower back and hip joint..   increased in the evening and through the night  hot pad - lessoned in the morning Fever 100.1 in the morning. Blood gloucose high 145 Blood Presure - not tested.
-itchy all over  - started on soles of feet but is now all over - hands, tummy, back. Degree of itchiness is bothersome, yet not intolerable.  -tingling of lips and tongue - no swelling of lips or tongue noticed -flushing at chest, neck, and face (flushed in color and skin is warm to the touch)  Planning to take some benadryl soon to attempt to curb itching. Had taken Tylenol at 6pm and then again at 10pm (4/8). 4/9 took daily prevacid and atorvastatin as usual in the morning.
The following day very early I wake up with lots of fever 102 and 103 I felt terrible lots of aching in my whole body, headache, redness on my arm and pain. The fever last 24h but the pain on my arm more than a week it was terrible believe me I am thinking on the second doses, also swelling on my arm.
Initial and follow up information has been received from a physician concerning a teenage female who in approximately November 2007 was vaccinated with her first dose of Gardasil via injection and fainted after receiving the dose.  The physician reported that this was probably due to a fear of needles as the patient had no problems with doses two and three.  No further information was provided regarding the adverse experience.  The patient recovered from her experience on an unspecified date.  No additional information is expected.
2 hrs post vaccine vomited forcefully, then developed rash that started on forehead and spread to abdomen, back, arms.
headache; swollen lymph nodes; back pain; This is a spontaneous report from a contactable pharmacist (patient).  A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced delayed reactions of headache, and back pain and swollen lymph nodes started on 07Jan2021 and continue to this day (4 days as well) on 07Jan2021 with outcome of not recovered. Lot/batch number has been requested.
No additional AEs were reported; 33 patients received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 25-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose, (lot # U026217 verified as valid with expiration date 02-NOV-2023) (exact dose number, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The temperature to which the vaccine was exposed was 34.3 Fahrenheit degrees for 55 minutes. There were no previous temperature excursions. It was unknown if a digital data logger was involved. No additional adverse events were reported (no adverse event).  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA001621: US-009507513-2204USA001657: US-009507513-2204USA001730: US-009507513-2204USA001821: US-009507513-2204USA001839: US-009507513-2204USA001926: US-009507513-2204USA001952: US-009507513-2204USA001980: US-009507513-2204USA001994: US-009507513-2204USA001998: US-009507513-2204USA002003: US-009507513-2204USA002007: US-009507513-2204USA002009: US-009507513-2204USA002052: US-009507513-2204USA002055: US-009507513-2204USA002072: US-009507513-2204USA002073: US-009507513-2204USA002074: US-009507513-2204USA002075:
Loose Stool every morning for 3 Weeks, I eventually tried the diet 2 days ago and symptoms appear to be subsiding. Loud stomach growling, which never happens to me. I have had confirmation that others are experiencing similar issues with Moderna
24 hours after injection pain started in arm, within 48 hours pain radiated down the arm, into the neck, chills, and still present a week later. Pain getting worse.
This 41 year old female reported receipt of her primary DRYVAX on 25 June 2003. Three AVA vaccinations were administered on 06 Sept 2003, 22 Sept 2003, and 11 Oct 2003 with no remembered adverse events to either vaccine. During a routine physical 14 Nov 2003 (1 month post 3rd AVA vac), a CBC identified "mild microcytic anemia" (WBC 5.2 (nl), High 12; HCT 37 MCV 85; neut 47%; lymph 47%) otherwise normal). She admitted to being tired and a family history of hypothyroidism otherwise no complaints documented or remembered. Providers suggested diagnosis of "high probability thalassemia". On 20 June 2004 ( months post vaccination) she complain of 2 day hx of itchy scalp with tender scalp and hair loss (hx of similar hair loss at age 9-10), headaches (hx tension ha), increased fatigue, and cervical-aural lymphadenopathy. She was diagnosed with superficial cellulitis and given KEFLEX. F/u eval 6/28/04 dx tinea capitis (positive woods lamp) and given griseofulvin and selenium sulfide shampoo. By 7/3/04 her symptoms had not changed and she now reported fever of 102 F with night sweats. She was treated with ROCEPHIN 1 gm IM X 3 days. By 7/9/04 the lymphadenopathy was resolving; however she exhibited a new vesicular papular itchy rash to bilateral arms, face and oral thrush with a sore throat-diagnosed with possible allergic reaction to griseofulvin. Meds were stopped and she was treated with 7 day taper of Prednisone and given DIFLUCAN with resolution of symptoms except alopecia. While hair regrowth did occur, new sites would develop, dermatology referral:  2 punch biopsies showed "inflammatory scarring alopecia with features consistent with lupus erythematosus. Negative GMS fungal stain". She was diagnosed with discoid lupus 18 August 2004 and referred to internal medicine doe SLE. October 2004 (12 months post AVA#3 vac) repetitive monthly flare ups of alopecia, fevers, arthralgia was associated with onset of menstrual cycles. She was admitted by rheumatology October 6-12, 2004 with neutropenic fever (ANC 325 and c/o 2 week hx fevers>102F, chills, HA, fatigue, sore throat, mouth ulcers, arthralgia, chronic LBP). Symptoms resolved with supportive therapy. Features were noted to be suggestive of SLE or DLE converting to SLE with negative ANA, cytopenia, fever, adenopathy, arthralgia, and fatigue (see below labs). Rheumatology diagnosed ANA-negative SLE based on DLE lesions and organ symptomatology (cytopenia from 2004 to present day, she continues to be followed by rheumatology, PCP, dermatology, GYN, et at for re-flare of symptoms.  Follow-up - Patient's last name updated.
Fever, body aches, tingling along spine, redness, swelling and pain at injection site.
tiredness/felt tired; headache; achiness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness/felt tired), HEADACHE (headache) and MYALGIA (achiness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 017E21A) for COVID-19 vaccination.     The patient had no history of Myocarditis/pericarditis and COVID-19 infection.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced FATIGUE (tiredness/felt tired), HEADACHE (headache) and MYALGIA (achiness). At the time of the report, FATIGUE (tiredness/felt tired), HEADACHE (headache) and MYALGIA (achiness) outcome was unknown.  No treatment information was reported.   This case was linked to MOD-2022-547011, MOD-2022-547015 (Patient Link).
A little over 24 hours after receiving my 2nd Moderna injection I felt a slightly raised portion of my arm (about an inch and a half circle around my injection site).  It does not have any prominent edges. It is warm to the touch and red. It seems to be similar to what I read about ?Covid Arm?.  It feels like a bruise and is slightly itchy. Otherwise I feel ok with not her symptoms as of now. The rest of my arm does not ache or feel sore. I just wanted to fill this out to help with any studies being done on this delayed skin reaction.
Deep muscle pain in arm, neck, back and numbness at injection site. Treated with prednisone, Motrin and Tagamet. Seen in ER on 4/15/01 for same and chest pain.
Pt had several hours of chest tightening, elevated heart rate starting immediately after the first Pfizer injection.  The second injection made these symptoms worse (Pfizer EW0172 given 5/1/21) and pt has since had chest tightness, nonexertional arm pain, as well as fatigue and decreased exercise tolerance.  Pt also has noted memory issues since this time.  Pt additionally contracted covid 12/21 which exacerbated the same symptoms.
small red hives around left wrist, then continued to spread in small hives and red dots on the back of both of my hand down into my fingers. with some small red dots on both forearms. hand are red and burn slightly. i've noticed that above my ankles on both legs (posterior) their is a dark marking, not a bruise, however could possibly pass as one. i have not noticed rashes or hives anywhere else.
Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Rec'd vaccine at 12:30pm. Next couple hrs were normal,  except tasted a fume-like vapor in back of throat. By 6 pm I started feeling aches, especially my joints and muscles. Was at a laundrymat and pulling clothes out of dryer -felt impossible to hold them up...burning and aching in shoulders and neck. Feel waves of fatigue.  Left, went home...felt hot and clammy.  Took temp- it was 101.7. Took tylenol, gabapentin, and went to sleep in recliner. Woke up at 11 pm, severe muscle weakness...so much that by the time I got out of the recliner...and on my feet...I already began to urinate on myself. It was like I could not control my body...I had very little ability to get up and out of recliner...everything was so HEAVY....my arms and legs were "weighted". After using restroom...it took 15 min just to change out of soiled clothing and clean up...and re-dress.  I laid down in the bed, but was very uncomfortable...so went back to recliner. Was physically unable to get the lid off the tylenol after trying very hard....I fell back to sleep.   At 3:15 am I woke up needing to pee, and once recliner was at normal seated position...I struggled to use my arms to lift myself up...my right arm, where I got vaccine hurt badly...it felt like PAIN...like beyond sore. I pitched to floor cuz legs wouldn't hold me.  My fever was 103.7... J feel hard-pressed to finish cuz I got a warning im about to time out. Guess I hope someone contacts me. I hav
Pt. had hives mostly on chest one hour after given flu vaccine.  Referred to ER and given Benadryl for hives.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 82-year-old male patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain, fever and neuropathic pain. In September 2018, the outcome of the injection site pain and fever were recovered/resolved. On an unknown date, the outcome of the neuropathic pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever and neuropathic pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the physician for himself. After the dose of SHINGRIX the patient had some minimal soreness at the injection site and might be a mild fever. About 2 weeks after the injection he developed neuropathic pain in his mid abdomen that did not cross the midline and went around towards his back. It hurted when pressed, but otherwise did not bother him. The patient had not experienced any rash, but the pain was similar to shingles. The patient had consented to follow up.
dizziness; Weakness; tight chest; temperature 99.8°F; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (Weakness), CHEST DISCOMFORT (tight chest) and PYREXIA (temperature 99.8°F) 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 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), ASTHENIA (Weakness), CHEST DISCOMFORT (tight chest) and PYREXIA (temperature 99.8°F). At the time of the report, DIZZINESS (dizziness), ASTHENIA (Weakness), CHEST DISCOMFORT (tight chest) and PYREXIA (temperature 99.8°F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: (High) 99.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.