chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient experienced COVID; The patient experienced COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4407091-00 (AbbVie).  A 53-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "recovered" (May2022) and all described as "The patient experienced COVID". The action taken for risankizumab was unknown. Clinical course of the events: Solicited report from the USA by a consumer with an event of non-serious COVID with Skyrizi (Risankizumab). There was no reported medical history. In 2022, the patient experienced COVID. In May2022, the COVID resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. In May2022, the patient recovered from COVID. Patient did not agree to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Skyrizi (Risankizumab): The reporter's causality for the event(s) of COVID with Skyrizi (Risankizumab) was no reasonable possibility. Did event abate after stopping drug: NA. Drug: Skyrizi (Risankizumab) Causality: covid-19 (covid-19): action(s) taken with drug : unknown. causality as per reporter (drug/vaccine) : not related. drug: pfizer biontech covid-19 vaccine (tozinameran) (tozinameran), unknown, unknown, unknown: causality. covid-19 (covid-19) causality as per reporter (drug/vaccine) : not reported.  The reporter's assessment of the causal relationship of "the patient experienced covid" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
On the same day of vaccination (Anthrax), redness, itching and soreness begain. Two days after vaccination symptoms got worse.
Colonic Inertia: First dose of Havrix. Pt became constipated, no bowel movement for 19 days. Persisted as of 10/14/99. As of 1/17/2000, condition of pt is unknown. Medically serious due to intervention required.
Arrived w/ c/o N,V,D, fever, chills, aches. + COVID, gastroperesis flare 2/2 COVID infection. Received vit-c, singulair. Did not require O2. DC home.
Felt like I could not breath, coughing, swollen throat, wheezing, itching and reddening of the eyes, and headache. Treatment consisted of taking 2 puffs of Proair Inhaler and Benadryl.
Pt. w/in 24hrs developed Guillain Barre w/numbness and tingling of extremities; was taken to hospital where he was diagnosed.
On 1/23/03, pt accompanied by mom and dad, walked in and parents were concerned about his leg that was swollen on upper left thigh with redness and warm to touch. He was given an appt. with MD. Pt had no fever but was started on Keflex.
No adverse reaction. Patient notified. Patient given Moderna Bivalent booster dose 0.25mL.
two bouts of Bell's palsy; patient received the first dose on 29Apr2021 on left arm as dose 1, single and second on 29Apr2021 on left arm as dose 2; A 48-years-old male patient received the first dose on 29Apr2021 on left arm as dose 1, single and second on 29Apr2021 on left arm as dose 2; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EWO151) via an unspecified route of administration on 29Apr2021 on left arm as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EWO170) via an unspecified route of administration on 29Apr2021 (at age 48-year-old) on left arm as dose 2, single for COVID-19 immunization. Medical history included several previous incidents of Bell's palsy and allergy to penicillin (start data and ongoing status unknown). The patient's concomitant medications were not reported. It was mentioned that patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. It was reported that, a 48-year-old male patient received the first dose on 29Apr2021 on left arm as dose 1, single and second on 29Apr2021 on left arm as dose 2 (inappropriate schedule of vaccine administered, overdose) and the patient experienced two bouts of bell's palsy on 25May2021. One 4 weeks after vaccination on the right side and now a second one on the left about four weeks after the first incident. Therapeutic measures were taken with valtrex and prednisone as a result of two bouts of bell's palsy. The outcome of event two bouts of Bell's palsy was recovering.   No follow-up attempts are possible. No further information is expected.
Brief 20 second loss of consciousness. Pale and diaphoretic. Placed recumbent. Vital signs with normal blood pressure but did have bradycardia at 50 BPM. Complete recovery in 3-5 minutes. Normal neuro exam and ambulatory. No respiratory abnormalities. BP 120/80 HR 66 RR 18 Pulse ox 98%.
Narrative: COVID infection following COVID vaccine series W02/01, Pfizer, dose #1 03/01, Pfizer, dose #2 08/23 SARS-COV-2 Variant Sequencing result: pending 08/23 COVID swab, result: detected 08/14 pt cc: cough, fatigue, myalgias exposure: unknown 08/23 CXR impression: Cardiomegaly with central vascular congestion. Small opacity in the right upper lobe adjacent to a monitor lead that limits exam Focal bronchopneumonia is possible. clinically resolved
Pt received vaccine approved for 4-6 yrs of age. Pt tolerated the vaccine with on adverse affects post event. Last communicated with parents on 4.9.2014 by dr.
pt recvd vax 28JUN95 & 29JUN devel lesions on face according to pt's mom could have been varicella;lesions progressed & pt was subsequently dx w/impetigo & tx w/unspecified oral & local ATB;
Bad, continuous stomach pains, fowl-smelling and loose stool, nausea, and loss of appetite
never received the third dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.  Previously administered products included Engerix B (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-Nov-2022 Reporter's comment: The nurse practitioner called to inquire for Engerix that could they complete it. Was there a maximum time to get the third dose or should they restart series. Nurse PR actioner reported 6 to 8 patients never received the third dose at 6 months for Engerix. The reporter wanted to know how to proceed. NP was unable to provide any patient or vaccine details. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022AMR159868:same reporter
Information has been received from a physician concerning his mother who in December 2006 was vaccinated SC with a first dose of Zostavax vaccine. Subsequently she experienced an injection site rash on her arm. As of Dec-2006 it was reported that the patient was recovering on an unspecified therapy. Medical attention was not sought and no laboratory diagnostic tests were performed. There was no product quality complaint involved. No further information is available.
Induration, pain, spreading erythema around the injection site up to around 8 cm in diameter.  Seen in clinic 2 days later, and clinically appeared to be cellulitis. Started on cephalexin, and the pain/redness/swelling was markedly improved the following day per mother's report on 12/7/19
Pt went to Emergency room around 10 pm with chest pain, confirmed Myocardial infarction - Occlusion of OM, MR per catherization
Pt had vaccine on 10/1/09. Next day came in with 4 a.m. under vaccine arm site was a 16 x 8 cm cellulitis horizontally around circumference of arm. It was the right arm. Pt was tender by vaccine injection site and slightly swollen.
COVID-19 vaccine under Emergency Use Authorization. Healthcare professional received Pfizer-Biontech COVID vaccine, Lot EK5730, on 12/16/20. Developed high grade fever for 1 day followed by significant muscle aches, headache, palpitations, nausea, and fatigue. Missed work for 4 days and went to ER on day 3. Still had some symptoms at time of report on 12/20/20.
Patient came in and spoke with RPh. Patient awoke feeling feverish. She then noticed a welp on arm at the injection site. On 9/19/2022 at 5 P.M. the reaction site measured 4 inches long by 2 & 1/2 inches in diamter. Patient stated she did not have any reaction to her previous Moderna primary series or her additional booster dose.  She did not have any breathing issues or any other involvement except at the local site.  Patient is going to take Benadryl tonight and if doesn't see improvement she will see her physician tomorrow for followup.
Case previously recorded as MA2009-6257. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN influenza A intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Agency reference no. NA09-008851.
PATIENT CALLED OUR OFFICE RECEIVED VACCINE ON 11-6-2014, PNEUMONIA 23 HAS DEVELOPED A TEMPERATURE AND BODY ACHES. ADVISED FOLLOW UP WITH PCP FOR FURTHER INSTRUCTIONS, PATIENT WILL TAKE TYLENOL AND OBSERVE AND CONTACT URGENT CARE IF NEEDED.
Severe diarrhea lasting approx 4 hours, lower back pain and muscle aches. No symptoms by the next morning.
Pt in clinic 02/22/2006 and received, MMR, DTaP, Hep B, IVP, PC07, Varivax around 2PM. Mother states pt broke out in a rash observed 2/23/06 around 9AM. ? fever. Pt cried at that time less than 2 hours. Mother states she gave her Tylenol as directed and Pt was not taken to MD/ER. Pt has rash x2 days and was fussy. Called MD today and he felt s/s were not related to shots. OK to give today's shots.
Day 1 after vaccine: nausea, malaise, fatigue, subjective fevers, decreased appetite Day 2: dizziness,  sharp, intermittent, pleuritic chest pain- mid sternal and left sided, no tenderness to palpation Day 3: complete resolution of symptoms
Today woke up sweating that pajamas and bed sheets were soaked. Temperature above 102 severe headache on back head upper neck weakness, trouble walking, wobbly. Site of injection swelling and redness 3 inches in diameter. By 4am fever broken down to 100. Right now on the warm side, sweaty, a bit of weakness. Did not receive Flu on same facility.
tachycardia (180s-200) x 2 days; tachypnea x 2 days; fever 103 x 2 days
HIVES LEFT AND RIGHT FOREARMS, ITCHING.  VACCINE RECEIVED IN LEFT ARM AT 1510.  SYMPTOMS STARTED AT 1520.  PATIENT ALSO FEELS HOT.  SAYING AT HOTEL, FRIEND ALSO AT HOTEL WILL CHECK IN WITH HER.  BENADRYL 25MG IM. SUBLINGUAL CLARITIN 1 TAB.  IMPROVING
Unclear if related to vaccines as 5 days post-vaccine & poorly controlled seizure disorder. Pt with increased seizures, presented to ED in status epilepticus, admitted to PICU, intubated during stay, 10 days in hospital.
My Blood Pressure shot up about 40 points; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (My Blood Pressure shot up about 40 points) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, LEVOTHYROXINE, FOLIC ACID, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), Orencia Weekly Injection, TEMAZEPAM and IBUPROFEN for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (My Blood Pressure shot up about 40 points). At the time of the report, BLOOD PRESSURE INCREASED (My Blood Pressure shot up about 40 points) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications included Blood pressure medication.  No treatment information was provided.
Dose give at 12:30pm by 6pm temp spiked to 102 degrees. ASA give temp decreased to 100.8. Pt breathing became worse and erratic. Wife nearly took to E.R. but symptoms decreased with ASA treatment.
This spontaneous report was received from a certified medical assistant (CMA refers to a 14 years, 11-month-old male patient. On 25-OCT-2012 the patient was vaccinated with, 0.5 milliliter (ml) PROQUAD (merck) (lot # H015631 expiration date 23-FEB-2014) on the right thigh. No concomitant medications were reported. No adverse effects reported. No other information provided. Follow up information was received from a medical assistant who reported that the 14 year old male patient with an allergy to amoxicillin, was vaccinated subcutaneously into the right tight with the first dose of PROQUAD (merck) (lot # H015631) on 25-OCT-2012 at 2:04 pm. There was no illness at the time of vaccination. Additional information is not expected.
I woke up with a low grade fever (100), chills, body aches, hot and cold sweats, nausea and extreme headache. These symptoms lasted around 12 hours. The headache lasted for 2 additional days. My injection site was red, had a welt and warm to the touch. It hurt for 3 days.
caller's eczema and TMJ was exacerbated; caller's eczema and TMJ was exacerbated; caller's eczema and TMJ was exacerbated; he had blistering on his fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "chronic Lyme's disease", start date: 1999 (unspecified if ongoing), notes: chronic Lyme's disease since 1999 but was only diagnosed on 2013; "flu" (unspecified if ongoing); "eczema", start date: 1999 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ECZEMA (non-serious), TEMPOROMANDIBULAR JOINT SYNDROME (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "caller's eczema and TMJ was exacerbated"; BLISTER INFECTED (non-serious), outcome "unknown", described as "he had blistering on his fingers".  Additional information: Caller was asking about Paxlovid and explained that he had chronic Lyme's disease since 1999 but was only diagnosed on 2013 when he pulled a tick out of his leg which he actually got very sick with flu like symptoms for. He states that his lyme disease presents itself as eczema on his fingers that are brutal have not gone away since 1999. He mentions that his doctor put him on and off different antibiotics (such as Doxycycline) from 2013. Caller shares that the eczema on his fingers worsens as the seasons transition and that typically there is only little eczema on the months of Jun, Jul, Aug, Sep, and at the onset of Oct onwards it gets worse. Now, caller reports that after he got his Pfizer covid 19 shot on Mar and Apr2021, and eventually the booster dose on Nov2021, caller's eczema and TMJ was exacerbated. caller's eczema and TMJ was exacerbated he had blistering on his fingers He reports that his eczema got worse than before the vaccine and that he had blistering on his fingers. Then at around Jul this year, caller was prescribed Paxlovid for 5 days by his doctor to try it out for his Lyme disease. Caller then states that when he used Paxlovid with another antibiotic Ceftin, his eczema healed but when he had to use Paxlovid with Amoxicillin his eczema came back, because of the success of his treatment his doctor had prescribed him again and again to take Paxlovid and is now on Day 39. He mentions he got 2 5 day packs of Paxlovid from his insurance and that he got his other doses from another Pharmacy he will not be naming. Caller was calling because he no longer has doses for Paxlovid and would like to ask Pfizer for help with this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) had resolved.        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. Reporter stated that they have administered expired Moderna COVID-19 vaccine that were given as booster shot to the patient.
Within 10 minutes of receiving vaccine the patient began having excessive itching with an ascending rash beginning  from finger tips and moving up hand/arm. He was given Benadryl x2. 30 minutes later the patient started developing splotchy rash on chest. There was no shortness of breathe/dyspnea or heart palpitations. Patient was instructed to take Zyrtec and continue Benadryl every 6 hours. Patient was able to work the next day, but the day after that he presented to the emergency room due to chest pain. All test came back normal.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, anatomical location and route of administration were not specified), as prescribed and/or administered by a healthcare provider at pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
midnight ethroid and maxillary sinusitis; Sprain or partial tear of the anterior tibofibular ligament; Tenosynovitis involving the flexor hallucis longus tendon; serum carbon dioxide decreased; alkaline phosphatase decreased; creatinine decreased; ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive; This is a spontaneous report received from contactable reporter (other healthcare professional).  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Feb2021 (Lot number: EL3302) at the age of 41 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Graves disease", start date: 2014 (unspecified if ongoing), notes: s/p RAI, on levothyroxine; "RAI" (unspecified if ongoing); "Celiac disease", start date: 2014 (unspecified if ongoing), notes: gluten free diet; "Expressive language disorder" (unspecified if ongoing); "left ankle pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, start date: 2015, reaction: "Allergy"; Effexor, start date: 2015, reaction: "Allergy". Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: EL1284, Time vaccination was given: 09:30, Route of administration: Intramuscular, Anatomical location: Arm left), administration date: 13Jan2021, for covid-19 immunization, reactions: "left side arm, leg and face tingling", "twitching", "sharp pain", "muscle spasms" and "brain fog"; Tdap, administration date: Dec2019, when the patient was 39 years old, for immunization; Mmr, for measles immunization; Hepc, administration date: 1999, for hepatitis immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "serum carbon dioxide decreased"; BLOOD ALKALINE PHOSPHATASE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "alkaline phosphatase decreased"; BLOOD CREATININE DECREASED (non-serious) with onset 03Feb2021, outcome "unknown", described as "creatinine decreased"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 03Feb2021, outcome "unknown", described as "ANA Scrn: positive, Anti scl 70: 1.8 positive, SSA Ab Positive"; LIGAMENT SPRAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "Sprain or partial tear of the anterior tibofibular ligament"; TENOSYNOVITIS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Tenosynovitis involving the flexor hallucis longus tendon"; SINUSITIS (non-serious) with onset 02Dec2021, outcome "unknown", described as "midnight ethroid and maxillary sinusitis". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.   Follow-Up (04Feb2022): Follow-up attempts are completed. No further information is expected.