chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt like ants were crawling on my back, neck and head. Eventually the itching besides on my back and head went to legs.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 08:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin, sulfur, tomatoes, citrus food, sugar and milk. Concomitant medications included unspecified vitamins. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 25Feb2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 20Mar2021, at 00:00 the patient felt like ants were crawling on her back, neck and head. Eventually the itching besides on her back and head went to her legs. The adverse event resulted in a Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event itching included treatment with Allegra and Zyrtec. The clinical outcome of the event itching was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected
Information has been received from a registered nurse concerning a 22 year old female with a history of tuberculosis skin test positive who on 05-FEB-2009 was vaccinated with the second dose of VARIVAX (Merck)  (lot # not reported, 0.5ml, subcutaneous injection) and has failed to seroconvert. Medical attention was sought via an office visit. The patient received her first dose of VARIVAX (Merck) on 28-AUG-1995. Concomitant therapy included isoniazid. Titers were down on an unspecified date (values not reported). No further information is available.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna on 12May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cardiovascular disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022, outcome "unknown", described as "vaccine brand other=Moderna on 12May2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: It was reported that patient had taken Paxlovid as COVID-19 treatment from 15Apr2023 to 20Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175794 same reporter/patient, different drug/event;
Fatigue since 2nd vaccination.  On 2/19 woke up just before midnight with delirium according to  partner. Disorientation lasted about an hour.
This spontaneous case reported by a consumer, describes the occurrence of pain and injection site nodule (a lump near her arm at the injection) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 26, 2021, patient experienced pain and injection site nodule (a lump near her arm at the injection). At the time of the report, pain and injection site nodule (a lump near her arm at the injection) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. Sender's comments: Case linked to MOD-2021-059945 (E2B linked report): Father case.
This case was reported by a pharmacist and described the occurrence of urine drug screen positive for opiates in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2012 the subject received a dose of FLULAVAL (unknown details). In 2012, less than a year after vaccination with FLULAVAL, the subject experienced urine drug screen positive for opiates. The pharmacist was "calling to ask if FLULAVAL could potentially cause a false positive on a drug screen." At the time of reporting the outcome of the event was unspecified.
Information has been received from a nurse practitioner concerning a 30 year old female who in 1995 or 1996 was vaccinated with varicella vaccine. In 2000, lab evaluation revealed that the pt did not seroconvert. Unspecified medical attention was sought. Additional info has been requested.
This spontaneous report was received from a 71 year old female patient, who was reporting on herself. The patient's pertinent medical history included shingles (years ago). Her concurrent conditions included diabetes and drug reaction/allergy to penicillin and codeine. Concomitant therapies included unspecified medications. On 11-JAN-2018, the patient was vaccinated with ZOSTAVAX 1 dose, in the left arm, for prophylaxis (strength, route, lot # and expiration date were not reported) which was reconstituted with a sterile diluent (MERCK). Patient mentioned that, according to nurse, the vaccine had to be given in the muscle and "it went deep"; therefore, "it hurt" (also reported as: the needle hurt).    On an unknown date in 2018, reported as "soon after vaccination", the patient stated that she developed "a big place on her arm that got to looking terrible"; further explained  that she had a bad reaction (vaccination complication) and her left arm "broke out" and became red (erythema), hot (feeling hot) and swollen. Additionally, she stated that the arm swelled to as big as the palm of her hand (peripheral swelling). Then, after several weeks, the patient recovered from these adverse events (vaccination complication, erythema, feeling hot and peripheral swelling) on an unspecified date in 2018.  Then, on an unknown date in 2018, reported as "a few weeks after receiving the vaccine", the patient had a horrible ear pain and on 08-FEB-2018, when she saw an unspecified nurse practitioner, she was diagnosed with shingles which were in an unspecified ear (herpes zoster oticus).  As treatment, the patient was put on cefdinir 300 mg and ofloxacin drops. She was informed that ofloxacin drops were eye drops but she was instructed to apply 5 drops to her ear, twice a day.  After that, on an unspecified date in 2018, the patient recovered from herpes zoster oticus as the shingles were no longer inside her ear, but they were behind the ear and in her hair (herpes zoster). Additionally, the patient stated that she had a headache and believed that she had shingles in her head as she heard from the nurse.  No laboratory studies were performed and the patient was not hospitalized.  At the reporting time, the patient was not recovered from headache and herpes zoster; and the outcome of injection site pain was unknown. The causality assessment between the aforementioned adverse events and zoster vaccine live (ZOSTAVAX) was not provided.  Upon internal review, herpes zoster oticus was considered to be a medically significant event.
Pt complained of transient muscle soreness and a rash distal to the injection site that developed three days after vaccination. Pt did not complain of pruritus or any systemic symptoms. On physical examination, the rash was described as a pink annular scaly plaque 3.5 x 4.0 cm. Pt used 0.05% halobetasol propionate ointment on the lesions BID. The lesions resolved within days. Pt was exempted from further AVA vaccinations and suffered no further sequela. Pt had similar resolving eruption on left arm from second immunization; also had similar eruption on right hip from skin prick test. Both resolved with treatment using 0.05% halobetasol propionate ointment.
At about 15 minutes post injection patient stated he thought he may feel a little "wheezy"  Expiratory wheezes in full right lung.  No shortness of breath. BP 148/90, Heart rate 63. O2% 98. Temp 98. Peak Flow 350. Dr. saw patient and ordered hydroxyzine 25mg po. Patient was observed another 30 minutes. He remained stable and then discharged at 5:25pm. Patient will contact Dr. if he continues to have symptoms.
This case was reported by a healthcare professional (quality assurance director for a network of clinics) and described the occurrence of flu-like symptoms in an unknown number of subjects of unspecified age and gender who were vaccinated with FLULAVAL (GlaxoSmithKline). In 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subject experienced flu-like symptoms. No further details were available for those subjects at the time of reporting. At the time of reporting the outcome of the event was unspecified. The reporter documented another case with FLULAVAL. See case A1046186A for details on the other case.
Information has been received from a certified medical assistant concerning a 13-month-old white female with no pertinent medical history or allergies who on 28-AUG-2007 at 16:40 was vaccinated subcutaneous with her first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 653517/1300F). Concomitant vaccines administered on 28-AUG-2007 included a first intramuscular dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot # 654379/0706F) administered in the right thigh and a first intramuscular dose of hepatitis A virus vaccine inactivated (MSD) (lot # 656320/1281F) administered in the left thigh. On 06-SEP-2007 at 10:00 (previously reported as "in 2007") the patient developed lesions after vaccination. Also reported as several chickenpox lesions behind her ear and a blister on her arm, as reported by the patient's mother. The patient's mother sought medical attention via a phone call to the physician. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. This is one of three reports concerning the same patient. Additional information is not expected.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported. No medical history was reported. Refigeration date 07 May 2021.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 015M20A and 04L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Moderna vaccine 044A21A expired on 31 Aug 2021. Vaccine administered to client on 01 Sep 2021 as a third dose.
Information has been received from a medical assistant concerning an 11 year old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced chickenpox. It was reported that six of his classmates came down with chickenpox and as a result the pt developed chickenpox. He was covered from head to toe with lesions. He was seen by the physician and prescribed acyclovir (ZOVIRAX) and ibuprofen (ADVIL). There was no product quality complaint involved. The reporter indicated that the pt's brothers and two other pt's had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Patient got vaccine on 3/20/21 started with sore throat on 3/26/21 which progressed on 3/27/21 to generalized malaise, fever. Patient was tested on 3/29/21 and came back positive for COVID 19
Booster administered to patient on 11/30/2022 to left deltoid. Patient at the time mentioned pain at the injection site but left without reporting additional adverse reactions or allergic reactions. Reported on 12/03/2022 that pain and tenderness did radiate laterally to left pectoral muscle. Reports that he was monitoring the adverse effects and overall inflammation and pain was subsiding. Tenderness and some pain still persists at injection site and left pectoral muscle. States that he will continue monitoring and will alert medical authorities if the adverse effects worsens, continually persists or signs of infection show.
Information was received from a registered nurse, who reported that multiple unspecified patient (demographics unknown) received GARDASIL 9 (dosages, routes of administration, lot numbers and expiration dates not provided) on multiple unspecified days, which had been improperly stored. No adverse effect reported. No additional information available.
Very tired, generalized weakness, no strength, fatigue, short of breath, insomnia, numbness/tingling to left hand & both feet.
Mild encephalopathy, absent seizures, temperament change, involuntary eye movements,  40 + episodes a day for 6 weeks, still having some possible absent seizures and some involuntary eye movements, but temperament has been getting back to normal since 6 weeks post vaccination.   Still experiencing some symptoms, has improved, but is not back to normal health. Will be continuing on diagnosis with second opinion if he does not fully recover soon.
NAUSEA & RASH ON BOTH ARMS, ITCHING ALL OVER BODY.
Achy arm; It felt more like a nerve ache; It felt more like a nerve ache than a muscle ache.; Aching all over; Little achy in the shoulders; Slight headache/Severe headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6208, expiration date was not reported) via an unspecified route of administration, in left arm, on 16Mar2021 (at the age of 60-years-old), at dose 1, single for covid-19 immunization. Medical history included arthritis. Concomitant medications included Vitamins (VITAMIN NOS) and a hormone patch (unspecified). Historical vaccine included flu shot (INFLUENZA VACCINE) and had a reaction before/after the shot. The patient experienced little achy in the shoulders on the night of the shot, slight headache and by sometime in the morning it was gone/ severe headache on 16Mar2021, aching all over; it felt more like a nerve ache than a muscle ache on 21Mar2021, achy arm; not the one she had the shot on an unspecified date. The patient went to the urgent care for achy arm. The patient underwent lab tests and procedures which included rapid test and a test for the flu, and both came back negative, the three-day test showed on Wednesday some blood in her urine on an unspecified date. Therapeutic measures took for all the events were included Tylenol sinus, Tylenol extra strength; acetaminophen for achiness and headache, someone suggested the headache might be sinus, took arthritis Tylenol extended release every 6 hours. Arthritis Tylenol extended release helped and the condition improved. The patient still had some of the aching all over, she will feel normal with the Tylenol. After the time to take the medicine it comes back and noticed it most in the mid night. The other night she had to get out of bed and come down, maybe the headache was so bad because she was lying down, that was before she started the arthritis Tylenol 650mg. The outcome of the events little achy in the shoulders recovered on 17Mar2021, achy arm was unknown, and outcome of all other events was not recovered.  No follow up attempts are possible. No further information is expected.
Jaw pain; Ribs hurt; Gagged; Body aches; Headache; Nausea; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN JAW (Jaw pain), MUSCULOSKELETAL CHEST PAIN (Ribs hurt), RETCHING (Gagged), MYALGIA (Body aches) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Tylenol. Past adverse reactions to the above products included No adverse event with Tylenol. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 01-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Nov-2023, the patient experienced PAIN IN JAW (Jaw pain), MUSCULOSKELETAL CHEST PAIN (Ribs hurt), RETCHING (Gagged), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea). On 02-Nov-2023, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN JAW (Jaw pain), MUSCULOSKELETAL CHEST PAIN (Ribs hurt), RETCHING (Gagged), MYALGIA (Body aches) and HEADACHE (Headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   On 19-Mar-2021, patient had 1st primary monovalent dose (Lot: 048A21A and Exp. Date: unknown).  On 17-Apr-2021, patient had 2nd primary monovalent dose (Lot: 025B21A and Exp. Date: unknown).  On 25-Oct-2021, patient had 3rd (1st monovalent booster) dose (Lot and Exp. Date: unknown).  On 30-Apr-2022, patient had 4th (2nd monovalent booster) dose (Lot: 056M21A and Exp. Date unknown).  On 05-Oct-2022, patient had 5th bivalent booster (Lot and Exp. Date: unknown).   On 01-Nov-2023 around noon, she received Spikevax vaccine and by midnight she got every side effect listed except for a rash. Side effects began at midnight: headache, body aches, nausea, gagged, ribs hurt and jaw pain.  On 02-Nov-2023, nausea went away in the morning.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748138, US-MODERNATX, INC.-MOD-2023-748219, US-MODERNATX, INC.-MOD-2023-748144 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2023: Live follow-up received: Reference number was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748138:Different patient (Sister-in-law) US-MODERNATX, INC.-MOD-2023-748219:Monovalent dose US-MODERNATX, INC.-MOD-2023-748144:Husband's case
2nd dosage - 102 fever, delusional, migraines.  Migraines have continued since 2nd shot , since 2/5/21.  Dr. has now prescribed blood pressure medicine as well as preventative migraine meds.
An MMR vaccine was administered to a patient today, and she received her Variax 24 hours ago; This spontaneous report was received from a pharmacist regarding a 30-year-old female patient.  Information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was unknown by the reporter.  On 06-JUN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), and on 07-JUN-2021, she was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), both of them subcutaneously for prophylaxis (dose, lot number and expiration date were unknown by the reporter; vaccination scheme and anatomical location of administration were not reported) (inappropriate schedule of product administration).
Swelling at site both arms with (L) being worse-fever. headache, chills, nausea.
Patient received ADACEL vaccine on 8/2/14. She said she has had shoulder pain since she received the shot. She notified us on 8/25/14.
Patient called office and reported being seen at Urgent Care 5/3/21 for severe case of shingles
tightness in throat; lymphedema; neck swelling; malaise; fever; weakness; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2022, the patient received the 2nd dose of Shingrix. On 10th January 2022, less than a day after receiving Shingrix, the patient experienced malaise, fever, weakness, throat tightness, lymphedema and neck swelling. On an unknown date, the outcome of the malaise, fever and weakness were recovered/resolved and the outcome of the throat tightness, lymphedema and neck swelling were not recovered/not resolved.   It was unknown if the reporter considered the malaise, fever, weakness, throat tightness, lymphedema and neck swelling to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and experienced fever, malaise, weakness for 3 to 4 days, tightness in throat, lymphedema, and neck swelling. Consent to follow up was granted.
pt recvd vax & felt funny; feverish- tired; washed out & flu like;
Fatigue and malaise since 5-6-04, almost 3 weeks. No temp. No n/v. Taking ASA, switched from IBU.
Referred from outpatient office for hypotension and diarrhea on 2/17/21.  Diarrhea has been lasting for three weeks.  Patient was to be admitted and was ordered a routine COVID test.  COVID test came back POSITVE.  Patient was not experiencing any respiratory symptoms and breathing well on room air.  A few days later, patient developed wheezing and required albuterol nebulizer, but still was breathing on room air.  Patient developed a NSTEMI during his stay, which required ICU level care.  Patient recovered and was discharged to ECF on 3/3/21.    PMH of afib, hypothyroidism, dementia, CAD, HTN, BPH, CABG, MVR,