chrisvoncsefalvay/vaers-outcomes huggingface dataset:
History of PDC and is happening again; This spontaneous case was reported by a physical therapist and describes the occurrence of ANXIETY DISORDER (History of PDC and is happening again) in a 39-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 (no historical condition was reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ANXIETY DISORDER (History of PDC and is happening again). At the time of the report, ANXIETY DISORDER (History of PDC and is happening again) had not resolved. Not Provided      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.
Patient had a J&J vaccine as a first dose and Moderna booster vaccines dose 0.5ml was given instead of the 0.25ml.
Very, very severe, widespread muscle pain; This is a spontaneous report from a contactable Consumer. A 73-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Left on 22Feb2021 07:15 as DOSE 1, SINGLE (at the age of 73-year-old) for covid-19 immunisation. Medical history included hypothyroidism, fibromyalgia, blood cholesterol increased. The patient's concomitant medications were not reported. The patient previously took vibramycin [doxycycline] and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021 08:00, the patient experienced very, very severe widespread muscle pain. AE resulted in doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the event. The outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Vaccination injuries to vestibular system; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR DISORDER (Vaccination injuries to vestibular system) in a  patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced VESTIBULAR DISORDER (Vaccination injuries to vestibular system). At the time of the report, VESTIBULAR DISORDER (Vaccination injuries to vestibular system) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported. There are entries related to Moderna vaccine. Not all the symptoms are exactly same. Has an incredible number.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (received expired doses of the Moderna COVID-19 vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 059H21A) for COVID-19 immunization. No medical history reported. On Mar 28, 2022, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 28, 2022, patient administered expired product (received expired doses of the Moderna COVID-19 vaccine). At the time of the report, administered expired product (received expired doses of the Moderna COVID-19 vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. It was reported the vial did not undergo any temperature excursions. The vial initially stored in the refrigerator on Mar 25, 2022. 8 patients received expired doses of the Moderna COVID-19 vaccine. This case linked to MOD-2022-534443 (patient link).
Flu like symptoms with no fever for 3 days. Tylenol for headaches. Then 1 month later oshe was on crutches with her knee buckling and low back pain. Then after 3 weeks it started to spread to her left knee, ankles and hips. She can't walk or stand on her own so Dr sends us to Hospital for tests stayed 4 days. She now has severe joint pain from head to toe with headaches. They said she had micoplasma pneumonia and sent us home with a Z-pack. Went home in a wheel chair. 2 weeks later went back to hospital for a headache that lasted 6 days. Had a brain MRI they said was normal so we go home again. She can not go to school due to lack of concentration, memory loss and just overall doesn't feel well so now she has been getting home instruction. Its now 7 weeks no walking and still in a lot of pain. We no longer see the Dr who gave her the shot.
contacted COVID; contacted COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RSV VACCINE taken for immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contacted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: tested positive, notes: tested positive after getting booster; Weight: approximately 115 (Pounds). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient stated that every single COVID shot that she have gotten and all the booster from top to bottom from the original shot all the way down to the 19Sep2023 dose they have all been Pfizer. The patient further mentioned that she tested positive after getting booster shot. So what happened was she was prescribed Paxlovid by the doctor.  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.
FEVER, CHILLS, VOMITING, DIARRHEA, MUSCLE ACHES. STARTED ABOUT 2 HOURS AFTER SHOT.  VERY BAD THE FIRST DAY. 2ND DAY, STILL SICK, BUT NOT AS BAD, JUST WEAK AND QUEAZY. 3RD DAY STILL SICK PLUS WAS DIZZY AND KEPT LOOSING MY BALANCE. 4TH DAY AND TODAY, MUCH BETTER, BUT NOT BACK TO NORMAL YET.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 13-NOV-2013, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 18-NOV-2013 and 10-FEB-2014, the patient was treated by a healthcare provider at an urgent care for shingles and neuropathic pain secondary to shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
itching head, neck, back started Wed am (8/22/07) raised, multiple circular areas all over body trunk & extremities by Wed evening, covered more area by Thurs. no blisters. Started Benadryl 50 mg every 6 hrs on Thurs (8/22/07) approx 4 pm. Fri am nurse observed same as above with some areas. Continued Benadryl and add Hydrocortisone 1% ointment to itchies areas no mucosal involvement reported no fever some diarrhea (really urgency) stools qd since Benadryl rash resolved with Benadryl by Sun (8/26/07) Did not develop any blisters.
Information has been received from a registered nurse concerning a 6 year old male with no pertinent medical history and no known drug allergies who in 2001 was vaccianted with a dose of varicella virus vaccine live. There was no concomitant medication. On 5/18/2005 the patient was seen by his physician in the ER and was diagnosed with breakthrough varicella. The patient was treated with acyclovir and diphenhydramine hydrochloride Benadryl. As of 20/20/2005, the patient had not recovered. No further information was available. No product quality complaint was involved. No additional information is expected.
Reddened warm and hard to the touch. Mother has tried cool compresses. Has not been bothersome to child only to mother of child.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. On an unknown date in 2007, the patient was vaccinated with dose 1 of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified). On an unknown date in 2009, the patient was vaccinated with dose 2 of VARVIAX (Merck) (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date (reported as now), the patient developed shingles. The patient was seen in an urgent care facility on an unknown date but was not admitted to hospital. The patient was treated with mometasone furoate and acyclovir. The outcome of shingles was unknown. The relatedness for shingles was unknown for VARIVAX (Merck). Additional information has been requested.
Self report by patient of anxiety, chest tightness/pain. Follow up appointment offered to patient but refused. Patient was not seen in our office post vaccine administration.
A pediatric patient received 3 doses of the monovalent vaccine instead of the intended bivalent booster after a primary series; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A pediatric patient received 3 doses of the monovalent vaccine instead of the intended bivalent booster after a primary series) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (A pediatric patient received 3 doses of the monovalent vaccine instead of the intended bivalent booster after a primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A pediatric patient received 3 doses of the monovalent vaccine instead of the intended bivalent booster after a primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A pediatric patient received 3 doses of the monovalent vaccine instead of the intended bivalent booster after a primary series).    No concomitant medication information provided. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No side effects were reported. No treatment information provided.
Widespread itching with no actual skin rash. Treated with prednisone and antihistamine.
Started to feel itchy pain in middle of back. Progressed to intense pain where I could not wear a bra or tight clothing. Lasted 7 days. I concluded it was non-herpetic shingles.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease -Artherosclerosis" (unspecified if ongoing). No known allergies. There were no concomitant medications. Other medication in 2weeks reported as no. Past drug history included: Prednisone for lung inflammation, notes: lung inflammation treated with prednisone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included product=COVID 19 Treatment, brand=Paxlovid from 27Sep2022 to 01Oct2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events drug ineffective ,COVID-19  and the suspect drug  BNT162b2.
started with pain in rt. eye. then shooting bright lights, then bright cloud covering  my vision, now at times complete black out of my right eys. been to the doctors 3 times so far. have another appt on the 15th of dec. because of the black out. no problem with the left eye.
Considerable pain in left shoulder muscle, around injection site. Pain got worse the day after injection (03/12/21), then fully resolved 48 hours after injection (03/13/21).
Information has been received from a nurse concerning a 72 year old female who on 28-SEP-2010 was vaccinated with PNEUMOVAX 23 (lot # 664608/1312Y) given as one shot for "prevention of invasive pneumococcal disease". Subsequently the patient experienced a 22 sonometer redness from the injection site past the elbow to the forearm. The patient has sought medical attention and was given prednisone for the event. At the time of reporting, outcome of the event was not reported. The reporting nurse considered the event to be serious as an other important medical event. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases: A0756483A - A0756507A, A0756509A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Day 1: Injection site soreness, fatigue, muscle ache, headache treated with Advil and sleep. Day 2: Same as Day 1. Day 3: Same as Day 1 and 2 with evening chills and nighttime diaphoresis. Day 4: Better morning and daytime but evening onset same as earlier with additional evening onset of hives treated with systemic BENADRYL (50) and topical BENADRYL and ADVIL with resolution of hives within an hour or so. Less nighttime diaphoresis. Increased nausea. Day 5: Better during the day evening return of symptoms with hives and swollen lower lip treated with the same dose of BENADRYL and ADVIL. Day 6: Recovering. Day 7: I believe resolved.
About five minutes after receiving the vaccine in his left arm, the patient developed redness itchiness and rash at the site of the vaccine.  No systemic symptoms. Received an ice pack to the area.  Pt was monitored in clinic for 30 minutes, during which time symptoms had fully resolved.
5 1/2" x 5 1/2" 9135mm x 135mm) erythema surrounding inj site upper rt arm over triceps beginning 16 hrs pos vax, described as increasing over next 24 hrs; 10SEP95 fading & 11SEP95 arm nl contour & appearance;
Patient reported RFA, left armpit, left thigh itching at the end of her 30 minutes observation. Brought her to EMS room and had PA, examine patient. Instructed patient to consume Benadryl once she arrives home and to continue to monitor her symptoms.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (also experienced fever, chills, body aches, pain at injection site and headache (refer the case for 1st dose_US2018GSK128833)). On 18th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 5 days after receiving SHINGRIX, the patient experienced ear pain, neck pain, shoulder blade pain, itchy scalp and pain in fingers. On 18th June 2018, the patient experienced influenza-like symptoms, injected limb mobility decreased, fever, chills, general body pain and headache. On 5th July 2018, the patient experienced shingles. On an unknown date, the patient experienced burning sensation. The patient was treated with VALTREX and gabapentin. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms, injected limb mobility decreased, fever, chills, headache, ear pain, neck pain and shoulder blade pain were recovered/resolved and the outcome of the general body pain and pain in fingers were recovering/resolving and the outcome of the itchy scalp and burning sensation were not recovered/not resolved and the outcome of the shingles was unknown. It was unknown if the reporter considered the influenza-like symptoms, injected limb mobility decreased, fever, chills, general body pain, headache, ear pain, neck pain, shoulder blade pain, itchy scalp, pain in fingers, shingles and burning sensation to be related to SHINGRIX. Additional details were provided as follows: In the morning, at 10:15 am, the patient received 2nd dose of SHINGRIX on left deltoid. By 7:00 pm, that evening, the patient experienced more intense flu like symptoms, could barely move his left arm, experienced fever, chills, body aches and headache. He also complained of aching in his fingers. These symptoms were lasted 48 hours and had 5 days of feeling normal without any issues. After 5 days of vaccination, the caller reported that the patient started pain behind his right ear, radiating down the right side of his neck, his right clavicle and pinging out to his right shoulder blade. This lasted for 3 to 4 days. The patient reported every day following these initial symptoms occurring and the symptoms worsened. On 5th July 2018, the patient went to his physician for evaluation and was to physician diagnosed he had shingles. The caller reported that he never had shingles before receiving the vaccine and began treatment of VALTREX and gabapentin for the next 3 days and the pain became more frequent and intense. By Monday morning, the patient developed burning along the right side of his face, right eye, right side of lip and scalp itchiness. The patient saw his physician on Monday morning for re-evaluation and was started on a course or oral prednisone and continues the oral Gabapentin. This is 1 of 2 cases reported by the same reporter for the same patient.
This spontaneous report was received from a nurse prescriber, and refers to a currently 43 year old female patient. No information was provided regarding the patient's concurrent conditions or concomitant medications; however, her medical history included ulcerative colitis. The patient had no drug reactions or allergies reported. On an unknown date,when the patient was young, she was vaccinated with M-M-R II for prevention of measles, mumps, and rubella (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced colitis ulcerative. The patient had been treated with HUMIRA. On a separate unspecified date, the same patient had measles, mumps, and rubella titers drawn and had low titers (rubella antibody negative) (antibody levels not provided). On 13-NOV-2017, the patient then received 1 dose of M-M-R II for prevention of measles, mumps, and rubella (route of administration, lot number and expiration date were not provided). At the reporting time, the patient had not recovered from colitis ulcerative and rubella antibody negative was unknown. Causality assessment between the events and M-M-R II was not provided. Upon internal review, the event of ulcerative colitis was considered to be medically significant.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Severe