chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experiencing a sore throat; experiencing a cough; experiencing a voice change; 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 OROPHARYNGEAL PAIN (experiencing a sore throat), COUGH (experiencing a cough) and DYSPHONIA (experiencing a voice change) 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 10-Nov-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (experiencing a sore throat), COUGH (experiencing a cough) and DYSPHONIA (experiencing a voice change). At the time of the report, OROPHARYNGEAL PAIN (experiencing a sore throat), COUGH (experiencing a cough) and DYSPHONIA (experiencing a voice change) had not resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.; Sender's Comments: This case concerns a patient, unknown age and gender,  with no known medical history, who experienced the non-serious, unexpected events of oropharyngeal pain, cough, and dysphonia. The events occurred  on unknown date after third dose of mRNA 1273 vaccine. The patient reports sore throat, voice change and cough that is ongoing as of receipt of the report.The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Felt throat tightness, warm, and had sweaty forehead. Given two bottles of water and improved enough to leave for home.
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2019 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Narcolepsy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive other medication in 2 weeks. The patient received treatment as Product: COVID 19, treatment Brand: paxlovid, treatment start date/ stop date: 01Sep2022/05Sep2022. The known allergies was all type meds and other medical history was narcolepsy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I experienced acute pain in my upper left arm where I had received my flu shot injection. The severe pain traveled down my arm to my thumb. My thumb has been numb at times and other times in severed pain as well. Eventually, after waiting until the discomfort to subside, I went to my Dr. and was given a thumb/wrist brace to wear. The pain/discomfort is still present today. After nearly 4 months I am not sure if the effects will subside. I am planning another trip to my Dr.
experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia) 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 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 FIBROMYALGIA (experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia). At the time of the report, FIBROMYALGIA (experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.                   No treatment medications were  reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: FU received on 13 Sep 2021 include no new information. On 13-Sep-2021: Follow-up received contains no new information
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Medical history and concomitant medications were not provided. On or about 13-AUG-2012, the patient was vaccinated with ZOSTAVAX at a pharmacy  as recommended for routine adult health maintenance for the prevention of shingles (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-SEP-2016, the patient was treated in emergency department for a vesicular outbreak that was diagnosed as severe shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of shingles was not recovered. Additional information has been requested.
During the 3-4 days after my shot I had a mild/moderate headache on two separate days.  Took Tylenol, headaches resolved.  On Sat March 27 about noon I got another headache, this one much worse.  Eventually took 2000 mg  Tylenol, no relief.  Headache was so severe my husband wanted to take me to ER.  I did not think they could do anything so did not go.  Severe headache lasted until late evening/overnight.  Sunday I was fine, nothing since.
6x8cm erythematous edematous tender area @ lt deltoid started w/in 12hr of vax;
heart fluttering; dizzy; heart was racing like she was running; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 14Jul2021 19:30 (lot number: 9W0170; as reported; at the age of 64 years old) as dose 1, single and then via an unspecified route of administration, administered in the right arm on 04Aug2021 19:30 (lot number: 9W0170; as reported; at the age of 64 years old) as dose 2, single for COVID-19 immunization. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included duloxetine taken for anxiety from an unspecified start date and ongoing. The patient experienced heart fluttering, dizzy and heart was racing like she was running on an unspecified date in 2021. It was reported that the patient had her first dose and after had heart fluttering, and she read it was more common with the second but had it with the first one as well and continues to have it sporadically. Specifically, the heart fluttering happened after both doses, but the second one wasn't as bad it didn't wake her up in the morning like the first. She got dizzy and laid there like she had been running and running forever heart pounding fast, but that it subsided after a while when she got herself calm. She has not had a lot of side effects. She also added that after the first shot she woke up at about 3 o'clock the next morning and her heart was racing like she was running. The severe racing part lasted about a couple of hours and then eased off. Now it is sporadic. After the second shot it has mainly stayed sporadic heart flutters. There were no prior vaccinations (within 4 weeks). The outcome of all events was unknown.
Patient given PNEUMOVAX 23 0.5ml in (L) deltoid on 10/31/11. Lot 0614AA Exp 9/27/12. Came to pharmacy on 11/2/11 with (L) biceps had normal sequelae (red, swollen & hot to touch).
Immediately after immunization the child began sneezing and having a runny nose. His eyes became swollen. Gave Benadryl immediately.
Received 3rd dose being not eligible; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received 3rd dose being not eligible) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received 3rd dose being not eligible). At the time of the report, INCORRECT DOSE ADMINISTERED (Received 3rd dose being not eligible) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab test data included Patient did antibody test PCR test but results are not provided.  No Concomitant medication was reported. No treatment medication use was reported.  Pharmacist used 100 ul instead of the 50 original two part series.   This case was linked to MOD-2021-329821 (Patient Link).
Information has been received from a physician's assistant concerning a 15 year old female who on an unspecified date was vaccinated with her second dose of GARDASIL. Subsequently the patient experienced amenorrhea for a couple months after administration of her second dose of GARDASIL. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from amenorrhea. Follow-up information has been received from a health professional concerning a 15 year old female student with "1.5 months without period" at the time of vaccination who on 27-OCT-2009 at 4:00 p.m. was vaccinated with the first dose of GARDASIL (lot # 663453/0249Y), and on 28-DEC-2009 at 4:00 p.m. was vaccinated with the second dose of GARDASIL (lot # 663453/0249Y). On 15-DEC-2009 the patient experienced amenorrhea. There were no laboratory studies performed. the patient's sister also experienced amenorrhea after vaccination with GARDASIL (MSD WAES#1001USA02084). Additional information is not expected.
extreme pain from shoulder to elbow, can't lift arm up. can move arm elbow down but not shoulder area
I am in menopause and after my second vaccine, I started to have a period.  I have not had a period in a long time so it was unusual. The period was light but it was still strange to have a period after not having one for so long.
I got my second shot on 13 may; Finger tips hurt; Finger tips to peel; Nails to fall off; Sensitivity to sun; tested positive for COVID-19; Stuffy nose; Coughing a bit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Finger tips hurt), SKIN EXFOLIATION (Finger tips to peel), ONYCHOCLASIS (Nails to fall off), PHOTOSENSITIVITY REACTION (Sensitivity to sun) and COVID-19 (tested positive for COVID-19) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Parkinson's disease. Concomitant products included CARBIDOPA MONOHYDRATE;LEVODOPA, CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) and RASAGILINE MESYLATE (AZILECT) for Parkinson's disease.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced NASAL CONGESTION (Stuffy nose) and COUGH (Coughing a bit). On 27-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19). On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Finger tips hurt), SKIN EXFOLIATION (Finger tips to peel), ONYCHOCLASIS (Nails to fall off) and PHOTOSENSITIVITY REACTION (Sensitivity to sun). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got my second shot on 13 may). The patient was treated with DOXYCYCLINE (DOXYCYCLIN [DOXYCYCLINE]) on 28-Jan-2021 at a dose of 1 dosage form. On 12-Feb-2021, PHOTOSENSITIVITY REACTION (Sensitivity to sun) had resolved. At the time of the report, PAIN IN EXTREMITY (Finger tips hurt), SKIN EXFOLIATION (Finger tips to peel), ONYCHOCLASIS (Nails to fall off), COVID-19 (tested positive for COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got my second shot on 13 may), NASAL CONGESTION (Stuffy nose) and COUGH (Coughing a bit) outcome was unknown.            No treatment information were reported.   This case was linked to MOD21-084040 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up was received on 15-Jun-2021 and contains significant information. Patient demographics, address were updated. The outcome date of the event (Photosensitivity) was updated.; Sender's Comments:  MOD21-084040:cross linked id
pt recvd vax; redness swelling both hands; tingling of tongue; redness, itching swelling of feet blister on toe & heel;
24 y/o patient admitted to ICU via ED with (?) Dx of smallpox vaccinia/encephalitis. SM received primary SPV (LUE), Typhoid VICPS and AVA (RUE) on 28APR10-no other vaccines in 30-day window. Symptoms: Headache (784.0), generalized Pain (780.96), rash, oth nonspecific skin eruption (782.1).
7/17-pt. stated that the injection site was painful, was not able to sleep on the left deltoid that night due to the pain 7/18-arm hurting, noticed some swelling. 7/22-swelling has been getting bigger since the injection, burning from inside the muscle going to surface, warmth on palpation, induration palpated with redness.
Same day evening and the over night I had fever, chills, sweating, headache and arm pain. I took Tylenol and allergy pill.  continued about 3 days. I started feeling better by the 4th day.
Chills fever aches. Next day at dinner time could not stand without falling, speech blurred, uncontrolled urinating.  Went to hospital had cat scan and MRI. All results were negative for mini stroke. Any further information needed my cell.
Information has been received from the Registered Nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL (dose and route not reported) on 19-DEC-2012 (dose, route and lot number not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
VAccine at 10am.  Returned to nurse at 1250 complaining of scratchy throat.  Diaphoretic; laid supine, elevated lower legs..  Administered benedryl 1ml IM right deltoid.  Called 911.  Symptoms better after 3 minutes-  No LOC.  REfused transport.  HR representative walked him to elevator and car.  Friend drove him home.
This spontaneous report was received from the medical assistant refers to a 4 year old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included sterile diluent (DILUENT MRK INJ) used to reconstitute the PROQUAD was properly stored. On 11-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.; Sender's Comments:  US-009507513-1806USA001756:
On April 14, 2000 the patient developed a lump at the injection site. The patient was seen by the physician on April 22, 2000 a diagnosis of sterile abscess was made. The patient recovered.
Chills, fever, body pain, numbness of face and hands. All started 17 hours after  injection
Information has been received from a physician concerning a 11 year old female on 02/19/2001 was vaccinated with a first dose of hep b vaccine recombinant in the left arm. On approximately on 03/07/2001 the pt experienced ecchymotic or purpuric rash on her legs only. The physician felt that the rash may be associated with some sort of vasculitis. The rash was later diagnosed as Henoch-Schonlein purpura. The pt recovered. No further info is expected.
accidently gave proquad instead of mmr and patient got proquad and varicella in same day
i developed a vitriol detachment a couple of weeks after my injection.  i see vein-type things in my eye and now am under a doctor's care for it. i'm not sure when it started, to the exact date, however, it was after my second dose. i can't find on the calendar when i went to see dr. i have a follow-up appointment next week. so, the date is approximate on this form.
Site: Bruising at Injection Site-Mild, Systemic: Weakness-Medium, Additional Details: pt was anxious and light headed she fainted on the floor gradualyl no bursing or hurt. pt was able to walk to car to head home and rest
Patient came to the pharmacy complaining of sore arm and rash and redness and pain around the injection site following second dose of Shingrix 48 hours ago. She stated she started feeling body ache and dizziness within a couple of hours of receiving the Shingrix and the fever lasted 24 hours despite taking Tyleonol. Her arm was still red around the injection site and painful. She was asked to contact her doctor for further evaluation. She stated she had similar reactions with the first Shingles shot but the adverse reactions are much more severe and lasts longer this time.
Patient's parent reports that patient c/o of not feeling well the day  following the shot.  2 days later, she c/o of a vague headache.  The H/A continued through the weekend and then she began to have nausea and vomiting.  She missed 3 days of school last week and was unable to go to school on Monday too.  During the course of a week she was taken to Dr. and with unfounded results.  The parents then called the Health Dept on 8/23/10, thinking it may be from shots.  We took the information and referred back to the Dr.  Family states that the Dr. is treating her for a migraine.  8/25/10 the father called again to report that the h/a remains and she is now having tingling in her lips and feet.  She has been back to the Dr. but family reports that he has no reason why she would be feeling poorly.
diagnosed with Covid; diagnosed with Covid; 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 66-year-old male patient received BNT162b2 (BNT162B2), 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 on 14Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Chronic myeloid leukemia" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; FLONASE [FLUTICASONE PROPIONATE]; RED YEAST RICE; TAMSULOSIN; FLOMAX [MORNIFLUMATE]; IMATINIB taken for chronic myeloid leukaemia. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "unknown" and all described as "diagnosed with Covid".  Clinical course: It was reported that patient was diagnosed with Covid about 2 days ago. He did received Pfizer covid vaccine and 2 booster shots also. caller wanted to know about paxlovid, its prescribed to him but he has not started it. He has HTN takes Lisinopril for it, Flonase, red yeast rice, Tamsulosin, flomax, has chronic myeloid leukemia takes imatinib 400mg for it. Patient stated his Covid symptoms are not that bad and may be he should not take Paxlovid. Patient wanted to know about any interactions in medications he is taking and Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 61-year-old male patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to SHINGRIX. Additional details were reported as follows: The reporter was the patient's wife. The patient received SHINGRIX vaccine on left arm. The reporter stated the day after receiving SHINGRIX vaccine, the patient experienced severe body aches. This case is linked with case US2018188574, reported by same reporter.
Pt reported hx of vasovagal to vax RN. Pt was advised that due to medical hx, it would be preferred to vaccinate the pt lying down, however the pt refused. Immediately post injection at 1026, the pt appeared pale and began to lull/sag forward. Legs were elevated. Pt was stabilized by additional RN. Ice packs were applied to nape of neck and chest. Pt lost consciousness for approximately 15 seconds. Pt began to arouse while still sitting in the chair but was quickly transferred over to the cot where VS were initiated. VS q3 WNL aside from slight bradycardia with set one and four, later determined to be pt baseline. At approximately 1036, pt reported feeling better. Pt was transferred to a seated position at approximately 1041, tolerated well. Pt moved to stand at approximately 1045, tolerated well.   Pt then walked over to observation at 1046 for an additional 20 minutes after reporting feeling completely better. Pt left observation with roommate at 1106 ambulatory with a steady gait.
Initial report received pharmacist on 18 October 2013. A 31 year old female patients whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (route intradermal, lot # UT4721AA and site of vaccination was right deltoid) on 17 October 2013. Reporter stated that on 17 October 2013 patient received FLUZONE ID in right deltoid and within few minutes experienced numbness in left side of face and neck. Patient also reported that numbness continued into the evening. On 10/18/2013, patient stated all numbness resolved and no other symptoms experienced. List of documents held by sender: none.