chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 19 or 20 year old niece with no known drug reactions/allergies and no pertinent medical history who over a year ago was vaccinated with the third dose of GARDASIL. There were no concomitant medications. The consumer reported that since receiving the third dose her niece had experienced ongoing occasional joint pain, muscle pain, tingling in her hands, and fainting spells ever since and was hospitalized. Labs diagnostic studies performed included checked heart and blood work (results not provided). At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Left arm felt heavy; Unable to operate his left arm freely; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left arm felt heavy) and HYPOKINESIA (Unable to operate his left arm freely) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and W2C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced LIMB DISCOMFORT (Left arm felt heavy) and HYPOKINESIA (Unable to operate his left arm freely). At the time of the report, LIMB DISCOMFORT (Left arm felt heavy) and HYPOKINESIA (Unable to operate his left arm freely) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
This patient received a second dose of her primary series on 01/04/2022. The dose was a Pfizer 12+ vaccine and should have been a Pfizer 5-11. The patient's age at the time of vaccination was 11 years of age.
Information has been received from a registered nurse RN concerning a 12 year old female with no pertinent medical history and no known allergies who on 06JAN2004 was vaccinated with the first dose of varicella virus vaccine live. The RN reported that on 08JAN2004, the patient developed breakthrough chickenpox characterized by a somewhat itchy rash with macular vesicles on her face, back arms and legs. The patient was noted to be afebrile. Unspecified medical attention was sought, but it was unknown if treatment was required. No laboratory/diagnostic tests were performed. At the time of this report, the outcome was unknown. Additional information is not expected.
Information has been received from the mother of a 12 year old female with systemic lupus erythematosus and penicillin allergy and a history of tonsillectomy who in May, June and November 1997, was vaccinated with Hepatitis B vaccine recombinant (yeast). The lot numbers for the Hepatitis B vaccine recombinant (yeast) were 622695/0049E; 622633/1628D: and 623489/0609E respectively. In May 1997, the child was also vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(lot #619798/0996D). There was no other concomitant medication following the November vaccination with hepatitis B vaccine recombinant (yeast), the child was "swollen and rashy from head to toe". The child's mother reported that in 1998, the child had braces for 2 years and she subsequently broke out the whole time she wore the braces. The mother also reported that "now the child frequently breaks out in rashes" Unspecified medical attention was sought. at the time of this report, the outcome of the events were unknown.  Additional information has been requested.
Approximately 1-2 days after my second dosage i developed progessivly severe pain in what i can best describe as my rotator cuff.  Over a couple days I then developed severe pain in both rotator cuffs, both knees throughout my back and in both thumbs at the bases between my thumb and wrists.  This pain has persisted in all areas to this day and continues at varying levels and has at times severely affects my mobility/activity.  I wore at times two or alternated knee braces and took lots of advil, ice, heat and self therapy with a vibrating muscle massager. I honestly feel that although the vaccine may not have caused all these issues it somehow attacked or targeted previous injuries or weak points in my body.  I have had injuries or pain in these areas before but most not for 5-15 years and they all became almost unbearable within days for no reason.  The severe lower groin pain that I felt very shortly after the first dosage had lessened substantially over the month.  After the second shot it abruptly came back and has not left.  It changes in severity but is now continually present and i will be seeking medical attention for it.
She had a reaction the first time she had the vaccine but that was also with the boosters.    She got her vaccine, 20 minutes after the vaccine she started complaining that her arm was getting sore.  She said that it felt like she had been bruised and could hardly move her arm.  The next morning her arm was swollen, it went down halfway down her arm from the shoulder was puffy and swollen and has a knot at the injection site.  It was hot to touch, fever.  She was complaining with body aches, especially in her thighs and hips area, and then down her arm.  The aching was in her shoulders, like she had been running high fever and affecting her joints.  She said it felt like when she had COVID.  She missed school the next day and still cannot pick up things with that arm as it is still swollen and puffed up.  Mother called the doctor, they did not tell her to bring her in and that there was really not much to do for her and to give her Ibuprofen and Tylenol and mother believes she has been taking Ibuprofen and ice packs.
Fever on and off for 1.5 days starting ~14 hours after initial injection, and swollen cervical lymph nodes starting ~72 hours after initial injection (ongoing).
Headache, shoulder and neck soreness, low grade fever-24 hours. Just tired today
Temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.).    The concomitant medication was not reported by reporter. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master Case
This literature marketed report has been received from authors of a published article, titled as above, referring to a female patient of unknown age (age between 21-38 years). The patient's histologic diagnosis showed cervical intraepithelial neoplasm (CIN) 3 and human papillomavirus (HPV) genotype detected was type 16. Concomitant medication was unknown.  On an unknown date (reported as at 14 years old), the patient was vaccinated with the first quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. The patient only received 2 doses of vaccine (incomplete course of vaccination)  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from same literature.; Sender's Comments:  US-009507513-2109USA002363:
Starting in Jan she started to have a hard time walking and breathing from COVID. I noticed when I went over there that her feet were blue. I took her to the ER and her O2 was at 82. They put her on oxygen and tested her for COVID. They put her on an inhaler which has helped and a walker.
sore arm; unable to sleep well; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Lot number: EWO153) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "enlarged thyroid" (unspecified if ongoing), notes: enlarged thyroid. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07May2021 11:00, outcome "not recovered", described as "sore arm"; INSOMNIA (non-serious) with onset 07May2021 11:00, outcome "not recovered", described as "unable to sleep well"; FATIGUE (non-serious) with onset 07May2021 11:00, outcome "not recovered", described as "tired". Therapeutic measures were not taken as a result of pain in extremity, insomnia, fatigue.  Additional information: Other medications in two weeks included dietary supplements and herbal remedies. No other vaccine in four weeks. Adverse event: 1st dose: major sore arm resulting in unable to sleep well, tired. No covid prior vaccination and no covid tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Minor: in the hours following the injection, I experienced headache, slight fever (+1 degree), slightly sore throat. All resolved that day. Moderate: the next day, I experienced high levels of arm pain around the injection site.  Pain was concentrated in the muscle and was painful when moving the arm or applying pressure to the affected area. I had full range of motion in the arm. The second day after injection, arm pain was slightly reduced and seems to be gradually improving. I also began to experience extreme tiredness and fatigue. Current events are ongoing.
No adverse effects reported; An expired dose of VARIVAX was administered to a patient; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 04-OCT-2019, an expired dose (expired product administered) of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous, lot number N026999, expiration date 28-SEP-2019 was administered to a patient for prophylaxis. The varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered with properly stored sterile diluent that was not expired. No adverse effects reported.
Raised, itchy, hive-like red spot; soreness. Taking Benadryl
4/22/21. Patient was very lethargic, His normal patterns of behavior changed. He would sleep through his alarm daily . I would have to wake him up by shaking him. He was confused as to date and time. He had a non productive cough, he appeared flushed, wheezing SOB on exertion. He had hallucinations, told me i had a delivery of bees for my garden. He must have been dreaming?  He remained  lethargic sleeping on & off throughout the day with confusion.  I pushed fluids  I notified his PMD Dr. on 5/6/2021 He advised to take the patient to the Emergency Room for a Covid test and a chest x-ray. The patient refused to go. On 5/7/2021 I took him to Immediate Care (Urgent Care Center) they Did a. Chest X-Ray and a Covid Test, results pending in 2. Days.  Chest X-ray was Negative. The doctor ordered a  Azithromycin, and Methylprednisolone taper .  Should he hold off getting the second vaccine?
vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer, lot number: Ew0162, lot unknown: False, administration date: 17Apr2021, administration time: 01:15 PM, dose number: 1, vaccine location: Left arm, vertigo exactly one week after receiving each dose of the covid vaccine.), administration date: 17Apr2021, when the patient was 25 years old, for Covid-19 immunisation, reaction(s): "vertigo", "couldnt sleep", "vomiting". The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo". The event "vertigo" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo.  Additional information: Adverse event: The patient experienced vertigo exactly one week after receiving each dose of the covid vaccine. Following the vertigo episodes the patient had an MRI and a VNG exam done and both came back normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Twitching started 1/21 in lower eyelids, also complained of tingling spread to face and hands; felt she couldn't move her upper lip and altered speech.  Symptoms most of evening.  Awoke 1/22 - face felt normal but hands (L) numb and tingling, thumb flexed.  Still complained of tingling on visit - sent to neurology.1/29/08-records received for DOS 1/24/08- DX: Hypocalcemia. Pseudohypoparathyroidism. C/O hand and leg tingling. Perioral and bilateral hand tingling and eyelid twitching. Started 4 days PTA developed episodic periorbital nonradiation nonpainful tingling. Pins and needls sensation in hands as well as numbness of left hand. Lockin up of fingers in flexed position.
No adverse event; Vaccine given 1 day beyond BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy (Allergy to sulfa), Ragweed allergy, Allergic to cats and Grass allergy.    On 23-Feb-2023 at 12:32 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 23-Feb-2023 at 12:32 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD).    Concomitant product use was not provided by the reporter.  Patient administered the Moderna bivalent vaccine on 23-Feb-2023 and the Use by date was 22-Feb-2023.  Lot assessment conducted and determined, Analysis of the vials associated with storage excursion was complete. The vaccine administered on 23-Feb-2023 from lot number AS7170B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  Patient notified at time of initial discovery of event as well as notified when the lot assessment was complete.  Treatment information was not provided.
Pt recvd vax 130PM w/no immediate adverse rxn; @ 7PM pt began itching under chin; Pt then noted hives about neck; no SOB noted; pt reported to have (5x8 cm area);
20 hours after the shot, I began experiencing chills and sore stiff muscles. This included vaginal soreness.  48 hours after the shot, most of the body soreness subsided, and the vaginal soreness remained.  72 hours after the shot, I noticed dark red blood blister type spots on my vaginal labia and made an appointment to see healthcare provider All spots that started as dark red blisters swelled and eventually burst into extremely painful sores.  HCP performed a battery of tests, with most results coming back clear.  These spots were a reaction from the Covid shot.
Last 2 days and into today, really terrible migraines; hot flashes; when sitting down feeling like moving; concerned; hard to look at moving objects; Last 2 days and into today, dizziness; chills; headache; Left eye was bruised around the skin; feeling very worn down after booster dose; kind of like the flu; Around 12PM, left eye completely swelled shut; Blurry vision; sore arm after booster dose; Maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling very worn down after booster dose), INFLUENZA LIKE ILLNESS (kind of like the flu), EYE SWELLING (Around 12PM, left eye completely swelled shut), VISION BLURRED (Blurry vision) and MIGRAINE (Last 2 days and into today, really terrible migraines) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045U21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On 05-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore arm after booster dose). On 06-Dec-2021, the patient experienced MALAISE (feeling very worn down after booster dose), INFLUENZA LIKE ILLNESS (kind of like the flu), EYE SWELLING (Around 12PM, left eye completely swelled shut), VISION BLURRED (Blurry vision), CONTUSION (Left eye was bruised around the skin) and HEADACHE (headache). On 07-Dec-2021, the patient experienced MIGRAINE (Last 2 days and into today, really terrible migraines), HOT FLUSH (hot flashes), FEELING ABNORMAL (when sitting down feeling like moving), ANXIETY (concerned), VISUAL IMPAIRMENT (hard to look at moving objects), DIZZINESS (Last 2 days and into today, dizziness) and CHILLS (chills). The patient was treated with IBUPROFEN for Chills and Hot flashes, at an unspecified dose and frequency. On 07-Dec-2021, EYE SWELLING (Around 12PM, left eye completely swelled shut) had resolved. At the time of the report, MALAISE (feeling very worn down after booster dose), INFLUENZA LIKE ILLNESS (kind of like the flu), VISION BLURRED (Blurry vision), MIGRAINE (Last 2 days and into today, really terrible migraines), HOT FLUSH (hot flashes), FEELING ABNORMAL (when sitting down feeling like moving), CONTUSION (Left eye was bruised around the skin), ANXIETY (concerned), VISUAL IMPAIRMENT (hard to look at moving objects), DIZZINESS (Last 2 days and into today, dizziness), VACCINATION SITE PAIN (sore arm after booster dose), HEADACHE (headache) and CHILLS (chills) outcome was unknown and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved.            No concomitant medications were reported. Patient took flu medication for chills and hot flashes.  Date of last menstrual period: 19-Dec-2020 Estimated Due date: 05-Oct-2021 Actual Due date: 01-Oct-2021   This case was linked to MOD-2021-407514, MOD-2021-407358 (Patient Link).
NOSE BLEEDS; FEVER; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 24 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced flu-like symptoms. On 31-MAR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced nose bleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and fever on 01-APR-2021, and had not recovered from nose bleeds. This report was non-serious.