chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was positive for covid 1 week after receiving 1st dose.; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient was positive for covid 1 week after receiving 1st dose.) 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.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Patient was positive for covid 1 week after receiving 1st dose.). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient was positive for covid 1 week after receiving 1st dose.) 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.
The main reaction I am experiencing is vaginal bleeding started May 20th 2021 and has not stopped it is now July 7th 20th 21 there have been days where it was spotty others were just normal type. Days. In the beginning I was 10 days early for my typical menstrual cycle and the blood seemed to be old. It was dark in color and not like a fresh shedding of the uterine wall. And then we're my normal period cycle came up it turned to what appeared to be my typical bleeding I continued to spot. And today on July 7th I started having clots large blood clots fresh in color but a lot of bleeding I have had two periods since it's began and July 7th would be a week after what would have been my typical cycle.  Another side effect of experiencing is painful cramping of my hands and feet and occasionally my calves. It's to the point where pressing on the gas pedal can make my toes cramp when driving holding grocery bags with my hand cramp. Any kind of body stretch will make any of my muscles cramp I never know which one.  I've had multiple side effects starting with a raised bumpy rash on both sides of my face. They were not pimples they never came to a head a few of the bumps ended with small scab on them I'm not sure if that's from me scratching at times it was itchy they started May 20th and I have just a scattering of the bumps at this point July 7th 2021.
Subsequent to receiving varicella virus vaccine live the pt experienced chickenpox with  100 lesions noted. Pt was afebrile on day 1 of the illness. A titer was checked on day 2 of the illness and it was noted to be 3.6, 4X the titer needed for protection. Information from physician indicated typical papules and small vesicles on an erythematous base each no larger than 3mm in diameter with the base being no larger than 8 mm in diameter. They are scattered discretely about the face including the right lower eyelid margin, a few scattered on the trunk and on each extremity.
This case was reported by a consumer via call center representative and described the occurrence of tenderness in a adult female patient who received unspecified Influenza vaccine for prophylaxis. The patient's past medical history included breast cancer (didn't get any vaccine or bloodwork done in right arm.). Previously administered products included herpes zoster live-attenuated vaccine (received ZVL vaccine 5 years before the reporting date). On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced tenderness. On an unknown date, the outcome of the tenderness was unknown. It was unknown if the reporter considered the tenderness to be related to Influenza vaccine. Additional details were reported as follows: The patient received influenza vaccine in left arm. The age at vaccination was not reported. Every year, the patient received flu vaccine, but did not always experience tenderness. The patient was unaware of the name brand of flu vaccine. HCP was not asked. The health care professional (HCP) not asked. This case linked with case US2018156128, reported by the same reporter for the same patient.
LEFT UPPER ARM DEVELOPED SEVERE WEAKNESS; LEFT UPPER ARM DEVELOPED PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced left upper arm developed severe weakness, and left upper arm developed pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left upper arm developed severe weakness and left upper arm developed pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210742246.
Hives ~ never experienced hives prior to having the second Moderna vaccine.  Vaccine was given on 4/1/2021 and by Sunday hives, were on my face, neck, arms and upper torso.  No amount of allergy cream or Benadryl would ease the itching.  First appointment with FNP, was 4/5/2021 given first round of Medrol dose pack Steroids.  Once completed dose pack, hives returned, then started second rounds of Steriods and Pepcid AD.  5/8/2021 after another appointment with FNP, I'm on daily Steriods and Pepcid AD (one in morning/one in evening).  I've been referred to an Allergist, and the appointment is scheduled for 5/8/2021.
Premature menstrual cycles/periods; Nipple discharge of left breast; This is a spontaneous report from a contactable nurse. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the arm left on 22Feb2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The medical history and known allergies were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the arm left on 01Feb2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 21:00, the patient experienced premature menstrual cycles/periods and nipple discharge of left breast. On an unknown date, the patient underwent mammogram, ultrasound and magnetic resonance imaging (MRI) and the result was unknown. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events premature menstrual cycles/periods and nipple discharge of left breast was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding their medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 30-MAR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # L046506, expiry date: 17-MAY-2017. Nurse reported a temperature excursion for the following products: (Oka-Merck) PROQUAD (lot # L046506, expiry date: 17-MAY-2017) and (Oka/Merck) VARIVAX (Lot # L041207, expiry date: 20-OCT-2017), however only (Oka-Merck) PROQUAD was administered. The vaccine underwent a temperature excursion of -13 degree Celsius for 6 hours. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient was supposed to receive Men B vaccine and instead received MenQuadFi dose #3. Patient had no adverse reactions in the office.   Patient left the office.  Nurse Manage reviewed with manufacturer of vaccine and they stated to watch for side effects due to vaccine being administered at 2 years instead of 4 years post second dose.  Dr. reviewed above with mother in the afternoon via phone.  Mother aware and reported no side effects to MD.  Mother will report any adverse effects to the office.
6days after first dose my  right wrist and right knee became swollen and painful. After about 10 days, my knee was no longer swollen but it still ?clicks? when I walk up stairs or hills. My right wrist in the joint area remains severely painful to the touch and when in use, especially when using my thumb. A bump formed on the interior wrist bone and grew larger day-by-day and then either disappeared or grew into my wrist bone.  Joints in my fingers - especially on my right hand are achy.
she had a bad reaction to the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (she had a bad reaction to the Moderna shot) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Dermatitis atopic and Prophylactic vaccination.    Past medical history, medical treatments and family history of patient were not provided.  Concomitant products included CIMETIDINE (TAGAMET HB), FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY), TRAZODONE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE, SERTRALINE HCL, TRIAMCINOLONE ACETONIDE, BUPROPION HYDROCHLORIDE (WELLBUTRIN SR), DENOSUMAB (PROLIA), MELOXICAM, LEVOTHYROXINE SODIUM, FAMOTIDINE, CYCLOBENZAPRINE HYDROCHLORIDE, MUPIROCIN, MECLIZINE HCL, GABAPENTIN, OXYCODONE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]), CLONAZEPAM and ALBUTEROL SULFATE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram once a week. On an unknown date, the patient experienced IMMUNISATION REACTION (she had a bad reaction to the Moderna shot). At the time of the report, IMMUNISATION REACTION (she had a bad reaction to the Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  On an unknown date the patient unsure if medication Dupixent was meeting treatment expectation with no reported adverse event.  It was not reported if the patient received a corrective treatment for the events.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Significant follow up- concomitant medication, suspect product information updated.
extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (extremely sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis, Rheumatoid arthritis and Seasonal allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MYALGIA (extremely sore). At the time of the report, MYALGIA (extremely sore) outcome was unknown.            No Treatment information was reported.
Feeling ache all over body, complained of pain in arm and spent the entire evening in bed. Vaccination sites sored. Normal temp.
Headache, Rash, ErythemaMultiform, NauseaVomiting, fatigue Narrative:
patient had throat discomfort, benadryl given, epi given, EMS notified, patient declined further evaluation in the EMS and further evaluation in the ER. patient was asymptomatic upon departure of clinic, vitals stable and taken by EMS
A report has been received from a Health Professional concerning a 3 year old female patient. Patient relevant history, concurrent diseases and concomitant drugs were not reported. Patient received nasal FLUMIST Quadrivalent on 01-DEC-2014. IT was reported that patient moved during administration, therefore accidentally spraying FLUMIST Quadrivalent in eye. They flushed the eye with water for about five minutes. Patient was sent home with recommendations to contact the office should any symptoms or reaction arise. Patient's mother has not contacted the office back, so they think patient is fine. The outcome of the event of administration into eye was unknown. The reporter considered the event to be non serious.
Arm hurt after shot.  I felt  okay until 1:30 pm the following day. It felt like I was coming down with the flu!  Took Tylenol. Felt slightly better.   That night severe chills, sweat out and had to change clothes twice!  Felt better by Friday Morning. Good from there
postherpetic neuralgia; fibromyalgia; herpes zoster; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 27-FEB-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After vaccination, the patient suffered from herpes zoster, postherpetic neuralgia (PHN) and fibromyalgia. As a result of those symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms had resulted in physical limitations not present prior to vaccination. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the herpes zoster, PHN and fibromyalgia to be disabling events.
Pharmacist gave vaccine to 9 patients which looks like the lots were expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  There were no specific dates when administration occurred, but they had the lot number, and it was before 13 Jul 2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. The patients were fine.   Dosage text for suspect product was reported as unknown.  No treatment medication was provided.  This case contains information for the patient 3 out of 9 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case (Patient 1)
Severe menstruation cramps/pain to the point of tears, inability to hold a conversation, or get out of bed. Symptoms began roughly 3.5 hours after second dose and are still continuing in waves nearly 8 hours later. I have had my menstrual cycle for nearly 15 years and have never experienced anything like this. Recently I had a well-women?s check-up/PAP and results were normal, so no reason to suspect any health issues that may suddenly cause this. I have tried applying heat, taking a magnesium supplement, and massaging my stomach to no avail.
Low grade temperature (98.8 ) Chills Fatigue  Mild myalgia Mild soreness at injection site
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On12-FEB-2013 the patient was vaccinated with a dose of expired ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012) orally. It was not known which dose in the ROTATEQ, oral vaccination series this dose of administered. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
29AUg98 pt entered ER w/ c/o fever, chills, achiness, h/a & tenderness @ inj site;instructed to take ASA q 6hr x 1wk;
This spontaneous report was received from a pharmacist, regarding a patient of unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 04-MAY-2018, the patient was vaccinated with VARIVAX intramuscularly instead of subcutaneously, for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported); and with M-M-R II, intramuscularly instead of subcutaneously, for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). No adverse effect was reported.
Fever, irritability, nickle-sized bruising at injection site w/ firm raised lump, mild rash on left arm and forehead. Treated with Tylenol.
Panting began about 20:00, progressively worse. Temperature 101-103 axillary. EMS called and taken to ER at 01:30 to 02:00. No color changes. No hives, rash or swelling. Went home that same morning.
D-dimer was positive; Racing heart rate/Rapid heart rate; palpitations; This is a spontaneous report from a non-contactable other health professional. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration on 23Dec2020 on right deltoid muscle at single dose for COVID-19 immunization. Medical history included episode of chest pain 6 weeks before unspecified date and was seen in ER. The patient's denied any history of previous adverse reactions to vaccines. The patient's concomitant medications were not reported. During her 15 minutes waiting period after the injection on 23Dec2020, the patient began to experience racing heart rate. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Patient presented with rapid heart rate and palpitations. Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing. Lab test included D-dimer was positive and CT negative. No FU since. The outcome of  the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient had the vaccine and then he fainted after the needled removed. He passed out and then he had seizure after. He brought to the Emergency room and was released.
The patient describes shoulder pain that her doctor says is attributable to a rotator cuff injury that may have to do with the vaccine
Pt with seasonal allergies and loose stools was vaccinated with one dose of varicella virus vaccine live and subsequently developed 5-6 lesions at the injection site with swelling and hardness to the elbow. The pt also experienced a fever of 101.8F and intense itching. Pt sought unspecified medical attention and was treated with Benadryl, calamine and ice to the injection site. The pt recovered. No further information is available.
After I received the shot the tingling intensified; After I received the shot the tingling intensified along with the numbness; This is a spontaneous report from a contactable consumer. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on the left arm on 12Apr2021 at 13:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, hypothyroidism, a compound fracture many years before and cholesterol. The patient received concomitant medications within two weeks of vaccination. The patient had known allergies to amoxicillin and food extenders. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021 at 13:45 the After patient received the vaccine the tingling intensified along with the numbness. The tingling is going from the tip of my pinky finger to just above my elbow. I had been over 3 hours since I received shot and the intensity of tingling has not subsided. It's like when you lay on a body part too long and it "goes to sleep" and feels tingly. Well this tingly and numbness never goes away. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events tingling sensation and numbness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recvd MMR vax on 20NOV91 & 13 days following vax pt devel a localized, red-raised rash; by 4DEC91 the rash had become fine & generalized; no further details were provided;
Raised hives on left arm and left leg. Left arm is where shot given. Started in evening the day of vaccination-itching and hives woke up with symptoms.