chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her arm was sore after she received the FLUZONE HIGH-DOSE shot. Even after several days, pain continues and she can't move/lift arm.
Three day post shot L arm-tenderness in arm. Whole length of arm-warm sensation, pins and needles, feels very weak.
A consumer report has been received. The report concerns an 11 year old, male consumer, who had been received nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated that a patient received a dose of expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) which started on 20-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by the reporter.
Headache, Myalgia, Arthralgia, "My brain was on fire" Narrative:
Cough; Headache; minor headache; Shortness of breath; This case was received via another Manufacturer (Reference number: UNT-2022-008175) on 21-Apr-2022 and was forwarded to Moderna on 21-Apr-2022.    This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Shortness of breath), COUGH (Cough) and HEADACHE (Headache; minor headache) in a 69-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhaler for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 06-Apr-2022, the patient TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to 18 microgram four times per day. In April 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) 24 microgram four times per day. On 12-Apr-2022, the patient experienced COUGH (Cough) and HEADACHE (Headache; minor headache). In April 2022, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath), COUGH (Cough) and HEADACHE (Headache; minor headache) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered DYSPNOEA (Shortness of breath) to be related. No further causality assessments were provided for COUGH (Cough) and HEADACHE (Headache; minor headache).    No concomitant medications were reported. No treatment medications were reported.  The patient received co-suspect IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A) via inhalation route.  The patient reported cough and minor headache. The physician was aware.  On an unreported date in Apr-2022 (last week), the patient reported some shortness of breath (dyspnea) after getting first COVID (corona virus disease) vaccine.  The reporter did not provide causality for the events of cough, headache and dyspnea for Tyvaso. The reporter's causality for the event of dyspnea with IH Tyvaso was considered to be possibly related.
Patient had no adverse event or outcome. After administration, was discovered that vaccine refrigerator was out of temperature range. Patient is notified and offered re-vaccination. Patient got Tdap on 9/3/2021 that was also discovered to be in vaccine refrigerator that was out of temperature range. Also no adverse event or outcome. Patient also notified of this and offered re-vaccination.
blood pressure over 200 systolic; eyes turned red; Initial information received on 12-Sep-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 39 years old female patient who experienced blood pressure over 200 systolic (blood pressure systolic increased) and red eyes (ocular hyperaemia), while she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, in 2013, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE lot UH906AE expiry date: 30-Jun-2014.  On an unknown date, in 2013, the patient had blood pressure over 200 systolic (blood pressure systolic increased) and red eyes (ocular hyperaemia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. The patient was admitted in a hospital at an emergency clinic. She was declining immunization on adverse events.  Relevant laboratory test results included: On an unknown date, the blood pressure systolic was over 200.   Final diagnosis was increased systolic blood pressure and ocular hyperaemia.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for increased systolic blood pressure and ocular hyperaemia.  List of document held by sender: none.; Sender's Comments: This case concerns a 39 years old female patient who had increased systolic blood pressure and ocular hyperaemia following the vaccination with FLUZONE. Exact time to onset was unknown. The patient's past medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
I was recently dx with early onset albeit mild carpal tunnel in both arms after a couple short numbness/tingling episodes over a period of several months. I started work at 6:45am today and suddenly noticed around 11:30am that if I bent my arms, rested on my elbows, or put any pressure against my elbows, that same numbness/tingling would shoot down my forearms and up my upper arms. I?ve never had this happen before and I have had no incident or added stress on/with my hands/wrists/arms. It?s almost as if the vaccine exacerbated this nerve issue. My entire body also aches but I was prepared for that possible side effect.
Information has been received from a registered nurse concerning a 24 year old female with epilepsy and asthma, who on 28-MAR-2007 was vaccinated with a second dose of Gardasil (Lot# 655849/0263U).  Subsequently, the patient passed out after she was given the second dose.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
On 5/15/99, the pt experienced multiple lesions in all stages on the face, torso, extremities, and one in the mouth. She experienced less lesions on the extremities. Follow up was received which indicated the lesions resolved after one week. The pt was treated with Benadryl.  No further information is available.
COVID vaccine breakthrough case. Moderna 2/26/21 010A21A, 3/26/21 018B21A and boosted 11/24/21 005C21A and 5/4/22 057M21A
Has complaints of swelling and rash on his right arm since 1/27/03 from vaccination. Denies CP, SOB or difficulty breathing. No throat swelling. DX: Allergic reaction. He was given Xenalog 40mg po. RX: Prednisolone 15/5cc 1 tsp q d 8 d, #30cc/Atarax 10/5cc, 1/2 tsp po Q10 prn #60cc.
Shot was given on April 6th. Mild arm pain and lymph node in armpit was sore the day after.  No other side effects till April 11th when injection site turned red and hot. April 14 back pain started in the middle of the day. Later that day fever spiked up to 101.4.  Major body aches, skin sore to the touch, sore throat, sore ears, swollen throat. April 15th, slept most of the day, side effects not so bad. Fever never went past 99.5. April 16, swollen throat and sore ears, temp still at 99.
Dealing with a headache around 6:30 p.m. the day of the shot. Aches and pains in arms and legs and severe fatigue by 10:00. Fever of 101 by the second day. Felt fine by the third day.
stomachache; swelling of lymph nodes of same arm of injection and its spreading to other arm; Body ache; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (swelling of lymph nodes of same arm of injection and its spreading to other arm), ABDOMINAL PAIN UPPER (stomachache), MYALGIA (Body ache) and HEADACHE (headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced LYMPHADENOPATHY (swelling of lymph nodes of same arm of injection and its spreading to other arm), ABDOMINAL PAIN UPPER (stomachache), MYALGIA (Body ache) and HEADACHE (headache). The patient was treated with ANTIBIOTICS-RESISTANT LACTIC ACID BACTERIAE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (swelling of lymph nodes of same arm of injection and its spreading to other arm), ABDOMINAL PAIN UPPER (stomachache) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   Reporter did not allow further contact
Arm soreness, arm fever, fatigue and vomiting all started at 5pm the next morning my arm was hurting bad Like it was ran over and the fever was all over 101.3 and was very fatigue.
Broke out in hives in the middle of the night. All over my legs and arms. Very itchy but otherwise doesn?t seem like a problem.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
A non-serious Spontaneous report of "Administration to two individuals over 49" was received from a Nurse/health professional concerning a two individuals over 49 year age. The relevant medical history was not been reported for this Patient. On 25-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
No additional AE/PQC reported; Patient received a dose of the RECOMBIVAX HB vaccine that was improperly stored; This spontaneous report has been received from a healthcare professional, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 18-MAY-2023, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (lot number W012032 has been verified to be valid, expiration date reported and confirmed as 19-NOV-2023), as prophylaxis (exact dose, route of administration, and anatomical location were not provided) (Product storage error). No additional adverse event (AE) nor product quality complaint (PQC) were reported.  This is one of multiple reports received from the same reporter. ; Sender's Comments:  US-009507513-2306USA003052: US-009507513-2306USA003084:
1234-Vaccinated 1258-C/O Throat itching and Shortness of breath Pulse 106,BP within normal, O2 sat 100.  1302- Epi Pen given 1308- Patient transferred to ER
Shortly after the shot, I had a bright red hot egg shape above my elbow, sore to the touch. I don't think the shot got in my muscle. I think it leaked down the skin to my elbow. No pain at injection site. The red and hard hot area has spread to about 6" x 5" area, is less hard and sore.   Will my body continue to absorb this and is it a real shot?  She didn't push that tiny needle into the muscle. I didn't go to the doctor; I'm asking you.
101 degree fever for 2 days, blurry vision for 3-4 days
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 09Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 06Aug2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CFIDS" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "COPD" (unspecified if ongoing); "DDD" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "severe sleep apnea" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "chronic pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Choline, reaction(s): "Allergy"; Amoxicillin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Se2023 to 16Sep2023.  Clinical course: Patient got COVID from her Caregiver and was exposed to it on 07Sep2023 (as reported) before this new and 5th vaccination was made available to her on 12Sep2023! So, instead of being proactive and making this latest vaccination available sooner, now they are getting sick and having to be reactive! Called (Withheld) three times to be checked out and to ER.
Double dose of Varicella on a 1 y/o. 1 shot of MMR-V; 1 shot of Varicella. No signs or symptoms.
devel redness, itching, skin hot to touch, & firm area under redness on rt upper arm 1" x 1 1/2" on 19FEB97 devel to 4" x 4" by 20FEB97;ice packs & PDH
Patient was given his 4th dose of Pfizer vaccine today.  This was under the direction of his oncologist.  He received an stem cell transplant on 06/11/2021 and it was recommended that he repeat all of his vaccines.
I developed shingles. At the time of doctor visit, I assumed it was stress, low immunity but having read newspaper articles, I realized I have adverse reaction to the vaccine. My mother received the Astra Zeneca vaccine and also developed shingles. This can't be bad luck or pure coincidence.
Dizziness. I'm dizzy, when I am moving or using my computer or just doing nothing. Lips and hands go numb. It kind of just comes out of nowhere. The most recent was when I was eating (all things I know I am not allergic to) and my lips just went numb. Before that, my hands went numb, and I have not pin-pointed why.
Child with 6"x8" induration left deltoid area. Area red, swollen and painful; hot to touch. No cold pack used or Tylenol given to child by parents.
I am a type 1 diabetic on insulin in a insulin pump for 2 days s/p vaccine I had an increase in amount of hypoglycemia, I needed to reduce my basal insulin by 50 % for > 24 hours.
Really bad tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Really bad tachycardia) 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 TACHYCARDIA (Really bad tachycardia). At the time of the report, TACHYCARDIA (Really bad tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the nurse practitioner is a female around aged 30-40years  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Followup received contained No New Information (NNI)
Heavy menstrual bleeding, swollen LUMPS down my left arm near wrist and elbow,  large fist size lump on side of left breast, , small plum size mass under arm, lump on left collar bone, swollen tendon inside arm, weakness, muscular pain, painful to move arm, tiredness
Pt reported next morning after shot, she developed extensive swelling on her left arm. It extended to her underarm and rash across chest. Reaction went away after 2 days.
Product was store after expration; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Product was store after expration) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was store after expration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Product was store after expration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No temperature excursion happened after vial was placed in refrigerator on 29-Oct-2021. No adverse event was reported.  No treatment medication was reported by reporter.
Combined initial physician report received via sales representative on 26 May 2010 and follow up physician report received on 27 May 2010: This polymedicated patient received treatment with DIOVAN AMIO 80/5 mg coated tablet, one tablet daily orally for hypertension on 09 Aug 2006. On an unknown date, In 2007 DIOVAN AMIO 80/5 mg was replaced with DIOVAN AMIO FIX 80/5 mg. On 17 May 2010, the patient experienced complete loss of taste The patient sweetened the vitamins with a lot of sugar and then also he did not feel the taste. The physician reported that the patient took H1N1 vaccine (manufacturer unknown) and lost the taste after that. He also lost 9 Kg of weight in 30 days. On an unknown date the patient experienced metabolic syndrome. On 26 May 2010, the patient stopped taking DIOVAN AMIO FIX and was put on AMLODIPINE 10 mg, once daily and INDAPAMIDE 1.5 mg once daily due to the events. It was reported that if the patient symptoms improved with these medication, then the physician would identify whether the reaction was caused by DIOVAN AMLO FIX. The outcomes of the events were reported as persist with same intensity/unchanged. The causality was not reported.
Information has been received from a registered nurse concerning a 14 month old black female with no allergies or medical history who on 12-JUN-2006 in the a.m. was vaccinated SC in the left arm with a first dose of Varivax (lot # 652798/0429F). Concomitant vaccination at the same time included a SC first dose in the right arm of MMR (lot # 650105/0829R), an IM first dose in the left thigh of VAQTA (lot # 651877/0706R), and an IM fifth dose of PEDVAXHIB (lot # 651986/0527R). There was no concomitant medication. There was no illness at the time of vaccination. On approximately 14-AUG-2006, two to three days prior to seeing a physician on 17-AUG-2006, the patient had broken out into a chickenpox-like rash. The patient had no fever and was exhibiting normal activity. There was a total of 10 or more lesions that were at variable stages of development. Noted on the patient's chart were three lesions on the face and four lesions on the legs. The lesions on the legs were crusting. There were one to two new red vesicular bumps on the patient's arm. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the nurse who reported that the patient's adverse event onset was 15-AUG-2006. The patient was examined on the second or third day of illness/rash. No fever was noted. The patient was positive for varicella lesions. The patient recovered on an unspecified date.
Had received Varicella and Prevnar, had left the building and came back about 15-20 minutes later and face was bright red with pea sized hives covering her face. Sent to the ER.
After receiving Menacta vaccine child developed severe unilateral headaches. Ten days after the vaccine was given she developed a headache with dizziness, nausea, vomiting and loss of speech. An EEG showed left temporal spikes and she was started on Tegretol for seizures. CSF was positive for Varicella by PCR. Child had Varicella disease at 2 years old. She had no rash at the time of the seizures.
Tenderness, erythema, edema and warmth over injection site of the L UE associated with chills/myalgias.
Information has been received from a registered nurse (R.N.) concerning about 5 patients who on an unknown date were vaccinated with improperly stored GARDASIL (dose, route and lot number were not reported). The vaccines were exposed to 30 degrees F over the 16 day period. There were no adverse effects reported. Follow up information was received from the office. The reporter indicated that there is no additional information for these patients. None reported any adverse effects other than that was provided initially. Follow up information was received from administering healthcare professional. It was reported that a 11 year old female patient with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination, on 20-DEC-2011 at 09:30 A.M., was vaccinated with the third dose of GARDASIL (lot number 671006/1291AA) I.M., left deltoid (dose not reported) at private doctor's office/hospital. It was also reported that on 11-FEB-2012 the patient was reimmunized with GARDASIL (lot number 672193/154AA, expiry date 25-AUG-2014), I.M., right deltoid (dose not reported). There was no reaction to reimmunization. The patient did not seek medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. No further information is available.
Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (Bad headache). At the time of the report, HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information was provided.
One week after inject,  pt devel dermatitis both arms, then to both legs.pt recv unspecified tx;As of 15DEC sl improvement was noted;
Left arm swelling/erythema/warmth/headache/temp 102 deg, onset 1 day after Dtap, left arm. Ice/ibuprofen prn.