chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills after booster; The enlarged lymph node came back again; After the booster she had  Headache; After the booster she had a Low grade fever; Today, 30DEC2021 she started having swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Today, 30DEC2021 she started having swollen lips), CHILLS (Chills after booster), LYMPHADENOPATHY (The enlarged lymph node came back again), HEADACHE (After the booster she had  Headache) and PYREXIA (After the booster she had a Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced LIP SWELLING (Today, 30DEC2021 she started having swollen lips). On an unknown date, the patient experienced CHILLS (Chills after booster), LYMPHADENOPATHY (The enlarged lymph node came back again), HEADACHE (After the booster she had  Headache) and PYREXIA (After the booster she had a Low grade fever). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) for Headache, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Today, 30DEC2021 she started having swollen lips), CHILLS (Chills after booster), LYMPHADENOPATHY (The enlarged lymph node came back again), HEADACHE (After the booster she had  Headache) and PYREXIA (After the booster she had a Low grade fever) outcome was unknown.            No concomitant medications were provided.   This case was linked to MOD-2021-435175 (Patient Link).
Pt complained of rash, dizziness, fever, headache and muscle pain. Went to the Dr and was given Flexeril and Keflex.
Pt was given varicella SQ in his (R) arm. Pt had pain & redness at site within first 30 mins of injection. Since then redness & swelling & pain have worsened.
After receiving the third dose of the Pfizer vaccine I started have a disruption to my menstrual cycle. This included significant bleeding between periods and after intercourse. I'm not pregnant or taking  birth control and I have no history of polyps or abnormal pap smears.  This carried on for two months and now has completely resolved. The only thing that was out of my usual routine was receiving the third dose of the covid vaccine.
Tuesday 10/25/2005 afternoon parents noticed injection site on left thigh with swelling and redness, itching at site. Increasing erythema and induration, but no systemic symptoms.
No adverse effects reported.; the patient was "inadvertently administered 3 doses of VAQTA instead of the recommended 2 doses."; the patient was "inadvertently administered 3 doses of VAQTA instead of the recommended 2 doses."; This spontaneous report has been received from a medical assistant referring to a 5 years old patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      The patient was inadvertently administered 3 doses of hepatitis a vaccine, inactivated (VAQTA) instead of the recommended 2 doses. On 11-NOV-2016, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (lot #: L030442, expiration date: 19-DEC-2016; route and dose details were unknown) for prophylaxis. On 24-MAY-2017, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (lot #: M039202, expiration date: 11-MAR-2018; route and dose details were unknown). On 22-MAY-2020, the patient was vaccinated with the third dose of hepatitis a vaccine, inactivated (VAQTA) (lot #: S032055, expiration date: 09-NOV-2020; route and dose details were unknown) (incorrect dose administered and extra dose administered). No adverse effects reported.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: L030442; expirationdate: 19-DEC-2016; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Received AFLURIA that reached 47F for 8 hours - no adverse event This spontaneous case initially received on 01-Sep-2016, was reported by a health professional and concerns and 86-year-old male patient. Weight: not provided; Height: not provided Administration of company suspect drug(s): The patient received AFLURIA from 01-Sep-2016 to 01-Sep-2016. Dose regimen: 0.5 ml 1 time dose, Route of administration: Intramuscular. Batch number: WT54006. No additional suspect drugs. Special circumstances: 01-Sep-2016, the patient was administered AFLURIA that reached 47F for 8 hours - no adverse event (special circumstances: drug administration error without adverse event). The outcome was reported as unknown. Reporter comments: The reporter considered the event as non-serious (medication error).
Woke up day after vaccination with very dry lips. Over a 3 day period they became severely chapped, dry, cracking, peeling, itchy, soreness. Medicated lip bam caused very uncomfortable stinging and itching.  I used a non medicated, natural lip lip balm constantly up until about 3/10/2021, when they started to feel a bit better. Received 2nd dose of Pfizer/BioNTech vaccine, same location, same appt time, Lot #EN6207 on 3/13/2021. The next day, 3/14/2021, my lips started to rapidly become very chapped, dry and irritated again. This time I had swelling and broken skin. I continued using the same lip balm consistently until 4/6/2021, when they started to feel better again. Today, 4/7/2021, my lips are almost back to normal. I have never experienced an issue like this in my life, that I can recall.  Just a major discomfort and inconvenience, and I haven?t heard of this anywhere.
Fever since 5 hours after injection. Chills, body ache, headache Fever as high as 102.6 at morning of the next day and 100.8 24 hours late
difficulty to swallow; eyelids swollen; swelling in right hands and wrists; Itchy; red; Broke out in hives and worsened; felt pretty tired; typical sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (typical sore arm), FATIGUE (felt pretty tired), PERIPHERAL SWELLING (swelling in right hands and wrists), PRURITUS (Itchy) and ERYTHEMA (red) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (typical sore arm). On 08-Mar-2021, the patient experienced FATIGUE (felt pretty tired). On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling in right hands and wrists), PRURITUS (Itchy), ERYTHEMA (red) and URTICARIA (Broke out in hives and worsened). On 12-Mar-2021, the patient experienced DYSPHAGIA (difficulty to swallow) and SWELLING OF EYELID (eyelids swollen). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (typical sore arm) had resolved. On 08-Mar-2021, FATIGUE (felt pretty tired) had resolved. At the time of the report, PERIPHERAL SWELLING (swelling in right hands and wrists), PRURITUS (Itchy), ERYTHEMA (red), URTICARIA (Broke out in hives and worsened), DYSPHAGIA (difficulty to swallow) and SWELLING OF EYELID (eyelids swollen) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported treatment of events was with cetirizine (Zyrtec) 20mg and methylprednisolone 6-day pack.
I had chills at night, before bedtime, on day I got second Moderna vaccine, left arm soreness, slight headache, muscle soreness and tightness from right calf to buttock (along right leg), and fatigue.  My symptoms were severe until March 4, 2021 which included all of the following: headache, right leg muscle soreness, fatigue, and left arm soreness.  I took a Tylenol 500 mg capsule on night of March 2, 2021, as advised by the pharmacist who gave my shot.  Also, my right leg tightness and soreness was finally reduced, significantly on March 12, 2021; prior to 3/12/21, I was unable to take along walks due to the discomfort and pain which I solved with ice and massage.
General Feeling Bad, Chronic Fatigue, Severe Headaches, Dizziness, Heart Palpitations, Tachycardia, Syncope, Chest Pain, Itchy and numbness in hands and feet, Brain fog, difficulty remembering things. These symptoms have come and gone since June 2013 with extreme fatigue worsening November 2014 causing to be withdrawn from school. Started IV Therapy treatment December 2015 containing high doses of Vitamin C and chelation materials.
Tenderness at injection site. Lasted 2 days. Muscle spasms periodically in right arm following injection. Occurred approximately 10 times in the week following the injection.
Headache, Myalgia, Arthralgia, Fever, Diarrhea,  NauseaVomiting, Localized pain; chills, fatigue Narrative:
pt had an extremely sore swollen arm for 9 days, pt had extreme flu-like symptoms and fatigue for 9 days.
developed COVID-19 infection; This is a spontaneous report from a contactable pharmacist. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced developed covid-19 infection. Reporter would like to know what patient should do about his second dose of the Pfizer COVID-19 vaccine that was scheduled on 13Aug2021 and by when he will be out of isolation. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The outcome of the event was unknown.
A red rash spread from under both arms down both sides and across my chest and abdomen.  I experienced burning, pain to the touch, swelling, and itchiness.   Hard knots under my arm from swollen lymph nodes.  The rash has lasted 17 days and is just now beginning to diminish.  New spots on my neck and chest are appearing even now.
ANXIETY; CHILLS; THROBBING HEADACHES; This spontaneous report received from a parent concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 12-APR-2021, the subject experienced anxiety. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced throbbing headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the throbbing headaches, chills and anxiety was not reported. This report was non-serious.
Increased TSH; This is a spontaneous report from a non-contactable other hcp (patient) reported for herself. A 77-years-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 23Jan2021 (at the age of 78-years-old) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via intramuscular, administered at an unspecified anatomical location on 13Feb2021 (at the age of 78-years-old) as dose 2, single both for COVID-19 immunization. Patient received co suspect levothyroxine, oral from 1980 to an unspecified date, at unspecified dose for an unspecified indication. Medical history included autoimmune thyroiditis from 2020 to 2020. The patient's concomitant medications were not reported. On an unspecified date in 2021 the patient experienced increased tsh. In 2020, the patient experienced hashimoto's hypothyroidism. In 2021, the patient experienced Elevated TSH levels after both covid vaccines. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone which showed 14.69 result on 01Mar2021, blood thyroid stimulating hormone which showed 14.16 result on 11Mar2021 and blood thyroid stimulating hormone which showed 6.6 on 04May2021. The action taken of levothyroxine was unknown. The outcome of the event was recovering. The reporter's causality for the event(s) of Elevated TSH Levels After Both COVID Vaccines was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 for 2 hours and 50 minutes.; Dose were administered after the excursion happened.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.), PRODUCT TEMPERATURE EXCURSION ISSUE (Some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 for 2 hours and 50 minutes.) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 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 04-Aug-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 for 2 hours and 50 minutes.). In August 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.), PRODUCT TEMPERATURE EXCURSION ISSUE (Some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 for 2 hours and 50 minutes.) 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 POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 for 2 hours and 50 minutes.).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19. No concomitant medication was reported.  HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 for 2 hours and 50 minutes. Maximum temperature reached was 21.4°F. That was the first and only excursion. 11 doses were administered after the excursion happened. No PQC was reported. No treatment information was reported.     This case contains information for patient 8 out of 11.   This case was linked to US-MODERNATX, INC.-MOD-2023-736913 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736913:Master case(Patient 1)
During screening, patient stated she has tested positive while in Ohio in early January, had symptoms of headaches and loss of taste.  Upon returning to CA, tested positive again Feb. 1st  and was diagnosed as a "long-hauler".  Denies any symptoms at this time except for loss of taste.  Approximately 10 minutes after injection in monitoring area, patient began complaining of dizziness, headache, nausea and feeling hot.  After about 10 minutes more, patient then began complaining about chills and stated she felt the need to throw up, spit up a small amount of sputum.  Offered to call for ambulance, patient stated she did not want to go to the hospital, just wanted to go home.  Approximately 10 minutes later, patient felt stable enough move her to a wheelchair and assisted outside so that she could remove her mask.  02 applied at 2L via nasal cannula, patient stated immediate relief of nausea and dizziness once outside.  After another 10 minutes, patient stated headache was now a dull ache and she felt well enough to go home.  Spouse provided nurse call number for local hospital, patient transported to vehicle via wheelchair.
Patient's left hand swelled up about 30 minutes after vaccine was given. Patient was able to breathe ok but felt dizzy. Patient was given 12.5mg of liquid diphenhydramine and was told to sit down. About an hour after that, the swelling went back down to about normal and patient was okayed to leave.
Had swollen/red deltoid L arm DTaP #4 (hep B #1) also given. Resolved. Hep B #2 9/17 L deltoid red swollen rxn. 9/18-9/19 eval. ques. if sensitive to hep B when reacted to DTaP.
Subsequent to receiving one dose of varicella virus vaccine live the pt presented to a physician with vesicles, pustules, a bruised appearance at the injection site and a fever. The pt was diagnosed with conjunctivitis and pharyngitis.
Client received 2nd COVID vaccine of Moderna (Lot# 024C21A expiration date 06/24/2021). At 1344, Client reported a "static noise" in both ears. EMT responded to this event at 1345. At 1345, vital signs are blood pressure 166/91, heart rate 102, oxygen saturation 98. RN and PHN responded to this event at 1346. Client reports history of Type 2 Diabetes, takes Metformin and potassium supplements daily. At 1350, vital signs are blood pressure 147/84, heart rate 106, oxygen saturation 97%. Client offered supplemental nutrition and fluids. Client accepted fluids, but denied nutrition. Client reports "all symptoms have gone away". RN educated Client about ED precautions and common adverse effects of COVID vaccines. Client reports allergies to dust, cotton, eggs, rice, beans. At 1357, vital signs are blood pressure 136/77, heart rate 103, oxygen saturation 99%. At 1403, Client is talking with staff and states "it's all gone". At 1410, vital signs are blood pressure 148/82, heart rate 102, oxygen saturation 98%. Client reports no new symptoms and that all reported symptoms has resolved. At 1411, Client stood up with no complaints. Client is accompanied with daughter, states "my sister is driving us home". At 1414, Client walked out of facility with a steady gait.
T104 R- 103.6 @ 110PM no other sx; CBC WNL temp resolved;
One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent female. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Covid reappeared; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2022 and was forwarded to Moderna on 24-May-2022.    This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid reappeared) in a 76-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 01-Mar-2022 at 9:00 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-May-2022 at 7:00 AM, the patient experienced COVID-19 (Covid reappeared). At the time of the report, COVID-19 (Covid reappeared) was resolving.            Reportedly, Patient did not received any other medications or products within 2 weeks of starting COVID-19 treatment and Patient previously received a COVID-19 vaccine.  Concomitant medications details were not reported by the reporter.  The patient had taken unspecified Pfizer drug from 02-May-2022 to 6-May-2022 for the COVID-19 treatment.  Device Date was reported as 23-May-2022. COMPANY COMMENT: This is an spontaneous case concerning a 76-years-old male patient with medical history of had taken unspecified Pfizer drug from 02-May-2022 to 6-May-2022 for the COVID-19 treatment and Drug allergy, who experienced the unexpected  event of COVID-19 (AESI) 69 days after  receiving 2nd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 76-years-old male patient with medical history of had taken unspecified Pfizer drug from 02-May-2022 to 6-May-2022 for the COVID-19 treatment and Drug allergy, who experienced the unexpected  event of COVID-19 (AESI) 69 days after  receiving 2nd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient's mother requested a Moderna Vaccine booster for her teenagers when she was receiving her Moderna booster.  She filled out the consent forms and the teenagers were incorrectly admininistered a Moderna booster (dose 0.25ml).  She showed the immunizer a copy of the teenager's vaccine card for the previous Covid vaccine doses.    The other teenager (age 14).  A separate VAERS form has been for.  The boosters were administered outside of guidance for age and for the booster.
1st dose 24Mar2021; no 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose 24Mar2021; no 2nd dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 24Mar2021; no 2nd dose). On 13-Aug-2021, PRODUCT DOSE OMISSION ISSUE (1st dose 24Mar2021; no 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had had an antibody test in end  of Jun2021 or beginning of Jul2021 with a result of 20 (no units). No concomitant medications were reported. No treatment information were reported.