chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen thyroid; Swollen thyroid and lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 11Aug2021 at 11:30 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication from an unknown date and unknown if ongoing. On 18Aug2021 at 12:00, the patient experienced swollen thyroid and lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen thyroid and lymph nodes were not resolved at the time of this report. The patient received second dose of BNT162b2 (COMIRNATY; Lot number: FC3183), via an unspecified route of administration in the left arm on 01Sep2021 at 11:15 (at the age of 34-years-old), as a single dose for COVID-19 immunisation.
Dizziness; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness) and FATIGUE (Fatigue) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not provided.   This case was linked to MOD-2021-079477 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information was received on 21-May-2021 contains information regarding the patient demographic details.
Nausea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and FATIGUE (Tiredness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and FATIGUE (Tiredness). At the time of the report, NAUSEA (Nausea) and FATIGUE (Tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv vax 8MAR96 & 11MAR96 pt exp puffy eyes;no further details were provided;
Patient received third dose of DTaP at approx 10am 3/24/06. On 3/25/06 at approx 8am small hive/welt was notice on her face.  By 11am hives were increasing.  Hives were on face, bands around uppper thighs, wrists, right ear and right eye.  I called pediatriacian she confirmed what hospital answering service said to give for treatment.  I gave her 2.5 ml of Benadryl since 3/25/06.  To date they are still pronounced.
Information has been received from a licensed practical nurse concerning a 17 year old female with no known allergies and no reported medical history who was vaccinated with 3 doses of Gardasil.  The licensed practical nurse reported that the patient tested high positive for HPV types 16 and 18.  It is unknown what type of test was done because it was done at another office.  All three doses were given by another office.  The patient sought medical attention by coming to the office and as of 19-Nov-2007 had not recovered.  Additional information has been requested.
Pt had vaccine on March 3 then Pt had posterior pain, extreme malaise and waves of nausea and dizziness about 2 weeks after injection.slight fever.  Otherwise previously  healthy . Seen by MD March 25. Second shot March 31. In Middlesex ED April 3 with same complaints. Ct scan revealed liver cyst aspirated.  Continues to this day with abd pain, malaise, waves of nausea and dizziness.
Received the Moderna COVID 19 vaccine after manufacturer date of expiry; Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083J21A) for COVID-19 vaccination.     Patient had no known drug allergies.     On 17-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The health care professional (HCP) stated that they administered the Moderna COVID 19 vaccine on 17-May-2022 and found out that the vaccine had expired for 2 weeks. The HCP explained that since the expiration date was not written on the vial, they did not notice that it had already expired. On 17-May-2022, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions. The patient did not report any side effects. Treatment information was not provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: BUSPIRONE; ARIPIPRAZOLE; FLUOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
chills; fatigue; Initial information received on 11-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 38 years old male patient who experienced chills (chills) and fatigue (fatigue), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5 ml) lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious chills (chills) and fatigue (fatigue) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests were not reported. Final diagnosis was fatigue and chills.  It was not reported if the patient received a corrective treatment.  The outcome was reported as recovered (lasted for 3 days).
Child received 0.25 FLUZONE and 0.25 H1N1 vaccines simultaneous B legs. 10 min. later developed hives-trunk, leg. Waning hive after BENADRYL 3/4 tsp. 12.5/5 given PO. 10/27/09 PCP medical records received service date 10/24/09 Assessment: Hives. Patient developed hives on thighs, right shoulder, abdomen, 10 minutes after H1N1 vaccine.
Arm Pain; Headache; Fever; This case was reported by a consumer and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, headache and fever. On an unknown date, the outcome of the pain in arm, headache and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm, headache and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported, but it could be 50 or 51 years. After receiving Shingrix, that night or the next night, the patient experienced fever, headache, and arm pain for four to five hours. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2021007474. This case is one of 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021007475:Husband's 1st dose US-GLAXOSMITHKLINE-US2021AMR008140:Husband's 2nd dose US-GLAXOSMITHKLINE-US2021007474:same patient, 2nd dose
Pt received moderna booster on 2/8/22 , rash to bilateral forearms started on 2/9/22 - rash is red, itchy , no sob , wheezing or hives , no other new products , foods, meds or travels pt did not have issues w/ first 2 moderna vaccines
25 hours after getting the vaccine, patient had a sudden onset high fever of 104, chills, aches, delirium and most alarmingly a racing heart. He was in bed with these symptoms for 14 hours, then they lifted as suddenly as they came on.
Injection site pain. Arm pain. Chills. Sweats. Feaver.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient was vaccinated IM on the right arm with the second dose of GARDASIL on 26-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 26-MAR-2012 the patient experienced loss of consciousness and fell in the waiting room. The patient regained consciousness and was doing fine. Upon internal review, loss of consciousness was considered medical significant. The original reporting source was not provided. Additional information is not expected.
Onset of erythema, warmth and induration from inoculation site to axilla 1 week after vaccine administration.   Axillary lymphadenopathy.  Dx: cellulitis.  Tx:  Setpra DS twice daily for 10 days.  24 hour follow-up with significant improvement.
Febrile seizure 12/18/09. ? relationship to vaccine as vaccine given 12/15/09.
Within 2 hours of vaccine: sore injection site; 21 hours after vaccine: chills, headache, mild nausea,  mild fever, heart rate elevated 20 bpm above resting, muscle aches (mostly legs and back). Treated with 400 mg Advil every 4-6 hours. Symptoms lasted through the night until about 40 hours after vaccine injection.
Information has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates of 2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M027886, expiration date: 03-JUN-2018, lot # M033211, expiration date: 13-JUL-2018, lot # M032493, expiration date: 06-JUL-2018, lot # M028547, expiration date: 07-JUN-2018) (dose, frequency and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature of 8 Fahrenheit degree during a time frame of 1 hour and 30 minutes. Previous temperature excursion was 25 Fahrenheit degree during a time frame of 1 hour. After the initial excursion and not the current excursion, the patients had administered the vaccine. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004451: US-009507513-1612USA014837.
legs so swollen and full of water he could not walk/Swelling of feet; he can hardly walk; having a hard time seeing; bones ache and hurt; ankles swollen and blue and black; massive pain in both ankles; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs so swollen and full of water he could not walk/Swelling of feet), GAIT DISTURBANCE (he can hardly walk), FEELING ABNORMAL (having a hard time seeing), BONE PAIN (bones ache and hurt), JOINT SWELLING (ankles swollen and blue and black) and ARTHRALGIA (massive pain in both ankles) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, LISINOPRIL, ARIPIPRAZOLE and ATORVASTATIN for an unknown indication.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (legs so swollen and full of water he could not walk/Swelling of feet) (seriousness criterion hospitalization), GAIT DISTURBANCE (he can hardly walk) (seriousness criterion hospitalization), FEELING ABNORMAL (having a hard time seeing) (seriousness criterion hospitalization), BONE PAIN (bones ache and hurt) (seriousness criterion hospitalization), JOINT SWELLING (ankles swollen and blue and black) (seriousness criterion hospitalization) and ARTHRALGIA (massive pain in both ankles) (seriousness criterion hospitalization). At the time of the report, PERIPHERAL SWELLING (legs so swollen and full of water he could not walk/Swelling of feet), GAIT DISTURBANCE (he can hardly walk), FEELING ABNORMAL (having a hard time seeing), BONE PAIN (bones ache and hurt), JOINT SWELLING (ankles swollen and blue and black) and ARTHRALGIA (massive pain in both ankles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: high (High) Cholesterol levels spiked.         No treatment information was provided.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
A spontaneous, non-serious report of two doses of FLUMIST given on the same day was received from a registered nurse concerning a six-year-old female patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Pt broke out in a itchy, generalized rash. Seen at local ER and treated with antihistamine and oral corticosteroid.
Patient stated her back left side (where kidneys located) was sore; Try to go to the bathroom but couldn't go; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Patient stated her back left side (where kidneys located) was sore) and DYSURIA (Try to go to the bathroom but couldn't go) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoedema (in left arm (constantly draining and swollen)) and Breast cancer.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced BACK PAIN (Patient stated her back left side (where kidneys located) was sore) and DYSURIA (Try to go to the bathroom but couldn't go). At the time of the report, BACK PAIN (Patient stated her back left side (where kidneys located) was sore) had not resolved and DYSURIA (Try to go to the bathroom but couldn't go) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-137903 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137903:Same reporter
CHILD'S DATE OF BIRTH WRITTEN AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY PERSON IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN SYSTEM WITH DIFFERENT DATE OF BIRTH. CHILD TOO YOUNG FOR VACCINE ON 08/13/2021.
Tinnitus followed by multiple ear infections leading to ruptured left ear drum. It took 3 rounds of antibiotics (amoxicillin, augmentin, codified) along with steroids and pain relievers to stop the infection. Tinnitus however still remains in the left ear.
No adverse reaction - reporting vaccine given to patient under 18. Patient had parental/guardian consent.
multiple outbreaks of herpes zoster; postherpetic neuralgia; vision issues; Information has been received from the lawyer and the consumer concerning a case in litigation and refers to a patient of unknown age and gender. On 04-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis. On an unknown date, the patient experienced multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions were not reported. On 13-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number not provided) (Strength and route were not reported). Concomitant medication was not reported. Then, on an unknown date, it was noticed that the product was expired as of March 2016. Additional information is not expected because no contact details were provided.
pt recv vax 7JAN97 & ever since vax pt exp pain in lt shoulder right where inj went in;pt also reports it hurts mostly @ noc when pt has been inactive;
I believe it triggered PMR.  I was in pain for three months.  It took three months to get into a rheumatology.  I never had ANY aches and pains before...not even old age.  I have been an avid walker.   After this, I was in a lot of pain in my arms and legs.  It was an effort to even push the covers off of me in the morning.  While waiting to get into rheumatology, I did go to physical therapy once a week for about 2 months.  This helped with my mental health.....and I think it kept me moving.
Severe diarrhea, vomiting, body aches, etc  In 2nd day but vomiting has stopped.
Staff presented with bruise on the left deltoid area. She was vaccinated with flu vaccine on 10/29/08 and state that she noted bluish/ purplish discoloration 2 fingers width below the injection site on 10/31/08. denies pain, swelling, nor SOB. Seen on 11/3/08 and today 11/5/08. No treatment provided.Seen patient and noted on left upper arm from the injection site now 4 fingers width bluish/ purplish discoloration,and 4 fingers width from the antecubital area; no lumps, no swelling, no pain, no redness noted. good pulses, and with  FROM.
pt recv vax 13FEB97 & 26FEB97 pt devel chickenpox;
1/15/23 I had a fever of a little over 100 and sinus infection. I contacted my doctor and started taking Augmentin that day. In March I had an upper respiratory infection, maybe ears or sinus and I took Tetracycline.
Large red bump at site of shot (one inch in diameter) which burns and itches. A really bad headache and a slight fever. Four days later I still have the itchy large rash.  I've been taking Advil and allergy pills which help a little. Also applying ice gives some relief.
And I had a terrible time with both the other doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (And I had a terrible time with both the other doses) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (And I had a terrible time with both the other doses). At the time of the report, VACCINATION COMPLICATION (And I had a terrible time with both the other doses) outcome was unknown.            No concomitant and treatment information were reported by the reporter The patient reported that she had a terrible time with both the other doses, but it wasn't as severe as this booster dose.   This case was linked to MOD-2022-437625, MOD-2022-437608 (Patient Link).   Reporter did not allow further contact
On 4/10/07; declined through 24 hours fever; body aches; headache; nausea Tx'd by parent with Acetaminophen/Ibuprofen alternately