chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever to 103 degrees, back ache, body aches, headache, nausea without vomiting, and immunization site "heavy" and sore, without redness or swelling. Patient was seen in my office on 10/26 for evaluation, T 100, no injection site inflammation, no joint inflammation, no back tenderness, no rash.
Patient c/o nausea and feeling sweaty after receiving vaccine. Symptoms included low HR and hypotension.
24 y/o who received primary SPV, AVA #1 (left arm) and Typhoid, Tdap (right arm) on 7/3/2007. The following day she noticed pain in her left upper arm, limited to the injection site areas, lasting approximately 4 days, then resolving completely. About 48 hours post vaccinations she noticed non-tender swelling in her right hand only, w/o redness, pain, or itching. She described this swelling as 'difficulty making a clenched fist'. This resolved in 24hrs after taking Motrin and Benadryl - no recurrence to date. During same time frame she also felt an enlarged lymph gland in her left neck, non-tender, and which is decreasing in size. SM then received AVA #2 in her left arm on 7/17/2007, noting recurrent pain in the same area within 24 hours and which persists to date. The pain is worsened with arm movements, which is what she describes as 'weakness', but there is no loss of strength. SM has noticed increased frequency of headaches since AVA#2. Headache onset was about a week before AVA#1, and occurred about 3 times per week. Since AVA#2, she has had daily headaches, located in the temples, up to intensity 7/10, lasting no more than 3 hours and relieved with Motrin.
About week later had low grade temperature. Wondering is it possible to get side effect a week later after getting vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "About week later had low grade temperature. Wondering is it possible to get side effect a week later after getting vaccine.". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below was the verbatim report. reporter reporting for son. patient Received 1st dose of covid vaccine. About week later had low grade temperature. The reporter was Wondering is it possible to get side effect a week later after getting vaccine. There were no unaddressed medical questions referred to medical information.  No follow-up attempts are possible. No further information is expected.
Vaccine was adminstered post expiration. A letter was sent to the patient's address on 2/17/2023 stating manufacturer's vaccine activity at the time of administration.   Manufacturer Statement: Moderna reviewed the stability of the vaccine you received and determined that it maintained the activity necessary to protect against COVID-19 at time of administration. Moderna cannot guarantee the protection you have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below.  This patient returned on 3/6/23 to be revaccinated; Moderna Lot#071B22A Exp: 3/19/23.
tested antibody non-reactive; receiving Havrix on 10/28/2002, 9/13/2002, 04/04/2003; receiving Havrix on 10/28/2002, 9/13/2002 and 4/4/2003; This case was reported by a physician via other manufacturer and described the occurrence of therapy non-responder in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis and HAV (Havrix) for prophylaxis.   On 13th September 2002, the patient received the 1st dose of Havrix. On 28th October 2002, the patient received the 2nd dose of Havrix. On 4th April 2003, the patient received the 3rd dose of Havrix. In October 2002, not applicable after receiving Havrix and Havrix and unknown after receiving Havrix, the patient experienced drug dose administration interval too short. In April 2003, the patient experienced extra dose administered. On 14th July 2020, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, extra dose administered and drug dose administration interval too short were unknown.  Additional details were provided as follows: The patient received 2nd dose of Havrix earlier than the recommended interval, which led to shortening of vaccination schedule. The patient received the 3rd dose of Havrix which led to extra dose administered.  The patient's tested Hepatitis A antibody test non reactive. The reporter declined consent to follow up.
(R) arm at injection site has induration of 4.5 cm diameter - Erythema size 7.5 cm diameter.
Expired moderna booster dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna booster dose administered) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 026C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna booster dose administered). On 13-Jan-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna booster dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The booster dose was administered out of a vial which was punctured more than 12 hours.  No concomitant medication were reported.  No treatment medication were reported.
Client was vaccinated at age 11 due to inaccurate date of birth provided by the guardian
possible drug interaction between Shingrix and Humira; This case was reported by a consumer via call center representative and described the occurrence of drug interaction in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for product used for unknown indication.   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Humira at an unknown dose and frequency. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced drug interaction (serious criteria death and hospitalization). The action taken with Humira was unknown. On 2nd December 2020, the outcome of the drug interaction was fatal. The patient died on 2nd December 2020. The reported cause of death was drug interaction.   It was unknown if the reporter considered the drug interaction to be related to Shingrix.  Additional details were provided as follows: The reporter was the wife of patient. In November 2020, the patient received Shingrix vaccine on same day (does not have exact date). The reporter asked, were there any contraindications or drug interactions between Shingrix and Humira. She stated that before they received first dose, healthcare professional (HCP) did not ask if the patient was on Humira and she and her husband (who was only one on Humira) received the first dose of Shingrix. Emergency room (ER) Visit Required. The reporter stated that 2 weeks later the patient was hospitalized and died on 2nd December 2020. The reporter stated when she went to get Shingrix dose 2 for herself in January 2021, HCP asked if she was taking Humira and she was not. She then realized that there might have been a connection with those two products (Humira and Shingrix) which encouraged her to provide this information to other pharma company. The reporter consented to follow up.; Reported Cause(s) of Death: Possible drug interaction
heart palpitations and tachycardia, mild resolved within 9 hours of administration; after that, fever and myalgia x 6 hours; next day, general myalgia only
Baby developed fever of 101.8 after vaccinations, stopped eating and drinking formula began vomiting. Fever spiked to 104.5 and was taken to the ER where she was diagnosed with pyelonephritis.
BITTER TASTE IN MOUTH; This spontaneous report received from a patient concerned a 77 year old female. The patient's weight was 132 (pound), and height was 5.3 inches. The patient's past medical history included urinary tract infection, and concurrent conditions included irritable bowel syndrome, sinus congestion, non alcohol user, non smoker, and pollen allergy, and other pre-existing medical conditions included the patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021;12:45 to left arm for prophylactic vaccination. Concomitant medications included vitamins nos for drug use for unapproved indication. On 10-MAR-2021, the subject experienced bitter taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bitter taste in mouth. This report was non-serious.
The Patient was given pfizer imz- post imz wait-patient alerted the pharmacist that she was not feeling good-nauseous. Took her back to imz booth and told her to sit down with her head down on the table. gave her ice pack. took her blood pressure and temp. Asked if she was diabetic, if she had eaten and any drink before coming. She said no also she has anxiety issues. Gave her glucose tabs and protein bar to eat. Notified Store mgr. Patient refused for ED call and said she would sit for a while more and was feeling ok. Took her blood pressure again- after about 20-mins she stated she is feeling lot better and said she after talking to her mom she is feeling lot better and is able to walk on her on and is headed home.
Started with nausea, quickly become vomiting, then headache and exhaustion. This cycle repeated every 20 minutes or so for approximately 3 hours until eventually each cycle would have more time in between each one and I rested for longer each time. I did not fully go to sleep until shortly after 2 am.   I was also supposed to get my period a week or so after I got the vaccine and it never happened. It is now 6/24/21 and I have still not had a period since receiving the 2nd dose of the pfizer vaccine. According to my cycle pattern, I should get my next period next week, but have yet to have any PMS symptoms that I usually get. If I don't get in by the end of June, I will be consulting medical help.
Patient went to the Birthday party on 09/03/2021 and exhibited the symptoms on 09/04/2021. He was admitted to the hospital on 09/04/2021 and was tested on 09/04/21 at the hospital.  Patient is fully vaccinated.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/3/2022 & 8/6/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a 17 year old female who on 18-JUN-2008 was vaccinated "in her buttocks"  with a first dose of GARDASIL.  In "June 2008", the patient experienced muscle pain and muscle tenderness.  On 18-AUG-2008 was vaccinated in her arm with a second dose of GARDASIL.  She stated the symptoms never resolved and have become worse since receiving her second dose.  At the time of reporting the patient's muscle pain and tenderness persisted.  The patient sought medical attention of the physician.  Additional information has been requested.  2/4/09 Received PCP medical records of 8/12-11/12/2008. FINAL DX: none provided Records reveal patient in good health 8/12.  RTC 11/12 w/pain right gluteal since received HPV #1 in 6/08 at GYN office.  Referred to GYN & neuro if sys persist.  Also had pharyngitis 11/12.  2/17/09 Received GYN vaccine records & medical records of 6/18-2/3/09. FINAL DX: none provided Records reveal patient experienced irregular periods, acne otherwise in good health for vaccinations.  6/18 vax given right gluteal.  11/6/08 note states had problems w/muscle in buttock since vax.  Had stiffness & discomfort in back & hip.  Referred to PCP.  RTC 2/3 for HPV #3 w/o complaints at that time.
Vaccine triggered Uveitis in my left eye and re-activated reactive arthritis that was in remission for 5+ years
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED ( doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED ( doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. Date of placed in refrigerator was on 05-Dec-2021. Vaccine did not undergone any temperature excursion. No  adverse events were reported for patient. No Treatment information was reported.
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Received usual vaccines with no problems. Next morning patient had a fainting spell, woke up, and fainted again. He reports was told he had convulsions. Was taken to ED, had spinal puncture and CT, observed, and discharged. That night (10pm) had lip swelling. The next AM had face swelling, hives all over (arms, legs, trunk) which were big red raised itchy splotches. Lips were swollen so he "looked like a duck". C/O throat tightness. Reports receiving EPI on ambulance back to hospital. Has had persistent head aches and "dizziness"/light headedness since then. Had uneventful breakfast at 0530 (french toast, blueberry, eggs, hashbrowns). Seen 04 Jun at clinic and given MOTRIN at 0900 for head ache. At 1200 hives recurred and also some throat tightening. No lip swelling today. Never had dyspnea, emesis, diarrhea, or abd cramping. No LH or presyncope today or with prior rash. Urticaria became chronic. No additional syncopal episodes.
This spontaneous report was received from a registered nurse and refers to an unspecified number patients of unknown age and gender. On an unknown date, the patients were vaccinated with an unspecified number of doses of PROQUAD lot # n008825 with expiration date 12-SEP-2018 (therapy type: rHA) and lot # n002336 with expiration date 19-JUL-2018 (therapy type: rHA), reconstituted with sterile diluent. There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion from 6 to 14 degrees Fahrenheit for 4 hours. There were previous excursions reported, from 6 to 14 degrees Fahrenheit for 6 hours. Data logger was involved. Sterile diluent used for reconstitution did not undergo a temperature excursion. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA011062:
Booster dose; "I" have not had any interest in sex or masturbation since receiving the booster on 08-October 2021; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the arm left on 08Oct2021 at 19:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The medical history included benign prostatic hyperplasia. The patient had no 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 vaccination. The concomitant medications included tamsulosin hydrochloride (TAMULOSIN), ascorbic acid (VITAMIN C) and ibuprofen (MANUFACTURER UNKNOWN); all for unknown indications from  unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm right on 24Feb2021 at 14:00 (at the age of 70-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm left on 17Mar2021 at 16:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 19:00, since receiving the booster, the patient had not had any interest in sex or masturbation. The patient considered this as a blessing and not a curse. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had not had any interest in sex or masturbation was not resolved at the time of this report.
less side effects and not as severe than those on her first dose; felt fuzzy; dizzy; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (less side effects and not as severe than those on her first dose), FEELING ABNORMAL (felt fuzzy), DIZZINESS (dizzy) and FATIGUE (Really tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING ABNORMAL (felt fuzzy), DIZZINESS (dizzy) and FATIGUE (Really tired). On 30-Mar-2021, the patient experienced ADVERSE DRUG REACTION (less side effects and not as severe than those on her first dose). At the time of the report, ADVERSE DRUG REACTION (less side effects and not as severe than those on her first dose), FEELING ABNORMAL (felt fuzzy), DIZZINESS (dizzy) and FATIGUE (Really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products and treatment medication were reported.   This case was linked to MOD21-050329 (Patient Link).
painful arm no redness-?swelling-anxiety w/SOB;went to MD dx local rxn tx Ibuprofen, heat, motion;
onset pain, redness, swelling, inc skin temp, itching; 6" long 3 1/2" wide swelling & redness (no fever); tx w/Amoxicillin & DPH
Patient reports that several days after shot she began to have a shingles outbreak at the site of injection. The infection has spread and has progressed to open sores and itchiness.
pt recv vax 24JUN95 & pt devel chickenpox w/about 16 bumps total scattered in hairline, behind ear, on thigh & buttocks;it was noted that pt daycare was full of chickenpox right now;MD felt there was a problem w/this particular lot;
7 hours post vax, the pt experienced a 5 minutes episode of pallor, limpness, staring, without jerking or shaking. Completely fine afterwards.
"Administered - 11:05 Adverse event started - 11:10 Patient had flushing/sweating, headache. BP 104/72 -- > 110/72, HR 82 -- > 66, RR 18 -- > 16, O2 = 100%. Patient stable, released from vaccination site."
Fever of 101-103 degrees all day 05/01/2021 (starting at 7am) with fever peaking at 104 degrees in the evening.  Headache, chills, shivering, mild nausea all day.  Profuse sweating at night with fever resolving in the morning.  Temperature normal morning of 5/2/2021 at 97 degrees.  All other symptoms resolved.  Treated with three 1 gram doses of acetaminophen 6 hours apart on 05/01/2021.
sleepy but was generally fine; This is a spontaneous report from a contactable nurse (patient's girlfriend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sleepy but was generally fine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
First Booster given 20 days before the 5 month mark. No adverse reaction was seen or reported by patient
pt return 15-20min p/vax father reported noting swelling of rt side of pt face on arriving home;no hx of breathing problems, rash or trauma to face;t100 ear; BP 80/50;lt posterior auricular node 1cm (non-tender);localized facial swelling;
11 Year old Female received 1st dose of pfizer vaccine and was inadvertently administered adult dose instead of Pfizer 5-11 Year old dose.
Adverse Events:  Exhibited extreme fatigue, persistent headache, persistent muscle aches, persistent joint pain,.
A hypertensive event: I walked from the injection station to a waiting area, by the time I arrived and took my seat I began to feel unwell and my body was disregulated. The on-duty nurse asked me if I was OK. I said I felt unwell, she retrieved the blood-pressure testing device. These are the results  My blood pressure, normally ~119/71p51, spiked to 185/90p56, 2nd test was 166/80(?)p62, 3rd test was 175. Head felt pressure. Body felt chills alternating with heat. Chills with lack of energy persisted for 2 days. Blood pressure on 1/27 was: 98/62p44, 102/51p43, 98/62p44, 94/57p50.
Very sore and sensitive to touch on the vaccination site, headache, soreness all over, stomach pain and cramping, restarted spotting and bleeding after being in menopause for 11/2 years
Site of injection reddened, warm, swollen, hard, and stayed this way for one week.
Within 24 hr. of twinrix 2nd dose,the first thing that happened was a tachy heart rate along with extreme soreness at the site of injection, I had fever, fatigue, N/V headache, gas and cramping, aches short period of resp. depression, very sleepy. It has only been 48 hours and I fear what other symptoms may come......very scared from this experience to have the last dose, box 8 does not apply to me YET!!!
2-2.5 hours after the injection, left shoulder/upper arm swelled and hardened. Injection site to neck and arm  were extremely painful and brought me near tears. Took 2 Advil. Hurt too much to lift or to move the shoulder & upper arm. Severe fatigue and queasy stomach.  Acid reflux/belching and nausea. Went to bed and woke up the next morning  after 8 hours of rest still very tired with somewhat less pain and  able to drive, go in to to work.
Red oval raised area around injection site. It is hot to the touch and slightly hard. 2 days later a rash appeared on the left side of my neck (same arm as injection site although not sure if that is related). Does not itch. Arm was heavy and sore for two days.
Patient was administered PNEUMOVAX 23 intramuscularly in right arm on 07/12/2017. Patient came by the pharmacy today on 07/13/2017 showing us her right arm that had the reaction. We suggested her to seek medical treatment since her arm was getting worse. Patient stated she was going to go into the E.R.