chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some pain; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and PAIN (some pain) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced PAIN (some pain). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown and PAIN (some pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.   Reporter did not allow further contact
Very large area of swelling and tenderness in leg. Resolved over 1 week. (at DTP site)
I had minimal pain in my arm the day of the actual vaccination but the next day my arm was completely sore and I had headaches which is understandable and I was warned about but then on the third day I around 4:00 am I woke up with my left eye severely swollen, red, and itchy. I took Benadryl and applied ice but now it?s 12:30 pm and it is still swollen and itchy
Stomach indigestion; Nausea; headache; diarrhea; Stomach distended; exhaustion; The morning after vaccine it hurt toraise my arm; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6205), administered in left arm on 09Mar2021 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to penicillin, imodium, shellfish and bees stings. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), Fexofenadine hydrochloride (ALLEGRA), Diphenhydramine hydrochloride (BENADRYL). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, patient was not tested for COVID-19. Since the vaccination, patient has not tested positive for COVID-19. On 10Mar2021 at 07:00, after the vaccination, the patient experienced pain in arm, around 14:00 he experienced exhaustion. On 11Mar2021, the patient experienced stomach indigestion, nausea, headache, diarrhea and stomach distended. It was reported that, the morning after vaccine it hurt to raise her arm. Around 14:00 PM she was very exhausted all she wanted to do was sleep. The next four days she had terrible stomach indigestion, nausea, headache and diarrhea which probably woke her up out of asleep. It felt like a volcano irrupting in her stomach and stomach was very distended. The patient took tumbs which would not help, but pepsid did help for the most part. The headache was constant, but at times it would go away and then come back. The patient only took Aleve once or twice for headache. Further it was reported that, the patient really did not feel good until the 17Mar2021.The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, exhaustion, stomach indigestion, nausea, headache, diarrhea and stomach distended were recovered on 17Mar2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician via company representative, concerning an 11-year-old female patient. The patient's medical history, concurrent conditions, historical drugs or allergies were unknown. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, MENACTRA, influenza virus vaccine (unspecified) and bacille Calmette-Guerin (BCG) vaccine. On 18-FEB-2019, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, lot number R008164, expiration date 12-NOV-2020 (strength, dose, frequency and anatomical location were not reported) for prevention of human papilloma (HPV). On the same date, the patient experienced syncope, described as "her eyes were rolling back". She did not receive any treatment for the event. It was reported that the patient was in the physician's office, and it was unknown if any laboratory diagnostics-studies were performed to her. The patient was observed for five to ten minutes and she recovered. The causality assessment between GARDASIL 9 and the aforementioned event was not provided. Upon internal review syncope was determined to be medically significant.
At 9:00 am, my daughter got extremely fussy and crabby and showed a 100.1 degree low grade fever. At that time, she was given 2.5 ml of Tylenol, which didn't help the fever at all. The doctor recommended increasing the Tylenol dosage and to give between 2.75 and 3.75 ml.
12/13/11 10:52 Patient called advice line: states had a tetanus shot in her right arm 12/8/11. States there is swelling under the arm & at the injection site.
02:20 Patient received Ist dose of Janssen.  02:24 Patient complained throat felt like it was closing and difficulty breathing, audible wheezing and stridor.  Given Epi Pen 0.3mcg IM Right thigh. 911 called.  02:26 Given 25 mg of liquid Benadryl PO.  02:30 BP 140/94 Pulse 96 RR 26.  02:34 EMTs arrived BP now 100/60 Pulse OX 97% Pulse 85.  02:40 Walked out by EMT and Paramedics to the ambulance.
About one week and a half after receiving the 3rd shot in the COVID series, I developed a whole body rash involving the scalp and neck, arms, torso, back, chest, arms, and legs. Both papular and maculopapular rash has appeared and disappeared on body. Rash appears in both small and large patches, with largest patches being on the torso and back.  One day of lower lip swelling was present (11/18/21) and one day of hand and wrist swelling was present (11/19/21).
I'm experiencing ptosis (droopy left eye) and double vision.  The Ophthalmologist diagnosed my condition as "Third Cranial Nerve Palsy" and that it would take 3 to 6 months to cure itself and that  sometimes this condition may take as long as a year.  If it doesn't cure itself surgery will be required and special glasses to wear.
The MODERNA 6mo-5Years was diluted with 2.2ml of 0.9% sodium chloride (normal saline, preservative -free diluent. Administered .2ml to left vastus lateralis. Parent notified 07/08/22 at 6:00pm of incident. No adverse reaction at that time. Educated parent to signs and symptoms of adverse reactions. A follow up call will ensue with the CDC recommendations for further vaccination information.
No adverse event; Dose 1 on 01-DEC-2020  and dose 2 on 21-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-DEC-2020  and dose 2 on 21-MAR-2021) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma, Cardiovascular disease, unspecified, Latex allergy, Drug allergy (morphine sulfate allergy), Drug allergy (compazine allergy) and Drug allergy (beta blockers allergy).   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-DEC-2020  and dose 2 on 21-MAR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 21-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-DEC-2020  and dose 2 on 21-MAR-2021) outcome was unknown. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-DEC-2020  and dose 2 on 21-MAR-2021).    Patient took 5th dose of Moderna bivalent vaccine on 12-Oct-2022 in the left arm.  Patient experienced rebound of COVID-19 after Paxlovid on 13-Feb-2023, symptoms included fever, cough, congestion, headaches.   The patient was also taking Theophylline, Gabapentin, Aspirin, Nexium, Ibuprofen, Zyrtec and Metoprolol.  Treatment information was not provided.   Device date was reported as 15 Feb 2023.
Information has been received from a registered nurse concerning an 18 year old female who on 11-SEP-2006 was vaccinated with a first dose of GARDASIL.  On 03-JUN-2008 she was vaccinated with a second dose of GARDASIL.  The patient experienced pain at the injection site after injections.  At the time of the report, the outcome of the injection site pain was unknown.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/9/2008. Follow up information was received from a registered nurse concerning a 19 year old female patient with seasonal and cat allergies, who on 03-JUN-2008, at 11:50 am was vaccinated with a second dose of GARDASIL (Lot # 660391/0063X) and with a second dose of HAVRIX (Lot # AHAVB 268AA). The nurse reported that more than one year elapsed between dose 1 and 2 of GARDASIL. No other problems with immunization. There was no illness at the time of vaccination. No further information is available.
20-30 min post injection, patient experienced tachycardia, palpitations, shortness of breath, syncope, loss of consciousness. 911 contacted by nursing home staff.  Patient was placed in nursing home bed, 1 EpiPen dose administered by clinic nurse (RN. Nursing home staff began supportive care, supplemental oxygen given. patient experienced petit mal seizure and was non-responsive for a few minutes.  Eventually came to but was still unstable.  Paramedics took over at this point and patient was evaluated and transferred to hospital.
Localized burning sensation, nausea, vomiting, headaches, insomnia, tremors, numbness on left side of head, balance. Information from 60 day follow-up report states: Currently being treated at hospital. Pt is in a study. Pt had an undetected immunoglobin A deficiency. According to immunologist. The vaccine triggered the deficiency.
This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBIN DECREASED (A steady decline in my hemoglobin levels) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMOGLOBIN DECREASED (A steady decline in my hemoglobin levels). At the time of the report, HAEMOGLOBIN DECREASED (A steady decline in my hemoglobin levels) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: 10 (Low) Decreased. Patient used to run hemoglobin 14 but now it decreased to 10. Patient does not have any life style changes and don`t have uterus. Concomitant medications were not provided. Treatment information was not provided.
syncopal episode @ time of vax 30SEP97;nausea & low grade fever for rest of 30SEP97;still w/fever, weakness, achy & knees will just given way;no rash;no vesicle;light h/a;site red;5cm erythema;
On 1/27/2021 at approximately 7:00pm, my left should area itched.  I lightly scratched it, and felt some slight swelling about the size of a quarter.  I felt slightly warm and was pink.  This swelling as less than one inch away from what I think is the injection site.  The injection site was a pink dot  which resembled a pimple or a small bug bit.  This morning the swelling has joined the area of the injection site.  Slightly itchy so I put cortisone cream on it.  Still pink, raised, and slightly warm.  I also have a slight headache, but not other issues/
Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Went for a short run  8 hours post vaccination and immediately (within 10 seconds of stopping running) felt the blood flow into my hands.  My hands turned bright red and  became incredibly itchy; shortly thereafter my feet began to feel incredibly itchy.  I went to take a shower and upon entering the bathroom immediately noticed that my face was red around the nose and mouth and I was breaking out in hives on my face, neck and back ( I have never had hives in my life).  Within less than a minute of that occurring my underarms began to itch severely and when I lifted them up there was a  rash under each arm and soon thereafter rash broke out all over my body (on my stomach, inner legs, back, groin,, etc.  I took 2 over-the-counter Benadryl tablets and within 2 hours the itense itching had subsided.  By the next morning my rash was gone and I was back to normal.
7/28/99 1 tab; next day, small raised, rash on chest. 7/30/99 1 tab; next day rash on trunk and arms. 8/1/99 1 tab; next day rash on body and all extremities plus swelling of lips. Took Benadryl and consult with MD's she works with at local hospital.
Expired vial 10/24/2021 administered 10/27/2021.
Night after vaccine administered patient developed joint pain, insomnia, numbness of certain areas on right side of body (cheek, elbow, thumb, heel), had headache, chilles, some complaint of chest pain.  3/12/09 MR received from PCP.  Pt in 2/3/09 for multiple vax (8 total) prior to travel abroad.  TC from pt 2/5/09 with c/o H/A and generalized aching, joint pain, and sporadic numbness in the L arm and face.  Seen 2/9/09 for numbness on the R side of body, R arm and hand pain, bilateral knee pain, heaviness in the head. chills, night sweats, chest pain and voice alteration. ROS (+) for fatigue, poor appetite, weight loss, nasal congestion, post nasal drip, muscle pain, joint pain and tingling in addition to above. PE (+) for murmur, sensory disturbance over the R cheek and mandible as well as R heel, numbness R elbow, knee effusion.  Impression:  R sided numbness in various locations.  Joint pain, primarily in R hand & knees.  Recent vaccines.  DM.  Bicuspid aortic valve with aortic insufficiency.  Chest pain.  Neurologist consulted suggests ? mild encephalitis.  Suspect r/t YF vaccine. F/U 3/9/09-overall better but still reports elbow pain and voice alteration.
Moderna COVID-19 Vaccin EUA Injection site reactions : redness, burning, itching. General side effects  : fatigue, headache.  Dizziness and weakness.
Facial tightening right side (already have Ramsay Hunt Syndrome); Altered taste; Altered sense of smell; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 06Apr2021 at 11:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included Ramsay-hunt syndrome which was still ongoing and post herpetic neuralgia.   Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously took cefaclor (CECLOR) on an unknown date for an unknown indication and experienced drug allergy. Concomitant medications included quetiapine fumarate (SEROQUEL), pregabalin (LYRICA), fluticasone propionate (FLONASE), fexofenadine hydrochloride (ALLEGRA) and paracetamol (TYLENOL); all from unknown dates for unknown indications and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient experienced facial tightening right side (already have Ramsay Hunt Syndrome) , altered taste and altered sense of smell. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of facial tightening right side, altered taste and altered sense of smell were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
My eyes, face and neck were very swollen.  My eyes  hurt really bad and my vision was blurry. Face and neck itchy.
sore behind her left ear, it was tender; sore behind her left ear, it was tender; swollen; it was red; it was hot; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (sore behind her left ear, it was tender), TENDERNESS (sore behind her left ear, it was tender), SWELLING (swollen), ERYTHEMA (it was red) and FEELING HOT (it was hot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL, PROGESTERONE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 10-Mar-2021, the patient experienced MYALGIA (sore arm). On 11-Mar-2021, the patient experienced EAR PAIN (sore behind her left ear, it was tender), TENDERNESS (sore behind her left ear, it was tender), SWELLING (swollen), ERYTHEMA (it was red) and FEELING HOT (it was hot). At the time of the report, EAR PAIN (sore behind her left ear, it was tender), TENDERNESS (sore behind her left ear, it was tender), SWELLING (swollen), ERYTHEMA (it was red), FEELING HOT (it was hot) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication reported includes Ibuprofen and ice pack
pt recvd vax 19JUL91 & 10 hrs later had severe pain, sensitive to touch; all joints painful; crack in arms, behind knees, wrists, shoulders, groin; 20JUL91 lt are swollen more, hard, red, itchy, pain radiating to head & up to lt arm pit;
Patient reported symptoms of pain in Right arm beginning 10/31/19 which is normal.  On 11/01/19 she reported hives, blotchy skin on Right bicep.  She self-treated with hydrocortisone.  She claimed it was painful, blotchy on right arm.  She searched symptoms.  Symptoms self-resolved 11/3/2019.
Pt got PREVNAR 13 injection on 7/27/17 and on 8/1/17 got arm left sided pain redness and swelling started getting short of breathe and excessive sweating on 8/7/17.
Day 4-6 URQ pain, pt took baking soda 2x/day. Day 8 strange feeling in jaw and problem swalllowing.   2 days later to Pt diagnosed was Belles palsy.
Received immunizations on 06.16.09. Fever and vomiting started on 6.17.09. Ataxia started on 6.20.09. Hospitalized from 6.20.09 - 6.22.09. Post infectious Cerebellar Ataxia.   7/7/09 Hospital records received DOS 6/20/09 to 6/22/09. Assessment: Postinfectious Cerebellar Ataxia, Global Developmental Delay. Patient presented with gastroenteritis, nausea, vomiting, fever, not feeling good, sudden onset of gait difficulty. Wobbly gait. Wide base and ataxic gait.  7/28/09 ICD-9 Codes: 780.69 Fever unspecified, 781.2 Abnormality of gait, 315.8 Developmental Delays, 780.91 Fussy infant
Broke out with the worst case of eczema I can ever remember having. It is on both wrists and hands. It?s also in small patches all the way up my left arm.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N010108, expiration date: 20-MAR-2019, for prophylaxis (dose #, route and anatomical location of administration were unknown). The dose was stored from -14 Celsius degrees (C) to -10 C (-14.1 C) for 76 minutes, from -9 C to 8 C (-8.7 C) for 103 minutes, and from -14 C to -10 C (-11.2 C) for 11 hours. The temperature excursion was detected by a data logger. The sterile diluent (manufacturer unknown) used for reconstitution was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA011997: US-009507513-1712USA006541: US-009507513-1712USA006542: US-009507513-1712USA006544: US-009507513-1712USA006545.
sick; Initial information was received on 28-Nov-2020 and a live follow up was received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown demographics who was sick (illness), after being vaccinated with INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date were not reported] at an unknown dose, via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patient reported of being sick for 3 weeks (illness) (unknown latency), following the administration of INFLUENZA VACCINE. The patient also reported that the patient might had COVID.  Details of laboratory data not reported.  Corrective treatment was unknown and event outcome was resolved at the time of reporting.  There will be no information available on the batch number for this case.
This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st DOSE SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported she recently had thyroid cancer and got pregnant a few months ago. She received the vaccine. The patient was not enrolled in a clinical trial. Clinical outcome of the events thyroid cancer and got pregnant a few months ago, received the vaccine was unknown.   Information on the lot/batch number has been requested.
Patient was administered a Bivalent vaccine as their second dose of COVID vaccine when they should have been administered a monovalent COVID vaccine to complete the primary series. There were no adverse reactions.