chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild headache.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Osteoarthritis. Concomitant products included CENTRUM SILVER ADVANCE, CALTRATE + D PLUS and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION AREDS) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (mild headache.). At the time of the report, HEADACHE (mild headache.) outcome was unknown. Not Provided      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.
increased discomfort on left arm; intermittent rashes; injection site rash; redness; Pain; looks like psoriasis; eczema; This case was reported by a nurse via call center representative and described the occurrence of arm discomfort in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 14th May 2019, refer case US2019169164).   On 17th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, 1 day after receiving Shingrix, the patient experienced psoriasis and eczema. On 18th July 2019, the patient experienced arm discomfort, rash recurrent, injection site rash, erythema and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the arm discomfort, rash recurrent, injection site rash, erythema, pain, psoriasis and eczema were not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort, rash recurrent, injection site rash, erythema, pain, psoriasis and eczema to be related to Shingrix.  Additional details were provided as follows: It was reported that with the second dose patient experienced redness and pain the day after vaccination.  The patient also experienced increased discomfort on her left arm, developed a rash on 18th July 2019. The patient experienced rash at the injection site after the second dose, and had been also experiencing random and intermittent rashes on her upper extremities.  She had one on her right arm that looks like psoriasis or eczema. These events were ongoing. The reporter consented to follow up.  No further details were provided.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 11-JUN-2013 the patient was vaccinated with M-M-R II (lot# H10135, expired date 17-MAY-2014), route, dose and frequency unspecified. The M-M-R II was improperly stored at 8.5 degrees C. -9.1 degrees C for 720 hours. There was no adverse effect reported. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
11/17-11/19 - Typical post vaccine symptoms (chills, fever, aches, fatigue, flu like symptoms) 11/20 - Mostly better but not 100%. Overworked myself that night, which caused a migraine 11/21 - migraine started. Lasted 4 days as a migraine (that never happens to me!) . Still getting headaches 2 weeks later. Coming about every other day. Took Excedrin, and Prednisone from 11/23-11/25 (per dr.) during this time.   11/28 (around 10:30pm) - Extreme itchiness started on head, and neck. 11/29 - Woke up with a bad headache, itchiness continued. Red patches/rash started to appear around neck, chest, and back. By 9pm was the itchiest I have ever been in my life and covered in hives, rashes, and welts from head to toe. Huge welts on the back of legs from hips to toes, head swelling. Burning. Hives all over. Took Benadryl and started a Medrol pack.  11/29 - Full body hives persisted. itching, burning.  Medrol and Benadryl helped, but couldn't wouldn't last. Could not sleep, had chest pressure and heart rate spike. 11/30 - Same as 11/29, hives persisted. Went to ER, switched to Prednisone (60mg), Pepcid, Benadryl, and cortisone. 12/1-12/4 - Medicine calmed down inflammation, but still itchy.  bruises appeared on the backs of my legs where the welts were. 12/5 - Cut down to 40mg of prednisone and rashes started appearing again at night. Looked like I had been attacked by a cat in places I was not scratching. 12/6 - cut down to 20 mg of prednisone, itchiness back, headache, nausea, redness. Met with allergist, who said he suspected it's either a reaction to the vaccine, or Excedrin from the migraines. Said I was the second person he treated that day who reported hives two weeks post booster. Who is to say, but I've never had a reaction to Excedrin before and have not taken any since 11/26. Never experienced anything like this!  I am still itchy, still breaking out in a rash. burning red patches when medicine runs out. On prednisone (20 mg), Zyrtec, and Pepcid. Much better than last week, but still uncomfortable and not under control! Cannot get the redness or itchiness to calm down without medicine. Also still getting headaches.
Less than 1 hour after immunizations, child reported not feeling well - approximately 45 minutes.  After immunizations, reportedly "fainted"/became unresponsive for 60-90 seconds.  Then crying, shaking, and irritable - reportedly "agitated and violent when returned home" - throwing items around house - atypical behavior for this child - called MD - assessed by 11AM - sent home - settled by 2-2:30 PM.  *1st reported to PHN 9/16/08*.
Maculopapular rash, not responding to antihistamines. Required oral prednisone.
Body aches; Feeling unwell; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is the 1st of 2 reports. A 63-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, feeling unwell and fever all on an unspecified date with outcome of unknown.    The information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518044 Same reporter/event, different patient
I am the medical director: I have been having tinnitus ever since waking up the day after the vaccine.  I had the expected side effects Chills, aches, headache but was not expecting the tinnitus and thought initially it would resolve with the other symptoms but it has not.  It is a constant high pitched tone.  I was not exposed to anything else that day.  No loud noises and have no symptoms other illness.  This is the first time I have experienced this. It doesn't seem to be in one ear or the other, It is just there , constantly.  I did not go to a doctor because I am one and know nothing can be done.
Patient 4 y/o. Checked in around 4:00 pm to get Moderna 6m - 5y bivalent booster. LVN, called patient in her station and prepared vaccine appropriately. The nurse asked all proper questions before administering. Patient sat in mothers lap and was calm. As soon as vaccinator initiated vaccine, the patient jerked and grabbed the vaccine out of nurses hand to take out the left arm.
On 3/23/2021 he had respiratory problems and high blood pressure, for which he was transferred to the hospital and days later he died.
This is a spontaneous report from a contactable pharmacist. A 59-year-old female patient received PREVENAR 13; (Lot Number N16562, Expiration Date: Oct2017), intramuscular from 07Nov2016 at 0.5ml single dose for immunization. Medical history included rheumatoid arthritis. Concomitant medication included ongoing HUMIRA at 40 mg (every 2 weeks) via subcutaneous route for rheumatoid arthritis. The pharmacist mentioned that the patient was given pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and she was experiencing some itchiness around the injection site 2-3 days after injection was administered in (Nov2016). Therapeutic measure included CORTIZONE-10 applied around the injection site. There was no laboratory data provided. The clinical outcome of the event, itchiness around the injection site, was not recovered.
The mother of this patient states that on 12/02/99 in the evening, the patient had a temp of 104 F, and that on 12/3/99 at 2 PM the patient had a temp of 102 F with Tylenol. The patient also had a slight red swollen area around at the injection site on 12/3/99 at 2 PM. The mother called back 2 hours later and stated that the physician stated the patient had the flu. The doctor gave him antibiotics. On 12/23/99 a call to the mother, the fever resolved after 3 days.
10:25 c/o nausea, lump in throat, pale, trendalenberg position, O2 via mask U.S:P 96, R 30, B/P 80/60. Notified 911. Epinephrine 1:1000-0.2cc SQ given R thigh (outer) at 10:30 and U.S at BP 94/64, R 24. 10:35-evaluated and transported via ambulance to hospital. Pt stated lump in throat gone now.
Vaccine (DTaP) given two days ago. Pt developed 3cm erythema and heat surrounding site with minimal swelling.
This report describes the occurrence of memory impairments in an adult male of unspecified age who was vaccinated with Lyme disease vaccine recombinant OspA for prophylaxis. This report was received as part of litigation proceedings, with forwarding of medical records. The subject's medical history included allergy to Lescol; allergic rhinitis; 40+ pack-years of tobacco use; occupational asbestos and coal exposure; rectal polyp; diverticulosis; constipation; pneumonia (February 1999); pericarditis; atypical chest pain; chronic obstructiv epulmonary disease; hypercholesterolemia; bilateral medial carpal tunnel neuropathies 91992); bilateral ulnar neuropathies at the elbows and wrists (1992); bilateral neuropathic involvement of both the upper and lower plexus components (1992); bilateral Dupuytren's contractures (1992); degenerative joint disease in both hands and wrists (1993); "mild" degenerative joint disease of the cervical spine (1992); "minimal" disc space narrowing  at C4-5, C5-6 and C6-7 (1994); and foraminal narrowing of the lower cervical spine (1994). Surgical history included tonsillectomy with adenoidectomy as a child, excision of Dupuytren's contracture of the right hand (1992), decompression of the right median nerve (1992), decompression of the ulnar nerve (1992), "extensive" mesoepineurolysis of the median nerve, extensor flexor tenosynovectomy of the right carpal canal (1992), decompression of the ulnar artery and palmar arch (1992), neurolysis of the neurovascular bundles of the right fourth finger (1992), mesoepineurolysis of the distal branches of the ulner nerve (1994), excision of Dupuytren's contacture of the left palm (1994), and lysis of the palmar arch (1994). Concurrent medications were not specified. The subject reportedly received LYMErix, the number of injections administered and the dates of administration were not reported. On 24 september 2002, in a Statement of Injuries, the subject's attorney alleged that the subject "suffers from joint pain, muscle weakness and cramps. He also suffers from flu-like symptoms, fatigue, sweats, blurred vision, memory impairments and driving difficulties." Time to onset following immunization, treatment, and outcomes of these events were not reported. This subject's spouse allegedly experienced arthralgias, fatigue, pain, sweating, foot swelling, leg cramping and numbness following receipt of LYMErix (A0369261A).
cellulitis-pain @ site of inj;swelling of rt arm, red & hot; Keflex while hospitalized-on PO Keflex;APAP for pain;pt has had cellulitis in the past;
Pt was given COVID vaccine #1. Approximately 10min after vaccine administration pt reported losing his vision, having difficulty breathing and numbness in left arm. Denied chest pain, headache, nausea. Pt pulse 59. SpO2 91-96%. Pt pupils dilated. Pt alert x2. This RN called 911 with mother's permission. EMS arrived @1800. At that time pt alert x3, no longer pale, numbness decreased, difficulty breathing resolved. Pt walked out of the office on his own. He was not taken to ED via Ambulance.
Committed next day, injection site remained warm/hot to touch for a couple of days, two days after shot a rash started on upper arms, neck (on top of eczema), chin, and cheeks. Rash lasted about 2-3 days but unclear if some remain because there's still additional red bumps/spots in areas not previously with eczema.
5/8/2021 buzz /dizzyness 2:30-7Pm. no fever,no aches.  5/21/2021 woke with body aches and slight fever 99. tylenol . 5/22/2021 slight fever 99 , no body aches . no tylenol 5/23/2021 fever 101, body aches . tylenol 2 tab every 6 hrs 5/24/2021 fever 102.5 no body aches tylenol 2 tab every 6hrs  5/24/2021 PCR test 5/25/2021 fever 101, no body aches , tyelnol 2 tab every 6hrs. started coughingduring day 5/25/2021 received results .negative pcr 5/26/2021 fever 102,  coughing went to emergency dept
Pt developed post TD swelling. She complained of restriction of motion and then pain down into biceps tendon at elbow. She had radicular symptoms down arm into hand and up into shoulder.
Insomnia; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Insomnia). At the time of the report, INSOMNIA (Insomnia) 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. Treatment information was not provided.
Soreness, redness and pain in arm around and below injection site. Got worse as evening went on. Up and down all night between pain and urination several times. 12/15 arm swollen and pain increased, cold compress and ibuprofen and rest. Arm swelled more and to elbow. 12/15 PM felt little better, still pain and stiffness. 12/16 continued cold compress, ibuprofen and rest. 12/17 arm still red and swollen and moved below elbow. Called Dr and he prescribed methylprednisolone. Upset stomach, light headed, flu like symptons, mild headache, cheeks blood red hot. 12/18 called Dr waiting for c/b.
PATIENT RECIEVED VACCINE ON 9/15/2021. ON 9/16/2021 THE PATIENT NOTICED A BRUISE DEVELOPING AT THE SITE OF VACCINATION, ABOUT 4 INCHES BELOW AND 6 INCHES WIDE THERE WAS A  RED PATCH. THE PATCH WAS SLIGHTLY RAISED, FIRM, AND WARM TO THE TOUCH. PATIENT SAID THAT IT WAS IMPROVING SLIGHTLY AFTER 24 HOURS.
Within seconds of receiving vaccines, noticed skin mottled and then bright red on back, face spreading to extremities.  Benadryl and Tylenol given per J tube per order.  Pt observed and D/c to home per Dr. order.
The next day of the vaccine on 2/6/2021 I had nausea, chills, headaches, & sore arm. The nausea lasted for 2 days the chills & headaches lasted for 3 days & the sore arm for about a week.
Subsequently post vax, the pt developed hib disease, sought unspecified medical attention and died. This was due to haemophilus b recombinant vax causing decreased antibody levels than haemophilus b conjugate vax. A follow up report received 9/25/2000 adds: On 8/15/2000 called reporter - she has no further info except that vaccine was Hib titer, not Comvax, and that pt was in Tx. She will try to contact drug rep who passed info to her to get more info.  Letter has been sent to MD concerning this report - As soon as she gets any feedback, she will pass it on to us. 9/25/2000: Pt did not die!  Change to serious status.
Expired LAIV Flumist administered to patient. LAIV expired 12/15/2014.
On 4/22 I felt two lymph nodes behind my left clavicle. Today is 4/26 and the lymph nodes felt larger so I saw the NP at the Drs Office and she gave me an order for an ultrasound of my neck if my lymph nodes don't go down in 10 days or if they get larger. The order states it is due to the assessment finding lymphadenopathy of left cervical region.
Patient received expired vaccine. Per documentation vaccine expired 11/10/2018. Patient received vaccine 11262018.
RN started to inject MMR vaccine into patient's left thigh, IM, and patient kicked, dislodging needle. Not all of the vaccine was administered, and needle scratched skin of left thigh with a pin sized scratch during dislodgement. Guardian was informed that dose needed to be repeated because not all of vaccine was administered, either repeated today or in 1 month. Guardian chose to have dose repeated in 1 month and an appointment was made.
Left Quadricep revealed an area of induration, erythema and warmth that measures 3cm in the vertical and 2cm in the horizonal.  Seems to withdraw on touching area.
Severe cramps in both feet that went up the side of legs Severe weakness in both legs Severe pain in both feet. The pain started at the spine of foot beneath the toes and was also in the ball of the foot. A wooden rolling pin was used to alleviate the pain.  Muscles in left and right buttocks were extremely painful. Experienced pain while sitting.  Headache  Dry cough
Pt felt arm soreness 4 hours later than felt fatigued, leg heaviness, arm heaviness, and then felt faint with black spots in eyes and numbness down left extremity. Symptoms are still persisting 5 days later today 2/25/21.  PT did not knowingly have COVID prior.
Shingrix given without mixing the vaccine; Shingrix given without mixing the vaccine; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date : 17-NOV-2022 Reporter's Comment:  The reporter did not have patient's initials, gender and date of birth. the reporter stated that Shingrix was given without mixing the vaccine to two different patients. Only the adjuvant part was received by patient. The reporter consented to follow up.  Additional Supportive Information: the patient received 2 doses of liquid adjuvant and no lyophilized antigen of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 2 cases reported by the same reporter; Sender's Comments:  US-GSK-US2022AMR172096:Same reporter. Patient 2.
12 days after the vaccine I noticed 4 red blotches(red, raised, itchy), one at injection site 2 inches diameter and 3 grouped together about 3 inches lower all about an inch in diameter.  Today (15 days after vaccine) all of the blotches have grown to make 2 large 4 inch blotches separated by just millimeters apart.  The 3 lower three blotches grew into one large welt and the injection site welt has also grown. These are red, raised and itchy.   Additionally, I have experienced extreme exhaustion from day 1 of my vaccine. Requiring several naps throughout each day. Also since day 1 I've had a headache that began as a severe headache and has gradually become more dull but on occasion will become more bothersome at times.
0 symptoms Sanofi Pasteur called incident of event report given 10-23-20
stroke; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 58-year-old male patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In August 2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On or about 30-DEC-2016, the patient presented Stroke. As a direct and proximate result, the patient had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result, he suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences; additionally, he had incurred significant expenses for medical care and treatment, his injuries and damages were permanent and would continue into the future.   The reporter considered the event of Stroke to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Stroke was considered as medically significant.
1st dose of Shingrix on 27Oct2021 and is late for 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 27-OCT-2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose of Shingrix on 27Oct2021 and is late for 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-OCT-2023 The reporter did not have lot/expiry date. The reporter consented to follow-up via postal mail. Till the time of vaccination, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Arm hurt. Next day a fever set in. It is now 3 days later, and her arm is still red and swollen. Fever up to 102.4.  Threw up 1 time. Redness area is the size of a softball. The area is hot.
Intense itching all over body 13 days following booster, particularly bottoms of feet and chest/trunk of body. Still having itching at day 15. Taking Benadryl and Claritin
Mother reported redness from knee to hip area, more prominent at injection site. Also a small anount of rash at site area to use Benadryl and ice at site. Return to office if no better in twenty-four hours
Left sided facial weakness, inability to close Lt upper eyelid & (L) sided mouth drooping.
Shingles; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number PAA156571) via an unspecified route of administration, on 20Dec2020, single dose for COVID-19 immunization. Relevant medical history included hypercholesterolemia. Concomitant medications were not reported.  The patient took unspecified medication for hypercholesterolemia however the patient stopped taking it for a month or two already. The patient got the first Pfizer vaccine shot on work (clinic) on 20Dec2020. On 28Dec2020, the patient developed shingles which is now being treated. The patient does not know if this is because of that or a part of it. The patient never had Shingles before. Outcome of the event was unknown.
Patient fainted and fell out of chair immediately upon receiving shot  Hit her head on the floor and chipped a tooth.  called 911 and put cold wet paper towel on patient's forehead until emt's arrived.  Emt's advised patient to be seen by a physician.