chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an administrator via company representative and refers to a non-pregnant adolescent (age also reported as "around 16") female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patient was vaccinated with GARDASIL 9 for HPV prevention (dose, anatomical location, lot# and expiration date were not reported, route of administration was reported as injection). It was reported that the patient completed 3 dose series of the GARDASIL 9. On an unknown date, also reported as just after 3 dose series of the GARDASIL 9 completion, the patient complained that "her breast were feeling sore and tender". The outcome of the went was unknown. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy on or about 05-FEB-2007, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-APR-2017, the patient was treated by a physician at an urgent care center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed famciclovir and lidocaine for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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.
ringing in the ears , tremors in my hands loss of some motor function in my arms and legs
TOOK ONE PILL AND FORGOT ABOUT IT; This spontaneous case report (PVX2019-2080) was received from a pharmacist on 12-Aug-2019. It described a male consumer who "took one pill and forgot about it" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took only first dose of Vivotif on 07-Aug-2019 and after that did not take the remaining doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one pill and forgot about it" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one pill and forgot about it" was considered as not applicable.
Vaccine administered in left arm, 5/10 minutes later sharp pain in right thumb and right lower stomac.  One  Day after headache on the very top of the head going down on the left side   My  heart beats became very slow during thirty seconds like it couldn't reach the next beat.  It happen twice in the same day. I was not doing any physical activities. I was even sited.  Second day headache all days.  Third day headache. Feeling very tired.  Heart beat slows about a couple of seconds.
Morning of 4/24/03, mother noticed injection site of left vastus laterus (thigh muscle) to be red and hard to touch. Child is without fever, active and in no acute distress. Left upper limb with area 2 cm x 4 cm of induration and erythema.
2FEB93 - 4FEB93 fever 103-105; 4FEB93 red rash & fever dec fluid intake, vomiting; 5FEB93 listless, refused food or fluid, awakened crying; smears of liquid stool; 8FEB93 pale-? swollen glands;
Severe shoulder and arm pain.  Pain has continued in the shoulder and arm since the day of the vaccine.  Not as severe as the first week but continuous.
Fever, chills, weakness, severe pain with swelling at location of injection and physically unable to lift arms or body, unable to walk without assistance, perform usual activities, personal hygiene, dressing or drive vehicle. Severe pain of joints, jaw, neck, spine. Headache, heart racing, nausea, vomiting, abdominal pain, blurry eyes, dizzy, unable to sleep or be comfortable, unusual behavior and moodiness.
Patient age: 83 years old; he received third dose of GARDASIL 9 on 12/8/2019 and noted his blood pressure went way up, 165/100; This spontaneous report was received from a male patient of 83-year-old reporting on himself. His current condition included hypertension. The patient's pertinent medical history, concomitant medications, and drug allergies or reactions were not reported.  On an unspecified date, his dermatologist advised him to have a series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) completed. So, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age). The patient did not experienced any symtoms with the first two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  On 08-DEC-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dosage schedule, route, anatomical location, lot number, and expiration date were not reported), and he noted his blood pressure went way up to 165/100 (units not provided) (blood pressure increased) where typical measure is 130/85 (units not provided). The patient sough for medical attention.        At the time of the report, the patient had not recovered from the blood pressure increased   The causality assessment between the aforementioned event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  was not provided.
Edema, pain and itching 48 hours post injection pt. treated for cellulitis with IV ceftriaxone, and oral KEFLEX to (R) deltoid.
nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-037272 (Patient Link).
Cellulitis-like reaction (red, inflamed, hot to the touch, pain, tenderness) in left arm from injection site down to hand.
Injection site pain; Lethargy; Headache; Sore throat; Muscle pain; Chills; Joint pain; Injection site swelling; it was hard but it was not red; Swollen lymph nodes; Severe abdominal pain; This is a spontaneous report from a contactable (Patient).   A 46-years-old female patient received second dose bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3302, expiry date was not reported), via an unspecified route of administration on 14Jan2021 as, SINGLE for covid-19 immunisation.The patient medical history was not reported. Concomitant medication(s) included Latuda, Synthroid taken for an unspecified indication. Patient previously took First dose of bnt162b2 (BNT162B2, solution for injection, Lot number EH9899 and expiry date was not reported), via an unspecified route of administration on 22Dec2020 as 1st dose single for covid-19 immunisation. The patient experienced injection site pain, lethargy, headache, sore throat, myalgia, chills, arthralgia, injection site swelling, lymphadenopathy, abdominal pain on 14Jan2021. Consumer who was a nurse Practitioner stated, "I wanted to report side effects for Pfizer-BioNTech COVID-19 Vaccine (later confirmed). I have injection site pain, lethargy, headache, sore throat, muscle pain, chill, joint pain, injection site swelling and it is so hard but it was not red and swollen lymph nodes and I felt feverish and then about 4 days later, I had severe abdominal pain but I do not know if that was related as she still had on and off abdominal pain, while everything else went away after about three days and when asked about expiration date of 1st dose consumer stated, "It does not say an expiration date here." Patient also informed that all the adverse events occurred after the second vaccination. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
pt recvd vax & 3 hrs post vax became fussy, inconsolable crying progressed to screaming lasted 5 hrs w/o sleeping or eating; mom contacted MD who prescribed Advil; pt recovered next day;
beginning about 24 hours after vaccine, fatigue, fever, headache, fever 100-99 lasted about 24 hours, HA lasted about 3 days, for initial 24 hours took tylenol prn, after that did not use any OTC
Headache, Sedation, Myalgia, NauseaVomiting, Chills, pain and swelling at the injection site Narrative:  Other Relevant History:
After patient had received her first dose of Pfizer, she went to the observation area. Shortly after arriving, she stated to feel dizzy. EMT's on site assessed her per the nurses request. Patient vomited soon after being put on a monitor, her heart rate was elevated at that time. When her  vomiting ceased, she stated that she felt much better. She denied feeling sick prior to having her vaccine. EMT's offered her a ride to the ER to have her checked out.  The patient accepted the ride to the ER after being offered a few times. She requested some water for the ride, at which time she was provided a bottle of water for the trip. The patient stated she would call her family to notify them, and have them pick up her children in the event she could not  do so herself later in the day.
Patient with uncomplicated TAH prepared for discharge given pneumococcal vaccine in right deltoid. Subsequently developed severe swelling, redness and induarted patch approximating 8-10 cm in circumference on right shoulder. Became febile, lethargic, nausea and required admission to hospital for care. Infectious Disease consult for possible cellulitis. No infectious etiology determined. 12/06/07-records received for DOS 10/15-10/17/07-Right upper extremity pain and inflammation. Discharged day prior after hysterectomy. C/O elevated temperature with cellulitis at the injection site of pneumococcal vaccine administered day before. Seen in ED on 10/14/07- and discharged home, returned on 10/15/07 with temperature greater than 103.0 and progressing cellulitis. No improvement transferred to another facility for possible worsening cellulitis versus servere allergic reaction to vaccination. 12/7/07-receiving facility records for DOS 10/17-10/20/07-DC DX: right upper arm cellulitis vesus allergic reactions fo intramuscular vaccine.
Pain upon injection of Shingrix Uncontrollable shivering for 45 minutes about 10 hours after injection *Left upper arm muscle soreness, which still is painful 1 month after injection.  Pharmacist suggested taking ibuprofen.  That has not helped.  Restrictions in  raising arm  due to pain.  Limited mobility.
Sicker than a dog; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sicker than a dog) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ILLNESS (Sicker than a dog). At the time of the report, ILLNESS (Sicker than a dog) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient may have took NSAID of some kind as treatment. Patient Ethnicity: Caucasian
-Episode of syncope + Dizziness immediately after vaccine -Onset of new chronic health conditions (hEDS,CRPS,MCAS,POTS,and gastroparesis) -Pain, nausea, vomiting, weakness, numbness, dizziness
DIZZINESS, HEADACHE, NAUSEA ABOUT 1 HOUR AFTER SHOT, PAIN ON LEFT DELTOID AREA, DEVELOPED LYPHADENOPATHY (SUBCLAVICULAR) GOT COVID INFECTION AFTER 2 WKS (1/8/21), THEN STARTED TO HAVE PARESTHESIA AND SHOOTING PAIN ON LEFT ARM TO HAND, DEVELOPED NUMBESS ON FINGERS OF LEFT HAND. PERSISTENT SHARP PAIN ON LEFT SHOULDER AREA WITH NUMBNESS ON FINGERS OF LEFT HAND.
On 10/4/04 at about noon, the patient noted swelling, erythema, and pruritus around the injection site and extending to the mid forearm. He presented to acute care and was prescribed Cefadroxil 500mg PO BID for 7 days on 10/4/04. On 10/5/04, the patient noted increased pain with movement, increased swelling, increased erythema, and pruritus. PE showed the reaction to be 39cm in length, erythematous, warm to the though, and indurated. No fevers, nausea, or vomiting.
Blood in stool. Vomiting. Ileocolic Intussusception. Admitted to hospital reduced by Ba enema.
3/12/2021 Moderna shot 1, 013A21A ? Pharmacy   4/9/2021   Moderna shot 2, 039A21A ? Pharmacy   5/26/2021 Moderna shot 3, 012F21A ? Pharmacy   11/4/2021 Dr. seen for right shoulder pain (going on for 2 months estimate) referred to physical therapy 12/2/2021 Physical Therapy started  12/30/2021 PA ? pain located right side of neck as well as anterior shoulder/deltoid region radiating down to the wrist. Pain described as dull and throbbing. X-rays taken of cervical spine and right shoulder.  Corticosteroid injection given in the shoulder and referred back to physical therapy for 4 ? 6 weeks. 2/10/2022 Physical Therapy last day 2/16/2022 Wrist x-rays taken on PA orders 2/18/2022 Virtual visit with PA ? shoulder pain almost completely resolved. Diagnosed with bilateral wrist ulnar-sided tendinitis with pain rated a 9 out of 10. Referred to hand therapy and to use Voltaren gel. 3/10/2022 ? Physiotherapy first visit for hand therapy 5/4/2022 ? Last hand therapy visit  5/18/22 Moderna shot 4, 038A22A, ? Pharmacy    I started losing strength in my arms after the second vaccine but didn?t know why.  It was getting better until I had the third vaccine and things slowly got worse. I could no longer crank the lawnmower or cut our grass. While doing therapy for the shoulder the wrist started getting so bad, I could not lift any thing with one hand.  It eventually started attacking the muscles in my arms. I could no longer sit on the floor because I couldn?t get myself up.  I kept thinking it was from the vaccine but was told it couldn?t be.  This was not a symptom.  Things finally became manageable with but not normal until I had the last vaccine.  My symptoms started getting worse again and that is when I knew no matter what anyone said, the vaccine caused all my problems.  As of May of 2023, I have to do light weight exercises, and wrist and finger exercises or they tend to freeze up.  My arm muscles feel like they are in a vise but the weights calm them down.  I can once again sit in the floor and get up slowly.
This spontaneous report as received from a 44 year old female patient, reporting on herself. On unknown dates the patient received doses 1 and 2 of GARDASIL (route, dosage and lot number unknown). On 20-DEC-2013 the patient was scheduled to receive her third dose of GARDASIL (route, dosage and lot number unknown). Her age is other than indicated in the prescribing information for this vaccine. No side effects have been reported. Additional information is not expected.
Pain in the legs where vaccine was administered, swelling of the leg, fever of 102 degrees, lethargy, limping, not eating.
little soreness where he had the shot the 3 times he received the shots; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (little soreness where he had the shot the 3 times he received the shots) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MYALGIA (little soreness where he had the shot the 3 times he received the shots). At the time of the report, MYALGIA (little soreness where he had the shot the 3 times he received the shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported the LOT number for first dose, but is unsure. First dose received on16February2021, Lot: 023M20 "4" (A or 4, caller is not sure). No concomitant medication details were reported. No treatment medication details were reported.   This case was linked to MOD-2021-375356, MOD-2021-375384 (Patient Link).
arm is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 65-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included spleen disorder (without spleen).   In August 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In August 2021, 1 week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient reported the case for herself. The patient without spleen received Bexsero and 1 week after Bexero injection her arm was still sore. The patient wanted to know was this common.
Localized hypersensitivity with erythema, warmth, pain and itching. Gradual improvement with cool compresses, no additional treatment required
After take out the needle her left hand jerk one and she ask for water, I turn around to ask my tech. give me the bottle of water but I saw her husband stand up to ward her so I turn right back and hold her head and tap her shoulder Are you ok for couple times ; her eyes ware rolling up and she was unconscious for couple second, she regain conscious after the bottle of water touch her lip.  we let her lay on the floor with her feet elevate for 15 minutes.
Patient collapsed 2-3 minutes after vaccination.  The whole body was pale and irresponsive.  She was laid down on the floor.  911 was called.  Within a minute, her skin color became pinkish, and breathing was detected.  She became aware of her environment.  While we waited for the paramedics, her breathing and skin came back to normal.  She reported of no breakfast or lunch before getting the vaccine.  We gave her some chocolate and water.  Her family later reported that she passed out after a flu shot a few years back.  Her family refused to take her to hospital after the paramedic's advice.
ER care, spent 5-7 hours under treatment of lactic acid, saline IV, ivsoln IV and ceftriaxone vial after receiving multiple imaging tests, EKG, and other tests. He started feeling bad in the evening, went to sleep, and woke up around 11pm that night shaking uncontrollably, unable to see, had an extreme headache and was throwing up. His heart rate was close to 180 while sitting down and he could not stand up. Was taken to the ER and seen immediately. Afterwards for about 2 weeks he had bad chest pains and extreme shortness of breath. He could not exert himself at all.
Took it and got it bad/suspected vaccination failure; Got it bad; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient took it and got them bad. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Feeling wind hurt; A lot of hot flashes; Extremely fatigued; Extreme chills; 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 FEELING ABNORMAL (Feeling wind hurt), HOT FLUSH (A lot of hot flashes), FATIGUE (Extremely fatigued) and CHILLS (Extreme chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In October 2021, the patient experienced FEELING ABNORMAL (Feeling wind hurt), HOT FLUSH (A lot of hot flashes), FATIGUE (Extremely fatigued) and CHILLS (Extreme chills). In October 2021, FEELING ABNORMAL (Feeling wind hurt), HOT FLUSH (A lot of hot flashes), FATIGUE (Extremely fatigued) and CHILLS (Extreme chills) had resolved.            No concomitant medication was reported. The treatment information was unknown.
(all events/symptoms resolved without treatment) fever (Tmax 102.6) x16hr chills x12hr headache - resolved in <48hr body/muscle aches - resolved within 48hr lightheadedness - resolved within 72hr fatigue - resolved within 72 hr
Felt fine following vaccination until I tried to stand up around 5:30pm.  Severe stiffnessit was difficult to rise from a sitted position or walk without assistance.  Severe pain bilaterally in ankle, knee, and hip joints.  Pain was enough that it disrupted sleep.  Generalized aches and pains in arms and shoulders.  Exhaustion that made it difficult to sit up or move my arms.  More severe migraine than usual.  Symptom onset was quite sudden and stong.  Continued throughout the evening.  Was much improved by 8am the next day and by roughly 1pm the next day, I felt much better and almost returned to normal     This was a Moderna Booster #1 shot; previous 2 doses were Pfizer received on 3/17/2021 and 4/9/2021;
Vaccine administered on 5th 24 hours later red and warm rash appears appropriately 3 cm below injection site. Rash and swelling and painful to touch approximately 2.5 x 5.0 cm in size. Still persisting after 72 hours. Also post 24 hours had chills, muscle aches and HA for 48 hours. HA still persisting after 72 hours.
Pt had large local reaction approximately 2-3 days after receiving Anthrax #2 (120mm X 140mm) Tx with allegra 60mg and changed to Prednisone taper (6mg for 2 days 50mg X 2 days, with resolution of symptoms. Rec'd Anthrax #3 SQ 2/1/03 w/o any  reaction.
10cm wheal, pain in area of ProQuad injection. No fever or chills. No nausea or vomiting.
Dizziness, Pounding Headache, Drowsiness, Nausea, Fatigue, Chills, Ringing In Ears.