chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 10 year old female who on 25-NOV-2008 was vaccinated with GARDASIL (lot # not provided) for her first dose.  ON 25-NOV-2008, after receiving GARDASIL, the patient fainted.  The patient sought medical attention and recovered on 25-NOV-2008.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008.  Follow up information was received from the nurse practitioner.  It was reported the patient was vaccinated with GARDASIL intramuscularly in the left deltoid.  Concomitant therapy also given on 25-NOV-2008 included FLUZONE (lot # U2772AA) which was was vaccinated with intramuscularly in the right deltoid on the same day.  Right after GARDASIL was given the patient fainted.  Her eyes rolled back and had some shakiness.  No further information was available.
This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a patient who received BEXSERO (batch number 164501A, expiry date April 2018) and (batch number 165401A, expiry date April 2018). This case was associated with a product complaint. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced local reaction and product complaint. On an unknown date, the outcome of the local reaction and product complaint were unknown. It was unknown if the reporter considered the local reaction to be related to BEXSERO. Additional details were reported as follows: The patient developed a local reaction after receiving a dose of BEXSERO. One of the reactions was severe enough, it required the patient to follow up with an orthopaedic doctor. The healthcare provider was on a tight schedule and it didn't have time to go through the adverse event details with the reporter. The physician said she would try and call back on Tuesday, 6th June 2017 with more details. This case is one of the 3 cases which were reported by the same reporter for the patients who received the same  lot of BEXSERO. The batch number reported for BEXSERO could 165401A or 1645401A, clarification has been requested for the same. No further details were given.
Hyperactive, no eye contact regressed back from his mil stones (quit walking, quit talking, no eye contact constant crying, quit playing with brother no affection, developmental difficulty violent. 10/3/07-records received for DOS 9/14 and 9/25/07-seen for possible autism parent concerned about behavior, temper and very short attention span, overly energetic. Patient sleeps for about and hour then wakes up screaming, does this all night long for past 2 weeks. Referral for neurology consult.  Parent will call with name of provider and records will be requested at that time.  1/14/08-records received for DOS 10/23/07-multidisciplinary developmental evaluation. Referred for concerns of autism. Walked at 10 months, first words between 9 and 10 months. Fever at one year of age with his immunizations. Stopped walking and went back to crawling. Lost all words. Activity level, going nonstop, short attention span, night terrors. No fear. Motor and language regression. Impaired language and communication skills, Poor reciprocal social interactive skills. Meets diagnostic criteria for autistic spectrum disorder.  Follow-up: Autism spectrum disorder. Hyperactivity speech problems developmental delays. Yes that you make it mandated that the simple blood test be done before children get there vaccines to see if they have the precursors to get autism and then allow the parents to make the choice. Also quit telling people that the vaccines are perfectly safe. When they are not.
hives; itchy; headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (itchy) and HEADACHE (headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HEADACHE (headache). On 03-May-2021, the patient experienced URTICARIA (hives) and PRURITUS (itchy). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) (oral) ongoing since an unknown date at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRINE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, URTICARIA (hives), PRURITUS (itchy) and HEADACHE (headache) outcome was unknown. Not Provided          No concomitant medication provided by the reporter After receiving her 2nd dose she started having headaches and hives daily which cleared up but skin is still itchy, headache still bothersome/intolerable after 3 weeks for which she has taken Advil and Aspirin   This case was linked to MOD-2021-168429 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up received on 25-may-2021
IPV-HIB on 29/11 - 12/10 Fever and pain. Hosp. from 12/10 through 12/13 - MRI inflammation muscle then treated with muscle infection w/ antibiotics. 12/18 Continue w/ left leg pain, unable to bear weight.  01/08/2008 MR received for 2 admissions DOS 12/10-13/2007 with D/C DX: Lower extremity Myositis and 12/26-28/2007 with D/C DX: Osteomyelitis. Infant initially presented to ER from PCP's office with 4-5 day hx of refusal to bear weight/ L leg/knee pain. (+) fever.  PE (+) for L knee swelling and tenderness to palpation. (+) productive cough. Txd with abx which finished 12/24/07.  Then returned with swelling over L distal thigh. Antibiotics resumed to be continued as outpt.
approx 3 days p/vax pt began having generalized pruritus followed by eruption of papular erythematous rash;began on legs & spread cephalad;
Fever of 102; chills; Body aches; Vomiting; Sick also, almost like sinus infection; Vestibular neuritis; Nystagmus on both eyes that makes her very dizzy.; joint pain; whole body was sore; severe headaches on and off; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), TENDERNESS (whole body was sore), HEADACHE (severe headaches on and off), DIZZINESS (dizziness) and PYREXIA (Fever of 102) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced ARTHRALGIA (joint pain), TENDERNESS (whole body was sore), HEADACHE (severe headaches on and off) and DIZZINESS (dizziness). On 25-Feb-2021, the patient experienced PYREXIA (Fever of 102), CHILLS (chills), PAIN (Body aches), VOMITING (Vomiting), SINUSITIS (Sick also, almost like sinus infection), NEURITIS (Vestibular neuritis) and NYSTAGMUS (Nystagmus on both eyes that makes her very dizzy.). At the time of the report, ARTHRALGIA (joint pain), TENDERNESS (whole body was sore), HEADACHE (severe headaches on and off), DIZZINESS (dizziness), PYREXIA (Fever of 102), CHILLS (chills), PAIN (Body aches), VOMITING (Vomiting), SINUSITIS (Sick also, almost like sinus infection), NEURITIS (Vestibular neuritis) and NYSTAGMUS (Nystagmus on both eyes that makes her very dizzy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Information has been received from a physician concerning a 19 year old male patient with no pertinent medical history and no drug reactions or allergies who on 13-JUN-2011 was vaccinated IM with the first dose of GARDASIL (lot number: 668554/0306AA, expiration date: 10-MAY-2013). There was no concomitant medication. The patient had been suffering some unusual events since having his first dose of GARDASIL immunization. It was reported that on 25-JUL-2011, the patient began experienced headaches, nausea, muscle aches and body aches. The patient was a competitive golfer and an athlete. Since 25-JUL-2011, the patient had had to drop out of some tournaments and had times even had trouble walking because of the pain. In approximately July of 2011, numerous tests had been done including blood test for "every organism imaginable" including syphilis, HIV, HFV, Lymes disease and various other organism. He had been tested for heavy metal poisoning. All blood test were normal. The patient had a spinal tap on 05-AUG-2011 and his CFS was normal. The patient spent one night in the hospital for this procedure. He had also had an MRI which was normal. At this time the diagnosis was fibromyalgia. The patient was being treated with doxycycline and gabapentin. The patient sought medical attention by an office visit. Therapy with GARDASIL was discontinued and no reintroduced. Fibromyalgia and trouble walking because of the pain were considered to be disabling by the physician. At the time of the report, the patient had not recovered. Additional information has been requested.
Within 5 hours, patient experienced motor function impairment with her legs buckling underneath her, 10-12 times over the next 3 hours falling each time uncontrollably even with me watching her trying to catch her each time.  She was irritable, pale in color, then became rather listless & lethargic & was overly drowsy over the next few days.  She lost her appetite for several days also and developed diarrhea lasting for 6-7 days following the shot. This all happened over Thanksgiving weekend with most symptoms occurring only within the first 48 hours, other than the diarrhea which lasted beyond the weekend.
the patient was administered improperly stored VARlVAX; This spontaneous report has been received from a physician referring to a 4 years old patient of unknown gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 07-JUL-2020, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX); lot # S032355, expiration date 14-OCT-2021 (strength and dose were not reported) subcutaneously for prophylaxis (reported as routine vaccination) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S032591, expiration date 16-AUG-2022).  The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.6 Fahrenheit degrees) for a time frame of 12 hours (multiple excursions) and in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees (16 Fahrenheit degrees) for a time frame of 30 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved.
within 15 minutes she developed lingering headache, major body aches, some chills and was light headed.  She became very fatigued.  Her right arm was swollen and painful.  Her symptoms lasted 3 days.
p/pt recv vax pt exp swelling of the arm; low grade fever; tenderness. pt seen by MD & placed on steroid therapy
Pt presents after injection with pain, redness, swelling at site. T - 99.1 degrees, P - 68, R - 16, BP - 158/72. 2 inch diameter, erythema to post. Upper (R) arm (center hard core.) MD advised and recommended ice, ibuprofen, BENADRYL. MD did not see pt. Pt scheduled OV today but canceled. Will f/u with clinic staff.
(1/9/12) Patient was seen in MD office for Physical. She was given Varicella at the time of visit. On 1/13/2012 to pick up forms and physician discovered patient had chicken pox. No other illness - temperature 99.3 - pt instructed for home isolation, counseled on fever, TYLENOL, ER if symptoms worsen.
Had 4 month vaccines the afternoon of 10/10/18- Daughter was fussy that night and seemed to act as if she didn't feel good so did give one dose of TYLENOL (2.5ML as instructed if needed). Morning after on 10/11/18, daughter developed a rash all over chest and the back of neck and ears. Rash was small red bumps. Injection sites to both left and right thighs also developed red bumps with a knot. That day consulted with Pedi via online portal to show pictures etc. Dr. was very nice, stated looked either like heat rash or eczema and said wasn't related to vaccines..offered to have me come in if I was still worried. Got an appointment for 10/12/18, saw one of the doctor's NP's who diagnosed it as eczema and to treat with Aquaphor, Vaseline or what I may have on hand for eczema cream. I had both Aquaphor and Eucerin brand especially for eczema at home (give to me as a baby shower present). It is Monday 10/15/18, bumps are no longer 'red' but still kind of there, injection site bumps are gone... We absolutely adore our pediatric dr office. They seem to think it is not related to vaccines but it is just very much a consequence that this developed the day after vaccines.
On 02/15/2001 the patient developed varicella lesions. On 02/17/2001 the patient had a fever of 102.5F and was diagnosed with bilateral otitis media. The patient was treated with Augmentin. The patient recovered.
developed small bumps; itchiness on her left thigh; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-AUG-2023, the patient received the 1st dose of Shingrix. In SEP-2023, 1 week after receiving Shingrix, the patient experienced local swelling (Verbatim: developed small bumps) and itchy legs (Verbatim: itchiness on her left thigh).  The outcome of the local swelling and itchy legs were not resolved.   It was unknown if the reporter considered the local swelling and itchy legs to be related to Shingrix.     It was unknown if the company considered the local swelling and itchy legs to be related to Shingrix.   Additional Information: GSK receipt date: 12-Sept-2023 The patient received a dose of Shingrix and she developed small bumps with itchiness on her left thigh. The reporter currently had a call out to her physician. The reporter consented to follow-up.
Narrative: Patient complained of rash after receiving  the 2nd COVID 19 Vaccine.
Received Prevnar 20, Pfizer pneumococcal vaccine on October 13. By October 14, experienced Supraclavicular lymphadenopathy that worsened on October 15.
Patient had increasing dyspnea - difficult to assess whether this was from her aortic stenosis, but this progressively worsened after the vaccine.  She a lower extremity dopplers and CT-Angiogram consistent with a pulmonary embolus.  She was initially started on IV heparin, which was transitioned to eliquis.  Her symptoms improved.
Symptoms present at the injection site: warmth, redness, swelling and arm pain. Patient reports potentially using Tylenol and a cool compress. Symptoms lasted 5-6 days. All symptoms resolved completely after the 5-6 days.
Pfizer-BioNTech COVID-19 Vaccine EUA: nine and thirteen days after vaccination patient evaluated for persistent, raised, pruritic rash on chest. Patient reports reaction is similar to previous allergic reactions to shrimp. Did not take any medications to treat rash prior to first evaluation. Patient denies wheezing, dyspnea, fever, chills, myalgias, arthralgias, bleeding, nausea, mouth sores, and angioedema. Vital signs within normal ranges. Patient advised to use diphenhydramine.
Pfizer-BioNTech COVID-19 Vaccine EUA: soon after vaccination patient noted swelling of left external auditory canal that subsequently drained yellow pus. Later in the day the patient noticed facial swelling. Presents to urgent care with fever, headache, nasal congestion, and sore throat. Diagnosed with  cellulitis, prescribed topical and oral antimicrobials, advised to manage pain with NSAIDs.
With the first shot, I had some rash, mostly on my stomach, however the 2nd shot I had A LOT of rash on my stomach, back, neck , and also several blood red dots
Approximately 4 hours post vax pt developed pinpoint red rash on chest. Doctor notified and Benadryl given. Rash resolved within 24 hours.
After week 2 after the vaccination, I felt pain, chest tightness, and numbness. (04/26) Went to Urgent care and had a urine test to see if it was a kidney stone (normal) and without finding anything they referred me to ER. There they took EKG, CT scan, X-Ray, and Blood panel and did not find any reason for the pain or numbness. No treatments and only one pill for the pain in office. 05/01 Had a new issue where it seems I was having some kind of stroke. Returned to ER and after a physical and MRI and found it was Bell's Palsy. Advised a set of massage exercises to restore face droop on right side. As of 12/29 still have muscle issues on right side of face.
This spontaneous report as received from a licensed practical nurse refers to a 3 years and 3 month old male patient. The patient's medical history was not reported. In approximately April 2013 the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, anatomical location, lot#, expiration date not provided). Patient's age at the time of first vaccine dose administration was 2 years and 3 months. On 04-APR-2014 the patient received his second dose of M-M-R II (dose, route of administration, anatomical location, lot#, expiration date not provided). At the time of second vaccine dose administration he was 3 years and 3 months old. No adverse effect reported. No product quality complaint (PQC) involved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of ROTATEQ (dose and route not reported) lot number J004875 expiration date 17-OCT-2014 that was improperly stored. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients was vaccinated with VAQTA (doses and lot numbers not reported), intramuscularly. The nurse noted that unspecified number of patients were administered the booster dose of VAQTA "several days too early" (earlier than 6 to 18 months after the primary dose) on unspecified dates. No adverse effects were reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Pericarditis,   ibuprofen on a schedule for a couple of days, return to Dr/ER if gets worse or doesn't improve.
Patient received TDAP vaccine on 12/29/15. On 12/30/15, patient phoned clinic and told nurse that her lips were swollen. Denied difficulty breathing or swallowing. Patient was advised to take Diphenhydramine 25 to 50 mg PO Q6H PRN. Was also instructed to call 911 with any difficulty breathing or swallowing. Per nursing visit note 12/31/15, patient reported improvement in lip swelling with diphenhydramine and denied difficulty breathing or swallowing.
Chills, Fever, Body Aches, Three days intense, some body ache after a week.
swelling, redness, warm to the touch then itching at injection site more than 2 to 3 days post injection. Patient complained of all symptoms except itching on 6/19. Added severe itching on 6/21. on 6/22 patient said itching is less and redness and swelling subsiding
Arm pain within 2 hours of dose. Extreme fatigue about 24 hours after dose was administered. Headache. 100-degree fever overnight after fatigue started.
rash 4inch below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash 4inch below the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided.  Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE, METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN and LEVOTHYROXINE for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE RASH (rash 4inch below the injection site). At the time of the report, VACCINATION SITE RASH (rash 4inch below the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
pt recvd vax; 12 hrs later, devel urticaria x 3 wks as of the date of this rpt;
Patient was transferred from facility on 2/6/21.  Prior to his transfer he had received the first dose of Moderna vaccine n 2/4/21.  He received a dose of Pfizer BioNTech vaccine on 2/17/21 at facility where he is now.
On of my friends had side effects after receiving the second booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (On of my friends had side effects after receiving the second booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    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 IMMUNISATION REACTION (On of my friends had side effects after receiving the second booster). At the time of the report, IMMUNISATION REACTION (On of my friends had side effects after receiving the second booster) outcome was unknown.            No concomitant medications were reported.   No treatment details were reported.
Patient received vaccine, waited for 15 minutes. Just as patient was getting ready to leave, he reported being dizzy and short of breath. Patient reported nausea and became very pale. Vital signs obtained. Epi administered via EPI Pen. Patient reported that he began to feel better. EMS called to transport patient to ED for observation.
This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unspecified dates, the patients received an improperly stored dose of RECOMBIVAX with a lot # K023863 and expiration date of 03-APR-2016, lot # L001626 and expiration date of 06-OCT-2016, lot # L016959 and expiration date of 12-MAR-2018, lot # L044707 and expiration date of 06-OCT-2018, lot # L045117 and expiration date of 06-OCT-2018, (strength, route of administration and dose were not provided). There was no concomitant therapy reported. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter.  Additional information has been requested.
Headaches( these are starting to subside)  Tiredness ( just the first couple days)  Injection swelling ( pretty much gone it was sore the first week and sensitive alittle)     The one I'm kind of concern about is hair loss I'm starting to see more hair come out when I brush it in the past week also if I just run my hand through my hair I have a good amount hair that wouldn't seem normal. I'm going to try and take some vitamins and stuff for hair and hopefully that works or in time it will just stop. I'm almost to two weeks and I hope this stops with that as mostly everything's is pretty much done