chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shot stung; sore right arm for a day; This case was reported by a consumer via call center representative and described the occurrence of stinging in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (In November patient had shingles on her left arm.), pain in arm and pruritus (Patient had neuropathic itching). Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced stinging and pain in arm. On an unknown date, the outcome of the stinging and pain in arm were recovered/resolved.   It was unknown if the reporter considered the stinging and pain in arm to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It as reported that patient had post neuropathic itching also in last November patient had bad shingles on her left arm and patient also has shingles vaccine before shingrix. Patient had previously soreness in arm and was not able to sleep at that time on that side.due to soreness It was reported that patient received the 1st dose of shingrix 6 months before and experienced shot stung and sore right arm for a day. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212982:Same suspect, same reporter, different dose (1st dose)
I took temp no fever but my arm temp is 100 and up my neck; My arm is so sore I can't do anything and  it's hot; This spontaneous case was reported by a nurse and describes the occurrence of FEELING HOT (I took temp no fever but my arm temp is 100 and up my neck) and PAIN IN EXTREMITY (My arm is so sore I can't do anything and  it's hot) 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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (I took temp no fever but my arm temp is 100 and up my neck) and PAIN IN EXTREMITY (My arm is so sore I can't do anything and  it's hot). At the time of the report, FEELING HOT (I took temp no fever but my arm temp is 100 and up my neck) had resolved and PAIN IN EXTREMITY (My arm is so sore I can't do anything and  it's hot) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Nov-2021: Follow-up received. Event outcome updated.
slurred speech/dysarthria/Moderate dysarthria; Bilateral facial weakness/R facial weakness; dysphagia/difficulty swallowing; difficulty speaking/gargled speech; difficulty chewing; difficulty closing his eyes; eyes feel heavy; unable to raise eyebrows; numb lips; lower extremity weakness; facial neuritis; Bell's palsy/left sided facial droop/Facial droop; Guillain-Barre syndrome; This case was reported by a lawyer and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for herpes zoster.   The initial information was received on 23 January 2020, via medical records(The case was medically confirmed). As per medical records, the patient had ingested Shingrix RZV 50MCG/0.5Ml (the new shingles vaccine 2 shots) for Zoster (shingles) on 22 March 2018. As per medical records, on 20 September 2019 the patient had acute onset left sided facial droop, lower extremity weakness and slurred speech. Bilateral linear enhancement of the facial nerves, probable facial neuritis, slight left facial droop on left side compared to right although the patient states that his entire face is weak and that is difficult for him to close his eyes and moderate dysarthria. As per progress note dated on 25 September 2019 the patient recommended to be addressed at the follow up visit for Bilateral facial weakness, dysarthria and dysphagia and the patient was diagnosis with Bell's palsy. The patient had bilateral linear enhancement at the fundus of the internal auditory canals bilaterally extending into the labyrinthine portions of the facial nerves bilaterally and geniculate ganglia on both sides. The evening prior to admission he noticed a Left facial droop, had difficulty speaking, chewing and swallowing. During his stay in the ER he developed R facial weakness and bilateral idiopathic Bell's palsy. He was still experiencing left sided facial droop with gargled speech. He has difficulty closing his eyes fully and complains that his eyes feel heavy when he tries to open them. Because of recent shingles vaccination 5 days ago, early Guillain-Barre syndrome would be on the differential. The patient was unable to raise eyebrows or smile, numb lips. The patient had difficulty with movement of lips, smiling, scrunching forehead, moving nose and raising eyebrows. The patient was unable to move facial muscles, unable to smile, puff cheeks, raise eyebrows could only move lower lip. The patient had difficulty talking with frozen face, tongue mid line, sensation was intact, left pupil greater than the right and moving all extremities equally. The patient had MRI on 29 September 2019 with impression Bilateral linear enhancement of the facial nerves. Probable facial neuritis.      Lab Comments: The patient had MRI on 29 September 2019 with impression Bilateral linear enhancement of the facial nerves. Probable facial neuritis.
3/21 Vaccination Later that evening, I experienced chills, very tired. I went to bed. Woke up middle of night with fever; 101. I was out of work for 2 days. I was feeling light headed on the 3rd day back at work and very fatigue, dizzy. I did have some stomach issues.  The very first night, every joint in my body ached.  *shortly after I came down with a really bad cold with sore throat within 2 weeks after; sinus infection with antibiotic with 10 day course of treatment. I haven't been sick till I had the vaccine.
Blood in feces began 2/11/10 - 3 episodes 1st wk, resumed 2/16 along with mucous in stool.
ON 08/01/2001, this child woke complaining of pain to injection site to left arm where DTAP was administered. Also complained of stomach hurting, vomiting, through out the day, fever of 102. Motrin was administered at 11:30 PM, the night before diarrhea, had six bowel movements through out the day. Taken to the ER at 8:30 PM, on 08/01/01 was told the child had a reaction to the DTAP vaccine.
Information has been received from a physician concerning an 11 year old patient who on 7/8/96 was vaccinated with a dose of varicella virus vaccine live. On 12/11/96, the patient experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no treatment and no hospitalization. The patient recovered. No product quality complaint was involved. This is one patient out of 40 reported. Thirty nine other cases (WAES0407USA01446, 0409USA01855 to 0409USA01867, 0409USA01869 to 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Baby was found seizing 15 hours after, arms/legs jerking staring blankly to the ceiling and making hiccupping sound. Seizure lasted 8 mins approx. Was taken to the ER at Hospital by ambulance after calling 911. EEG normal, no signs of infection. Then transferred to different hospital. Second seizure (grand mal 45 mins long). Taken to ER at hospital, CAT scan normal/transferred to different hospital, MRI normal.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 12May2023 to 16May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
25May2021, the patient received a dose of GARDASIL 9 and will receive a 2nd dose today; No other AEs reported; patient received one dose of GARDASIL during Jun2012 and never received subsequent doses/ 25May2021, the patient received a dose of GARDASIL 9 and will receive a 2nd dose today; This spontaneous report has been received from a registered nurse referring to a 27-year-old patient whose gender was not reported. The patient's pertinent medical history, concomitant medications, drug reactions, and allergies were not reported.  In June 2012, the patient received one first dose (also reported as "1 injection") of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (formulation, vaccination scheme frequency, route and anatomical location of administration, lot number, and expiration date were not reported). The patient never received subsequent doses (product dose omission issue). On 25-MAY-2021, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number T026168  with an expiration date on 04-DEC-2022, which has been verified to be valid for syringe formulation) as prophylaxis (vaccination scheme frequency, route and anatomical location of administration) (interchange of vaccine products).   On 29-JUL-2021 (reported as "today"), the patient would receive a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, vaccination scheme frequency, route, and anatomical location of administration, lot number, and expiration date were not reported). No other adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Fever, headache, shivers, upset stomach, nauseous, Red hot arm at injection site, approx entire upper arm. Continue spreading to inside arm. Some pain and tenderness. Itching towards end of reaction. Started on 10/24 and continued to 11/1.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 62-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the local Health Authority at this time and she was calling in to report the same to Moderna. Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing.  It was reported that no adverse reactions were reported by any patients.
Patient received 1st dose on 28Dec and presented symptoms on 05Jan; Patient received 1st dose on 28Dec and presented symptoms on 05Jan; This is a spontaneous report from a contactable pharmacist reporting for self via Pfizer field representative (Field Medical Director). A patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) on 28Dec2020 via an unspecified route of administration for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient presented COVID-19 symptoms on 05Jan2021. No lab tests reported. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020, and patient presented COVID-19 symptoms on 05Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, patient's COVID-19 symptoms on 05Jan2021 likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
pt recv vax;1 wk later,pt devel myalgias,backache & fever;pt did not recv 2nd & 3rd of vax;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-MAY-2015, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot # reported as K016313, expiration date 31-MAY-2016, oral; dose was not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mom report 911 called due to patient very pale, cyanotic and clammy.  EMT evaluated and told to call MD office.  Now crying excessively.  Instructed Tylenol 0.6ml.
screaming for 2-3 days intermittantly--1 spell lasted 10-12 hrs; no fever;
Had MMR 3/7/03, had fever & febrile seizure on 3/17. (no other symptoms of illness, lab work benign)
Convulsions 2x on 21APR93 & transported to hosp via ambulance; hospitalized for sedation & observation; dismissed 23APR93;
red rash, warm to the touch approximately 3 inches below the injection site. It is unknown when it developed as the accompanying arm pain from the shot was expected, but not concerning. It was when I touched my lower upper arm the evening of 4/27 that I noticed the warmth, and then the red area approximatey 2" x 3" in size.
pt states that her arm got really hot and started to break out in hives all down her left arm the day after receiving the shot
Large raised red swollen lesion (like hives) at/around injection site, hard like a rock, extremely painful & also very itchy (from Moderna booster).  NOTE:  This did not happen with the first 2 vaccines, which were Pfizer.
Pain and rash in face, diagnosed with Shingles; Pain and rash in face, diagnosed with Shingles; Pain and rash in face, diagnosed with Shingles; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included losartan 100 milligram (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 12:00 the patient experienced pain and rash in face, and was diagnosed with Shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of pain and rash in face, and Shingles and included treatment with Valacyclovir. The clinical outcome of the events pain and rash in face, diagnosed with Shingles was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Depression, anxiety disorder, panic disorder, ibs, joint pain, chronic fatigue, short term memory loss, food allergies, exercise induced urticaria. Treatment with antidepressants 10 years after symptoms started and with xozal at times when needed.
Pt vax w/ hepta B; exp elevated liver enzymes AST & elevated LDH p/ 2nd dose. Pt undergoing testing for hepatitis.
After first shot an uptick in paranoia as every day got worse.  Before second shot I was having the vivid dreams.  I was also hearing, seeing, smelling, tasting things that weren't there.  The second shot put me over the edge immediately.  I felt as if I was being poisoned, the vial with medicine inside turned amber color and I shut down as paranoia turned into an orchestrated conspiracy against me.  for the next 3- 4 weeks I hallucinated daily,  I believed reality was a dream and fiction was my reality.  My wife tried multiple times to make me understand that what I was going through was not real, yet because my paranoia and psychosis I remained shut down and basically sleeping for two weeks. I could not speak about what was going on b/c I could not formulate a tangible and coherent thought.  During this time I believed everyone was against me, which now I know is not true.  It was a nightmare that lasted months.  On June 4th I saw Dr., whom recommended a psychologist.  I was able to book the first appointment on June 15th and have been going to Dr. on a weekly basis.  The internal hysteria, paranoia, hallucinations kept me mute for about a month.  About a month after my second shot I began to speak about it although it was disjointed.  It was on May 13th.  It took weeks of trying to formulate thoughts to go to a doctor.  I am still having issues remembering words.  Psychologist suggests I see a neurologist.  That is why it has taken me so long to report.
31March2021 rec'd the 2nd Pfizer shot. Next morning 1April, multiple stripes of severe muscle pain from both ears, extending down the rear corners of neck across top of both shoulders to the shoulder joints. The 2nd set of severe pain was thin stripes of pain on the left & right sides of the spinal column from the neck to waist. The pain strips along spine disappeared in 3 days. The neck pain has continued to this day with varying intensity, sometimes random increases in pain.  7th of April 2021: Sudden onset of Covid like symptoms: extreme fatigue, extreme nausea, wild swings in perception of body temp from freezing cold which nothing warms me, to internal heat like a very high temp but not exhibiting any outward signs of fever. Felt like internal organs were heating up and nothing else like forehead or limbs etc.  The symptoms of 7April2021 kept up for at least 2 weeks. No symptoms occurred together, each symptom came for varying lengths of time before subsiding and the next symptom surfaced.  Towards the end of April the intensity of the symptoms was easing and eruptions were getting fewer with more time between.  By end of May only the neck pain remained. BUT.... then the other symptoms reappeared in stronger form and still ongoing.
The shot was given maybe an inch from the shoulder bone. After 13 days of trying to just make it through the pain, I called the facility, and they told me to go see my PCP. My doctor believes the needle hit either a nerve or the tendon.  I could not use my arm regularly for over a week, partially from pain, but more from the lack of ability to lift it. I am still getting pains and a ?catch? in my shoulder when I try to move in certain ways. My arm was in no way injured prior to the shot. The intense pain I had for over a week had me sleeping upright so the throbbing would be less intense. Simple jobs like showering, closing my car door, and even lifting my arm to put a purse on it were very difficult for approximately 10 days. While the pain has gone down tremendously, I rolled my kids? bikes out to a shed & moved some items (less than 15 lbs- I can typically move 50 with no problem) on Tuesday, Feb 2, 2021 and ended up in severe pain again with the throbbing that night. That is when I decided to call the facility regarding the issues I am having.
In 1998, 4 mon old fetus exposed to vax; fetus dx= possible Down's syndrome