chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WHOLE BODY SHAKES; DIZZINESS; TROUBLE WALKING AND HAND TO WALK REAL SLOW; FEELING SICK; CHILLS/SHIVERS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included pace maker, and concurrent conditions included arthritis, herniating disk in the lower back, and dyslexia.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 15:00, the subject experienced whole body shakes. On 08-APR-2021 15:00, the subject experienced dizziness. On 08-APR-2021 15:00, the subject experienced trouble walking and hand to walk real slow. On 08-APR-2021 15:00, the subject experienced feeling sick. On 08-APR-2021 15:00, the subject experienced chills/shivers. On 08-APR-2021 15:00, the subject experienced tiredness. On 08-APR-2021 15:00, the subject experienced headache. Treatment medications (dates unspecified) included: lorazepam, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body shakes, feeling sick, and headache, recovered with sequelae from chills/shivers, had not recovered from dizziness, and tiredness, and the outcome of trouble walking and hand to walk real slow was not reported. This report was non-serious.
I gave patient a high dose flu vaccine instead of a regular flu vaccine.  She did not have any adverse events.  This was a vaccine error on my part.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.  The patient's past medical history included Spontaneous abortion (Miscarriage) on 25-Aug-2020 and Alcohol use (Socially) from 03-Apr-2008 to 24-Oct-2020. Concurrent medical conditions included Mitral valve prolapse (Stable) since 2009, Allergy and Anxiety. Concomitant products included CETIRIZINE for Allergy, SERTRALINE for Anxiety, VITAMIN D3 for Supplementation therapy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and PROBIOTICS NOS for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Oct-2020 and the estimated date of delivery was 09-Jul-2021. On 05-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 02-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2020, Pregnancy test: positive (Positive) Positive.         Patient had labs which included Genetic testing- low risk, and Ultrasound. No treatment information was provided. Estimated date of conception was 15 Oct 2020.
After 12 months shot my baby starting having fever 102.4 is the highest after 2 days.. then Baby refused to eat.. then runny nose and whinny.. even nursing he doesn't do it like he usually do and seems like having hard time to swallow.
When I got home from work 2/17 I had chills and on the outside my forehead did not feel that hot but when I finally took my temperature it was 100.5.  My head also ached a little.  I took one 400 mg goldenseal and 250 mg tylenol (I know not to mix the maximum dose of those).   I went to bed and I got nauseous and the kind of bubbling air buildup in my abdomen/chest where it's hard to fully expel it that you get when you have a stomach bug or food poisoning even though I didn't have either one of those.  And it wasn't from the Tylenol or goldenseal (I never have those side effects with those and goldenseal usually helps my stomach).  I was able to fall asleep without getting sick and I woke up sweating as my fever had broken.  The next day I still had trouble eating (I had only managed to eat a very little bit before bed the night before, some soup and one bite of bread and one bite of cheese).  Mainly little bites of things, cream of wheat, and ultimately working myself back to eating normally toward the night of 2/18.  On 2/18 I didn't take my temperature again in the morning  and my forehead felt cool to the touch.  but I finally took it later in the afternoon, maybe about 3:00 p.m., only to find it was 101.7.  That's when I really felt it starting to burn up again.  I took a nap for 4 hours and when I woke up it was down to 99.8.  It went down to normal by the next morning.
Thought she had lost sight of her left eye; Left eye looking droopy; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (Thought she had lost sight of her left eye) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease. Concomitant products included USTEKINUMAB (STELARA) for Crohn's disease.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced EYELID PTOSIS (Left eye looking droopy). On 18-Mar-2021, the patient experienced BLINDNESS TRANSIENT (Thought she had lost sight of her left eye) (seriousness criterion medically significant). On 18-Mar-2021, BLINDNESS TRANSIENT (Thought she had lost sight of her left eye) and EYELID PTOSIS (Left eye looking droopy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I began to feel numbness in my hands and feet. Then, I gradually began to have numbness between both my knees and feet. It became more difficult to stand up and walk without a walker. Then, I fell out of bed and could not walk anymore. I was bed bound. This progressed slowly over a period of three and one-half months before my PCP recommended going to the Emergency Dept due to loosing my balance, increased weakness in my arms and legs and difficulty walking.  Pt was admitted to  Rehabilitation Hospital on 08/26/2021 until 09/16/2021 until she was discharged to a sub-acute Skilled Nursing Facility for continued rehab with Physical Therapy and Occupational Therapy.
About 2 months after receiving vaccine I was diagnosed with a breakthrough case of COVID-19. My symptoms include fatigue, body aches, hacking cough, loss of appetite and very elevated blood sugars.  Called doctor and was instructed to take 5 day course of Paxlovid. Symptoms began resolving with-in 48 hours.
She is 7 weeks pregnant; sore arm; swollen lymph nodes.; This is a spontaneous report from a contactable consumer or other non HCP. This consumer or other non HCP reported information for both mother and fetus/baby.    A 38-years-old pregnant female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation (age at the vaccination 38 years old). The mother reported she became pregnant while taking bnt162b2. She was 7 weeks pregnant. The patient medical history concomitant medications were not reported. The patient experienced sore arm, and swollen lymph nodes. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient self-reported bruising but not at injection site, a little further down. The bruising was yellow around margins but not panful. Pt also reported tingling in finger that had resolved near completely.
the resident was noted to be leaning to the right side from w/c almost falling to the floor before cna caught her and assisted her upright. loss of consciousness noted, jerking to the left side, left eye twitching approximately 1 minute. assisted to bed to assess, unable to follow direction, unable to stand, mouth drawn to the left side. she began to arouse in and out with verbal stimuli but was not able to follow directions. . Sent to ER for medical evaluation   Diagnosis updated: 9/29/2021 -  EPILEPSY, UNSP, NOT INTRACTABLE, WITHOUT STATUS EPILEPTICUS, I69.398: OTHER SEQUELAE OF CEREBRAL INFARCTION  The patient started on Keppra
Pt's mother phoned in on 3/19/15 stating that the pt. developed a red hive looking rash directly below the inj. site of her (L) leg. The mother did send me pictures of the rash which they were shown to Dr. Dr. rec. Hydrocortisone cream and BENADRYL.
pt recvd 2 doses of Engerix-B & exp elevated liver funct tests; No further details are available;
Upon administering the Moderna COVID vaccine to her patient, our intern experienced a syringe failure. She described injecting the needle into the patient's arm and pushing the plunger when the medication expelled out of the barrel and onto the patient's arm. The patient was then revaccinated in the opposite arm (right).
By evening time of getting my first covid shot, the  muscles in my shoulder were sore as though I strained my arm.  This pain has never gone away.  I have severe limitations with lifting weights and heavy items due to the pain.  Additionally, there is a severe pain in my left wrist; sometimes it is a burning sensation.  It hurts even without lifting items.  I have had the chiropractor work on my wrist and shoulder; it only provides slight temporary relief but then continues on.
Member received Smallpox Vaccine on Jan. 25, 2004.  Member noticed rash all over body on Feb. 2, 2004.  Member has received treatment of Amoxicillian.
pt devel erythema, indurated plaques w/ central clearing to thorax & extremity consistent w/erythema multiform 1wk p/vax; urticaria;
Vomiting and nausea started 14 hours after vaccines received.  Fever between 100 and 103 lasting for 68 hours after vaccine received.  Full body aches, headache, full body sweats, chills.
Patient received Twinrix #3. She was too early for time for Hepatitis B, but too early for her Hepatitis A. Patient was advised to return to test for Hepatitis A immunity. If immune, patient will not have to receive her last Hepatitis A dose, if not, patient agreed to vaccination.
Patient informed vaccinator about previous allergic reaction to dose 1 that spontaneously resolved, was instructed to stay 30 minutes for monitoring. Reports no adverse events to any vaccines in the past, including the flu vaccine. She received dose 2 Pfizer COVID vaccine at 10:57 am, started experiencing throat discomfort at 11:25 am (BP 146/65 HR 96), and was given 50mg IM  Benadryl. Five minutes later, patient reported an improvement. Vital signs remained stable throughout observation. BP 126/85 HR 83 at 11:40 am and  BP 120/84, HR 60 at 12 pm.
she received the COVID-19 vaccine and the next day she tested positive for the viral infection; she received the COVID-19 vaccine and the next day she tested positive for the viral infection; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient was tested on 02Jan2021, and did not get the results till 06Jan2021 and tested positive. The patient wanted to know if she could have any side effects if she received the COVID-19 vaccine and the next day she tested positive for the viral infection. She is unsure of when she contracted the infection. The outcome was unknown.   Information on the lot/batch number has been requested.
4-5 days of Diarrhea. Ongoing dizziness/vertigo.
I got my first shot of Pfizer on 07/30/2021 in my left arm. I noticed pain in my arm just around the injection site. That went away in a few days and then about 1 week after that injection, I felt a small lump where the injection happened, similar to the size of a lymph node. This also went away in a couple of days. I got my second shot of Pfizer on 08/20/2021. I did have a headache the night after my second shot but I also have severe allergies right now so it could?ve been contributed to my sinus pressure. The day after my second dose, I no longer had a headache but I did develop a red spot around the injection site (about the size of a half dollar coin). It is warm to touch, slightly itchy, and now it has developed a lump at the site, much bigger than the first one. The lump is slightly smaller than the red spot. As of right now, those are the only symptoms I have noticed. I also was not knowingly infected with covid before my vaccination.
9/14 started itching and redness, 9/16 went to Dr. - Dx cellulitis. Started Doxycycline and hot packs. Nausea from Doxycycline - DC'd - started LEVAQUIN on 9/23. 9/27 - looks much better. Just a brown spot remains.
Pt complained site was hot, red, swollen and hard also had bruising on back and side of arm went to ER on 10/2/10 told pt had cellulitis.
Information has been received from a male consumer who reported that a woman who he had spoken remembered a case of a patient who was vaccinated with a dose of ZOSTAVAX (Merck) (Dose, route and Lot# not reported). The consumer stated that the patient's blood sugar raised after ZOSTAVAX (Merck) was administered. At the time of the report the patient's outcome was unknown. This is one of two reports received from the same source. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.
attempted to inject smallpox vaccine via intradermal route - no weal noticed. Attempted second time, no weal.  Vaccine give via subcutaneous route with 0.5ml dosage.
The two days immediately following the second dose,  I felt general malaise and was lethargic despite having an extremely sore arm at the injection site.  I could not raise my arm above my head without pain. COVID arm  appeared two days after the second dose.  It covered about a three inch diameter. (I previously developed COVID arm nine days after the first shot in my other arm.)  My digital thermometer read 97 degrees on my forehead and 100 degrees F on my injection site.  I put an ice pack on my arm to alleviate some of the pain, heat and redness.  On the fifth day after the vaccination, the COVID rash subsided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicilin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included Paxlovid (from 20Jun2023 to 24Jun2023).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID vaccine booster was given at 3:50pm. The vial was opened at 9:15 am and the time expired for the vaccine was at 3:15pm.
Pt recv vax on 7/15/96; on 12/17/98 pt exp chicken pox
This spontaneous report was received from a registered nurse refers to a 6 months old patient (gender not reported). On 10-SEP-2012 or 11-SEP-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, dose and route not reported) due to human error. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
This is a spontaneous report from a contactable consumer reported for his wife. A 67-year-old female patient received the first dose of PREVNAR 13 via intramuscular route in the left arm, for immunisation at 0,5ml single dose on 31Aug2017. On the same date the patient received also influenza vaccine via intramuscular route in the right arm, she has had it every year for the past 15 years. On 01Sep2017 the patient experienced who she has not been feeling well since she had the injection, on 31Aug2017 the site of injection was swollen, red, and very warm and on unknown date the patient experienced tiredness and dizziness. The outcome of the events tiredness and dizziness was unknown while the outcome of the other adverse events was not recovered.
pt recv vax 10AUG97 & on 18AUG97 pt devel a mild case of chickenpox that consisted of 10 bumps;
received PNE/FLU vaccine in right arm and Td in left arm on friday Nov 7,2008.  Pt awakened at 0230am Nov 8th to pain in right arm and redness.  Pt took Tylenol.  Pt states felt better on Nov 9th.  Pt called this morning to report the s/s and we asked her to come to the clinic so we could document our findings.  Her right arm has pinkish streak mid upper arm about 1 in wide by 4 in long. No swelling.  Pt states still painful to touch.  Pt states feeling better today.  Pt instructed to continue taking Tylenol prn pain.  Pt instructed that s/s should resolve fully and she should feel better.  If s/s worsen she needs to call her doctor.  Pt instructed that we will follow up with her in one week.  Pt also instructed to call clinic if any questions/concerns.  Pt voices understanding of above.
This was originally reported by a registered nurse concerning a 4 year old female who on 08/07/01 was vaccinated SC in the left deltoid with a second dose of MMRII. Concomitant therapy on 08/07/01 included a fifth dose IM in the left deltoid with second dose of MMRII. Concomitant therapy on 08/07/01 included a fifth dose IM in the left deltoid of Infanrix. Within 24 hours of vaccination, the patient developed cellulitis and an allergic reaction. She was treated with Keflex and Atarax . It was reported that her symptoms resolved by 08/17/01. No further information was provided. Additional information has been requested.
On 06/20/01: Prevnar (pneumococcal) vaccine administered on the right deltoid, a red mass developed at the site of the injection. On 06/21/01: red "ball" mass continued at the site of injection. On 06/22/01: red small rash developed at the site of the injection. Denies any other symptoms.
Day 1: Fever,  acute localized inflammation around the injection site, overall weakness Day 2: Decreased fever, localized inflammation around the injection site Day 3: No fever, the inflammation seems to be decreased a bit. The area around the injection site still feels harder and bulged.   Dr. suggested Ibuprofen, Zyrtec, and ice application to the injection site.
Initial unsolicited report received from an Office Staff on 14-Mar-2018. This case involves a 68-year-old male patient, who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, route, dose not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient reported Guillian Barre syndrome. Lab test and corrective treatment was not reported. Outcome of the event was not reported. Upon internal review the case was considered as serious because of important medical event: Guillian Barre syndrome. Documents held by sender: none. Sender's Comments: Patient developed Guillain Barre syndrome after vaccination. Exact time to onset has not been mentioned. Further information regarding vaccination details, time to onset, symptoms and their evolution, medical history as well as concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the given information the role of the vaccine cannot be assessed.
Warm and dizzy with hypotension; feet up and juice given; transported to ED; improved with rest
Lightheadedness. No loss of consciousness. 10-15 minutes to recover. Water given orally.
Patient called office on 5/19/2021 to report that after her 2nd shot of Moderna she was sick in bed for several days with nausea, no appetite, pain in her legs and R knee swelling. The R knee swelling has become progressively worse and it is now (5/19) double in size. She acknowledged that she has osteoarthritis and her primary provider has recommended an X-ray.
Slapped Cheeks Rash, Low Grade Fever, Nausea, Stomach Cramping --- 3 days later, sister with the same symptoms (she had received the same vaccine at the same time).
Immunizing technician went to administer dose and had leakage/splattering from administration. The needle and barrel separated while in her Left arm and it was unknown how much quantity was administered. I contacted Pfizer (case # 00288067) and they recommended if less than 1/2 dose is administered or not able to estimate dose to repeat dose immediately in opposite arm. Pt received 2nd dose in Right arm.
daily fever for past 3 weeks between 100- 102 ,  headaches.    Fever of 103.7 ,  nausea,  headache,  really feeling lousy the first day after second vaccine.   Fever has been consistent for 3 weeks now.
High Fever, Red Rash & Lump AT INJECTION SITE, LUMP AND RASH SPREAD UP TO SHOULDER AND DOWN ARM.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no known pertinent medical history or previous illness was vaccinated intramuscular into the left arm with first dose of GARDASIL (lot # 671994/1537AA) on 12-MAR-2012. A tuberculin (TB) test was performed. The patient experienced concussion, fall, head injury, loss of consciousness, neck pain, syncope and visual impairment on 12-MAR-2012. Patient had syncopal episode in lobby striking her head on floor and had brief LOC (lever of consciousness). She was transferred to ER (emergency room) due to neck pain/visual disturb. The patient was evaluated and released to home and diagnosed with mild concussion. Episode occurred 10 minutes after injection. The listing indicated that one or more of the events required ER visit but were not serious. Upon internal review, loss of consciousness was considered to be a medically significant event. No further information is available. The original reporting source was not provided.
Herpes Zoster in Face and one Eye (Shingles) with extreme pain on head over about 6 month. Almost got blinded in one Eye. Treated with special pills and steroid Eye drops over several month.....until today. Eye sight back to about 95%. but still under treatment by Eye Doctor.
Developed chicken pox like rash around waste and where cloths are tighter and warmer-blisters with itching and spreading. Doctor prescribed ZOVIRAX oint and stated was chicken pox rash.