chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Trouble sleeping after second shot; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Trouble sleeping after second shot) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INSOMNIA (Trouble sleeping after second shot). At the time of the report, INSOMNIA (Trouble sleeping after second shot) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided   Reporter did not allow further contact
It was reported that a 65 year old female received Fluzone 98-99 sometime between 10/9/98 to 10/12/98. Reportedly sometime after the vaccination, the pt experienced systemic reactions of headache, nausea, vomiting and myalgia. From additional information received 11/3/98 it was reported that the pt's experience of nausea, vomiting and myalgia lasted 8 hours. Reportedly the pt experienced a severe headache lasting 72 hours, slightly eased by Tylenol two, four times a day. After the headache eased up the pt experienced pain in the cervical spine and across shoulders lasting 3 more days. Reportedly the pt recovered from this experience.
Report 2001017844-1 described swollen injection site in a six month old female who received Infanrix. The vaccinee was described as a "well child." No illness at the time of vaccination was reported. On 05/11/2001, the vaccinee received her third 0.5cc left thigh muscle dose of Infanrix, her third right thigh muscle doseof Haemophilus influenzae type B vaccine, and her first right thigh muscle dose of Prevnar. On 05/12/2001, the reporting registered nurse received a phone call from the vaccinee's mother: she reported that the vaccinee's left leg had a red spot 2 x 2inch (3 x 25cent piece size) which started one day ago. There was no streaking. The physician instructed to mother to apply a warm towel and to administer Tylenol. No return call was received. The reporter stated that the adverse events were of moderate intensity and were possibly related to Infanrix. As of 07/20/2001, the adverse events had resolved.
This is a spontaneous report from a contactable 80-year-old female consumer reported for herself. An 80-years-old female patient started to receive PREVNAR 13 Lot M69971; Exp. 01Dec2016, via an unspecified route of administration at single at right arm on 04Dec2015 10:00 or 11:00 a.m. as she had not spleen and so she has a low immune system. Medical history included splenectomy from 2002 to an unknown date spleen was punctured during a colonoscopy and so it had to be removed, had pneumonia on 29Jun2015 or 30Jun2015 which put her in the hospital for a week, had like to have died -Hurt very bad from an unknown date and unknown if ongoing, colonoscopy from an unknown date and unknown if ongoing. Concomitant medication included metoprolol started about 2 1/2 years before and ongoing for heart attack prevention, Vitamin B12 injection 1000 units once a month, Vitamin B12 oral 100mg tablet once a day ongoing. About 2 or 3 years before this report, her XANAX prescription was given to her for her nerves with orange pills instead of her usual pink pills. She does  not remember exactly how, but the orange alprazolam messed her up, maybe they hurt her stomach, and so she had to go to the pharmacy and specially order white alprazolam pills. She took 0.25mg pills, 2 in the morning, 2 at lunch and 2 at night, by mouth. She will not take the orange alprazolam again. The patient experienced hurting/epigastric pain/muscle pain/joint pain on 05Dec2015 with outcome of recovering, felt sick/very sick on an unspecified date with outcome of recovering, fatigue/like to have died fatigue/fatigue unspecified type on an unspecified date with outcome of not recovered, was more jittery on an unspecified date with outcome of recovering, feels a pin like sensation in her legs on an unspecified date with outcome of unknown, nausea on 24Jan2016 with outcome of not recovered, vaginal irritation on 13Feb2016 with outcome of recovering, acute cystitis without hematuria on 16Feb2016 with outcome of recovered, chill-rash on an unspecified date with outcome of unknown. The patient was hospitalized multiple times for hurting/epigastric pain/muscle pain/joint pain from 24Jan2016 to an unknown date, for sick/very sick from 13Feb2016 to an unknown date, and for fatigue/like to have died fatigue/fatigue unspecified type from 27Feb2016 to an unknown date. The patient was treated due to the events with amoxicillin 500 mg 3 times a day from 12Jan2016 to 15Jan2016, DIFLUCAN tablet 100 mg, ZOFRAN 4 mg-1-every 8 hrs from 24Jan2016 to 30Jan2016, MICATIN Cream from 13Feb2016 to 2016, Eucerin 2 time a day from 13Feb2016 to 05Mar2016, Vaseline 05Mar2016 and ongoing, MACROBID from 16Feb2016 one every 12 hrs for 17 days. Follow-up (14Mar2016): New information from the same contactable consumer includes: new events and outcome, hospitalization details, treatment.
Warm and red skin, bloodshot eyes, dropping blood pressure, fainting, dizziness, nausea, purple feet
Fluzone shot 10/27/2006 left arm. Within 12 hours axillary adenopathy left side. Feels well otherwise. No abnormality at site of shot.
Pt called and left a message stating after she had her vaccination she had swelling of adenoids, neck, face, mouth, her ears and gums were also  affected. She also stated she was on "the tail end of it". I called her back and left a message. Her message was clear, it did not sound like she had trouble breathing or speaking in full sentences. I left a message waiting for a call back.
I had horrible PMS symptoms that I never experienced before including severe cramping for several days, pain in upper legs, headache and very strong emotional feelings. It might be given my age that's it's not related to the Covid vaccine but I have never experienced such intense physical and mental feelings prior to my period. I did call my doctor and they couldn't say one way or another whether it was the vaccine or just other medical issues for a woman my age.
This spontaneous report was received from a medical assistant concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ taken orally, lot # N022173 with expiration date 15-MAR-2019 (dose, strength and frequency) for prophylaxis. No adverse effect reported. The storage temperature of the vaccine was reported as 53.1 degrees Fahrenheit for a time frame of 15 minutes. There was no previous temperature excursion. No product complaint was involved. The call was due to a data logger. This is a non-valid case due to lack of patient identifiers. Follow-up information was received from the Medical assistant on 12-NOV-2018 concerning a 4 months old female patient. On 18-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ. Upon receipt of follow-up information, it was determined that this case is now valid because patient identifier was received.
Received vaccines (PENTACEL, PREVNAR 13 and Rotavirus) on Friday, May 13, 2016. Reported on May 18, 2016 the baby has been crying and fussy everyday since including day received. No other symptoms per parent.
A week after the vaccination (Friday), I developed a red welt at the injection site.  It was itching, red, and hot to the touch.  The next day (Saturday), it continued to be itchy and grew in size.  Around 6:00pm, I took benadryl.  By Sunday morning, the redness had lessened and it did not grow in size.  I took benadryl throughout the day on Sunday.  By Monday, it was completely gone and no longer needed benadryl.
My adverse event started on approximately on 01/2023. I had cough and fluids in my ear. I went to the urgent care because I was experiencing hearing loss. They prescribed cough medication. The second time I went to the urgent care they prescribe me cough medication and ear drops. On the third visit to the urgent care they prescribed me antibiotics. I requested to get an X-ray because I was concerned with  the ongoing cough. The X-ray report showed everything was normal. I also went to the ENT on 01/05/2023 where the doctor prescribed antibiotics, prednisone, ear drops, fluticasone, esomeprazole. On 01/26/2023 I went back to the ENT, he then prescribed me more prednisone. On 02/09/2023 I went again to the ENT because I was developing hearing loss. I went to my doctor's office on  03/23/2023 he prescribed me BROMFED DM for cough. My doctor told me that it might be allergy related. I told him that my cough wasn't stopping so he also prescribed me a Z-PAK. My cough stopped for 2 days completely but it came back again. I am experiencing memory loss which I've noticed from Jan. My doctor advised me to see a Neurologist to see what causing the problem. I didn't go yet but will be going soon after my cough stops.
VERY SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced very sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sore arm was not reported. This report was non-serious.
FEELING UNWELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 27-MAY-2021, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling unwell. This report was non-serious.
Headache, Myalgia, Arthralgia, Fever, SkinRash,  Fatigue, Swollen glands, Facial swelling Narrative: 5 days after having hives and facial swelling was seen by PCP and put on Prednisone prescription.
Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210306 same reporter/vaccine/event, different patient;
admitted 9/10/2021 with heartburn issues as well as headache, fatigue and sore throat
Swollen glands, fever, joint and muscle pain, injection site swelling, redness and pain, lasted about 3 days.
patient has been  experiencing  random foul smells  ,  he  is  changing his  toothbrush because of  smell , cleaning  out  car becasue of  smell,  smelling his  food before  eating,  just  saying  randomly  that  hes  smelling  weird   smells that he  cant  discribe...  we  have  all had our  1st  dose  and  none of  us smell  what he is  smelling.
Pain in the location of vaccine and increase temperature in the area. Pain was moderate and lasted 3 days
pt recvd vax & 9hrs post vax exp polymorphic & diffuse wheals on arms ,legs & itching on back;tx w/12 capsules of DPH in 3 days;sx resolved w/in 3 days;
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 24-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as M006733 with expiration date 09-FEB-2018). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Information has been received from a physician via a field employee referring to a female patient of unknown age. The patient's current conditions, concomitant medication and medical history were not reported. On 08-FEB-2019, the patient was vaccinated with GARDASIL 9 (1 dosage form; route of administration, lot number and expiration date were unknown) for prophylaxis. On 14-FEB-2019, the patient developed an unspecified rash in an unspecified location. On 15-FEB-2019, the patient visited physician who prescribed diphenhydramine (BENADRYL). On 18-FEB-2019, the rash resolved. The causality between the event and GARDASIL 9 was unknown.
Swelling in the area of ??the vaccine, then swelling in the armpit in a ball shape and it is still a little swollen and with a little pain.
about 3 1/2 hours after injection arm started hurting; started to notice slight wheeze and coughing upon deep breath; as evening progressed wheezing and resultant cough got significantly worse; by 11:30 chest began to tighten and body aches began.  Fever of 99.1.  Blood pressure rose to 158/ 78 and heart rate increased to 98; blood glucose levels rose to 190 and would not respond to bolused insulin. Sought medical advice but dr. office closed, no Urgent Cares open so called Nurse Hotline for advice at 12:30 am.  Described symptoms and advised not immediately life threatening but good idea to go to ER; checked local ER and wait time to be seen over 3 hours.  Decided to see if symptoms continued to get worse.  From 1:30 to 5:00 am temp rose to 99.9; body aches continued and chest tightness/wheezing/coughing continued.  Oxygenation was 99% with oxometer and no ketones inspite of elevated glucose.  around 5 am wheeziness began to reduce and fever began to come down.  By 6 am temp down to 99.4 and chest tightness easing.  By 8 am blood glucose responded appropriately and blood pressure returned to 122/63; heart rate 73.  Aches were less although still present and arm still sore.  Remaining symptoms resolved by early afternoon except for wheezing which continued until the following day (Sept 11) and temperature which remained high normal (98.4 - 8).  Temperature  back to 96.9 (usual am temp ) by Sept 12.
pt recvd vax 18OCT94 pt states that had edema almost immed but did contact our office until 24OCT94; pt came into the office w/13.5 x 14 cm erythema & 2+ edema, itching & warm to touch;
I developed Numbness in right leg and heaviness; I developed Numbness in right leg and heaviness; I now have extreme squeaky and pain when walking; I now have extreme squeaky and pain when walking. I have not been able to daily activities and have had to get a cane to help me walk.; I have not been able to daily activities and have had to get a cane to help me walk.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 15Apr2021 at 13:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's syndrome, fibromyalgia and hip replacement two years ago. Concomitant medications taken within two weeks of vaccination included duloxetine hydrochloride (CYMBALTA), gabapentin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received tetanus vaccine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 19:30, the patient developed numbness in right leg and heaviness. The patient had a hip replacement two years ago and no problems up till time of vaccine. The patient, on 15Apr2021 at 19:30, had extreme squeaky and pain when walking. She had not been able to do daily activities and had to get a cane to help her walk. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included medicine (unspecified). On an unknown date in Apr2021, the patient had an x-ray taken and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events developed numbness in right leg and heaviness; had extreme squeaky and pain when walking; had not been able to do daily activities and has had to get a cane to help her walk was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
I did not see or feel the pharmacist insert a needle into my arm. What I saw was a square little box pressed against my skin and then she said it was done. I felt absolutely nothing and was surprised that the injection had been administered. The day after I felt all right just a very sore arm.  But the following day some side effects started occurring which still have not gone away after three weeks. Severe fatigue not able to function at normal level, exercise I can only do about a third what I usually do. Brain fog. Listlessness. All muscles and joints achy and burning all of the time, skin flaring up red, sensation of systemic inflammation. Tremendous water retention, picked up about 7 pounds without any dietary change. Urination is scant even though I drink about 64 ounces of water a day. Stool is a lot less than it used to be, and I?m usually very regular . I wake up very groggy and tired in the morning. Very heavy sensation in the body.  What I should mention is that I was about 80 pounds overweight and tests showed heightened inflammation markers two years ago. Since then I lost about 30 pounds on a high-protein diet with 4 to 5 times a week exercising and strength training. The heightened inflammation disappeared as well as the chronic tinnitus in 2018. . Two days after I had the vaccine, all my inflammation symptoms tinnitus, water retention and weight gain returned, despite no change to my diet or exercise regime.
Initial misuse report received from a healthcare professional on 29 October 2013 and on 21 March 2014. This case concerns second patient of the two patients with 63 years of age. A 63 year old patient who had received FLUZONE HD on an unknown date. The patient received FLUZONE HD at the incorrect age. No adverse event was reported. The list of documents held by sender: None.
Pt. had involuntary jerking and twitching of body. Also had arching of back.
No adverse events reported.  PT. did receive two doses of RECOMBIVAX-HB approximately 3.5 hours apart, 5mcg of preservative-free vaccine IM given to two day old patient.  CDC + poison center consulted.  Recs were to observe for increased injection site reactions only.
Approximately 3-5 minutes post-vaccination, patient was seated, texting a message on cell phone, and fainted. Slumped out of chair face down. Witnessed by several volunteer employees. Not witnessed by pharmacist who had administered the vaccine. Volunteers called for help. Immediately pharmacist responded to patient. Loss of conscious noted. Patient was assessed and gently rolled to back with head support and began to regain consciousness, stiffened arms and legs noted. Patient asked, "Do you have a history of seizure disorder?" Initially unable to respond. Pharmacist requested 911 be called as is looked like a seizure. Asked again, and then patient shook head no and then verbal no. Muscles more relaxed. Stroke assessment performed with arms and legs equal to weight, no facial droop, verbal back to normal. Patient asked if he would like to sit up in chair after about 5 minutes on back. Patient complained of headache but no other injuries. Stated he had no bump on his head. Paramedics arrive in less than 10 minutes from call.  Assessed patient. Vitals normal. Skin color normal from pale. Paramedics assumed vasovagal fainting episode. Pharmacist agreed. Patient offered water and consumed 12 ounces. Stayed additional 30 minutes. Stood and sit tested for balance. Left without complaint.
A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headache, no appetite, and tired/achy. I slept for 3 hours and woke up a little after 8 p.m. Temperature was 100.5. After calling work and notifying my doctor, I drank a Powerade and went to bed. This morning, I feel almost normal. Slight headache (maybe from lack of food) and my stomach is still a little upset.
Narrative:  36 year old male with no pertinent pmhx who presented to ER on  4/19/21 with a four day history of headache and left eye visual blurring which  began last night. Blurring peripheral in nature. Patient denied nausea, dizziness, no  antecedent trauma. He reported no occupational exposure history nor migraine  headache hx. Location of pain was the top of the head, intensity is 6/10, he had  taken no medications to ameliorate symptoms nor had he endorsed any antecedent  drug tobacco or alcohol use. Patient noted that he received the johnson and  johnson covid 19 vaccine 4/7/21 (vaccine was not received from the specific facility). ER  physician followed up with patient day after presenting to ED today, and patient  reported he was doing well. ER presentation may represent a simple tension type  headache given his single episode, relief with NSAID and the location that the  patient described the pain.
Febrile seizure on the evening that vaccines were administered. Pt brought to ER, labs were drawn and were normal. Pt observed and then discharged to home.
had my booster they did a test to see the efficacy of the drug and it was down to 37%; had my booster they did a test to see the efficacy of the drug and it was down to 37%; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), 30 ug single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization; Bnt162b2 (Second dose), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant), outcome "unknown" and all described as "had my booster they did a test to see the efficacy of the drug and it was down to 37%".  The lot number for bnt162b2 was not provided and will be requested during follow up.