chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache, back of the head pain; memory loss; blurred vision; pain down my neck; stumbling; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 51-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration on an unspecified date (At the age of 51-years old)as 2ND DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (Comirnaty) (Batch/Lot Number: EL3247) on 20Jan2021 for Covid-19 immunisation. It was reported that after second vaccine dose and next day patient was feeling okay and day and a half later, it all started all over again, headache, back of the head pain, memory loss, blurred vision, all started again. The patient got an MRI this time and the other day, since having severe headache all day, every day, pain down my neck and still little bit stumbling. The patient went to neurologist and he said all of my symptoms are symptoms that someone would have with the concussion but patient never felt like, she don't have a concussion (hence, concussion not captured as event as consumer was not sure). So, neurologist wanted me to call this number as she said that she believes that memory cognitive issues are all from the vaccine and I guess it is needed to be reported. Consumer stated, "Yes, they actually took me to the emergency room and they did blood work, EKG, MRI results were unknown. The outcome of the events were unknown .  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Weak and dizzy first day. Shortness of breath next 2 days, light fever.
Soreness at injection site, fatigue, sinus headache beginning on 11/8/2021 lasting throughout the week, took OTC sinus/headache meds, gave mild relief but would return as meds wore off.  Saturday 11/13/2021 woke up congested, coughing, low grade fever of 100, had been fatigued all week even though had been on vacation from work and at home.  Symptoms worsened until going to Urgent Clinic on Monday morning 11/15/2021 and testing negative for flu A and B as well as Covid.  Was diagnosed with a bad sinus infection and prescribed Amor-Clav 875mg every 12 hours for 10 days.  Symptoms worsened, daily low grade fever, very lethargic to the point of feeling limp on Wednesday.  Called primary care Dr and reported symptoms,  Primary care Dr prescribed steriodal nasal spray twice daily.  As of today 11/18/2021 symptoms are minimal.  Primary care Dr said antibiotics needed 48 hours to take effect.  Have had to work from home the past 4 days, severe cough, sneezing like an allergic reaction to something (big loud sneezes) all week.  Still have some coughing.
This case was reported by a pharmacist and described the occurrence of injection site pain in a 18-year-old male patient who received BEXSERO for prophylaxis. On 9th August 2018, the patient received BEXSERO. In August 2018, less than a week after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details reported as follows: This case was reported by the patient's mother. The patient experienced sore arm after the vaccine used before the day of reporting.
Received injection (flu) at school Nov 8, 2010. Had pain and a little redness at site. Mother stated about a week later a lump formed & there is pain at the lump. Went to Pediatrician and pediatrician not sure so referred to dermatologist. Waiting for approval from agency.
Unexpected high pulse while at rest 180/bpm, sweats,  hard mass felt in upper left arm.... occurred approx 34 hours after injection... lasted approx 1 hour..... felt normal after full nights rest, but fatigued
Nausea/sick to her stomach; Headache; stomach is upset; not feeling great; dizziness; Vertigo; This is a spontaneous report from a contactable consumer. A 78-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on her left arm, via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. It was reported that the patient got shot on Friday and last night she woke up with vertigo on 25Jan2021. This morning (26Jan2021), she could not eat breakfast because she was nauseous and sick to her stomach; stomach is upset. She is walking around now and just is not feeling great. She also has a headache and dizziness. The outcome of the event nausea was recovering while unknown for the other events.
Fever starting 14-16 hours after. Fever lasting 50-60 hours. Mostly around 100 degress, but topped out at 102.5; shakes; Minimal pain at injection site; Aches and pains starting about 12 hours after; This is a spontaneous report from a contactable consumer (Patient). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 16:00 (at the age of 35 year) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration in right arm on 22Jan2021 at 18:00 as dose 1, single (at the age of 35 year) for COVID-19 immunisation. On 13Feb2021 at 06:00, patient experienced minimal pain at injection site. Aches and pains started about 12 hours after. Aches, pains, shakes lasted about 36 hours. On 15Feb2021, 14-16 hours after, patient experienced fever. Fever lasting 50-60 hours. Mostly around 100 degrees but topped out at 102.5. The patient underwent lab tests and procedures on 15Feb2021 which included body temperature: 100 centigrade and 102.5 centigrade. It was reported that no therapeutic measures were taken for the events experienced. The outcome of event fever was recovered on 17Feb2021, for shaking and ache was recovered on 14Feb2021 at 18:00 and for Vaccination site pain was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Mother reports pt. vomited during night of 4-24-12 - 4-25-12 and woke at 0730 w/ slight temp. Mom adm. 1.25 mL acetaminophen. Pt proceeded to vomit 4x btwn 8-12am. Fever increased to 103F. Another dose of 1.25 mL of acetaminophen adm. Pt. taken to hospital ER. Tmax 104 (R), tremors, pt had one wet diaper from physician visit 4-24-12 at 12pm until hospital visit 4-25-12 at 1200. Pt was catheterized. Given 2 mg ODT ZOFRAN q 8 hrs & 1.25 mL ibuprofen alternating w/ 1.25 mL acetaminophen. Discharged. Advised to push flds. Dx w/ vaccine adverse reaction. No reaction at injection site. Hospital report on file.
Small Bowel Obstruction possibly intussusception 12/11/2006 (approximately 7 week after Rotateq). Report came in with MR attached documenting an almost 4 month old's admission for bilious vomiting and lethargy. PMH previously healthy infant with hx. of hyperbilirubinemia after birth which required phototherapy. Mother noticed infant to be more irritable than usual but with no other symptoms initially.  The following day she noticed yellowish-green emesis and continued vomiting as well as lethargy. 911 was called and an IV was started in the field which caused the child to perk up some. PE was unremarkable with 1 episode of emesis during exam. PE at this time showed voluntary guarding and mild distension.   NG tube was placed and patient did well and was d/c'd home after 2 days.  Working DX is transient intussusception reduced with contrast enema. Addendum: spoke with office RN/reporter who confirmed final dx. is the same as primary dx.: bilious emesis, probable intussusception and that Rotateq was given, lot # 0849F./
Dizzy; vomitted; Sick; A spontaneous report was received from consumer, concerning a female patient of unspecified age, who received Moderna's covid-19 vaccine (mRNA-1273) and vomited during night, dizzy this morning and was sick.  The patient's medical history and concomitant medication was not provided.  On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of covid-19 infection.  On 11 Feb 2021 the patient was sick. On 14 Feb 2021 the patient vomited during night. On 15 eb 2021, this morning, the patient felt dizzy.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the events vomited, dizzy and sick were considered unknown.; Reporter's Comments: Based on the information provide which includes a strong temporal association, a causal association between the reported event and the administration of the mRNA-1273 vaccine cannot be excluded. Vomiting is  consistent with the known safety profile of vaccine and hence, a causal relationship cannot be excluded.
Fri after pt developed chills/fever 100 and above for 1 week - Right arm very sore/tender/unusable vomiting Sat thru Tues. Went to DR on Wed - arm still swollen - told her allergic reaction to PNEUMOVAX. 1/13 - doing better - arm still tender.
Moderna shot 1. Feb 8, 2021 Severe headaches and slight sore arm Moderna shot 2, Mar 8, 2021 Headaches within a few hours of the shot,  next day around noon headache, nausea, light headed, then turned into body aches and felt feverish.. Flu like symptoms until apx midnight. Very large rash about 5? wide and 10? long around and below injection site. Day 3. No more side effects. I did not notify my doctor.
chills; tiredness; Fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (tiredness) and PYREXIA (Fever of 102) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE, APIXABAN (ELIQUIS), ESCITALOPRAM OXALATE (LEXAPRO) and LISINOPRIL for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced CHILLS (chills), FATIGUE (tiredness) and PYREXIA (Fever of 102). On 18-Feb-2021, CHILLS (chills), FATIGUE (tiredness) and PYREXIA (Fever of 102) had resolved. Not Provided
Concussion; blurred vision; Nausea; dizzy/dizziness; felt a fogginess and cloudiness; head injury; Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 09:45 (age at vaccination is 63years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. On 23May2021 Caller states I noticed after my first shot I felt like I had a concussion. I felt dizzy. As I was driving back home the concussion symptoms aggravated. I had a blurred vision, nausea and dizzy. I feel the same way today. Is this normal. Received an auto call back 2021-03-24 9:39 Outbound call attempted #1 2021-03-24 9:43Outbound disclaimer provided. Informed caller dizziness and nausea has been reported post vaccine. But blurred vision has not been associated with the vaccine. However, these may not be all the possible side effects of the Pfizer BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer BioNTech COVID-19 Vaccine is still being studied in clinical trials. Please speak to your HCP if these symptoms persist. I am afraid to get second dose. Can I get the second shot despite all the symptoms I had, Informed caller to monitor the symptoms. The eligibility of the second dose would depend on the severity of the symptoms. Please discuss this with your HCP. Caller states he got Pfizer Covid vaccine around 9:45AM on 23Mar2021, states he waited the 15 minutes and as he was sitting in the chair he felt a fogginess and cloudiness, states when he was driving home he felt like he had a concussion, not sure what is going on, felt fine until the shot, states it was like a head injury or something, with some nausea and dizziness, states he is still feeling it today Product Details: unable to locate NDC, Lot or Expiration Date on patient cared, states the following number is listed and either reads: PAA165969 or PAAL65969 States his main reason for calling is he is trying to figure out if there is something he should do for this concussion feeling, and should he forgo the second dose as he is not doing so well with this first dose. Communication: The caller was provided with phone number of (PHONE NUMBER), option 3, and business hours prior to transfer to queue, hold times are longer than normal. Outcome of events was recovered on 28Mar2021.   Follow-up(24Mar2021) This is a Follow-up spontaneous report received from a contactable consumer (patient). This male patient reported for himself added   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
CHRONIC HYPOTENSION HYPOTENSION 12/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by an advanced registered nurse practitioner (ARNP) for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
one week later broke out in hives/urticaria on R forearm, left upper trunk, R lower trunk, R posterior knee, shortness of breath.  Used triamcinolone cream, rash and itching  went away in 4 days.
This spontaneous report as received from a 76 year old female consumer reporting on herself with heart condition, pacemaker and no drug reactions or allergies. The patient's medical history included heart attack when she was 38 years old in approximately 1977. The patient did not have any known drug reactions or allergies. In approximately 2014 (reported as about three years ago), the patient was vaccinated with an unspecified  dose of ZOSTAVAX (dose, lot #, expiration date and anatomical location were not reported) (route reported as "injection") for prevention of shingles. The vacine was reconstitued with sterile diluent (manufacturer unknown) (dosage schedule, lot number and expiration date were not reported). The patient's concomitant therapies included  "several unspecified medications." On 20-APR-2016, the patient developed shingles (herpes zoster). The shingles developed on her "left breast, underneath the left breast, on her stomach, and on her back." The patient stated that she had to go to the "Emergency Room" for treatment. The patient was given "oxycodone-apap cap 7.5-325." The patient stated that she recovered from shingles on an unspecified date; however, some areas on her back still itch. There were no lab diagnostic studies performed. The causality assessment between the adverse event and the suspect therapies was  not provided.
Within 2.5 hours of receiving vaccination (noted by 6pm Monday), a red spot occurred on my nose, slightly larger than the size of a dime. It was dark red. there was no itching, pain, or swelling. Called HCP in after-hours. Was asked to come in to the office in the next few days. I came in Tuesday 4pm. Spot was there, without change.  Discussed with HCP who ruled out shingles (I am not vaxxed for shingles). Was aked to monitor if fluid will build up. Over the next days, the spot got lighter and lighter. By Saturday (5 days after COVD vaxx) the spot was disappeared and my nose looked normal.
people are getting sick of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (people are getting sick of the vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (people are getting sick of the vaccine). At the time of the report, ILLNESS (people are getting sick of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient inquired if they could take Tylenol before getting the second dose of Moderna COVID-19 vaccine in order to prevent adverse events, because was told that people were getting sick of the vaccine and was strongly concerned.   No treatment information was provided.
Pt recvd vax on 22JUN92 & exp arm pain & looked pale; also devel hot flashes, dizziness & nausea;
Narrative:  Patient experienced a marble-sized lump in the right axilla and tenderness after receiving the COVID-19 vaccine in the right deltoid. It was reported that the lump did not have a head to it but was draining clear fluid.
He didn't feel good, lethargic, slept a lot, diarrhea, no fever.
Approx 1 hour after injections given - pt very fussy, Mom said pt slept for approx 1 hour. Woke very pale and whimpering. Fever (cough). Symptoms lasted approx 24 hours. Color improved sooner.
her sugar always controlled but skyrocketed to 600 and will not get down; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown, expiration date: not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history included diabetic. Concomitant medications were not reported. Reporter stated that, on an unspecified date, her sugar always controlled but skyrocketed to 600 and will not get down. Reporter also stated that one diabetic patient that came in with her sugar always controlled but skyrocketed to 600 and will not get down no matter what they give her. Lab test included sugar measurement: increased; (skyrocketed to 600 and will not get down). The outcome of event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient stated that she got hives one day after the vaccine and that it cleared up the same day with diphenhydramine
Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies reported as none who on 09-MAR-2007 was vaccinated with the first dose of Gardasil (lot #655849/0263U), 0.5 ml, IM in the deltoid. Concomitant therapy included montelukast sodium (MSD). Subsequently on an unspecified date, the patient experienced hair loss after her first dose of Gardasil. The patient sought unspecified medical attention. The patient's hair loss persisted. Additional information has been requested.
Information has been received from a 77 year old female with no drug reactions or allergies and a history of "blood pressure" who on 14-APR-2008 was vaccinated with a "single dose" of zoster vaccine live (Oka/Merck). Concomitant therapy included DIOVAN. On 15-APR-2008 the patient developed swelling of the eyes, redness, circles around the eyes, difficulty breathing. The patient also noted that she had swelling of the face, which lasted for about two days. The patient was seen by an opthamologist who prescribed eye drops, PATANOL. At the time of reporting the patient was recovering from swelling of the eyes, redness, circles around the eyes, and difficulty breathing. It was noted "it had improved a little bit," and that the patient still had some difficulty breathing. Unspecified medical attention was sought. There was no lab diagnostic studies performed. There was no product quality complaint.
First dose: 03-DEC-2013, second dose: 20-JAN-2016; This spontaneous report has been received from a health care professional via immunization record from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS #2302USA008539), concerning a 12-year-old male patient.  The patient was vaccinated with the first, and second dose of Hepatitis A Vaccine, Inactivated (manufacturer unknown) on 03-DEC-2013 and 20-JAN-2016 (inappropriate schedule of product administration), respectively; as prophylaxis (formulations, strengths, doses, anatomical locations, routes of administration, lot numbers and expiration dates were not reported).; Sender's Comments:  US-009507513-2302USA008539:
Anaphylactic reaction requiring IM epinephrine following dose #2 of Pfizer vaccine.  Patient experienced nausea ~30 minutes after administration and went on to experience throat tightness and SOB. During this reaction, the patient reported she had an anaphylactic reaction to an influenza vaccine in the past  with an onset of ~2 hours s/p administration.  This was not in her chart nor reported on intake. Epi-Pen 0.3 mg was administered and a Code Blue was called.  Code team transported the patient to the ED.
Upper back and right flank pain. Herpes Zoster with out complication - right thoracic dermatome braline, T5 area).
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Symptoms of dizziness and numbness to face after receiving 2nd GARDASIL vaccine as per patient. ER final diagnosis - allergic reaction.
I WAS IN A TRAINING WHEN I LEFT THE PARKING LOT AND GOING TO MY CURRENT WORK OFFICE A PACK OF DOGS LAUNCHED ON ME, MANAGING TO SCRATCH AND DRAW BLOOD FROM MY LEFT LEG. BLOOD CAME OUT OF THOSE TEARS WHEN SEEING CONTACT OF SALIVA AND BLOOD ON NOV 8, 2022, I WAS REFERRED TO THE INSURANCE FUND. DURING THIS DAY I WAS ATTENDED BY DR, WHO REFERRED ME TO THE EPIDEMIOLOGIST NURSE. FIRST DOSE OF THE RAMUNIET VACCINE WAS NOV/29/2022. SECOND DOSE DEC/2/2022, THIRD DOSE DEC 6, 2022 AND FOURTH DOSE DEC/13/2022. AFTER ABOUT 4-5 DAYS I HAD A SMALL LUMP THAT I HAD TO FOLLOW TREATING ME ON THE RIGHT LEG BECOMING A LITTLE ULCER THAT TODAY I AM TREATING WITH THE INFECTOLOGIST. I PREVIOUSLY SEEN WITH SURGEON. HE OPENED AND TAKEN OUT WHAT I HAD TAKING TWO DOSES OF ANTIBIOTICS BEFORE REFERRING TO THE INFECTIONOLOGIST. THIS DR GIVES ME ANOTHER DOSE OF ANTIBIOTIC AT THE FINISH OF THEM. HE MADE A CULTURE THAT CAME OUT NEGATIVE, IT IS RECORDED IN HIS MEDICAL RECORDS. TODAY I CONTINUE CURING THIS LITTLE ULCER ON MONDAYS AND THURSDAYS IN DR'S OFFICE.