chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VAC WAS NOT GIVEN IN THIS CLINIC PT WAS TREATED AFTER SURGERY PT RECIVED THE FIRST ROUND 12/23/20 AND SEC ROUIND 1/20/2021 THEN 7 DAYS POST VAC PT SUFFERED FROM A SUBDURAL HEMATOMA .
10/22/09 fever, cough, SOB: healthy 14 yo sib with clinical H1N1. TAMIFLU began 75 BID. 10/23/09 seen in office & at home resp decompensation admitted to PICU: BiPAP. DNI order. Bilateral severe pneumonia died approx. 1pm 10/25/09.  12/14/09 Death Certificate received. DOD 10/25/09. Cause of death: Pneumonia. Additional information abstracted: Rett Syndrome.  12/14/09 Hospital records received, service dates 10/23/09 to 10/25/09. Assessment: Medically frail with hypovolemia, respiratory distress, ABG concerning for ARDS, likely due to H1N1 infection w/ bacterial superinfection. Patient presents with increasing work of breathing, fever, and cough. O2 Tamiflu at home. Tachypnea. Wheeze, shortness of breath. Crackles, rhonchi, flaring, retractions. Decreased responsiveness. Admitted to ICU. Mechanical ventilation. Edema of feet. Expired.  12/17/09 Hospital records and discharge summary received. Service dates 10/23/09 to 10/25/09.  Assessment: Pneumonia present on admission, respiratory distress present on admission.
This spontaneous report was received from the patient's mother refers to her 15 year old son with SINGULAIR allergy, ZYRTEC allergy and QVAR allergy. The patient's medical history included viral induced asthma. On an unknown date in 2012 (reported as last year), the patient was vaccinated intramuscularly with dose 1 and dose 2 of GARDASIL (lot# and dose not reported). No concomitant medications were reported. On an unknown date in 2012, the patient developed headachy and dizzy feeling after receiving each of his first 2 doses of GARDASIL. The reporter was unable to recall if the feeling also occurred with the patient's last dose as well. No treatment was received. No medical attention was sought. The outcome of headache and dizzy feeling was unknown. The relatedness for the events with GARDASIL was unknown. Additional information is not expected.
Chills began 1/25 evening, felt feverish - temp taken on 1/26/2019 in the morning: 100.2 orally.  Not feeling well. Redness at injection site. Very painful. Redness and pain still present on  1/28/2019. Chills and fever resolved after about 24 hours by evening on 1/26/2019.
I am 49 years old  and started having very heavy, longer lasting menstrual cycles. I had a period for 4 days on January 14-18, 2021 prior to second dose of Pfizer vaccine. Then, I had my second Pfizer shot on January 20, 2021.  I started my period again on January 26, 2021. It was  very heavy and lasted 11 days until a February 6, 2021 .  I went to see my PCP who sent me for testing and treatment with Ob/ gyn on 2/17/2021. She started me on Progestin.  There was no immediate relief.  My next period started on March 2, 2021. It lasted through March 26,2021, .  On March 12,  2021, I  completely bled through a long, super maxi pad in a matter of an hour. I was bleeding so much that I started losing hair. I saw dermatologist for hair loss. She  recommended I take iron supplements.  Finally, ended up getting Mirena.l to help with bleeding. Since then, I have had multiple ultrasounds and and MRI. I now have ovarian cysts which I never had before and fibroids.
Dizziness 15 minutes after adminstration.  Patient reports this happened at her first administration and relieved with apple juice.  Provided the apple juice per patient's request and immediately dizziness was resolved.  Patient discharged in stable condition.
This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A male patient of unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 11 Mar 2021 (at an unspecified age) at 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient felt pain in the shoulder. The patient would like to take pain medicine meloxicam and was asking if this will affect the effectiveness of the vaccine. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Listlessness x 7-8hrs, crying (high-pitched) x 15 hrs, fever high x 10 hrs; low grade fever continues & continues to have irritability;
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported) at a medical office by a physician for the long-term prevention of shingles and zoster-related conditions. Subsequent to her zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by the physician for shingles (date unknown). As a direct and proximate result of her use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not reported.
Vomiting, fever, chills, injection site swollen, red, size of a softball, limited movement of arm.
Information has been received from a consumer referring to her 2 years old grandson. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date in June 1996, the patient was vaccinated with an unspecified chicken pox vaccine (dose 1, dose, route, lot number and expiration date were unknown) (the patient was approximately 2 years when vaccination). On an unknown date in September 1996, after receipt of the initial unspecified chicken pox vaccine, the patient became very sick. The patient developed the following symptoms: fevers over 40 centigrade degrees (reported as 104 degrees), swollen gums and broke out in pox all over the patient's body. The patient sought unspecified medical attention via office visit. No treatment was given for the adverse events. The patient's present status was reported as recovered (date unspecified). The causal relationship between the unspecified chicken pox vaccine and the events was unknown. Additional information is not expected as no consent was given to contact the reporter.
The pt developed rash, hives, edema to bilateral hands and feet and a temperature of 101.8F (R). The pt went to ER at approx. 23:00.
I initially received the J&J vaccine in April 2021 having minimal side effects. I chose the Moderna booster on 12/20/21 The following day I had the more common results of chills, fever, and headache.  Later that same evening my throat became sore, and then started to swell. By around 2 am I considered going to emergency as I could visibly see the swelling and my voice was affected. I tried to breathe out of my nose, but when I fell asleep and started snoring I'd wake up choking. The swelling started going down but remained very sore. This is one week later and my throat is still sore, albeit less than it was. What is unusual is that it's not like a normal sore throat. When I eat foods, it burns the area of redness in passing more as if it were a blister or an abrasion.
bulls eye" circle at site of injection - diameter of circle is  is approximately 2 inches; Fever; Chills; headache; joint aches; felt like having flu; fatigue; Red at site of injection; swollen at the site of injection; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache), ARTHRALGIA (joint aches) and INFLUENZA LIKE ILLNESS (felt like having flu) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache), ARTHRALGIA (joint aches), INFLUENZA LIKE ILLNESS (felt like having flu), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red at site of injection), VACCINATION SITE SWELLING (swollen at the site of injection) and VACCINATION SITE PAIN (pain at injection site). On 29-Apr-2021, the patient experienced VACCINATION SITE REACTION (bulls eye" circle at site of injection - diameter of circle is  is approximately 2 inches). At the time of the report, PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache), ARTHRALGIA (joint aches), INFLUENZA LIKE ILLNESS (felt like having flu), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red at site of injection), VACCINATION SITE SWELLING (swollen at the site of injection), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE REACTION (bulls eye" circle at site of injection - diameter of circle is  is approximately 2 inches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.   This case was linked to MOD-2021-097899 (Patient Link).
This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was reported regarding the patient's concurrent conditions, concomitant medications or medical history. On 23-JAN-2019, the patient was vaccinated inadvertently with an expired dose of ROTATEQ lot # N005078 with expiration date on 22-NOV-2018, per oral for prophylaxis (dose was not reported). However, no adverse effects were reported.
Induration x 6 wks. FEver to 102.8 48 hours post vaccine given.
Breakthrough case admission after 3 vaccines Moderna 1/20/21 lot# 025J20A'  Moderna 2/17/21 lot# 004M20A'  Moderna 12/4/21 NO LOT#
Had muscle aches and pains, nausea, fever or 101.5, extreme fatigue. Symptoms lasted about 28 hours. Pharmacist called the day after the vaccine and we discussed effects, he advised ibuprofen and rest. (Slept about 16 to 17 hours during this period.)
patient states his arm is still very sore a month after the vaccination and gives him discomfort when he moves his shoulder
Patient developed intussusception requiring bowel resection on 1/20/2015. Pt. developed symptoms of vomiting and diarrhea on 1/18/2015.
Sweats day after 2nd dose; Low grade fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats day after 2nd dose), PYREXIA (Low grade fever) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 HYPERHIDROSIS (Sweats day after 2nd dose), PYREXIA (Low grade fever) and NAUSEA (Nausea). At the time of the report, HYPERHIDROSIS (Sweats day after 2nd dose), PYREXIA (Low grade fever) and NAUSEA (Nausea) outcome was unknown.            No concomitant medication were reported.  No treatment information was reported  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Fever; Soreness at injection site; Inflammation at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (received 1st dose on 10th July 2019 and experienced injection site soreness and injection site inflammation, refer case US2019AMR186537).   On 11th October 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site inflammation. On 12th October 2019, the patient experienced fever. Rechallenge with Shingrix was positive. On 13th October 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site inflammation was unknown.   It was unknown if the reporter considered the fever, injection site pain and injection site inflammation to be related to Shingrix.  Additional details were provided as follows: The patient experienced soreness at injection site after receiving Shingrix which was worse than the 1st dose. The patient also experienced inflammation about 3 inches in diameter at the injection site. The patient also experienced fever that went up to100 degrees, and broke the next day. No further details were provided.
Fever, headache, hives, small red raised rash on arms and trunk of body.
Having severe pain in my arm since I got the second shot of Covid vaccine Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Having severe pain in my arm since I got the second shot of Covid vaccine Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Having severe pain in my arm since I got the second shot of Covid vaccine Moderna). At the time of the report, PAIN IN EXTREMITY (Having severe pain in my arm since I got the second shot of Covid vaccine Moderna) had not resolved.            Concomitant medications details were not reported by the reporter.  It was reported that patient had this pain over 3 months and developed severe pain that feels like if someone put a dagger in arm. Patient did not have a doctor now and was hoping it would get better but it was still there and the patient was worried now.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Mar-2022: Follow-up document contains no additional information.
ACUTE RASH BILATERAL FACE AND RIGHT LOWER LEG 30 MINS AFTER INJECTION NO RESPIRATORY/GI SYMPTOMS OR HYPOTENSION DIPHENHYDRAMINE 50MG GIVEN OBSERVED FOR 3 HOURS FULL RECOVERY, DISCHARGED HOME; PLAN FOR OTC DX: ACUTE URTICARIA
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 49-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 11 days after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt started with blanchable rash to hands and shoulders that is atypical of vaccination rashes.
Immediate surge of tingling at injection site of right arm.  Now have pain with range of motion to that arm and pain in shoulder after getting the flu shot.
Patient returned to pharmacy on 12/03/07 presenting an intense rash reaction on the lefty arm.  The condition of the lesions reflects trauma and secondary infection potentially due to intense itching.  Recommended patient to see his PCP ASAP.  Patient was stable.
On 12/26/21 I started with a dry cough. I do not think I ever had a fever, I just felt bad. ON 12/27/21 I got tested and on 12/29/21 I was informed that I tested positive for Covid 19. On 01/08/22 I took a Covid test and I was still positive.  On 01/11/22 I went to doctor and was given medicine for my cough and was advised to keep taking Mucinex. On 01/13/22 from coughing so much I ended up damaging my sternum and had to go to the urgent care. Urgent care may have prescribed me steroids and antibiotics. Once I started taking the steroids and antibiotics, I noticed the next day I felt better. The cough continued to lingered for about another 2 weeks. I still have brain fog today.
Starting 1 day after injection, left upper arm with moderate redness, warmth, and itching, and moderate-severe pain extending from deltoid to bicep. Currently (day 5) still with redness, warmth, itchiness and mild pain, although improved. Distribution of symptoms has decreased to just over bicep.
she lost her sense of taste.; she had a bad UT infection; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Batch/Lot Number: Pfizer6203) as 2nd dose, single for covid-19 immunisation. Medical history included blood pressure, diabetes type II from an unknown date. Concomitant medication(s) included ATORVASTATIN; acetylsalicylic acid (BAYER ASPIRIN); CLOPIDOGREL 75mg; ubidecarenone (COQ-10); FLUOXETINE; FISH OIL; GABAPENTIN taken for fibromyalgia,METFORMIN taken for diabetes mellitus; PANTOPRAZOLE; PRAMIPEXOLE taken for restless legs syndrome; VALSARTAN taken for blood pressure abnormal,VITAMIN D3; VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE] taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced she lost her sense of taste and she had a bad UT (urinary tract) infection. Caller stated patient received her first Pfizer Covid-19 vaccination bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Feb2021 10:30 (Batch/Lot Number: EL9265) as 1st dose, single for covid-19 immunisation. On 04Feb2021 she lost her sense of taste. Caller stated, and still to this day patient didn't have it. Caller stated she received her second Pfizer Covid-19 vaccine on 23Feb2021. Caller asked, she want to know when will she get her taste back. How long would this last. She still can't taste anything. Is that a side effect and for how long. She went to the doctor yesterday. They said she had a bad UT infection. They gave her a shot. Caller doesn't know the name of the shot she was given. Maybe it was an antibiotic. She did ask the doctor about not being able to taste, but the doctor didn't know. She had asked lots of people and doctors, but no one knows. The patient underwent lab tests and procedures which included weight was 175 or 176 lbs on unknown date. Therapeutic measures were taken as a result of she had a bad UT (urinary tract) infection which include antibiotic. The clinical outcome for event she lost her sense of taste was not recovered while outcome for the event she had a bad UT infection was unknown.  No follow-up attempts are possible. No further information is expected.
I had a bad cough, a fever, chills, and body aches. I took a home COVID-19 and that was positive so I called my doctor.  He put me on Paxlovid. Within about two of starting the Paxlovid the symptoms started to decrease but I continued to test positive.  I then developed a bad cold.  It took a good 10 days before I got a negative test.
No other AE; ROTATEQ was administered to patients after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 02-NOV-2021 , the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, lot # 1742081, expiration date 18-JUL-2022 (exact dose, route of administration, anatomical location were not reported) for prophylaxis.  Administered dose of vaccine has been stored in the temperature of 35.0 degrees Fahrenheit (°F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There were no previous temperature excursions reported. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001753: US-009507513-2111USA004488: US-009507513-2112USA001755:
Information has been received from a registered nurse concerning a 6 year old male with attention deficit hyperactivity disorder and no drug allergies who on 1/10/2000 was vaccianted with a dose of varicella virus vaccine live (lot 631479/1007J). Concomitant vaccination included the fourth dose of diphtheria toxoid + pertussis acellular 3 component vaccine + tetanus toxoid Infanrix (lot DTPa914A2) given intramuscularly in the right deltoid. There was no illness at the time of vaccination. Other concomitant therapy included amphetamine Aspartate + amphetamine sulfate + dextroamphetamine saccharate + dextroamphetamine sulfate Adderall tablets PO. On 611/2005 the patient developed breakthrough chickenpox characterized by a rash of 50 or less pox on his chest, back and perineal areas. it was reported that the rash was no severe and there were no complications. As of 6/15/2005 the patient was recovered. it was also noted that on 10/18/1999 the patient had been administered the fourth dose of Hib vaccine unspecified and the first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) manufacturer unknown. No product quality complaint was involved. The nurse also reported that the patients sister developed breakthrough chickenpox (associated WAES0506USA02387).
Phone call from patient 8/24/16: Had a shingles vaccine on Monday in her left arm. It was the only vaccine she had at the time. Now has a rash at the injection is about 4 inches and is slight itchy and red and hot.   Under her arm and to the side of her breast is achy, and is also sore to press on. Pain is worse under her armpit.  States it almost feels like when she had shingles in the past. It feels better if she keeps her arm down.  No visible rash.
Client's mom called to report client feels extremely tired and nauseous. Per mom, client complains of a headache and her eyes hurting and having a blind spot in one of her eyes. Mom reported client has frequent migraines.