chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY PAIN; CHILLS; FEVER; NAUSEA; EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body pain, chills, fever, nausea, extreme fatigue, and headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from body pain, chills, fever, nausea, extreme fatigue, and headache. This report was non-serious.
Within 12 hours after administration of vaccine, pt c/o nausea, vomiting, body aches, fever 102 degrees. Resolved approx 48 hours later. Pt c/o nausea only at vaccine visit.
At the moment of injection I said that the fluid going in really burned.  She said that was normal.  About 15 minutes later the front and back muscles in my upper arm were getting stiff.  I asked the nurse that gave me my shot and she said to keep moving my arm.  I went home and took a tylenol and laid down.  4 hours later (almost 5 hours after injection), my arm muscles were really hard and my arm was stiff.  I took another tylenol and went to bed.  The stiffness in my arm (and now in my left chest too) woke me up throughout the night.  I got up in the morning and my arm had a 3 1/3"X 2" patch of hives on my upper front muscle with a 'finger' line going into my arm pit.  My upper arm was stiff and swollen.  I put ice on it.  I had a low grade fever, nausia, stiff arm and now chest muscle stiffness.  (26 hours after injection)I called my insurance company 24 hour number and spoke to a nurse.  She suggested that I get to an urgent care center as soon as possible.  (34 hours after injection)I went to the urgent care center.  The doctor said I was having a reaction to my shot and gave me some Benedril to take every 4 hours and advised me to ice my arm every hour and to be seen for follow up visit.  (72 hours after injection) After the Benadryl and ice took affect, my swelling went down, the redness started going away and the pain was gone.  All of the redness and swelling finally was gone a week after injection.  The hives did not itch or burn.
Case number PHHY2015US037684, is an initial literature report received on 25 Mar 2015. The authors discussed about evaluation and subsequent safe administration of rabies vaccine to a child presumably allergic to the gelatin content of PCECV RABAVERT. This report refers to a 07 years old male patient. His medical history revealed no ancillary atopic problems to date. Specifically, he had no history of atopic dermatitis, asthma, allergic rhinitis, food and drug allergy. His growth and development were appropriate for his chronological age. He ate chicken frequently but did not care for egg although he could eat egg without obvious adverse effects. He had a history of eating gelatin-containing foods such as Jell-O without adversity. His family history was negative for atopic disease. His vaccination history included administration of all childhood immunizations including MMR (manufacturer and batch number unknown) and varicella vaccines (manufacturer and batch number unknown) without adverse reactions. On an unknown date, he was bitten by feral cat. Immediately after cat bite, he was vaccinated with first dose of PCECV RABAVERT (batch number: unknown) with concurrent administration of rabies immune globulin and amoxicillin at local emergency department. At home, within 1 hour of RABAVERT administration, he complained of chest discomfort, nausea and facial swelling. The symptoms resolved without intervention and he continued his prescribed amoxicillin without incident. The authors concluded that gelatin can cause IgE-mediated or non IgE-mediated reactions. Hence it was important to know the components of vaccines and be aware of the potential for reactions. Desensitization can be considered for vaccine administration in certain cases. Seriousness assessment of chest discomfort, nausea and facial swelling was upgraded based on information in the source document. On an unknown date, 3 days after first dose, he was vaccinated with second dose of RABAVERT (batch number: unknown) and experienced acute allergic reaction (see case: PHHY2015US038494).                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
severe vomiting and uncontrolable diarrehia, stomach pains, body aches, chills, headache, weekness, fever, unable to eat or drink for 12 hours.
Blood work, Platelet count <5,000 result in hosp admin. Petechia and bruising cheeks, fussy off and on, pale.
Patient stated that approximately 11:30 am she noted left facial cheek feeling numb and tingling.  Then became tingling all over face that lasted for approximately on hour.  Patient returned to Clinic to report symptoms at approximately 1445.  Patient stated that symptoms had resolved prior to arrival.  Patient was seen for symptoms by  FNP.
Fever; Cold sores; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number K2397, expiry date 17th December 2021) for prophylaxis.   Additional patient notes included Patient medical history-none.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, the patient experienced fever and cold sores. On an unknown date, the outcome of the fever and cold sores were unknown.   It was unknown if the reporter considered the fever and cold sores to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient had fever cold sores, since got first Shingle vaccine. For tolerance after 2nd dose refer case US2019205733.
PT REPORTED HAVING A SEIZURE EPISODE (LASTING 2 TO 3 MINUTES) AT 1:00 AM THE NEXT DAY.  EMT ARRIVED AND ASSESSED AND PT WAS OK.  NO HOSPITALIZATIONS AND PT HAVE FOLLOW UP WITH NEUROLOGIST SINCE INCIDENT.
(DOB 04/08/2006) received the 2nd COVID dose (Pfizer, lot # ER8735 use by 07/04/2021 at 1400) at 1347.  Approached EMT and stated, " I feel a little lightheaded." EMT immediately assisted the client to the anti-gravity chair and placed him in a semi-Fowler's position. The client was immediately given juice and a granola bar. RN assessed the client who was A & O x4 and denied SOB, abdominal pain, nausea/vomiting, or chest pain. Vital signs taken at 1356, BP-120/80, RR-18, HR-54, oxygen saturation- 98%. The client stated, " I feel a lot better." The client stated the last time he ate was breakfast, around 0700. The client denied any known drug allergies or having any chronic medical conditions. The client was speaking in full sentences with his parent, Fabiano Sarmento, and was in no apparent distress. Vital signs taken at 1401, BP- 120/80, HR-56, RR-18, oxygen saturation-98%. The client stated, " I feel better." The client reported being very active and reported playing sports regularly. Denied shortness of breath, lightheadedness, dizziness, chest pain, or vision changes. RN educated the client and about V-safe, PCP precautions, and Emergency Room precautions. The client ambulated with a steady and even gait to the car at 1426.
Initial unsolicited report received from a physician via other company (Pfizer) on 18 November 2015. Manufacturer Report Number: 2015390253. This case involves a male patient (age reported as "18") who was vaccinated with a dose of MENACTRA and a dose of TRUMENBA (batch number, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccines) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's face was pale, he was sweaty, dizzy, had cold hands, nauseous and he could not see. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration on 17Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joint pain on an unspecified date. Patient wanted to check how many days usually the symptoms appear after getting the dose of the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swelling arm; redness on arm; painful to the touch; arm a little stiff; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th July 2019, the patient experienced limbs stiffness and pain in arm. On 17th July 2019, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the injection site pain, limbs stiffness, swelling arm, erythema of extremities and pain in arm were recovering/resolving.   It was unknown if the reporter considered the injection site pain, limbs stiffness, swelling arm, erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of Shingrix, the patient experienced some soreness in his arm at the injection site. The patient arm was little stiff and also very painful to the touch and noticed redness and swelling in his arm. The patient was concerned by the amount of redness, so went to Urgent Care, where they drew a line around the redness and advised to start antibiotics if the redness spread. The redness has not spread and the patient has not filled the prescription for antibiotics. The symptoms were not improving. The patient consented to follow up. The emergency room visit was required.
Patient described extreme chills the morning after the vaccine. She reports vomiting the morning after shot. She describes feeling very fatigued for 3 days after vaccine.
New onset of dizziness lasting approx 1 day. Temp 101-102 degrees F. Reported difficulty walking comfortably. Twin w/same side effects.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to 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 include 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 will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Patient experienced dizziness, general malaise, heart palpitations, injection site pain, chills, shivering, heavy muscle pain approximately 10-12 hours from time of injection. Patient also experienced a low-grade fever of 100.3 the next day (9/16/2020).
Patient received dose 1 of Moderna COVID-19 vaccine. Approximately 5-10 minutes after administration, the patient's mother alerted me that the patient was feeling faint and sweaty. I came to check on the patient. He appeared pale and diaphoretic. Patient said his vision was narrowing and he subsequently lost consciousness for approximately 10-20 seconds. I checked the patient's blood pressure and initial result was 88/64. Upon regaining consciousness, patient reported immediately feeling better. His blood pressure was still low at 94/70. He remained seated and drank some cold water and a cool compress was applied to his forehead. I questioned the patient to determine if he was experiencing any other symptoms that may indicate anaphylaxis (skin itchiness, tight throat, stomach upset) and he denied any other symptoms. I continued to monitor the patient for approximately 30 minutes. During monitoring, the patient told me he is nervous of needles, and has fainted trying to give blood in the past. After 30 minutes of monitoring, diaphoresis had resolved, color returned to patient's face, blood pressure recheck was 116/84, and patient self-reported feeling fine. He was escorted home by his mother.
Two days post vax pt developed fatigue , body aches and felt feverish.  She recovered after 5 days.
Information has been received from a registered nurse concerning a 6 year old male with no known medical history or allergies who on 15-JUN-2001 was vaccinated with a dose of Varivax (Oka/Merck). It was unknown if there was an illness at the time of vaccination. On 22-JUN-2006 the patient developed a chickenpox-like rash that started on the trunk and spread to his neck, face, shoulder and legs. There were greater that 50 lesions. There was no fever. It was not reported if medical attention was sought. On 28-JUN-2006 the patient recovered. Additional information is not expected.
This non-serious spontaneous case, initially received on 15-Mar-2018, reported by other health professional (nurse), concerning a male patient of unspecified age. It was reported that, the patient's current condition included asthma or wheezing (since an unspecified date). It was also reported that, the patient was a weed smoker (since an unspecified date). The concomitant medication included pneumococcal vaccine (administered on 02-Jan-2018). On 02-Jan-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, anatomical location: left arm, batch number: XT59906, expiry date: 06-Jun-2018 and route of administration: intramuscular, anatomical location: left arm) after first temperature excursion). On an unspecified date, the vaccine was stored out of range for 65 hours and 35 minutes, that reached highest temperature of 60 F which was the fifth (5th) excursion with those vaccines. It was reported that, the patient did not experience any adverse effects. This case was cross-linked to the original case 201800429 (due to the same reporter). Follow-up report received on 09-Apr-2018: Route of administration (intramuscular), anatomical location (left arm) was updated. No adverse effects were noted. Amended narrative accordingly.
1st dose was not given into RA due to needle not being tightly screwed onto the syringe. 2nd dose was given immeidately into LA per CDC guidelines after getting permission from Clinic Supervisors.
About five months after receiving my fourth dose of the COVID vaccine, Pfizer, I came down with the COVID-19 virus twice. I went on a cruise and after the cruise I started with a cough, feeling exhausted, got headaches and had a sore throat. I did receive the anti-viral and it worked perfectly.
Information has been received from a Certified Medical Assistant (C.M.A) concerning of unknown number of patients of unknown demographics. There were no medical history or drug reactions/allergies reported. It was reported that since 04-MAY-2014, the patients had been administered improperly stored ROTATEQ (dose, frequency, route, lot number and expiration were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
ADMITTED TO HOSPITAL ON 3/5/2022; PRIOR ADMISSION WAS ON 2/8/202 DURING COID-19 DIAGNOSIS AND PHEUMONIA. A WEEK PRIOR TO 3/5/2022 ADMISSION, HE WAS ADMITTED TO AN OTHER HOSPITAL. BECAME SEVERELY DYSPNEIC AND HYPOXIC. DNR STATUS AND DISCHARGE TO HOSPICE CARE.
5:30 vaccine administered. Dizziness, nausea, felt like vomiting, pallor - 5 minutes following injection - lasted for 30-45 minutes - Heavy chest started about 15 minutes following injection EMT checked vitals.
About 2 mins after the vaccine was administered patient stated that she did not feel good. She was hot, pale, sweaty, nauseas, almost passed out. We laid her on the floor and elevated her legs, then she started feeling better. The paramedics came. BP was 90/48. when they left her BP was 101/60. Her parents decided to take her home for observation. I called them at 7:58pm and mom said she was perfectly fine. Vaccine given at 4:55, paramedics left at 5:20.
A report has been received from a Health Professional via medical representative concerning a 7 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started during NOV-2014. It was reported that patient receiving  FLUMIST 2 doses with two weeks of each other which started during NOV-2014. The outcome of the event of 7 year old child received 2 doses of FLUMIST Quadrivalent within two weeks of each other is unknown. The report was considered to be non-serious.
It began with pain on my left shin. It then moved down into the top of my ankle bone. It then moved forward along my foot. It became painful on the top of my foot. I went to see a doctor for a referral. They said it didn't appear to be neurologic. He sent me to an Orthopedic doctor. The PA diagnosed it as Interior Tibialisis Tendonitis. I am currently having physical therapy. The pain diminished quickly during the first few days of physical therapy. It has been plateaued for the last few weeks. It has not resolved. Treatment has included ice, compression, elevation, a tall air cast, and physical therapy. There was no trauma before this occurred.  It is possible that it is due to my walking for my cardiac health. It may also be possible that my very flexible arch contributed to it. I do not believe that it was caused by the vaccine.
transient ischemic attack; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration, administered in the left arm, on 30Jan2021 17:30, as single dose, for COVID-19 immunisation, at a hospital. Medical history included migraine and back pain. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included ketoconazole and hydrocortisone (HYDROCORTISONE), all taken for unspecified indications, start and stop dates were not reported. The patient previously took codeine and sulfur dioxide and experienced allergies to both. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on an unspecified date, for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. On 19Feb2021 at 11:00, the patient experienced transient ischemic attack. This resulted to emergency room visit and hospitalization on an unspecified date. The patient was hospitalized for 1 day. Treatment for the event included unspecified blood thinners. The patient underwent COVID nasal swab on 19Feb2021 which resulted to negative, and an unspecified test on an unknown date with unknown result. The outcome of the event was recovered with sequel (reported as recovered with lasting effects).  No follow-up attempts are possible. No further information expected.
Hives, swollen throat and tongue. A lump on his neck. Treatment included 5ml of Benadryl and injection of Epi-Pen Jr. Activated EMS and was taken to the ER after 20 mins of the reaction.
Rash. Initially in right arm. Later extended through legs chest and back; This is a spontaneous report from a contactable consumer (Patient). A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 20Feb2021 14:30 (At the age of 65-year-old) as single dose for covid-19 immunisation. Medical history included HTA, cholesterol. No allergies reported. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tot been tested for COVID-19. On 20Feb2021 16:30, the patient experienced rash, initially in right arm. later extended through legs chest and back. Seriousness criteria reported as non-serious. Therapeutic measures were taken which included Allegra. The outcome of event was recovering.  Information on the lot/batch number has been requested.
pt recv vax;devel multi sclerosis;f/u stated: pt not being tx w/ reporting md,however md believed pt devel optic neuritis & recovered completely;
Extremely Loud Ringing Buzzing Whooshing in both ears  Accompanied by headache-
Loss of vision in one eye, loss of consciousness, report of seizure activity by husband, night sweats.
Had VARIVAX, TDAP & MENACTRA given on 8/30/10. 1 hr after the immunizations his (L) arm was red, slightly itchy. C/O axillary pain also was seen in office 9/2/10 and started on PO antibiotic for cellulitis at the site of VARIVAX immunization.
Patient  discharged from clinic . Patient came back 30 minutes later stated she had rash and itching . Patients assessed for 1 hr . Vitals assessed x 1 hr .within normal ranges. Patient administered Benadryl per provider order and provider sent prescription for steriods to pharmacy . Patient denied sob, chest pain before leaving and stated itching was better.
3 injections of PCV7 (PREVNAR), reaction to each of three vaccines administered @ 2ms, 4mo and 6mo of age. Pt has had a reaction with all three of his administered PREVNAR vaccine. During each of his vaccines, redness to varying degrees and with last two injections, wheals/knot at site of injection developed and lasted about two weeks. Each of the injections for PREVNAR was given in a single thigh without any other vaccines in the same leg. Vaccines over the three visits (2 month, 4 month, and 6 month well child visits) were performed by two different nurses. Patient also received PENTACEL and HEPATITIS B vaccines at the same time in opposite thigh.
Noticed hot, red, swollen area where shot was given in right arm on getting up out of bed.  States it was itchy as well.   red area was about 2 inches in diameter and had a streak of about 1 inch wide and 2 inches long around the arm towards the inner arm.    the area lasted a couple of days this way and then started decreasing in redness and feeling so hot and being swollen.   We used an ice pack on it a few times a day.   It was finally all gone in a week.
This patient had joint pain (extreme arthritis), headaches, tiredness; began over year after vaccine, no treatment possible.