chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre syndrome; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 22-FEB-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered right upper weakness, tingling, numbness and dizziness and was diagnosed with Guillain Barre Syndrome. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event Guillain Barre Syndrome was not recovered and causal relationship was assessed as related.   The lawyer considered the event Guillain Barre Syndrome to be disability.   Upon internal review, the event Guillain Barre Syndrome was determined to be medically significant.
< 24 hr after vaccine. Pt developed urticaria. Given Zyrtec, Orapred. Given pedi epipen to have at home.
Pfizer-BioNTech COVID-19 Vaccine EUA  Loss of taste to a moderate degree about two hours after injection. Smell unaffected. Slight odd metallic taste as well. Currently ongoing.
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 17-year-old female patient receive the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for Prevention of Meningitis. The patient's medical history and concomitant medications were not reported. The patient got the shot, the one initial, the first dose of meningococcal group b rlp2086, when the patient got back, on 02Jul2018, the patient had chills, headache, nauseous and body ache. The outcome of the events was unknown. The information on the batch number has been requested.
I started feeling bad. I was unable to stand up I told my husband I felt like I would pass out. I eventually ended up going to the hospital 3 times due to the abdominal pain and elevated blood pressure. I am going through menopause, but my hot flashes stopped completely. Since then, they have come back but I am dealing with them via estrogen patches. I had a headache for about a week before it started letting up. I had a mild and constant headache at the back of my skull. I had slight nausea and stomach pain. I was unable to do anything. At the hospital, in April, they did an abdominal CT scan with contrast which showed colitis. The second time I went to the hospital was in May where they told me I had diverticulitis. The 3rd time, they told me I still had colitis. I followed up with a lot of specialists. I had an endoscopy and colonoscopy done. Aside from a few polyps, everything was normal. I received a neurologist referral. I was diagnosed with Chiari malformation. This is something diagnosed at birth. I have had numerous scans done over the years and this was never detected.  The neurologist did not prescribe anything because this was not something they could treat. I have since been diagnosed with nystagmus by my eye doctor. This is not something i have ever had. I am not back to myself prior to the vaccine.
Patient developed shortness of breath, chest pain 'fuzzy head,' headache, rhinorrhea, diarrhea, and increased fatigue around 3/28/21  had clinic appointment 3/30/21, diagnosed with pneumonia.  XR CHEST 2 VIEWS (PA AND LATERAL), TRANSTHORACIC ECHO (TTE) ADULT NON CONGENITAL, EKG 12-LEAD completed. given cefTRIAXone (ROCEPHIN-Equivalent) injection 1,000mg IM, and doxycycline monohydrate (MONODOX) 100 mg capsule  PO.  was evaluated in ED 4/5/21  CT Abdomen Pelvis with IV Contrast  Final Result  1. Positive for extensive acute bilateral pulmonary emboli at the lung bases as  detailed in the body of the report.  DX Chest Portable 1 View  Final Result  Mild left ventricular prominence is noted. Small right pleural  effusion is seen. Minimal discoid atelectatic changes in the left perihilar  region and left lung base. Elevated right hemidiaphragm suggests eventration.   Admitted to Hospital 4/5/21, per admission diagnosis: Acute pulmonary embolism (*) submassive likely secondary to covid 19  Per hospital course notes:Patient presented with acute hypoxic respiratory failure and was show to have submassive PE with severe pulmonary hypertension seen on TTE. He should be on lifelong therapy given 2nd VTE and severity.  Iwould consider unprovoked (COVID in 11/20 wouldn't count I wouldn't think).  He was started on eliquis 10 mg BID x 7 days than 5 mg bid. Given his severe pulm htn on TTE, left atrial pressure normal.  We would have outpatient sleep study as well He will need VQ scan to assure no CTEPH. Will have outpatient follow up. We discontinued his aspirin on discharge as well.
Tinnitus in both ears, more in left ear.  More bothersome/more noticeable at night and early morning.   was worse the first 6 months of 2022 but has decreased in intensity with time, but still exists even today.
became feverish w/in a short time p/recvd inject; By Saturday rt arm was swollen & painful & had devel severe muscle achness;
Palpitations, flushing, dizziness, shaky, chills, evaluated by EMS-cleared
The patient was administered an improperly sotered dose of ROTATEQ on 5/26/2020; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender.   The patient's concurrent conditions, pertinent medical history, drug reactions allergies, and concomitant therapies were not reported.   On 26-MAY-2020, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  lot number 1660704, expiration date 20-MAR-2021, for prophylaxis (dose and route of administration were not reported). There was no additional adverse effect reported. Administered doses of vaccines experienced the temperature excursion of12.1 (°C)  degrees Celsius for 16 hours 11 minutes. Data logger was involved. There were no previous excursions reported.
pt reports bodyaches chills rigors today after receiving 2nd dose of moderna yesterday.  requesting qrtrs.
Felling of sickness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Felling of sickness) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felling of sickness). At the time of the report, MALAISE (Felling of sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was not provided.
Sore arm, can't lift left arm where shot was given. Pain in my neck and back, chills and headaches.  Chills last  2 days. No appetite.
18 hours after shot-body aches, headache, fever, fatigue,sore arm, fever.  2 days later arm started to swell, get red, and hard as a rock.  As the week continued, swelling increased, arm got redder and hot to the touch, a rash appeared, lymph nodes under my arm swollen.  8 days after the shot I woke up with swelling below my elbow in addition to all the other symptoms.
General weakness; nausea; stomach cramps; high blood pressure; aches all over the body especially in lower extremities; aches all over the body especially in lower extremities; severe headaches; This is a spontaneous report from a contactable nurse reported for self. This 56-year-old female patient the second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) via an unspecified route of administration on 12Jan2021 at single dose in left arm for COVID-19 immunisation. The patient is not pregnant. The patient had no other medical history. The patient had no known allergies. The patient concomitant medication was none. The patient previously received first dose of BNT162B2 (Lot number EL0140) at 22Dec2020 09:00 AM at single dose in left arm for COVID-19 immunisation. The patient experienced general weakness, nausea, stomach cramps, high blood pressure, aches all over the body especially in lower extremities, severe headaches on 17Jan2021. These events resulted in emergency room/department or urgent care. The patient received amlodipine besilate (NOVARSC) 5mg, hydroxyzine (ATARAX) for treatment. The patient had no COVID prior and post vaccination. The patient was recovering from the events.
Fever, upset stomach, diarrhea  the next day but it stopped with 48 hours. Then a rash started on my left arm where I had the second shot of the vaccine and now has spread  to other arm, neck, and legs (not as much as the neck and arms).
pt developed chills, nausea and vomiting. Reports > 10 episodes of vomiting total. Went to lunch and continued to have chills and vomiting. Also developed chest pain - described as burning and heaviness. Denies any shortness of breath. CT negative for any changes.  Chest X ray normal.
pt recv vax 2AUG95 & pt devel a moderate case of chickenpox;the reporting MD felt there was a problem w/this particular lot;
It was reported that a doctor administered a 0.5cc Fluzone SV '01-'02 vaccination, lot# U0600AA in the left deltoid of her 22 year old MA on 1/05/01. Within 10 minutes, the patient felt tightness in her left deltoid. A half-hour later, the patient developed numbness and tingling in her left hand. Further information is requested.
Not receiving 2nd dose on time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not receiving 2nd dose on time) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008c21a and 052e21a) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not receiving 2nd dose on time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not receiving 2nd dose on time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Gets hot/got really hot again/ it wakes her up; Developed a fever, but isn't sure because she doesn't have a thermometer; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Gets hot/got really hot again/ it wakes her up) and PYREXIA (Developed a fever, but isn't sure because she doesn't have a thermometer) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Gets hot/got really hot again/ it wakes her up) and PYREXIA (Developed a fever, but isn't sure because she doesn't have a thermometer). At the time of the report, FEELING HOT (Gets hot/got really hot again/ it wakes her up) and PYREXIA (Developed a fever, but isn't sure because she doesn't have a thermometer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure med, thyroid med, stomach med for drug use for unknown indication.  No treatment related information has been reported.      Reporter did not allow further contact
I call patient to follow on his immunization.  Patient went to his PCP and doctor because of a rash that developed all over his body the next morning .  The doctor said that it's not life threatening and will resolve.  Patient said he was doing better.
pt awakened from nap on afternoon of receiving vax-high pitched-non consolable cry-over 1 hr, t101+ APAP had been given & was repeated per direction of PMD; leg not overly inflammed or swollen, didn't look bad;
tested positive after taking the first dose of the vaccine; exposed to a family member with the virus/tested positive after taking the first dose of the vaccine; tested positive after taking the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse reported for a 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who tested and was positive for the virus after being exposed to a family member with the virus after taking the first dose of the vaccine. Patient was asymptomatic. The Nurse asking if we have any recommendations for the 2nd dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the events lack of effect (suspected COVID-19, tested and was positive) with BNT162b2 can not be completely excluded.
A report has been received from a physician concerning a 3 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient reported administered expired FLUMIST QUADRIVALENT which started on 08-Sep-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Moderna second dose was give 7 days too early.  Provider notified No adverse effects noted.
Lightheaded then headache-cold hands, flush. Received shot, anxious prior to shot.
Fever; soreness; sore throat; runny nose; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for himself. A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  on 14Jan2021 at 12:00 at single dose in left arm for COVID-19 immunization.  Medical history included diabetes. No Known allergies. Concomitant medication included metformin.  On 15Jan2021 at 15:45 the patient experienced fever, soreness, sore throat and runny nose. No treatment given.Outcome of the events was recovering. Information on the batch number has been requested.
morning p/shots fever & irritability, given APAP; next day persistant fever, fussiness; exam & lab tests done; seen again w/persistent irritability, no fever, diarrhea; admitted;
pt recv vax 13MAY97 & MAY97 exp pain in lt arm;pt unspecified problems grew worse over the next few days & ultimately resulted in pt death on 24MAY98;
Immun. given 5/18/05. Today presents to clinic with redness, swelling and localized reaction 7cm x 9cm left thigh.
9 days after receiving the vaccine the injection site became swollen, red, hot to the touch, with a raised rash, and it was extremely itchy. I was concerned the site was infected. The symptoms decreased markedly over the next 4 days when they resolved.
Severe joint pain in lower back, both hips, both knees, both ankles, left shoulder, left elbow starting from about 10-12 hours after the injection.
cold; redness at injection site; stuffiness; This case was reported by a consumer via call center representative and described the occurrence of cold in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nasopharyngitis (received 1st dose on 27th December 2018, refer link case US2019GSK092788).   On 29th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced cold, injection site erythema and upper respiratory tract congestion. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the cold, injection site erythema and upper respiratory tract congestion were unknown.   It was unknown if the reporter considered the cold, injection site erythema and upper respiratory tract congestion to be related to Shingrix.  Additional details were provided as follows: This case was reported by a patient's husband. On Monday, the patient received Shingrix and since then, the patient felt like she was getting a cold. At first it was in her chest but now feels it might be in her upper respiratory due to her stuffiness. The patient dose not feel bad though. The patient also experienced redness at the injection site. The reporter consented to follow up.
I had low grade fever under 100, fatigue, body ache, nasal congestion, and head congestion. I tested positive for COVID-19 at home. I talked to my doctor, and she did not prescribe me anything.
mom said pt was burning up 1 hr p/vax; pt cried & about 2 hrs p/vax had nausea & vomiting; dx red throat & red ears, sore in throat; cold ulcer
Warm to the touch red welt that appeared 8 days after the vaccine was received; accompanied by pain around the injection site and area is very itchy; welt started out around 1 inch in diameter this morning and is currently about 3 inches in diameter.
Stress; extreme muscle tension at the base of her skull where the shoulder blades; nervous; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 21May2021 (Batch/Lot Number: EW0186) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first shot of Pfizer two weeks and five days ago on 21May2021 and was scheduled to get her second dose for Friday. She had noticed something that she did not know if it's related to the vaccine or not, and she was concerned about it before she goes and gets a second dose. She had some extreme muscle tension at the base of her skull where the shoulder blades- like right where the back meets the neck. The patient experienced extreme tension at the base of the skull and wanted to know if that was a common side effect and if she takes the second dose will it get worse. Patient states that it was localized to one area and she was not sure if it was due to stress because everyone was under more stress because of COVID. She just did not know if she would have taken the vaccine if she had the tension, and she did not know if its just stress. Patient wanted to know if this was a common side effect being reported, wonders if it will get worse after the second dose. Patient states shes nervous now. Caller wanted to know if she should get the second dose. The patient was informed that we cannot provide treatment information, patient was referred to health care provider. Patient states she has limited time available and was concerned if this was a reaction or should she get another dose. Outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Intermittent muscle twitch in left arm and hand, persisting for 2 days, easing in severity over time. Also minor headache and fatigue.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, between late December 2014 and early January 2015, the patients were vaccinated with improperly stored VAQTA. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Strong pain throughout my body. Stronger pain in lower back and neck. Fatigue and tiredness. Stomach malaise
Received Janssen vaccine on 8/6/21 COVID-19 positive by PCR on 1/7/22 admitted to hospital on 1/7/22 d/t COVID pneumonia
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling and injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: the age at vaccination was not reported. the nurse stated that the patient got FLUARIX QIV from last season and experienced the events. No further information was provided.
On day 8 after receiving the injection in my right arm, the injection site became firm and red to about the size of a quarter. Previously on days 3-7 the area was a bluish green purple color, like a bruise. Today is day 11 after my injection and the site is still firm, red and the size of a quarter.
This case was reported by a nurse to a sales representative and described the occurrence of injection site pruritus in a child of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or before 11 May 2006, the subject received a dose of Infanrix (dose number not provided; lot AC14B018AA). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 May 2006, the subject experienced injection site pruritus, injection site redness and swelling injection site. The outcome of the events was not reported.