chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with multiple underlying conditions presented to hospital with severe LE pain on 6/15/2021. Recently treated for cellulitis (6/15/2021). SOB and poor po intake were baseline x 1 year 2/2 cancer and PE. 1L o2 at baseline. Difficult to distinguish any possible COVID sx from other causes, unknown onset of sx. Tested negative upon admission and positive on Hospital Day 3. Hospital course complicated by hypoxemia 2/2 COVID PNA and HF exacerbation, hallucination. Transferred to ICU 6/27-6/30  recieved dexamethasone, remdesivir, piperacillin/tazobactam and then again 7/6. 7/6 asystole/PEA arrest with ROSC achieved after 20 min of CPR and 4 x epinephrine. Intubated 7/6. Increasing pressor requirements, transitioned to comfort care.
mental fatigue; inflammation; severe pain; fatigue; gum sores; gum bleeding; soft lumps in right abdomen; Lymphodema; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2022 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "overweight" (unspecified if ongoing), notes: other medical history: overweight; "work stress" (unspecified if ongoing), notes: other medical history: work stress; "previous surgery sites" (unspecified if ongoing), notes: Inflammation & Severe PAIN at ALL of the previous surgery sites. Mostly last 20 years; "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT NUMBER and expiry date were not reported, vaccine location: Upper left arm, vaccine administration date: 04Jan2022, vaccine administration time: 09:00 AM,), administration date: 04Jan2022, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "First does extreme mental fatigue", "minor soreness". The following information was reported: LYMPHOEDEMA (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "Lymphedema"; FATIGUE (non-serious) with onset Jan2022, outcome "not recovered"; GINGIVAL BLEEDING (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "gum bleeding"; GINGIVAL PAIN (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "gum sores"; INFLAMMATION (non-serious) with onset Jan2022, outcome "not recovered"; PAIN (non-serious) with onset Jan2022, outcome "not recovered", described as "severe pain"; ABDOMINAL DISTENSION (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "soft lumps in right abdomen"; MENTAL FATIGUE (non-serious) with onset Mar2022, outcome "not recovered". Therapeutic measures were not taken as a result of inflammation, pain, fatigue, gingival pain, gingival bleeding, abdominal distension, lymphoedema, mental fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
INTERMITTENT NERVE/MUSCLE PAIN IN LEFT ARM EVER SINCE SHE RECEIVED SHINGRIX.
Got the shot on right Arm.  Under Armpits,  I can feel  and touch swelling of lymph nodes. It hurts. No fever or other symptoms.
Shortly after injection, the pt developed dizziness and tingling/numbness in extremities. He was noted to be diaphoretic. HR 70, SP02:99%, BP 110/70. Symptoms resolved after appx. 15 minnutes.  The pt was feeling completely back to normal before he departed. Family drove him home.
Information has been received from a licensed practical nurse concerning a patient who was vaccinated with a three dose series of RECOMBIVAX HB. It was reported that the patient had a negative antibody titer. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
flu-like symptoms; heart rate was fast; eyes are blurry; pain in his left arm which is hot; difficulty to breathing; bed all day today; weakness; dizzy; pain under his shoulder, at his arm pit that goes all the way down; tired; massive headaches; pain in the shot area; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot) and DYSPNOEA (difficulty to breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 07-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot), DYSPNOEA (difficulty to breathing), SOMNOLENCE (bed all day today), ASTHENIA (weakness), DIZZINESS (dizzy), ARTHRALGIA (pain under his shoulder, at his arm pit that goes all the way down), FATIGUE (tired), HEADACHE (massive headaches), VACCINATION SITE PAIN (pain in the shot area) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), HEART RATE INCREASED (heart rate was fast), VISION BLURRED (eyes are blurry), VACCINATION SITE WARMTH (pain in his left arm which is hot), DYSPNOEA (difficulty to breathing), SOMNOLENCE (bed all day today), ASTHENIA (weakness), DIZZINESS (dizzy), ARTHRALGIA (pain under his shoulder, at his arm pit that goes all the way down), FATIGUE (tired), HEADACHE (massive headaches), VACCINATION SITE PAIN (pain in the shot area) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Day of immunization, pt awoke with visual hallucinations. Pt stated those things are flying all around. Lasted about 30 minutes. Pt did have a cortisone shot in the shoulder on 9/29/11. But pt has never hallucinated in the past, has never had an adverse reaction to a flu shot.
receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient received 2nd booster. No treatment medications were provided.
pt recvd DTP/HIB/OPV & mom reported that pt was unresponsive, pale, eyes rolled back; taken to ER: upon arrival, pt had stable vital signs; no tx initiated; dx hypotonic hyporesponsive episode; recovered;
Transverse myelitis - spinal cord T1-T4 sensory and motor loss from nipple line down. Loss of GU and GI total control. Loss of motor gait, stability, muscle strength, "endurance lower extr.". Sensory changes hands. 1/18/08-records received for DOS 11/8-11/16/07 and 11/28-12/1/07-DC DX: Transverse myelitis. C/O increasing paresthesias, felt well in 8/07, developed upper respiratory infection symtpoms and improved. Began to feel ill 2 weeks after receiving flu vaccine. C/O sore throat, rhinorrhea, nasal congestion, postnasal drip, productive cough, chills and nausea. On 10/24/07 developed progressive neuropathy to ankles, felt numbness of feet progressing superiorly to knees, thighs and upper abdomen. Watery stool. Discharged and readmitted with paresthesias in ascending fashion up to the previous level (umbilicus), 2-3 days after steroid taper.  Follow-up: Residual bowel and GU problems. Paraesthesia of legs - minor gait and stability problems. Have me advised by neurology and infectious disease physicians never to get flu shots, hepatitis, PNEUMOVAX or tetanus shots again. I submitted an event report and responded to a subsequent request. I am responding to this subsequent request but in return, I have a request. Do I get any responses or conclusions from either you, the CDC? It seems to be a one-way street of information in and nothing but stonewalling out from three federal taxpayer funded agencies who should be responding on the subject matter. A response from your agency is requested. 02/02/2010 Senso-neurological changes in feet, legs, groin, back, abdomen and chest. Motor function loss of the lower extremities right greater than left with weakness muscle fatigue, pain and contractility. Pain back awith increased motor activity. Neurological changes affecting the normalcy of bowel, bladder and sexuality functions. Mental stresses associated with pain, disability and recovery; avoidance of depression and demoralization from debilitating disorder and length of recovery time.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported). The reporter reported patient developed chickenpox after receiving ZOSTAVAX. The patient "was in the (unspecified) hospital in January (2014) and she had developed chickenpox." The pharmacist did not clarify when the patient received the dose of ZOSTAVAX or why the patient was in the hospital. She states that the patient's medical record states that the "chickenpox was from the vaccine." The pharmacist did not know if any tests were performed to confirm whether or not the causative agent was from ZOSTAVAX or another type. She indicated that the patient had since recovered from her chickenpox.
Patient received 2nd booster to early. Received it at 3 months instead of 4 months after 1st booster
Information has been received from a health professional concerning a 16 month old female with no medical history and no allergies who on 05-JAN-2007 was vaccinated with a 0.5ml subcutaneous dose of ProQuad (Lot # 655845/1350F) in the left leg. There was no concomitant medication. On 13-MAY-2007 the patient experienced a couple of varicella spots on the left buttock. On 17-MAY-2007, the child's mother informed the prescriber that several clusters of papules spread down the posterior of the child's leg. No treatment was given. At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Day 1: Very sore arm leading to headache and neck stiffness.  Minor brain fog. Day2: Same as above plus all over body ache & fatigue. Day 3: same as above plus very chilled (no fever) plus nausea and vomiting. Day 4: headache with minor aches. Day 5: only a hint of a sore arm.
3/26- Thirst 3/27- Achy especially joints, chills with no fever, tired 3/28- Same as 3/27 with severe diarrhea and nausea 3/29-Fine 3/30-Fine 3/31- Return of all symptoms from 3/27 4/1- Woke up covered in sweat, still no fever, symptoms from previous day gone
I am immunocompromised with no spleen.  It was removed in 2008. I was diagnosed Crohn's disease in 2002.  It has been in remission for 18+ years,  Within two weeks of the 2nd COVID vaccine, I had a severe Crohn's flare.
pt recv vax 16AUG97 & 25AUG97 pt exp 6 lesions on face, trunk, arms;26AUG97 pt had 12 lesions scattered throughout body;pt mom spoken to a peds who felt child probably devel natural chickenpox;
upon leaving clinic thru to time of report (4 hrs) pt has been hyper, crying uncontrolled/unconsoled & eyes described as dilated; grandfather called in report for parent; unk if temp elevated; advised to seek medical f/u immed. 1/21/93 Still unable to reach by phone- has not responded to letter.
Headache about 10-15 min after administration, self-resolved. Vital signs stable.
Presents with worsening shortness of breath and repiratory failure due to covid. Treated with oxygen, steroids, and remdesivir. Pt will discharge home with oxygen.
patient developed general malaise, body aches, cough, and diarrhea, temperature 99-100 F. Sought out pcp for testing/workup.
Shaking chills for 2 nights, Temp  99.2 or lower, starting on 2-13-21 at about 6:30 pm until bedtime.  May or may not be related to vaccine.  I felt fine otherwise.  No resulting illness.  Did not seek treatment.
almost passed out; blood pressure was 40/60; tired after the shot.; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (almost passed out) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Breast cancer (11 years ago). Concomitant products included VENLAFAXINE, ROSUVASTATIN and LEVOTHYROXINE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (almost passed out) (seriousness criterion medically significant), BLOOD PRESSURE DECREASED (blood pressure was 40/60) and FATIGUE (tired after the shot.). At the time of the report, LOSS OF CONSCIOUSNESS (almost passed out), BLOOD PRESSURE DECREASED (blood pressure was 40/60) and FATIGUE (tired after the shot.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 40/60 Low. On an unknown date, Heart rate: 50 (Low) went down.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested   This case was linked to US-MODERNATX, INC.-MOD-2021-103634 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested US-MODERNATX, INC.-MOD-2021-103634:Case for dose 2
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient pertinent medical history was not reported. The pharmacist reported that a patient received an unspecified hepatitis B vaccine (manufacturer unknown) (unknown to the pharmacist to which hepatitis B vaccine the patient received so this being reported as Merck's RECOMBIVAX) when the patient was younger (unspecified of how many doses of Hepatitis B vaccine were administered to the patient and unspecified dates of administration) and the patient reported to the pharmacist that when she had a titer drawn on an unspecified date, the titer showed that she was below 10. No product quality complaint was reported. The causality of the event was not reported. Additional information has been requested.
Soreness Dizziness, light headed, nausea , a little high temperature due to medications
Daughter refused to use leg in which vaccine was administered. She was acting paralyzed and in a lot of pain. She refused to walk all day. The following three days she was limping and walking much less than normal. Also had a fever for 3 days.
Pt complained of dizziness after vaccine.  Never hypotensive, no edema, no wheezing.
This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a female patient who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to Meningococcal B vaccine. Additional information received as follows: The case was reported by the patient's mother. The age at vaccination was not reported. The patient had not been the same since she got the vaccine. She had been chronically ill. Side effects of the vaccine were not worth the risks. The reporter asked to look at how many people actually died from meningitis each year and then look at how many had became ill from this vaccine.
Patient developed COVID symptoms on 3/22/2021 despite 2 doses of Pfizer-BIONet vaccine.    Tested positive for COVID.  Symptoms include chills, body aches, diarrhea, headache, nasusea/vomiting, and rhinorrhea.
This was not an adverse event it was an administrative error. Medical Assistant administered Flubok (adult flu vaccine) in error. Pt should have received the Fluzone which is the appropriate for patients age. DOH was notified and mother of child was notified. No adverse reaction was noted or reported.
day 1-7 redness, slight itching.  Day 7, increased itching, swelling at injection site. Hardness around injections site. 2 bumps/areas of itching/swelling
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Feb2021 as dose 1, single (Lot number: 023M20A), in left arm, on 23Mar2021 as dose 2, single (Lot number: 013M20A), in left arm, on 04Dec2021 as dose 3 (booster), single (Lot number: 012H21B), in left arm and on 22Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 10Mar2023 to 15Mar2023 as COVID 19 Treatment.
received injection and got shingles/suspected vaccine failure; received injection and got shingles; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included diabetes and immunocompromised (was immunocompromised because of diabetes).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: received injection and got shingles/suspected vaccine failure) (serious criteria GSK medically significant), shingles (Verbatim: received injection and got shingles) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was recovered/resolved (duration 3 days).   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the reporter considered the pain to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient via interactive digital media. The patient received his or she injection and got a light case of shingles only because he or she got the injection. The patient stated that but he or she could told in the small areas where the shingles was it was painful, the pain lasted three days because of additional medication. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
pt recv vax 15NOV97 & 11DEC97 pt was found to have elevated liver function tests;
This case involves Adult and unknown gender patient who experienced after getting the shot, feeling bad (feeling abnormal), rash and hives (urticaria) after receiving vaccine INFLUENZA VACCINE. The patient past medical history, medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious after getting the shot, feeling bad (feeling abnormal), rash and hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "had a serious reaction to my flu shot this year. have taken the flu shot for years but three weeks ago after getting the shot at my Dr office, he started feeling bad before he got home. By midnight he was developing a rash. By morning the rash had turned into hives. Went back to Doctor he gave me shot of prednisone and Medical prescription (Rxs) Instructed to go to Emergency room (ER) if the hives continued to spread. It did. At the ER, I received an IV of benadryl and prednisone and more RXs. It was over a week to recover. No more flu shots for me. But that worries me. He don't want to catch the flu". It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  The patient was treated with PREDNISONE for Hives and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  On an unknown date, the patient recovered from all events.
Patient states pain immediately after vaccine given. "Most painful" flu shot ever. Pain and decreased range of left arm. Patient feels immunization too high on arm.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/3/2022 &  8/31/2022  --  RECURRENCE OF SAME SYMPTOMS
Diarrhea started on 11/18/06-Blood and mucus in stools.
I woke up in the middle of the night with a fever over 102, and pretty bad flu-like symptoms. Bad headache, aches and pains, dizziness. Only lasted 1 day