chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sense of Deja Vu,  could smell burnt rubber, and sense of impending doom. Started on Saturday 22 and increased in frequency throughout the week.  Each episode lasted about 15 seconds.   Went to the  Clinic on 5/28 who then sent him to the emergency room where they treated him for prefrontal cortex seizures.  He was released from the hospital with a referral to a neurologist.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 11-APR-2012 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-NOV-2012, the patient was treated by a physician for the onset of a painful vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
raised red area on rt upper arm;hives, red over entire trunk, more on lt side, lt arm, entire neck ears, some on rt armppit w/in 1hr of vax;tx w/DPH;
A spontaneous consumer report has been received. The report concerns a 41 year old, female patient. No information regarding the relevant history and concomitant drug was provided. Concomitant disease included multiple sclerosis. On 24-Dec-2014 the patient received FLUMIST (intranasal), subcutaneous COPAXONE, 40.0 milligrams, unknown for multiple sclerosis and unknown Tetanus vaccine. Patient mentioned she had a MS attack on CHristmas last year. Said she and her son had a Tetanus shot vaccine and FLUMIST nasal vaccine on same day 24-Dec-2014, and she awoke in middle of the night and couldn't get up, could not walk, could not hardly move. Said she had to use the bathroom but could not get up on her own. Patient's husband called ambulance and taken to medical center and given oral steroids. She also took her COPAXONE that same day. She was released once her daughter was able to help her get out of the bed in hospital. Patient went home and recovered well. Reporter considered the events MS attack and couldn't walk to be serious as important medical event.
Pt devel t (?) on 13APR92; devel t102 ax on 14APR92, & broke out in rash on 15APR92 (started on forehead, then went to chest, then to back);
death N17.9 - Acute renal injury J18.9 - Multifocal pneumonia
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L0026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Pt had a history of adverse reaction to Covid vaccine (Moderna). Received Pfizer booster today. Approx 20 min after vaccine Pt stated she had upper body itching, mild. Pt given 25mg PO Benadryl
pt recv vax 12MAR96 & lab eval revealed that has not seroconverted as of this time;
t101.5, vomiting, diarrhea-evening p/vax 19JAN96;23JAN96 vomited/diarrhea-advised to contact MD;24JAN96 family notified MD (chest congestion);25JAN96 took pt to ER (viral infect) t103
She is out of breath when she goes for her regular walk; She has no energy; I just don't feel good; She has constant headache; She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F); This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), HEADACHE (She has constant headache) and PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)) in a 72-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), HEADACHE (She has constant headache) and PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)). The patient was treated with PARACETAMOL (TYLENOL) for Low grade fever, at a dose of 2 dosage form. At the time of the report, DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), HEADACHE (She has constant headache) and PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2023, Body temperature: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)..     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient states that after all the other Moderna shots, she had similar side effects but with previous shots the side effects lasted only 4 days. After the shot on 06NOV2023, the side effects did not go away. It has been 15 days now. When she takes 2 Tylenol the fever goes away, but it comes back the next day. No Concomitant medications were reported.   This case was linked to MOD-2023-750464 (Patient Link).
COVID 19 that lead to hospitalization, had fever, myalgia, nonproductive cough
Patient began experiencing  itching all over body 15 minutes after IM injection. Patient was given benadryl 25mg  at 09:22. Benadryl 25 mg dose given again  and pepcid 20 mg at 09:53. Patient symptoms are resolving at this time. Notified patient to inform primary physician of itching reaction.
he had a racing heart; blood pressure was slightly low but still within normal range; on the verge of vomiting; fever; chills; nausea; headache; has felt sick; This is a This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 18-year-old male patient that: A 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an unspecified route of administration in left arm on 06May2021 at 15:00 (at the age of 18-year-old) as dose 2, single for COVID-19 immunisation at medical facility. Medical history included COVID-19 in late Feb2021-early Mar2021 and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an unspecified route of administration on 15Apr2021 at 12:20 (at the age of 18-year-old) as dose 1, single for COVID-19 immunisation. The patient had drug allergy to amoxicillin and developed hives. It was reported that the patient had both doses of the vaccine. He had the second dose on 06May2021. The patient has felt sick with nausea and headache started on the 07May2021. He had his most severe symptoms on 07May2021. He also had fever and chills. These symptoms continued through the weekend, 08May2021-09May2021. On 09May2021, her son started having a racing heart. Her son went to the urgent care on Monday, 10May2021 and had an EKG (electrocardiogram) and a blood pressure check. His blood pressure was slightly low but still within normal range. He may have had blood work or labs done but she and her son had to leave the urgent care because the urgent care was backed up and running behind. Her son was waking up today with nausea and headache. He cannot keep missing school. He no longer has the fever, chills, or racing heart. She reports his fever was just a low-grade fever, she just felt his forehead, she guesses his temperature was only elevated by a degree. He has not vomited but was on the verge of vomiting. She reports her son did have the COVID 19 virus in late Feb2021-early Mar2021. She reports her son had an allergic reaction to Amoxicillin when he was a baby and he developed hives. The caller asked if having COVID prior to getting the vaccine would affect the side effects you have after the vaccine. The patient underwent lab tests and procedures which included blood pressure: unknown result on 10May2021, EKG (electrocardiogram): unknown result on 10May2021. The outcome of he had a racing heart, fever, chills was reported as resolved on an unknown in 2021; nausea, headache, on the verge of vomiting was not resolved and blood pressure was slightly low but still within normal range, has felt sick was unknown.   No follow-up attempts are needed. No further information is expected.
pt exp swelling & erythema @ inject site p/receiving flu vax; reaction lasted 3-4 days;
Rt arm swollen w/ redness & warm to touch one day after receiving vax.Dx w/ cellulitis.
09:05 moved from his seat to lay on the floor stating he felt lightheaded and some nausea.  At 09:07AM vitals were BP 118/62, SO2 98%, HR 53.  He states he did not eat breakfast and he was very nervous to get the vaccine.  At 09:08 water given and states he is starting to feel better.  09:11AM requested to sit up and states he is 100% better denying any symptoms.  Nurse continued to monitor and discharged at 9:31AM.  Nurse advised him to contact his PCP to inform them of today's event.  Was present and they both verbalized understanding.
26 hours after the shot he was too weak; This is a spontaneous report from a contactable consumer reported that a 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history included he has moderate to advanced Parkinson's disease and typically suffers from weakness. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. Twenty-six hours (26) after the shot he was too weak need help getting out of bed. The outcome of the event was unknown.   Information about Lot/batch no has been requested.
Shaking of hands; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 22Mar2021 at 07:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy. The patient had no known allergies. Concomitant medications included lamotrigine (LAMICTAL XR)  and zonisamide (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 04:00, the patient experienced shaking of hands. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. It was unknown whether the patient had received any treatment for the reported event. The clinical outcome of the event shaking of hands was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received Moderna vaccine IM to LD. No signs or symptoms of adverse reaction at this time. Patient can move extremity without difficulty.  Mom was given handout and advised to monitor for signs and symptoms of adverse reaction. Mom voiced understanding.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. In August (reported as "last week"), the patient was vaccinated with a single dose of 0.65 ml ZOSTAVAX (lot # not reported) subcutaneous. No other co-suspects were reported. On 27-AUG-2012 the patient experienced several lesions on the right torso area. There was no treatment information because patients had not yet been seen by the health professional. The patients had sought unspecified medical attention. The outcome was reported as not recovered. Follow up information has been received from the nurse practitioner refers to the patient, the nurse stated that the patient "now has full blown shingles all over the body." The nurse will now start treating the patient with acyclovir and TYLENOL. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of hepatitis A antibody negative in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On 7 December 2011, 12 January 2012 and 12 June 2012 the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (unknown). On 25 July 2012, 43 days after vaccination with 3rd dose of TWINRIX, 6 months after vaccination with 2nd of TWINRIX, 8 months after vaccination with 1st of dose TWINRIX, the subject experienced hepatitis A antibody negative. The subject had a titer performed on 25 July 2012 Hepatitis A was non reactive and Hepatitis B was reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see cases A0994236A, A0994238A- A0994244A, A0994245A - A0994246A.
Possible tendonitis or bursitis of rotator cuff after AFLURIA QUAD Flu vaccine administration. Injection site may have been too high.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 21-OCT-2013 the patients were vaccinated with MMRII lot number J002505. Dose, route and frequency were not provided. On 21-OCT-2013, the patients were vaccinated with MMR II stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to 1311USA008054, 1311USA007704, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA0077700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Information has been received from a physician concerning a 17 year old female, with no pertinent medical history or drug reactions/allergies, who on 18-JAN-2008 was vaccinated with Gardasil (lot # "0972U"). The patient received her second dose of Gardasil (lot # 659653/1448U) on 17-JAN-2008, which resulted in an inappropriate schedule of vaccine administered. Concomitant therapy included hormonal contraceptives (unspecified). On 18-JAN-2008 the patient experienced fatigue and lymphadenopathy in the left supraclavicular area. The patient's fatigue and lymphadenopathy persisted. The patient was examined by the physician on 21-JAN-2008 and the lymphedematous area remained the same although the patient was less fatigued. Additional information has been requested.
Pt received vaccination on 10/06/18 and reported low grade fever with body aches and mucus in chest. Pt called back on 10/09/18 at 5pm stating she was doing much better and no longer had a fever. Pt called 10/09/18 8:30pm stating she discovered 3 red spots one where the barrier was and 2 smaller ones below. Advised to apply cool packs to sight and to notify her doctor if they progressed.
Information has been received from a pharmacist referring to a 76 year old female patient. Information about concomitant medications, and medical history and drug reactions was not provided. On 04-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 (lot # N020502 and expiration date 08-FEB-2019; route was unknown) on unspecified arm for prophylaxis. On an unknown date in October 2018 after the administration of PNEUMOVAX 23, the patient was admitted to an unspecified hospital for "cellulitis with metabolic septic encephalopathy"(cellulitis, septic encephalopathy and metabolic encephalopathy). The patient was later discharged from the hospital on an unspecified day and at the reporting time the patient was recovering. The causality was not provided. Upon internal review, cellulitis, septic encephalopathy and metabolic encephalopathy were determined to be medically significant.
Patient first HPV vaccine was administered in the left arm, within seconds after administration patient fell backwards onto the exam table. His face was pale, mom told us his skin felt clammy. Not long after patient was back alert and woke up asking "where am I".  I told patient to stay there, mom was beside him while I went to get patient some water and get some providers to examine patient. Vital signs were normal afterwards, MD listened to patient, and he sounded normal, mom checked his blood sugar on his Dexcom and it was normal. We had patient positioned on the exam table with his head at one end then his legs positioned upwards to allow blood flow to his head. Patient got up slowly on the exam table to finish his water and he was back to his normal self. We had patient wait in the room for about 10-15 minutes, checked on him again and he was ok, he felt better and normal. He was able to check out afterwards.
I experienced flu symptoms for a couple of days after taking my second dose. In September 2021, I had a big welt under my arm. My doctor took a sample of it and I was diagnosed with MRSA. I was prescribed with Bactrim.
Rash close to the injection site; Small red area close to the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash close to the injection site) and VACCINATION SITE ERYTHEMA (Small red area close to the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash close to the injection site) and VACCINATION SITE ERYTHEMA (Small red area close to the injection site). At the time of the report, VACCINATION SITE RASH (Rash close to the injection site) and VACCINATION SITE ERYTHEMA (Small red area close to the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. The patient did not receive any treatment.
Pt developed maculopapular, erythematous rash approximately 48 hours after immunizations. Pt also had some crankiness/irritability.
patient decribes searing pain upon injection "felt like knives in her shoulder" .  immediate and extremely painful.  shoulder is frozen in place with lack of movement.  PCP prescribed Oxycodone and ibuprofen 800.  which have relieved some of the pain.
Arm tenderness; Fatigue; Some joint pain; Tired the next day; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm tenderness), FATIGUE (Fatigue), ARTHRALGIA (Some joint pain) and FATIGUE (Tired the next day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Jan-2021, the patient experienced TENDERNESS (Arm tenderness), FATIGUE (Fatigue), ARTHRALGIA (Some joint pain) and FATIGUE (Tired the next day). At the time of the report, TENDERNESS (Arm tenderness), FATIGUE (Fatigue), ARTHRALGIA (Some joint pain) and FATIGUE (Tired the next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information provided.    This case was linked to MOD21-017877 (E2B Linked Report).; Sender's Comments:  MOD21-017877:Husband informed during his callback
20 minutes after immunization patient had what appeared to be a vasovagal response. Patient has LOC, diaphoretic, low BP, difficulty breathing.  EMS was called. BP was 70/50. Patient was able to state name and speak with staff. No medications were administered. EMS evaluated patient and patient refused further treatment.
This non-serious initial spontaneous case, was received from other health professional (pharmacist) on 01-Oct-2017, concerning a 61-year-old female patient. The patient's medical history included asthma (since an unspecified date). The patient's concomitant medications were not reported. On 17-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, batch number: 1720801, expiry date: Apr-2018, route of administration: intramuscular and anatomical location: left deltoid). The pharmacist stated that, they only had 1-inch needle and the patient had intramuscular administration with 1-inch needle, although patient stated that, she felt it was shorter needle and was given subcutaneously, which was considered as wrong device used. It was reported that, no adverse event was experienced by the patient after the administration of the vaccine. The reporter assessed the report as non-serious. Significant case correction received 01-Oct-2017: The LLT of the event (The patient believes that the vaccine was administered with a shorter needle/she suddenly had a revelation that we administered with a shorter needle/Patient stated she felt it was shorter needle [and subcutaneous, given in L Deltoid]) was changed from wrong device used to wrong injection technique and labeling was done accordingly.
Large swelling, redness and heat entire thigh- left thigh. No systemic signs or symptoms.