chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described a 22 yr old male pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. Initially the nurse reported that 13 other pt's did not respond to the Engerix B immunization series (no pt identifiers were provided). On follow up, however, 10 other pt's were identified. On an unspecified date in 2002 or 2003, the pt received the third dose of Engerix B (lot number not specified). Approx 6 to 12 weeks later, a hep B surface antibody titer was negative. The nurse stated that, all injections were given IM in the deltoid muscle with a 1 inch needle. All vaccine is refrigerated and the temp is monitored daily. The nurse considered the event to be probably related to vaccination with Engerix B.
THE CHILD RECEIVED THE BIVALENT PFIZER AS THE PRIMARY DOSE IN THE SERIES INSTEAD OF THE PFIZER ORANGE CAP 0.2ML.
This case was reported by a pharmacist via call center representative and described the occurrence of agitation in a 77-year-old male patient who received SHINGRIX (batch number GG2GA, expiry date 16th April 2021) for prophylaxis. Concurrent medical conditions included dementia. On 7th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th November 2018, immediately after receiving SHINGRIX, the patient experienced agitation, injection site pain, tiredness, pain and discomfort. On 9th November 2018, the patient experienced influenza-like symptoms. On 10th November 2018, the patient experienced confusion and activities of daily living impaired. On an unknown date, the outcome of the agitation, injection site pain, activities of daily living impaired, pain and discomfort were unknown and the outcome of the influenza-like symptoms and confusion were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the agitation, injection site pain, influenza-like symptoms, confusion, tiredness, activities of daily living impaired, pain and discomfort to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received his dose of SHINGRIX on his left deltoid at 11:30 PM. As soon as the SHINGRIX vaccine was administered, the patient became agitated and said that the area was really sore. The patient's wife explained that he had dementia and that he could not distinguish between discomfort and pain. On 7th November 2018 and 8th November 2018, the patient was tired. On 9th November 2018, the patient was agitated and started flu like symptoms. On 10th November 2018 and 11th November 2018, the patient was confused and forgot how to brush his teeth, wash his face and swallow his medication. On 12th November 2018 and 13th November 2018, the patient was tired. The reporter consented to be followed up.
Patient fainted after the Shot  and regained consciousness  .He complained about dizziness and nausea. 911 was called. He was advised to sit and be observed until they arrived
This spontaneous report as received from a nurse concerning 2 siblings of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported). Concomitant therapies were not reported. On an unspecified date, the patients experienced swelling and redness at the injection site and nausea. The outcome of nausea, redness at the injection site and swelling at the injection site was unknown. This case is linked to MARRS 1404USA009349. Additional information has been requested.
I developed similar side effects as with the second dose. Again, I experienced another episode of tachycardia that lasted about 3 hours.
stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps). On 22-Feb-2021, ABDOMINAL PAIN UPPER (stomach cramps) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information not provided. Concomitant medications were not provided.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. A 44 year-old male subject whose past medical history included chest pain, chest pressure, abnormal ECG, and blood clots was found to have encephalitis following immunization procedures on 29 November 2013 after the subject had received on 19 November 2013 an injection of ACAM2000 (lot number, route and site of administration not reported) and the following vaccines on 18 November 2013: TYPHIM VI (lot number, route and site of administration not reported), Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 3 (manufacturer, lot number, route and site of administration not reported). Troponin I, ECG and echocardiogram results were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Very fatigued. not acting like himself; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very fatigued. not acting like himself) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Very fatigued. not acting like himself). At the time of the report, FATIGUE (Very fatigued. not acting like himself) outcome was unknown.            No concomitant medication listed.   No treatment information provided.
T 103 day of MMRV vaccine & diarrhea. Decreased appetite.
extreme fatigue with, headache. Went to ER And Received fluids And meds for headache. SEEN IN E.D 1/7 & 12/19 (after both 1st & 2nd vaccine) ZOFRAN & FLUIDS IN E.D. DIAGNOSIS "NEAR SYNCOPE"
Information has been received from a nurse practitioner concerning a 24 year old female who on 09-AUG-2007 was vaccinated with a 0.5ml intramuscular dose of Recombivax HB in the right deltoid. There was no concomitant medication. On 09-AUG-2007 the patient developed a hard, red lump that was tender, swollen and itchy at the injection site after receiving Recombivax HB. The patient reported that the itching is less than it was on 09-AUG-2007, however, the hard lump is still red and tender. The outcome is not recovered. No laboratory or diagnostic testing was done. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Received MENACTRA (R) arm & ADACEL (L) arm on 11/17/11. On 11/18/11 went ER painful, swollen (R) arm at site of MENACTRA. No fever. Tx for cellulitis (R) arm with clindamycin 300mg tid x 10 days.
My blood pressure has gone up since taking the vaccine. My blood pressure before taking the vaccine average 135/85 After taking the vaccine my blood pressure shot to 200/110 My doctor increased my medication Diavon from 80 mg to 180 mg The blood pressure came to average 165/95 It went up again to 200/110 My doctor supplemented the medicine with Norvasc 5mg  I never had this high blood pressure before. I believe it the side effect of the Moderna vaccine.   My wife is having the same issue with her blood pressure which started going up after she took the vaccination.
Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose; 62 days since date of first dose 8Apr2021.; This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose) in a 21-year-old male patient 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-May-2021, the patient experienced ANKLE FRACTURE (Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose) (seriousness criterion hospitalization). On 06-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (62 days since date of first dose 8Apr2021.). The patient was treated with Surgery for Ankle fracture. On 06-May-2021, PRODUCT DOSE OMISSION ISSUE (62 days since date of first dose 8Apr2021.) had resolved. At the time of the report, ANKLE FRACTURE (Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. Due to fractured ankle, the patient never received the second dose which was scheduled for 6May2021. The patient could not get the vaccine due to surgery for fractured ankle.  This case concerns a 21-year-old male patient  who did not to receive the second dose (product dose omission) due to fractured ankle. .  The event of fracturesd ankle is assessed as not related to mRNA-1273 use based on biological implausibility.  Product dose omission is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Patient age was updated.; Sender's Comments: This case concerns a 21-year-old male patient  who did not to receive the second dose (product dose omission) due to fractured ankle. .  The event of fracturesd ankle is assessed as not related to mRNA-1273 use based on biological implausibility.  Product dose omission is assessed as not applicable.
Arm soreness (start within 10 minutes) Chills, body ache, mild fever: started within 14 hours, continuing 24+ hours (present)
h/a to point of vomiting, sl foggy feeling-24 hr duration neurologic sx suggesting mild encephalopathy;
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) bradycardic and hypotensive three days after vaccination and immediately following a syncopal episode. Found to have high grade AV block while on metoprolol and verapamil. Patient admitted and symptoms improved with glucagon administration and medication dose adjustments. Discharged to home medically stable.
patient expired 3 days after first vaccination.  Did not present to our facility for care after vaccination; did not have any adverse reactions during vaccination waiting period.  Per the Medical examiner, patient passed away at his residence, and his death was not related to the COVID vaccine.
itchy; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and ERYTHEMA (Redness) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy) and ERYTHEMA (Redness). At the time of the report, PRURITUS (itchy) and ERYTHEMA (Redness) was resolving.            Medical history was not provided.  Concomitant and treatment medications were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up document received and outcome of the events updated unknown to recovered.; Sender's Comments: Very limited information provided at this time.
TOOK TWO DOSES OF VIVOTIF WITH FOOD; This spontaneous case report (PVX2019-1811) was received from a pharmacist on 15-Jul-2019. It describes a female consumer who "took two doses of Vivotif with food" (PT: Product administration error). The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took first two doses of Vivotif with food, last week.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses of Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses of Vivotif with food" was considered as not applicable.
Hair loss / it has gotten worse; This spontaneous case was received on 05-Oct-2023 from other non-healthcare professional (consumer) (reference number: SEQW23-03063) and concerned a male patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On 28-Sep-2023, at 05:02 pm, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for flu vaccination. The batch number reported was 370647 and the expiry date was 24-May-2024.  On an unspecified date in Oct-2023, reported as three to four days after receiving Flucelvax Quadrivalent, the patient was experiencing hair loss. As reported, the vaccine was the only thing that went into the patient's body, and he had not changed any of his eating habits or medications.  On 05-Oct-2023, the hair loss had gotten worse and was noticed. The patient did not receive any treatment for the event of hair loss.  At the time of initial reporting on 05-Oct-2023, the patient had not recovered from the event of hair loss. As reported, the event was unresolved and ongoing.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked with the case 202304654 (the same reporter).  Company comment: On an unspecified date in Oct-2023, reported as three to four days after receiving Flucelvax Quadrivalent, the patient was experiencing hair loss. The patient's medical history and concomitant medications were not reported. Due to insufficient information regarding diagnostic findings and medical history, causal role of the suspect vaccine is unassessable.; Sender's Comments: On an unspecified date in Oct-2023, reported as three to four days after receiving Flucelvax Quadrivalent, the patient was experiencing hair loss. The patient's medical history and concomitant medications were not reported. Due to insufficient information regarding diagnostic findings and medical history, causal role of the suspect vaccine is unassessable.
After 5 minutes of the vaccine, I felt lightheaded, pulse got week, tongue tingly and slightly swelling. The ER doctor at the vaccination site administered an epi-pen and I got sent to the ER via rapid response, received 15 liters of oxygen for 1 hours, rapid shallow breaths respiration in the 30'. 2 hours later received decadron orally then observed for 1 more hour. Symptoms resolved and went home. The following day, I woke up with a massive headache and lightheadedness.
Timeline: 5/10 @4pm received second dose, immediate arm pain 5/11 @6am bad arm pain(feels like i got beaten up), no fever @11am suddenly have fever 100.3F @4pm fever increase to 101.3F, headache, body lethargic, but wide awake and can't sleep @8pm fever continues, more severe headaches, severe heart burn and heart ache, increase heart rate. heart rate was hovering 80-100bpm through out the night laying still according to fitbit.  5/12 @5am fever was gone @11am back to normal with mild headache, rash/ swelling/ bruising at injection site. Looks just like covid arm on google search, it's not itchy but slightly painful
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 25-APR-2014, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions which was recommended and/or prescribed to the patient by her physician (dose, route, and lot # not provided). On or about 10 and 12-SEP-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Super Fatigue; This spontaneous report has been received from a consumer regarding to himself, a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug allergies or reaction were not provided.  On 22-JUL-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis.         On the same date, the patient experienced fatigue; he said that he was feeling "super fatigue" after vaccination. The patient reporter that he was feeling good after sleeping for 10 hours. At the reporting time, the outcome of fatigue was reported as recovering.     The reporter considered fatigue to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) and not to the warm weather or exercise tolerance since he walked 1 mile most days.
Patient received vaccine 11/11/2005 to her left deltoid. Arm felt painful and warm to toucjh that evening (which was a Friday).  Was seen 3 days later with complaints of arm pain, swelling, and erythema at the injection site and down below her elbow. Patient was treated with Cephalexin 500 mg TID for 5 days and Allegra 180 mg daily for 5 days. She was diagnosed with cellulitis versus allergic reaction to Pneumovax.
Adult dosage of 1.0mL given to 18yo when pediatric dose of 0.5ml should have been given. However pt will be "adult" and 19yo when he returns for second dosage. Pt informed of this via phone. No adverse reaction reported by pt at this time.
headache, muscle aches, extreme tiredness for months, feeling better since September 1, 2021
After a couple of weeks of pain at the injection site, the pain began to grow steadily until today it reaches down the top of my right arm, the underside of my right arm, and down my side from my arm pit to below my ribcage. It used to hurt only when I would utilize certain ranges of motion. Now, it hurts on and off regardless of my movements. Sometimes it hurts all the way to my hand.  I cannot sleep on my right side anymore and if I accidentally move it in too large of a motion the pain is at a 10.
I received SHINGRIX shot at pharmacy on 24Jul2018 at 6:00pm, next morning on 25th I started feel chilly and had low fever 98F, also felt very tired, light headache, lost taste bud, pain where the shot was given and felt the arm heavy, pain in neck area on the same side the shot was given, hard to fall in sleep due to arm pain and awake. On 26Jul my fever symptom was gone, and less tired and headache but still weird taste bud and observed rash on injection area around 4cm in diameter, more pain in the arm and hard to lift. On 27, arm still red and pain, but physically feel much better. Later in the day felt more energy than before and arm less heavy and can lift with much easier effort. On 28th morning, rash seems shifting lower and less red but bigger, around 6cm in diameter. Feel better than yesterday.
Extreme fatigue/no energy, low fever, migraine type headache, slight body aches, injection site pain.  I accepted this as a normal reaction.  These symptoms appeared on Saturday (the next day) and subsided by Sunday evening.  By Monday I felt that I was back to normal.  Therefore, Monday evening I returned to my normal routine of light weight lifting.  As I was bent over, lifting two 5lb weights from the rear (strengthening my upper back arm), suddenly an INTENSE SHOW-STOPPING PAIN occurred in my brain that caused me to immediately put the weights down, stammer (unsure what to do) and just held my head!  All I could do was stand still and pray the pain would go away.  I had never experienced such a pain.  It felt like the blood rushed upward and had no where to go and my brain would explode!  For this reason, I'm reporting the occurrence.  I'm fine now, but the incident was sudden and very severe.  I had stammered in pain for a few seconds (not even a minute).  I stood upright, closed my eyes, and held my head until the pain went away.
Presented to the ED with complaints of shortness of breath, fatigue and nonproductive cough.COVID-19 positiVE, admitted, tx w/ Decadron  oral doxycycline  , supplemental O2
Patient reported the following unusual side effects: Fever > 102 , nausea, diarrhea, sores all over lip , mouth and nose
20AUG shot given; 5SEP onset fatigue; 7SEP vomiting, numbness in legs; 10SEP MD visit for vomiting, paralysis, urinary difficulty; 12SEP adm to ER & hosp for paralysis, urinary prob; 17SEP released from hosp-urinary difficulties x 1yr 6mo
Difficulty walking; Chills; Joint on her leg has been hurting; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficulty walking), CHILLS (Chills) and ARTHRALGIA (Joint on her leg has been hurting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced GAIT DISTURBANCE (Difficulty walking), CHILLS (Chills) and ARTHRALGIA (Joint on her leg has been hurting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. At the time of the report, GAIT DISTURBANCE (Difficulty walking), CHILLS (Chills) and ARTHRALGIA (Joint on her leg has been hurting) outcome was unknown.            Patient was taking other medication.  No treatment medication information was provided.  Action taken with mRNA-1273 in response to the drug was not applicable.