chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness on her torso, as well as the front and back of her arms and legs described as red rash; tired; This spontaneous case was reported by a physician and describes the occurrence of RASH ERYTHEMATOUS (redness on her torso, as well as the front and back of her arms and legs described as red rash) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FATIGUE (tired). On 16-Mar-2021, the patient experienced RASH ERYTHEMATOUS (redness on her torso, as well as the front and back of her arms and legs described as red rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Red rash, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (redness on her torso, as well as the front and back of her arms and legs described as red rash) was resolving and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Information regarding patient, suspect drug and events was received and case became valid.
No other adverse effects; that a 16 year old patient received an adult dose of VAQTA; This spontaneous report as received from a medical assistant refers to a 16-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-FEB-2020, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) 50/1.0 units/ml (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.
12/17/09 Pt presented to office with erythema and warmth, tenderness and edema.
Extreme joint pain in my right elbow that worsens when my arm is bent for any length of time.  Still in pain and 2 1/2 weeks later.  Rash that began on 3/19/2021.
This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
FLU; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal), via nasal route, on an unknown date.     On an unknown date, the patient experienced flu (preferred term: Influenza).     The outcome of the event was unknown.    The event was considered non-serious.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium
Headache, Neck Ache, Back Ache, Body Ache, Upset Stomach, Nausea, Diarrhea, Loss of sleep, Exhaustion, Fever, Chills.
Aching; Headache; Weak; Feel sick; I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse; "I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse; Aching muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: FA7484) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Chronic fatigue" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. Vaccination history included: Bnt162b2 (First Shot: LOT#: FA6780.), administration date: 08Jul2021, when the patient was 77 years old, for COVID-19 immunization, reaction(s): "I suffered for months, when I got first shot and I didn't feel well for three week", "My sodium chloride was little on the low side"; Bnt162b2 (First Shot: LOT#: FA6780.), administration date: 08Jul2021, when the patient was 77 years old, for Covid-19 Immunization, reaction(s): "high cholesterol". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Aching"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weak"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Feel sick"; FIBROMYALGIA (non-serious) with onset 2021, outcome "unknown", described as "I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as ""I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Aching muscle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, myalgia. Therapeutic measures were not taken as a result of asthenia, illness, fibromyalgia, fatigue.  Additional information: Consumer stated, She had fibromyalgia and chronic fatigue and it is like it made it 10 times worse, the fatigue its just its dragging and aching the aching muscle. Patient did not have heart issues, she is not diabetic. Consumer stated that she took Ibuprofen for her pain and aspirin for headache. Concomitants medication also included multivitamins. Family History: Consumer stated, No my family, my sister and they have no problems at all. Some of them has Pfizer some have Moderna.The day that felt a little tired but nothing like what I am having.  No follow-up attempts are possible. No further information is expected.
Nurse doing a PPD read noticed RD red-swollen warm to touch. Pt didn't complain of pain. No fever.
Patient reported right arm, neck, and right face itching at approximately 11:45 AM after receiving immunizations and bicillin injection at 11:15 AM. 25mg Benadryl given IM at 12:00 PM per provider's order. Patient reported improvement in symptoms after 10 minutes and was released at 1245 with resolved symptoms.
0946-Moderna Vaccine 1106- Anaphylactic reaction, N/V 1115-methylprednisolone 1122- Epinephrine 1125-promethazine, 1206-Transfered to local hospital
hand stiffness; hand hurting; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (hand stiffness) and PAIN IN EXTREMITY (hand hurting) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Previously administered products included for Influenza immunisation: Flu shot. Past adverse reactions to the above products included Pain in arm with Flu shot.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (hand stiffness) and PAIN IN EXTREMITY (hand hurting). At the time of the report, MUSCULOSKELETAL STIFFNESS (hand stiffness) and PAIN IN EXTREMITY (hand hurting) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medication was reported.  No treatment information was provided.
Elevated heart rate. Over 100 from 6am until 2pm following day. At times it jumped to over 140 while sitting at work.
Onset of shingles 05/23/2021. Still an active case as of filling out this form. Also, 04/15/2021, chills, fever 100.6, aches all over, pain at sight of injection, weak, nauseated, headache in sinuses and around eyes.
Shot given Monday, February 2, 2009. Per patient: Tuesday night I could barely move. Sore all over, kinda like a flu ache but much worse. Wednesday night 911 was called.  Blood sugar had dropped low enough that I was unconscious. I bit my tongue and started seizures.  The paramedics that responsed said that this was something kinda common they had seen with the Tdap shot and diabetics. I thought I had taken too much insulin, but because the paramedics said there was some correlation between the shot and my BSL I decided to let you know.
never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In October 2020, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 10-AUG-2023 The reporter reported that the patient never got the 2nd dose of Shingrix  after receiving the 1st dose. The reporter did consent to follow up via email. The reporter reported that till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which lead to incomplete course of vaccination.
PAtient ststes that approximately 2.5 days after receiving her 1st pfizer vaccine, she started to experience extremely painful muscle spasms throughout her entire body. She was seen at and urgent care for this reaction. They gfave her toradol and told her the body aches and spasms would go away within 10 days. After around 10 days she stats thaat the pain and spasms did stop. No other complaints from patient following Pfizer vaccination.
9/22/21: Patient arrived at the ER who was sent from nursing home on 09/22 for fever and respiratory distress.  Patient tested positive for coronavirus 19.  Transferred to ICU from ER due to hypoxia necessitating high-flow and significant hypernatremia.  Patient nonverbal and altered on admission.  Patient started on hypotonic fluids along with free water flushes, tube feed (protein content adjusted).  Patient was recently admitted this ICU for AFib with RVR causing hypotension.  Treated with Levophed and fluid boluses and transferred to PCU on 09/26.  This evening the patient acutely hypoxic with gurgly breath sounds from aspiration of tube feeds.  Intubated on arrival to ICU.
Tiredness; Feeling Weak; This case was reported by a other health professional via interactive digital media and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tiredness and feelings of weakness. On an unknown date, the outcome of the tiredness and feelings of weakness were recovered/resolved.   It was unknown if the reporter considered the tiredness and feelings of weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a bad reaction to the shinrix vaccine which has lasted over 3 weeks. The patient had a reaction to shinrix in the form of tiredness feeling weak at times.
Hospitalization: Admitted 8/10/2022; discharged 8/29/2022. Presentation to the ED: Shortness of breath, productive cough and sepsis. COVID-19+ date: 8/10/2022. Treatment: Patient started on ceftriaxone, azithromycin, remdesivir, steroids, IV diuresis and bronchodilator nebulization with improvement in signs and symptoms. Discharge to rehab facility.
This is a spontaneous report from a contactable other HCP via a Pfizer sales representative. This other HCP reported the same event for two patients. This is the first of two reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5ml single. The patient medical history and the patient's concomitant medications were not reported. The patient experienced cellulitis on an unspecified date with outcome of unknown.
RAYNAUD'S PHENOMENON; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included raynaud's phenomenon, and concurrent conditions included high cholesterol, and arthritis in hands. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced raynaud's phenomenon. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of raynaud's phenomenon was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Swelling below the injection site that was raised and about the size of a softball and quite itchy.  4/15/22 Swelling and  raised area had decreased in size but still visible 4/19/22
1.5 hrs p/inject hives started on face continues to have rash; pt taking DPH @ present;
Initial unsolicited report received from a literature on 16-Jan-2018. This case is linked with 2018SA017671, 2018SA017679 and 2018SA017692 (Same literature). The following is the abstract from the article: Lichen planus is an inflammatory dermatosis with a prevalence of approximately 1%. Recent meta-analyses show that patients with hepatitis C virus have a 2.5- to 4.5-fold increased risk of developing lichen planus. Lichen planus has also followed vaccinations and has specifically been attributed to the hepatitis B vaccine, the influenza vaccine, and the tetanus-diphtheria-acellular pertussis vaccine. We describe a case of lichen planus in a hepatitis C virus-infected male occurring in temporal association with the administration of the tetanus-diphtheria-acellular pertussis vaccine. The patient's presentation was clinically consistent with lichen planus and confirmed by biopsy. It is likely that many cases of vaccine induced lichen planus have gone unpublished or unrecognized. In areas with high prevalence of hepatitis C virus infection, we may expect to see more cases of vaccine-induced lichen planus especially in light of the updated Centers for Disease Control and Prevention tetanus-diphtheria-acellular pertussis vaccination recommendations. This case serves to educate healthcare providers about vaccine-induced lichen planus and, in particular, the need to counsel hepatitis C virus-infected patients about a potential risk of developing lichen planus following vaccination. We also reflect on current theories suggesting the T-cell-mediated pathogenesis of lichen planus and the role that hepatitis C virus and toxoid or protein vaccines may play in initiating the disease. This case involves patient (Age and gender was not reported) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, two weeks post vaccination patient had oral lichen planus. Laboratory investigation and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
No symptoms within 15 minutes of monitoring post vaccination.  Reported 1/6/2021. Went home and noticed LEFT arm was itchy.  Woke up in the morning with hives running along her left arm.  Took an antihistamine and hives reduced to red dots with some residual itching.  no other symptoms. no respiratory issues.
Client received FLUMIST on 10/16/15 at Dr office, and received FLUMIST at school on 10-28-15.
pt recv vax;exp numbness perioral,head,arm,lt leg,difficulty standing & walking;referred to hosp;
SHINGLES/ZOSTAVAX SEVERE REACTION. RED SWOLLEN AREA ABOUT THE SIZE OF A BASEBALL.  HOT, TENDER AND WHITE AREA IN THE MIDDLE.  TRAVELED FROM A LITTLE PAST MY ELBOW TO MY UNDERARMS.  MANY BLISTERS. I HAVE SEVERAL PHOTOS THAT I CAN SEND IF NEEDED.  WE MARKED THE AREA WITH A MARKER TO OBSERVE HOW FAST IT WAS SPREADING.  I'M ON DAY 3, AND IT'S STILL BAD. WENT TO DR. TO GET ANTIBIOTICS AND TOPICAL. 2ND DAY OF ANTIBIOTICS AND HAVE NOT SEEN A CHANGE YET.
Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-day 3. Chills-day 4.
Dark erythematons triangle type lesion on right upper leg surrounded by some pink erythema hot to the touch, non tender to palpitation. Slightly indurated
Severe arm pain. Inability to move or use it. Followed by a flare in arthritis through out my body. Severe pain. Swelling in joints. Fatigue. More than 10 days and ongoing.
Night of vaccination approx. 10pm, very painful body aches with fever and chills; especially in lower legs, felt like a deep muscular ache that could not be stretched out; I would relate this feeling to "growing pains" experienced as an adolescent. Fatigue lasted for 3 days after this event
Next day my left arm was sore, and my lymph node was swollen and hard and painful. Over next few days my neck got sore. Took ibuprofen but that didn't help. Went to chiropractor but neck pain got worse. By 12/11 my face was getting numb. I felt like a spider was crawling up my face. Numbness spread to my arms. I passed out and my husband found me. When I woke up my whole body was numb. Called ambulance, went to hospital, tested for stroke and heart attack, both tests negative. I couldn't lift my left leg and slurring my words. Spent one night in hospital, threw up constantly. Sent home with poor balance. Sent home with migraine meds which didn't work. Went to PCP. She put me on BP meds and pain meds. BP was 152/102. Now 133/107. Taking Metoprolol 50mg and Lisinopril 20mg. Going back to PCP on 12/22. Sending me to neurologist in Jan.
PT CAME IN DURING STORE HOURS AND STATED THAT HE NOTICED ACNE-LIKE BUMPS ON HIS NECK. HE STATED HE DIDN'T HAVE THAT BEFORE. ADVISED PT TO SEE HIS PRIMARY CARE PHYSICIAN
pt c/o nausea, pain @ inj site, swelling @ inj;mom had to go get child @ school 12noon d/t inc sx;c/o nausea & paresthesia rt little finger;arm swollen shoulder to wrist;pale;vax poss given too far back in muscle w/poss nerve involvement;
injection site is warm; hard bump; sore; pink; pinkness has spread; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (hard bump), VACCINATION SITE PAIN (sore), VACCINATION SITE ERYTHEMA (pink) and VACCINATION SITE ERYTHEMA (pinkness has spread) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (hard bump), VACCINATION SITE PAIN (sore), VACCINATION SITE ERYTHEMA (pink) and VACCINATION SITE ERYTHEMA (pinkness has spread). At the time of the report, VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (hard bump), VACCINATION SITE PAIN (sore), VACCINATION SITE ERYTHEMA (pink) and VACCINATION SITE ERYTHEMA (pinkness has spread) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information and concomitant product is not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Vaccination site induration, vaccination site pain and vaccination site erythema  are consistent with the product safety profile
Suspected vaccination failure/The immunization causes herpes breakouts often; herpes breakouts; 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.   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: Suspected vaccination failure/The immunization causes herpes breakouts often) (serious criteria GSK medically significant) and shingles (Verbatim: herpes breakouts).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 This case was reported the patient via interactive digital media. The patient reported that immunization caused herpes breakouts often. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
9/20 - 9/27/16 - Pt. started having joint pain (knees and ankles) and edema in feet and ankles. 9/22/16 - 9/25/16 - Pt. had rash on stomach, neck, petechial rash without itching and bright red flushed look on face and neck.
On April 17, 2021 following my initial vaccine shot on May 29, 2021 I had a stroke requiring emergency surgery for removal of the blood clot in my brain. I was hospitalized in icu for two days and am currently receiving follow up care. Testing shows that it was not heart nor genetically related.
Summary of Call: Patient received 2nd dose vaccine,  return to work daycare (accross from street) 30 min after and fell to the floor.  Call our clinic for futher evaluation by provider.    VS  140/85 right arm SPO2 100%  temp 97.1 oral second reading 160/96. BG 145 HR 95.  Pt was found sitting on a chair at parking lot of daycare across clinic 20-25vminutes after second dose of moderna  She said she was feeling like drunk, VS as above  her gait was weak and uncoordinated  and was barely able to stand up, she was brought to hospital via car. Speech:    Speech is normal; fluent and spontaneous with normal comprehension Cognition:    The patient is oriented to person, place, and time; memory intact; language fluent; normal attention, concentration, and fund of knowledge Cranial Nerves:     Trigeminal sensation is intact. The face is symmetric. The palate elevates in the midline. Voice is normal. Shoulder shrug is weak.  Coordination:    clumsy  Gait:    uncoordinated gate, wheelchair bound. EMS was called  and transported to another hospital  for  Stroke work up
RN had order for Hep B vaccine, however, during removal of vaccine from the dispenser RN inadvertently grab Influenza vaccine. RN unfortunately did not utilize medication scanning and realized the incorrect medication was administered. Mangement and medical provider made aware.
Pfizer vaccine was diluted with NS 0.9% Bacteriostatic which is not recommended for use with this vaccines. Reported to Pfizer and agency. As per recommendation from agency, affected dose should be repeated. Pt was notified and all questions answered. Pt repeated dose on 9/15/21.