chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness in legs after 2nd shot; On & off burning sensation injection site continued after 2nd shot; Diarrhea continued after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea continued after 2nd shot), HYPOAESTHESIA (Numbness in legs after 2nd shot) and VACCINATION SITE PAIN (On & off burning sensation injection site continued after 2nd shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B231A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced DIARRHOEA (Diarrhea continued after 2nd shot) and VACCINATION SITE PAIN (On & off burning sensation injection site continued after 2nd shot). In May 2021, the patient experienced HYPOAESTHESIA (Numbness in legs after 2nd shot). The patient was treated with TINIDAZOLE for Diarrhea, at an unspecified dose and frequency. On 30-Dec-2021, VACCINATION SITE PAIN (On & off burning sensation injection site continued after 2nd shot) had resolved. At the time of the report, DIARRHOEA (Diarrhea continued after 2nd shot) and HYPOAESTHESIA (Numbness in legs after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Antibody test: 705 (High) very high antibody count.         Patient reported  that patient  has not had it for a while but does not remember the date of the last episode. Patient visited 2  doctors and both prescribed antibiotics tinidazole. No concomitant medications information was reported.   This case was linked to MOD-2021-435671 (Patient Link).
Patient received an undiluted dose of pediatric Pfizer Covid-19 on 4/5/22. Patient did not experience any adverse events as of 0800 on 4/6/22
Sore imm site. Numbness radiating from inj site to right jaw and down to lower back. Headache, nausea, dizziness.
Pt. received MMR and Varicella on 4/6/17. On 4/8/17 noticed redness and itching to both sites - she took Ibuprofen at time. She was seen today 4-12-17 by RN at Clinic. Redness remains to both arms but no itching and pt. relays both arms are feeling much better.
Muscle pain at various location of body. Redness at location of shot. On Friday felt like I would before getting fever/sick. Still having pain on Monday morning, 7/30/2018, 11 AM.
Sense of smell altered. Metallic/blood scent and/or rancid/rotten meat smell persists consistently.  Altered perception of food flavoring resulting in consistent nausea. This issue with nausea results in loss of work/excessive sick days.
Started 3 weeks ago, improving now. 2 months of joint and muscle aches, weakness, fatigue, migraines, sinus pressure. nausea, vomiting, and diarrhea began 2 weeks after injection and resolved. nausea, vomiting, diarrhea again 3 weeks ago. Intermittent chest pain and shortness of breath 3 weeks ago. Bloody nasal discharge. 1/15/09-records received-6/13/08-did  not follow up with referral due to lack of insurance. Pevlic pain now resolved. Changed pills now C/O circumoral rash and increased headaches. 7/8/08-Gardasil given C/O feeling tired. 9/10/08-Gardasil given.12/1/08-C/O fatigue, nausea, vomiting,diarrhea, dizziness, migraines, since last gardasil shot, 2 months of  joint and muscle  aches, weak, exhaustion.Hair loss improving. PE:normal  hair pattern. 1/27/09-records received-on 11/10/08 C/O nausea, vomiting, diarrhea since night prior, increased malaise, joint pain, epigastric pain. Stressed regarding complaints related to Gardasil. Assessment:anxiety, gastritis. 11/19/08-weight loss of 15 pounds. Loose stools and constipation. Tired. Assessment:fatigue, muscle ache, diarrhea/constipation. 11/26/08-diarrhea continues intermittently, mucle aches, joint pain intermittent. Assessment: symptoms related to anxiety and sedentary lifestyle and poor dieting with numerous somatic complaints.
patient received pediatric vaccine instead of adult vaccine. no adverse reaction noted, patient was monitored and consulted with MD. Per MD patient should experience no/little side effect due to smaller dose given to patient.
Paresthesias of left hand, general malaise, fatigue, ? HTN urgency ? however missed HTN med doses at the time of evaluation
No ADR, timing ERROR, 2nd dose given 45 days after 1st Narrative:  No ADR, timing ERROR, 2nd dose given 45 days after 1st
patient had a Blood pressure of 195/115; vomited; Chills; A spontaneous report was received from a consumer concerning her 31-year-old, husband, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a blood pressure of 195/115( hypertensive crisis)and nonserious events like vomiting and chills.  The patient's medical history was not reported. Concomitant medications were not reported.  On 19-03-2021, Approximately 1 day prior event patient received their second of two planned doses of mRNA-1273(Batch Number 003B21A) for prophylaxis of COVID-19 infection.  On 20 Mar 2021, after receiving mRNA-1273 dose, patient had a Blood pressure of 195/115 where previous ones only ranges from 150/97-161/100. Patient also vomited and had chills. The patient did not had these reaction with the first dose. Treatment were not reported. The patient received both scheduled doses of mRNA-1273 prior to the events: therefore, action taken with the drug in response to the events is not applicable. The outcome of the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.; Reporter's Comments: This case concerns a male of unknown who had serious unexpected events of hypertensive crisis along with nonserious expected vomiting, chills.  Event onset occurred Day 2 after the second dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
low grade fever; felt pressure on chest; slight difficulty breathing; This is spontaneous report received from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:45 (Lot Number: EP6955) (Age at vaccination: 49 Years) as single dose for covid-19 immunisation. Medical history included Psoriasis; psoriatic arthritis; No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included rosuvastatin; valacyclovir [valaciclovir]; finasteride; vitamin d [vitamin d nos]; cetirizine hydrochloride (ALLERTEC, OTC allergy medication)). The patient previously received the first dose of bnt162b2 (lot number: EP6955) in Left arm on 17Mar2021 10:00 for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Apr2021 14: 00 (also reported as 13 minutes post injection), the patient felt pressure on chest/slight difficulty breathing for 15-20 minutes. On 08Apr2021 20:00 (one day post injection) had a low grade fever. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of events felt pressure on chest/slight difficulty breathing was recovered on 07Apr2021, of low grade fever was recovered on 08Apr2021.  No follow-up attempts are needed. No further information is expected.
severe nose bleeds; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EPISTAXIS (severe nose bleeds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) 1 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 28-May-2021, the patient experienced EPISTAXIS (severe nose bleeds). At the time of the report, EPISTAXIS (severe nose bleeds) outcome was unknown.            Treatment information were not provided.
I had a slight fever of 99.8 the next day and a general feeling of lethargy. I had the shot on Tuesday, the described condition was on Wednesday and I am feeling fine today (Thursday with no fever).
Normal menstrual cycle (i.e. week 4/inactive pills) on birth control pill ran April 4-10, but menstruation continued for 1 further week while taking the first week of active BC pills, April 11-17, 2021. Everything seemed normal for the second week, but menstruation began again during the third week of active BC pills, April 25-today. Menstrual flow has been heavier than normal, and I've noticed many blood clots.
Immediate very bad flu symptoms -- joint pain, tinnitus, rhinitis, high fever, uncontrolled shaking, muscle soreness, blurred vision, inability to sleep (same as when previously had interferon injections for Hep C treatments) -- started a couple of hours after immunization and lasted for about two weeks. Muscle weakness, Depression, Dizziness and Brain Fog which continues to this day (have tried Sertraline, Bupropion and Fluoxetine with no help).  Magnesium Calm has help with inability to sleep.  Eye puffiness -- eye doctor prescribed eye treatments which seemed to help, but still have puffy/crusty eyes.  Crusty skin on face and chest -Clobetasol 0.05% Cream has helped.  Diagnosed with cutaneous lichen planus in the eye area by Dr.
pt recvd vax; muscle aches, joint pain, lymphadenopathy, dizziness, redness, swelling, pain, itching warmth at site p/ dose 1; local rxn dose 2 & 3; pre tx w/ dph & ibuprophen;
No co-morbidities, in ideal weight and health, 46 year old male patient, has no vaccination history. Migraine morning after vaccine, patient has no history of migraines. Two days with peculiar muscle tingling and weakness in legs.  Subsided within a couple of days.  Within 6 days, developed inflammation in right foot, assumed to be muscle related, sought no medical treatment, symptoms subsided within 48 hours.  Day 12 after vaccine, woke up with extreme pain in right toe.  Thought to resemble that of a sprain initially.  Pain progressed, went to urgent care for X-ray.  Initial X-ray thought as well to be a sprain, no prescriptions authorized.  Followup call the day-after from Rheumatologist confirmed gout.  Patient has zero medical history of gout or arthritic conditions.  Immense pain and inflammation persisted in right toe for more than 10 days.  Still recovering.
Rash; Redness about 3 in long x 2 in wide; Slightly itchy injection site; Swollen lymph nodes right above her clavicle; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of RASH (Rash), VACCINATION SITE ERYTHEMA (Redness about 3 in long x 2 in wide), VACCINATION SITE PRURITUS (Slightly itchy injection site) and LYMPHADENOPATHY (Swollen lymph nodes right above her clavicle) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Anxiety. Concomitant products included CETIRIZINE for Allergy, SERTRALINE for Anxiety.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced RASH (Rash), VACCINATION SITE ERYTHEMA (Redness about 3 in long x 2 in wide), VACCINATION SITE PRURITUS (Slightly itchy injection site) and LYMPHADENOPATHY (Swollen lymph nodes right above her clavicle). In January 2021, RASH (Rash), VACCINATION SITE ERYTHEMA (Redness about 3 in long x 2 in wide) and LYMPHADENOPATHY (Swollen lymph nodes right above her clavicle) had resolved and VACCINATION SITE PRURITUS (Slightly itchy injection site) outcome was unknown.        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 included Cortisone cream and Benadryl for 1 day.   Reporter did not allow further contact
great fatigue and then weakness (2 days) Head feels full (1 day), Lower abdomen tenderness, urinary frequency, less tenderness the next day on the next , No fever at all,
I developed a very bad headache on 2/27/2021. The following day, 2/28/2021, the headache was a little better but I noticed a loud sound that I thought was a jet plane or machinery running outside. After checking outside and seeing nothing in site, I realized that the sound was in my head. On 3/5/2021, I emailed my primary care physician and told her that I believe I have a severe case of tinnitus. She advised me to see an audiologist. I meet with an audiologist on 3/8/2021. The audiologist referred me to an ENT. The ENT confirmed that I had tinnitus and gave me some literature on tinnitus, and suggested that I see a neurologist for my headaches. I had a video visit with the neurologist on 4/14/2021.The neurologist scheduled me for an MRI which will be on May 3, 2021.
Patient stated that the injection site developed a raised, itchy, warm, red bump the size of a nickel.  She also stated that she had a temperature of 98.8 and was tired.
Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: unconscious and not responding and stiffed up-Severe
No additional AE reported; Caller reported that PROQUAD got administered to a patient via intramuscular route instead of subcutaneous route today (09/15/2022).; This spontaneous report was received from a nurse practitioner and refers to a 4-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-SEP-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, quantity: 1, for prophylaxis (strength, lot #, and expiry date were not provided) via intramuscular route instead of subcutaneous route today (incorrect route of product administration).  No additional adverse event reported. No product quality complaint reported. No further information was provided.
3 MONTHS AFTER PATIENT RECEIVED VACCINE, SHE CAME TO CLINIC C/O FEVER, JOINT PAINS, SORE THROAT AND HEAD ACHE. STARTED ON ANTIBIOTICS. PT. CLINICAL STATUS GOT WORSE, FEVER PERSISTED, NUCAL RIGIDITY AND PHOTOPHOBIA. REFERED TO WAKE MED HOSP TO R/O MENINGITIS. 7/29/08-records received for ED visit 11/2/07-presented with fevers since 10/28/07-initially seen by PCP on 10/30/07 for sore throat and antibiotics but did not start treatment until 11/1/07-on 10/30/07-developed diffuse rash and seen at another ED where antibiotic was changed, patient did not start the treatment-returned to PCP on 11/1/07- with C/O worsening sore throat and diffuse upper abdominal pain, temp 104 and now at ED 102.9. Mild frontal headache and 1 episode of emesis. PE:tonsils mildy erythematous, diffuse maculopapular rash to arms and legs and fine papular rash to bilateral inner thighs and trunk.  8/5/08-records received for DOS 11/2-11/12/07-DC DX: Fever, myalgias, weakness, rash, proteinuria.  Presented with one week history of fevers, stiff neck for 3 days and rash for 3 days. Sore throat for 5 days. Abdominal pain and diarrhea, bilateral wrist pain, full body myalgias and vomiting on 10/31 and 11/1/07. Leg pain, dizziness when standing and intermittent servere headaches for past 5 days. Transferred to another facility.  08/18/08-records received for DOS 11/23-11/26/07-DC DX: Stil's Disease/Systemic onset JRA.presented with C/O headache, altered mental status. New onset of neck pain associated with headace. Head bobbing tremor noted. Symptoms could be related to Prednisone.
Patient had redness and swelling at injection site, and patient began to have a fever, chills, and body aches approximately 4 hours after vaccination.
For a couple of days, patient felt a soreness/little of pain in left arm after vaccinated. She mentioned that she did exercise after vaccination and on 05/06/21, she experienced a strong contraction/pain in left arm down through her wrist/ hand with a lack of ability to move her left arm freely. She took Tylenol but it did not help her much so she is following up with a doctor.
Breakthrough case admission after three vaccines Moderna 1/25/1 Lot# 029L20A;  Moderna 2/25/21 Lot# 010A21A ; Moderna 12/1/21 Lot# 005C21A
No other AE reported; temperature excursion involving V ARlV AX / the V ARlV AX was administered to one patient; This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.     On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) at a dose of 0.5 ml, lot number S025611 and expiration date of 18-AUG-2021 (route of administration and anatomical location were unknown) for prophylaxis. The vaccine was exposed to a temperature excursion of 16°F with a time frame of 11 hours and 5 minutes. There was no previous temperature excursion. A "data logger" was involved. No other adverse event was reported.
vaccine taken on right arm on Wednesday 4/7/21 at 12:30 pm -symptoms began at 3am in the morning with a swelling 5cm by 3.5 cm at the site that was painful firm and hot to the touch, I was also febrile (temp not taken) with chills, sweating and body aches.  The swelling has persisted until Sunday 4/11/21 and I went to urgent care and was prescribed cephalexin. The fever lasted until the Saturday morning and was self treated with over the counter Tylenol.
After my second vaccination shot on 3/5/21 I started with a low grade fever on 3/6/21.  On 3/7/21 after getting up I started feeling funny while going to the restroom.  I laid on the floor for a while and then proceeded to the couch.  I passed out on the couch.  Upon waking up I was sweating very bad.  My clothes were wet.
11/2: No pain from shot until about 2 hours later, then swelling, redness in 4" circle on upper right arm, muscle contraction and minor pain (level 2-3) in upper right arm. No pain or swelling in left arm. 11/3: Increased swelling, larger area of redness encircling upper right arm (6-8"), prolonged extreme muscle contraction and pain (level 5-6) in right upper arm, minor itching at edges of redness, overall body aching and joint pain (level 4-5); general feeling of illness, minor difficulty breathing. Extreme muscle contraction described: my upper arm looked like a Popeye cartoon character's arm, a large 6" area of rock hard muscles. 11/4 Continued swelling, 4" band of redness encircling upper right arm, continued muscle contraction and pain (level 5-6) in upper right arm, signs of generalized bruising (blue) in muscle contraction area, overall body aching and joint pain (level 4-5), general feeling of illness. Took antihistamine and TYLENOL to address breathing and joint pain. 11/5 Lessened swelling and muscle contraction and pain (level 3-4) in upper right arm, generalized bruising (green/yellow) in muscle area, continued with antihistamine and TYLENOL, (pain levels reduced). 11/5 Called pharmacy and reported issues.
This spontaneous report has been received from a female patient of unknown age, who was reporting on herself. The patient had no pertinent medical history. The patient's concurrent conditions included multiple unspecified allergies to unspecified pain medications (she could take only TYLENOL). In 2012 (reported as "3 years ago"), the patient was vaccinated with an unspecified pneumococcal vaccine and she was advised that an updated version of the pneumococcal vaccine was required. On 28-SEP-2015 at 12:00, the patient was vaccinated intramuscularly in the arm with an unknown dose of PNEUMOVAX 23 (lot# and expiry date were not reported). Concomitant therapies included influenza virus vaccine (unspecified), also administered on 28-SEP-2015 at 12:00, in the other arm, and TYLENOL, which the patient took as premedication thirty minutes before and post vaccination. On 28-SEP-2015 at 18:00, 6 hours after vaccination, the patient experienced swelling and burning of her fingers and her shoulder started hurting. She took another TYLENOL, but it did not work. On 28-SEP-2015 at 20:00, 8 hours after vaccination, the patient was not able to move her arm. She tried using a cold pack on her arm, which helped, but her hand was still swollen. In the night of 28-SEP-2015, she did not sleep well, and "could not move in bed". She also used alternating "cold water bottles and hot", but only slept for 2 hours. On 29-SEP-2015, when she woke up, she could only feel the first bend on her fingers, and her hand was still swollen and sore. On 29-SEP-2015 at 14:00, 26 hours post vaccination, she can lift her arm, but it was still sore, "but getting better". The patient did not seek medical attention, because she considered that the physician would tell her to go to the emergency room and she did not want to pay so much money, because her arm seemed to be getting better. No lab diagnostics studies were performed. The patient reported that inability to move her arm lasted for 24 hours (resolved on approximately 29-SEP-2015 at 20:00). At the time of report, the patient was recovering from the events of swelling and burning of her fingers, hurting shoulder, sleeping unwell, movement disorder, sleep decreased, hypoaesthesia of fingers, hand swollen and sore. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information is not expected as no contact details were provided and the reporter did not wish contact the physician.
pt is currently in hospital with double pneumonia...pt wife stated that she thinks it is related to the flu shot. Pt was feeling poorly right after the flu shot was given
Patient was given vaccine that was beyond its "use by" date. Patient was contacted by pharmacy with no response.
Redness, inflammation,  area hard and hot to the touch. Water vesicles on the right arm. Administration Cleocin 200 mg every 8 hours Famotidine 10 mg every 12 hours Solumedrol 10 mg Iv .45 Dx
Within an hour to a couple hours after receiving flu vaccine: - At injection site, experienced red swelling at least 3 inches in diameter, which became hot, hard, and itchy,     and was extremely sore to the touch.    This lasted for at least 10 days. - A little later in the day,  developed  fever at least 101 F.     Also began  sweating, but also experiencing chills and shivering at the same time. - Experienced fast heart beat, could feel palpitations in chest, which came with the fever. - Developed slight cough. - Felt weak and achy all over.  Within 2 weeks after receiving the flu shot: - Breathing difficulty, with audible wheezing at the base of the right lung.    Difficult breathing also trying to walk up stairs or to talk. - Coughing worsened. -  Felt pounding in chest (heartbeat).
This spontaneous report was received from a pharmacy technician refers to a patient of unknown age. The patient pertinent medical history, concurrent conditions and concomitant medications were not reported. On 18-JUL-2016, the patient was vaccinated with improperly stored ZOSTAVAX (lot # L024999 and expiry date 06-OCT-2016). The vaccine was exposed to a temperature of 16F for 9 hours and 20F for 15 hours. Additional information has been requested.