chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Caller reports vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug reactions/allergies were not reported.  On 01-OCT-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (0.5 mL, lot # U015689 has been verified to be a valid lot number, expiration date was reported as 13-MAY-2023, but upon internal validation it was established as 18-MAY-2023; strength not reported), administered subcutaneously for prophylaxis. It was reported that the vaccine had a temperature excursion and was exposed to 25.9 Fahrenheit for 1 hour and 30 minutes (product storage error), but there was no pervious temperature excursion. No other adverse events were reported.
The pt presented to my office quite unexpectedly on 11/20/01 with complaints of worsening ecchymosis and bleeding from his mouth and nose. A stat CBC showed a platelet count of 8,000. Two weeks earlier, his platelets were stable at 68,000 while on Danocrine 200mg daily and prednisone, 5mg daily. In taking a history from the pt, the only thing new was the fact that he had received an influenza vaccination approx. 2 weeks earlier. What was quite fascinating was the fact that the day before, another pt of mine with a history  of ITP, also presented to my office with a relapse of his disease 12-14 days after an influenza vaccination. I took the liberty of treating the pt with high dose IG IV, I raised his dose of prednisone, gave him 1 dose of Vincristine and 2 units of platelet transfusion because of his bleeding. On 11/27/01, his platelet count was still low at 6,000. He then received a dose of WinRho as an outpatient on 11/27/01. On 11/29/01, his platelets were still low. Test showed elevated Transaminases of uncertain etiology which could certainly be due to the Danocrine or to perhaps the WinRho. I will ask the pt to discontinue the Danocrine at this time and raised his prednisone to 80mg/day. Platelets were up to 40,000 on 12/3/01. In 17 years of practice, I have never seen this. This is considered to be an "Other Important Medical Event".
Subjective: 25 yrs old presents with fever, chills, and malaise x 24 hours after receiving a first dose of COVID vaccine yesterday and an MMR booster on the day before. He states he has not had a COVID infection to his knowledge, despite working on the COVID unit at the clinic. Member admits to nausea, fever, chills, hallucination,  and malaise. Denies HA, cp, sob, abdominal pain, diarrhea, dysuria, or LE swelling.   A/P: 1. Adverse effect of other viral vaccines, initial encounter Plan/Comment(s):  - 25 yo presents with what is likely a normal adverse reaction in a patient that has been exposed or infected by Coronavirus 19 in the past. He likely contracted the virus while working 2 months on the COVID ward at Clinic, which would be considered an asymptomatic infection. He denies having symptoms of COVID. While he did have an MMR booster the day before receiving the COVID vaccine dose #1, it was my opinion that because of his age and health status at the time of the screening, he was clear to receive the first dose of the COVID vaccine. I did consider possibility of cytokine storm, having been given two vaccines in such close intervals, but again he is young, healthy, and denied having COVID infection in the past,  and he did not exhibit any adverse reactions to the MMR booster.  I anticipate his condition will be self-limiting and the SM will return to full duty in 48 hours.   Reference:   11) Have you received any vaccine in the past 14 days or plan to receive any vaccine in the next 14 days? Currently there is no data on safety or efficacy of a COVID-19 vaccine administered with other vaccines, however, the agency recommends that COVID-19 vaccines be administered alone with a minimum interval of 14 days before or after administration with any other vaccines. Vaccines required for post-exposure prophylaxis (e.g., rabies vaccine) may be administered within the 14-day period.   ***************Additionally, providers and patients can consider other vaccines, including the influenza vaccine, within the 14-day window on a case-by-case basis with shared clinical decision-making for Health Protection and other important co-administration vaccination needs.************  - will Rx Zofran - will Rx Tylenol - will Rx Motrin - SIQ  48 hours - Patient counseled on dx, tx, and plan; pt understands and concurs
Still having breathing issues as a result of the lung blood clot; Trouble with leg; Sore arm; Blood clot in his leg/Another blood clot developed on his right lung; Blood clot developed on his right lung; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in his leg/Another blood clot developed on his right lung), PULMONARY THROMBOSIS (Blood clot developed on his right lung), DYSPNOEA (Still having breathing issues as a result of the lung blood clot), LIMB DISCOMFORT (Trouble with leg) and PAIN IN EXTREMITY (Sore arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced THROMBOSIS (Blood clot in his leg/Another blood clot developed on his right lung) (seriousness criteria hospitalization and medically significant) and PULMONARY THROMBOSIS (Blood clot developed on his right lung) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Still having breathing issues as a result of the lung blood clot) (seriousness criterion hospitalization), LIMB DISCOMFORT (Trouble with leg) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (Sore arm) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (Blood clot in his leg/Another blood clot developed on his right lung), DYSPNOEA (Still having breathing issues as a result of the lung blood clot) and LIMB DISCOMFORT (Trouble with leg) had not resolved and PULMONARY THROMBOSIS (Blood clot developed on his right lung) and PAIN IN EXTREMITY (Sore arm) 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.   Concomitant product use was not provided by the reporter. Treatment medication included a blood thinner.  Company Comment: This case concerns a 51-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Pulmonary thrombosis, thrombosis, dyspnoea, limb discomfort and pain in extremity. The events occurred on an unknown day after the first dose of Spikevax. The rechallenge was unknown since there is no information about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 51-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Pulmonary thrombosis, thrombosis, dyspnoea, limb discomfort and pain in extremity. The events occurred on an unknown day after the first dose of Spikevax. The rechallenge was unknown since there is no information about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.
Fever of 102 for 5 hours. Severe headache, chills, fatigue lasting 24 hours Abnormal swelling and tenderness  at injection site lasting 2+ weeks. Inability to raise left arm. Acetaminophen taken throughout recovery.
Bleeding from mouth; Chest pain; Could not breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Could not breath) and MOUTH HAEMORRHAGE (Bleeding from mouth) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced CHEST PAIN (Chest pain) and DYSPNOEA (Could not breath). On 11-Apr-2021, the patient experienced MOUTH HAEMORRHAGE (Bleeding from mouth). On 10-Apr-2021, CHEST PAIN (Chest pain) and DYSPNOEA (Could not breath) had resolved. On 11-Apr-2021, MOUTH HAEMORRHAGE (Bleeding from mouth) had resolved.        This case was linked to MOD-2021-073072 (Patient Link).
Swollen feet; fast heart beat; rush in her risk to her elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen feet), HEART RATE INCREASED (fast heart beat) and FEELING ABNORMAL (rush in her risk to her elbow) in a 77-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen feet), HEART RATE INCREASED (fast heart beat) and FEELING ABNORMAL (rush in her risk to her elbow). At the time of the report, PERIPHERAL SWELLING (Swollen feet), HEART RATE INCREASED (fast heart beat) and FEELING ABNORMAL (rush in her risk to her elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Pt. called today 4/29/09 at 12:10 PM to report breaking out with rash around injection site on 4/26/09. States has other areas involved now (legs, face, stomach) states went to MD today who states she has chickenpox. Placed on VALTREX.
0.2CC OF COVID-19 PEDATRIC DOSE OF PFIZER FOR 5 YRS OLD -11 YRS OLD WAS INJECTED TO A 12 YR OLD PATIENT
can't bring the arm up; sore in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (can't bring the arm up) and PAIN IN EXTREMITY (sore in the arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (can't bring the arm up) and PAIN IN EXTREMITY (sore in the arm). The patient was treated with IBUPROFEN (ADVIL MUSCLE AND JOINT) for Pain in arm, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (can't bring the arm up) and PAIN IN EXTREMITY (sore in the arm) outcome was unknown.            no concomitant medications are provided. Action taken with mRNA-1273 in response to the event was not applicable  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
pt recvd vax; shaking & felt hot eve of vax; went to er; fever of 103 w/ tachycardia; was adm; in am 16nov93 t 101, then nl; 19jan94 fully recovered in 24 hrs; CBC & blood chemistries nl;
weakness; foggy thinking; migraine; exhaustion; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), THINKING ABNORMAL (foggy thinking), MIGRAINE (migraine) and FATIGUE (exhaustion) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced ASTHENIA (weakness), THINKING ABNORMAL (foggy thinking), MIGRAINE (migraine) and FATIGUE (exhaustion). At the time of the report, ASTHENIA (weakness), THINKING ABNORMAL (foggy thinking), MIGRAINE (migraine) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided. List of concomitant medication were not given.
Fever from 6/1/08 to 6/21/08.  Exanthema started on trunk expanded to extremities.
FBE reported AE for HCP.  HCP reported GARDASIL 9 series was started/administered to a 53 year old male patient.  It is unknown age of patient at 2nd and 3rd doses.   No other information was provided.  No additional AEs or PQC reported. AE reported; no adverse event; This spontaneous report was received from a physician via a company representative, and refers to a 53-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date at the age of 53 years, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered as prophylaxis (Drug use in unapproved age group) ( (strength, dose description, lot #, expiry date, and route of administration were not provided). On an unspecified date, the patient received 2 and 3 doses of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse events were reported.
With the first shot hands started itching and continued for about a week and half. Did'nt go to Doctor just took otc  Bendryl.Arm was a little sore. The second shot about 35 minutes later hands started itching but not as bad as the first shot and I did'nt take any otc Bendryl this time .shot was in same arm (left) it was more sore than the first shot and next day mild headache and sore throat by 3rd day felt better.
This spontaneous report was received from a pharmacist and refers to a female patient of approximately 79 years old. The patient doesn't have any pertinent medical history. Patient is allergic to penicillin. On 02-NOV-2015 the patient was vaccinated with ZOSTAVAX 0.65 mL once lot # L013546 expiry date not reported subcutaneously. Concomitant therapies included LIPITOR. On an unknown date in November 2015 (also reported a couple of days later) the patient developed injection site reaction, described as redness and soreness of the skin surrounding the injection site with a radius of "about the size of a quarter." Also the reporter stated on an unknown date in November 2015, (a couple of days ago (from 13-NOV-2015) patient developed shortness of breath and visited her physician, who determined the patient has fluid in lungs and was diagnosed with a respiratory infection. Patient received treatment, she was prescribed with azithromycin and prednisone. The outcome of the events injection site erythema and injection site pain was reported as recovered/resolved. The outcome of respiratory tract infection was unknown. The reporter did not provide the causality between the events and the suspect therapy. There was no product quality complaint. Additional information has been requested.
i was so stiff i couldn't move; burning in my hands, wrists, arms, legs, feet and ankles; aching in my hands, wrists, arms, legs, feet and ankles; depressed beacuse her husband passed away; Initial information received on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 70 years old female patient (162 cm and 58.967 kg) who was so stiff she couldn't move, burning in her hands, wrists, arms, legs, feet and ankles, aching in her hands, wrists, arms, legs, feet and ankles and depressed because her husband passed away while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Gastrooesophageal reflux disease, Osteoporosis, Hypertension and Allergies: codeine phosphate, Penicillins, Opioids (Drug hypersensitivity)  Concomitant medications included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (FEMHRT); PROPRANOLOL HYDROCHLORIDE (INDERAL); ACETYLSALICYLIC ACID, BUTALBITAL, CAFFEINE (BUTALBITAL, ASPIRIN AND CAFFEINE); MAGNESIUM (MAGNESIUM); CALCIUM (CALCIUM); and VITAMIN D3 (VITAMIN D3).  On 28-Sep-2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported in unknown administration site as Flu vaccine  On 29-SEP-2022 the patient was so stiff she couldn't move (musculoskeletal stiffness) burning in her hands, wrists, arms, legs, feet and ankles (burning sensation) aching in her hands, wrists, arms, legs, feet and ankles (pain in extremity) depressed because her husband passed away (depression)1 day following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  corrective treatment was received for the event -antidepressants for (depressed because her husband passed away). It was not reported if the patient received a corrective treatment for the events (i was so stiff i couldn't move, burning in my hands, wrists, arms, legs, feet and ankles, aching in my hands, wrists, arms, legs, feet and ankles).  At time of reporting, the outcome was not recovered for depression and Recovered / Resolved in 2022 for all others.
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown gender and age. The patient was vaccinated with ZOSTAVAX (lot #0748AA, exp: 18-AUG-2012) on 06-NOV-2012. This day, the patient received an expired dose of ZOSTAVAX. No treatment information was reported. The patient outcome was unknown. No adverse symptoms reported. Additional information has been requested.
VOICED BECOMING LIGHTHEADED, DIZZY, AND HAVING VISION CHANGES POST VACCINE. PALE, DIAPHORETIC UPON ARRIVAL TO OBS AT 1353. PLACED IN TRENDELENBERG, VSS, SNACK PROVIDED, S/S RESOLVED. ESCORTED TO EXIT WITH NO ISSUES WITH SIG OTHER AT 1409. 1353 INITIAL BP 125/70 HR 63 SATS 95% RA 1400 BP 118/71 HR 64 SATS 96% RA 1505 STANDING BP 128/84 HR 60 SATS 97% RA
Vaginal bleeding she is pregnant 18 weeks 6 days. Pt has been pregant 14 times 9 para, 9 term 4 ab 8 living with 9 live births
Very severe headache-still hurts today 4 days after injection-I have been taking Tylenol.  Left arm very sore still can not lift it past shoulder.
This case was reported by a pharmacist via call center representative and described the occurrence of vasculitis in an adult female patient who received FLUARIX QUADRIVALENT (batch number UNKNOWN, expiry date unknown). The patient's past medical history included vasculitis and cellulitis (in left arm). Concurrent medical conditions included lymphatic disorder (in left arm) and esophageal disorder. In 2014, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In 2014, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced vasculitis, movements involuntary of limbs (serious criteria disability), unstable feeling (serious criteria disability), movement disorder (serious criteria disability), gait shuffling (serious criteria disability), dizziness (serious criteria disability), swelling arm and erythematous rash. On an unknown date, the patient experienced fever. The patient was treated with medication unknown (Unknown). On an unknown date, the outcome of the vasculitis, movements involuntary of limbs, unstable feeling, movement disorder, gait shuffling, dizziness, swelling arm, erythematous rash and fever were recovered/resolved. The reporter considered the vasculitis, movements involuntary of limbs, unstable feeling, movement disorder, gait shuffling, dizziness, swelling arm, erythematous rash and fever to be related to FLUARIX QUADRIVALENT. Additional details provided: The pharmacist reported to field representative that about 4 hours after she received a FLUARIX QUADRIVALENT vaccine as required by her hospital she started having involuntary movement in her right hand. She felt unstable and had difficulty moving her legs such that she was shuffling her feet, and she was dizzy. She went home because of the symptoms, so the representative thought they were disabling for her. When she got home she had a fever, which she treated with medication. She fell asleep for several hours. When she woke up she was feeling less unstable but not 100%. 1 day after receiving the vaccination and a couple hours after waking up her left arm was swollen with red rash all down. She received the vaccine in her right arm, but she has a history of cellulitis and impaired lymphatic system in her left arm. She saw her HCP who stated that it looked like vasculitis. The symptoms all resolved after a couple days. The pharmacist was concerned about Guillain-Barre, but it was never mentioned as an actual diagnosis. The pharmacist could not remember when the vaccination happened, but it might have been in Nov or Dec 2014. The rep believes the pharmacist is currently 59 years old, and that she administered the vaccine to herself, but is not certain.
Slurring of speech. Went to hospital. Suspected Stroke, hospital administered tPA shot. Neurologist diagnosed a stroke caused by calcification.
Information has been received from a LPN concerning a 15 month old white male with a history of diaper rash who on 05Jan04 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot 646535/0575N). Concomitant therapy included loratadine (Claritin) and nystatin cream for the diaper rash. On 20Apr04 the pt developed classic pox like pustules all of his body. The onset of symptoms occurred after exposure to a sibling who was exposed. The pt was reported to have pox on his arms, legs, abdomen and hand. At the time of the report, the pt was being treated with diphenhydramine and Aveeno baths. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 20Apr04, three months after vaccination, the pt developed chicken pox. Only 25-50 lesions were noted. Additional information has been requested.
Warm; Inflammation; Itching; Hardened; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE INFLAMMATION (Inflammation), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE INDURATION (Hardened) and VACCINATION SITE ERYTHEMA (redness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE INFLAMMATION (Inflammation), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE INDURATION (Hardened) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE INFLAMMATION (Inflammation), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE INDURATION (Hardened) and VACCINATION SITE ERYTHEMA (redness) had not resolved.        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.   No concomitant Medication was available. No treatment Medication was available.