chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 4 month old patient of unknown gender who on 09-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot#J011344, expiration date 10-MAY-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were inadvertently vaccinated with improperly stored VAQTA (lot#, expiration date, dose and frequency not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the physician cannot be contacted.
On 8th day after injection pain, redness, swelling, hardness developed at the injection site.
pneumococcal immunization given 9/13/06. Received email from patient on 11/2/06. Complained of itching at injection site since injection was given.
Extreme tenderness at injection site, all over body aches, especially concentrated in the back, hot sweaty followed by cold/chills.
sore arm; very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Latex allergy, Multiple sclerosis since 1995 and Heart disease, unspecified. Concomitant products included ACEBUTOLOL for Heart disease, unspecified, OCRELIZUMAB (OCREVUS) for Infusion, GABAPENTIN, ROPINIROLE, BACLOFEN, PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DIAZEPAM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ), DICYCLOMINE HCL, PROMETHAZINE and MELOXICAM (MOBIC) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever). On 25-Feb-2021, PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever) had 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.   The patient never had COVID-19 positive test or diagnosis. The patient did not have a history of Myocarditis/pericarditis. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. Concomitant products included Pantoprazole for her Stomach. Treatment information was unknown.   This case was linked to MOD-2022-517704 (Patient Link).
started menstruating today with blood clots in her period; soreness of muscle; a bit fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (started menstruating today with blood clots in her period), MYALGIA (soreness of muscle) and FATIGUE (a bit fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE, COLECALCIFEROL (D3) and Serotonin Inhibitor for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced MENSTRUAL DISORDER (started menstruating today with blood clots in her period), MYALGIA (soreness of muscle) and FATIGUE (a bit fatigue). At the time of the report, MENSTRUAL DISORDER (started menstruating today with blood clots in her period), MYALGIA (soreness of muscle) and FATIGUE (a bit fatigue) 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 information was not provided.   This case was linked to MOD21-090276, US-MODERNATX, INC.-MOD-2021-128629 (E2B Linked Report).; Sender's Comments:  MOD21-090276:crosslink US-MODERNATX, INC.-MOD-2021-128629:
pt recvd vax; on 9nov95 devel chicken pox on head, face & back & two sores in vagina; pt felt exp not related to vax;
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported the same event for three patients. This is the 2nd of three reports. An elderly female patient of unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5ml single, for immunisation. Medical history and concomitant medications were not reported. On an unknown date the patient experienced hard swollen arm and redness around the injection site. The outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017081303 Same reporter/product/event, different patient.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: swelling of the entire arm-Medium
Patient admitted with ascending muscle weakness and elevated CK. Questionable association for guillian barre. Stated symptoms occured starting the day after flu shot administered, was admitted 6 days after shot with above. Patient treated for rhabdo then transferred to another local hospital. No fever, no chills. Feeling week for 1 week prior to admission. DC Summary received for DOS 10/16-10/31/07-DC DX: acute renal failure secondary to superimposed chronic renal insufficience.  11/13-07-records received for DOS 10/16-10/30/07-DX: Acute renal failure. Rhabdomyolysis. C/O generalized weakness.Rhabdomyolysis status post Tesio catheter. Lower extremity weakness inability to ambulate.
Was given seasonal influenza vaccination on 11-06-09. That day had temp of 103.5 degrees F. Fever on Sunday 11-8-09 of 102.00 degrees F. Mom called hospital ER. Was told to keep him home, use OTC fever reducer. Monday 11-09-09 client c/o stomach ache. Mom reported this to DSHS. SA .p no fever at this time. Later in day client had fever, taken to ER. was told she had all symptoms of flu, released to home. No treatment. Returned to school on 11-12-09.
Initial report received from a nurse on 15 Jul 2010: This patient was vaccinated with MENVEO (batch number: unknown) on an unspecified date. The patient concomitantly received HEPATITIS A vaccine (manufacturer unknown; therefore conservatively considered as HAVPUR INN). The patient experienced syncope associated with "seizure like movements". The patient fell and head struck. The patient was admitted to hospital on an unknown date. The outcome of the events was not reported.
Pregnant after 1st dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant after 1st dose). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant after 1st dose) had resolved. Not Provided      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.   No relevant concomitant medications were reported. No treatment information was provided. Patient would like to be on the pregnancy registry.   This case was linked to MOD-2021-040962 (Patient Link).
No adverse effect reported.; received improperly stored PROQUAD; Information has been received from a medical assistant referring to a 11 year old female patient. Concomitant therapy included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided.  On 16-AUG-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type was rHA, lot # was R015741, expiration date was 02-DEC-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (lot # and expiration were unknown by the reporter). No adverse effects were reported.  The vaccine had temperature excursion of 6 Fahrenheit (F) degree to 14F degree (14F degree) for 1 hour and 8 minutes. Previous temperature excursion of 15F degree to 46F degree (42.8F degree) for 37 hours and 7 minutes. The call was due to the digital data logger.
BLISTERS ON THE RIGHT ARM; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included tested positive for covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 16:30 at right deltoid for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 101 F. On 05-APR-2021, the subject experienced blisters on the right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever, and had not recovered from blisters on the right arm. This report was non-serious.
2 hours post vaccination- vaccinated arm was throbbing and was eventually like lead weight. Later that evening patient was nauseated and vomited. We are now 2 days post vaccination and patient still can't get his arm over his head and he can only move it 2 to 3 inches away from his body. Patient also reported swelling and itching in the hand the evening of the vaccination.
Developed numbness/tingling of legs ascending to knees with associated weakness/"heaviness" of legs. Also, paresthesias and weakness of hands/wrists. Hospitalized for 5 days, receiving 5 days of IVIG, and discharged with improvement but continued difficulty walking unless holding on to wall. The patient's flu vaccine was administered by a coworker who was in training, and did not have much vaccine administration experience. The patient's first "shot" administered "did not go in" according to this coworker (i.e., leaked out?). The second shot administered was done correctly according to the coworker. However, the patient herself was unable to visually confirm that the first "shot" leaked completely or didn't get administered at all. Thus, there is a strong possibility that the patient ended up receiving greater than 1 dose.
Patient visited ED 17 days after receiving COVID vaccine dose 2. Patient was admitted to hospital 31 days after receiving COVID dose #2.
Injection site reaction 12 cm x 10.5 cm, redness 15.1 cm x 18 cm.
Sore in left arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200374157 (Pfizer).  The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 11Feb2022, this case now contains all required information to be considered valid]  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: EW0182) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid condition" (unspecified if ongoing), notes: she has a thyroid condition. Concomitant medication(s) included: LEVOTHYROXINE; VITAMIN D3 1000. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21May2021, outcome "unknown", described as "Sore in left arm at injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior vaccination: None. Concurrent medication included Morning: Levothyroxine 37.5 mg (takes 1/2 of 75mg tablet) and Evening: Sodium chloride tablet 394 mg, Vitamin D3 25mg, Periactin 4mg, Zofran 4mg. Investigation Assessment: Not Provided.  No follow-up attempts are possible. No further information is expected.
Moderna Covid 19 Vaccine EUA Soreness at injection site, chills, body aches, headache
Flu-like symptoms; Afluria quadrivalent administered on 17-Jan-19 but on 20-Dec-18 had already had another unnamed flu vaccine administered; This is a spontaneous case initially received from other health professional (nurse) on 24-Jan-2019, concerning a 33-year-old, adult male patient.  The patient's current conditions included opioid abuse and muscle spasms.  The patient's concomitant medications included Vivitrol (naltrexone) for opioid abuse, Tizanidine for muscle spasms, clozapine (pregabalin) and naproxen. It was reported that the opioid abuse and muscle spasms had occurred before the administration of the flu vaccines.  On 20-Dec-2018, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication.  On 17-Jan-2019 (in the same season), the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF43809 and expiry date: 30-Jun-2019) (explicitly coded as extra dose administered) for active immunization against influenza.  On an unspecified date, after vaccination with Afluria Quadrivalent, the patient experienced flu-like symptoms and not the flu.  The reporter assessed the case as non-serious.  Follow up received from nurse on 12-Feb-2019: Added start dates for concomitant medications Vivitrol: 17-Jan-2019, Tizanidine: 17-Jan-2019, Naproxen: 17-Jan-2019, Clozapine: 10-May-2017 and concomitant medication's indications for Vivitrol: opioid abuse and Tizanidine: muscle spasms in product tab. The nurse stated they did not see the patient for 1 month. The narrative was amended accordingly.  Follow up received from other health professional (nurse) on 20-Feb-2019: The classification 'special case with no AE' was deleted in the general tab. The event 'flu like symptoms' was added in the event tab. It was reported that the opioid abuse and muscle spasms had occurred before the administration of the flu vaccines. The narrative and case comment were amended accordingly.; Reporter's Comments: A 33-year-old, male patient was administered an INN Flu Vaccine Seasonal and Afluria Quadrivalent in the same season (extra dose administered). On an unspecified date after vaccination with Afluria Quadrivalent, the patient experienced flu-like symptoms. The company assessed the causality of the event extra dose administered as not related to the suspect vaccine due to accidental nature of the event. The company assessed the causality of the event flu-like symptoms as not related to the suspect vaccine INN Flu Vaccine Seasonal due to implausible temporal relationship between event and suspect vaccine. The causality of the event flu-like symptoms with respect to Afluria Quadrivalent vaccine was unassessable due to the lack of information regarding onset latency of the event.
about 10 min. my chest swelled up pain up and down arm  pain in center of chest. half hour reported to nurse, blood pressure was almost 200, stayed there about hour until blood pressure went down. during night arm swelled and wheezing in chest tool claudin allergy pill  over 100 degree temp 2 days then second day about 3:30 pm hives started around my waist  took allergy pill
Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number n99p3, expiry date 19th October 2021) and (adjuvant batch number unknown, expiry date 28th February 2022) for prophylaxis.   On 17th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 17th February 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Shingrix, which led to expired vaccine used. The reporter consented to follow up. This case had been linked with case US2022029587, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022029587:Same reporter.
Pt recvd 1st dose of Hep B vax AUG 1991 & w/in 24 hrs following vax pt devel urticaria on face;
Pt noted pale/ leaned over to mother's shoulders. Not responsive to verbal command and with myoclonic jerk of hands and arms.
Hives, welts, blisters from injection site to middle of arm near elbow. Was told it was localized and could take the 2nd shot. Took 2nd shot 9/9/21 (IM, RA, Lot # 048F21A) On the 10th, couldn't close right hand; right hand didn't work. Fever of 103 degrees lasted 18 hours. Knots on both arm after the injections, Swollen and hard and itched at the injection site. Severe swelling in the right hand. Been to orthopedics, is going to the reumatologist. Is right handed, so having difficulty with basic daily activities.
Multiple salmon colored scattered raised macules, non tender, non-pruritic in trunk and extremities.
Pt devel urticaria following 1st dose of Hep B vax; pt was treated w/DPH; No further details were provided;
I have been having joint pain since about two weeks after vaccine. Joints are still sore. Everyone said it's going to go away but it hasn't. My knees, elbows and shoulders. I take Advil every day to help with it. My regular doctor visit said it would go away. I see a pain doctor too and she said it will go away.
WAS OUT A WHOLE DAY; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (WAS OUT A WHOLE DAY) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (WAS OUT A WHOLE DAY). At the time of the report, HYPERSOMNIA (WAS OUT A WHOLE DAY) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concominant medications were not reported.  Treatment information was not provided.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 17-DEC-2018, the patient was vaccinated with improperly stored dose of ROTATEQ, lot # R000911, expiration date on 28-FEB-2019 orally, for prophylaxis (strength, dose and anatomical location were not reported). The vaccine was improperly stored at a temperature of 8.62 degrees C during a time frame of 30 minutes. Previous temperature excursion reported were: below 0 degrees C (-0.58 degrees C) for 1.75 hours (1 cycle) and 0 degrees C to 1 degrees C for 10.25 hours. No adverse effects were reported.
Increased sensitivity to antibiotics and other meds-naproxen and breathing treatments (severe anaphylactic allergic reactions with multiple trips to ER), increased tiredness/exhaustion, terrible blood work, weakened immune system, sensitivity to OTC vitamins, muscle cramps.
Arm sore for a couple of days, then pain began increasing and spreading from upper arm down to elbow.  Arm is still sore more than  2 weeks after the shot.  Provider recommended she see her doctor since the pain is persistent.
Right deltoid area swollen and warm, sore two days after immunization. DTap given on 7/13/05 in right deltoid.
I had a room spinning dizzy spell on the 3rd day after the shot but didn't think too much of it after it passed. The 4th day I remember thinking I felt dizzy again, and the next thing I knew I was on the floor and hit my head really hard. I think I must have passed out for a nano second. (The first time in my life!) On the 8th day, Feb. 14th, I got a rash on the injection site. It was red, swollen, hot and shaped like a square about 2 inches diameter. I haven't had an event since.
Tingling, numbness, pain to both arms, legs, lasted all day. Resolved 1 1/2 days.
Patient is a 88 y.o. female patient of, MD with a history of cough   Discharge Diagnoses: Covid 19    Acute on chronic hypoxic respiratory failure              - baseline 2 L NC  Chronic Hyponatremia             - baseline around 129  Metabolic encephalopathy             - previous history of same; previous admissions with full neurology evaluation  HTN COPD Overweight; POA BMI 35  Emphysema    Patient presented to Hospital with SOB, AMS. Has known history of encephalopathy and hyponatremia noted on previous admissions. Currently stays at facility and roommate was + for Covid. Patient also noted to be Covid +; has had vaccinations and booster. Initially required Bipap from ED; deescalated to her ba  Patient is a 88 y.o. female patient of, MD with a history of cough   Discharge Diagnoses: Covid 19    Acute on chronic hypoxic respiratory failure              - baseline 2 L NC  Chronic Hyponatremia             - baseline around 129  Metabolic encephalopathy             - previous history of same; previous admissions with full neurology evaluation  HTN COPD Overweight; POA BMI 35  Emphysema    Patient presented to Hospital with SOB, AMS. Has known history of encephalopathy and hyponatremia noted on previous admissions. Currently stays at facility and roommate was + for Covid. Patient also noted to be Covid +; has had vaccinations and booster. Initially required Bipap from ED; deescalated to her baseline 2 L NC; pulmonary evaluated patient and recommended 10 day course of 6 mg Decadron. Patient will return to facility