chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse symptoms were reported.; Nurse called and reported that the patient was administered a dose of improperly stored VARIVAX (S024366, exp: 08/06/2021) on 11-MAR-2020.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and previous drug reactions/allergies were not reported.  On 11-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S024366 was verified to be a valid lot number, expiration date reported and established as 06-AGU-2021), as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported). As concomitant medication sterile diluent (MERCK STERILE DILUENT) (lot number R019504 was verified to be a valid lot number, expiration date reported and established as 04-NOV-2021), was properly stored and used to reconstituted the suspect product. The administered dose of the vaccine experienced a temperature excursion -14 degrees Celsius to -10 degrees Celsius (-12 degrees Celsius) for 4 days 11 hours 40 minutes (product storage error), as recorded by a data logger. There was no previous temperature excursion and no adverse symptoms reported.
pt recvd vax 19SEP95 & 4OCT95 devel a rash that appeared as little red pimples on trunk,feet,hands & mouth;also devel a sl fever;MD called the pt's mom who indicated that pt did not have an adverse rxn;
Could not walk the evening of 9/12/12. Also had chills & then became very hot.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In September 2017, a pharmacist at a pharmacy administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). In October 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
very sensitive to alcohol; Severe chills; Night sweats; Muscle pain; little pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little pain), ALCOHOL PROBLEM (very sensitive to alcohol), CHILLS (Severe chills), NIGHT SWEATS (Night sweats) and MYALGIA (Muscle pain) 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 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Feb-2021, the patient experienced PAIN (little pain). On an unknown date, the patient experienced ALCOHOL PROBLEM (very sensitive to alcohol), CHILLS (Severe chills), NIGHT SWEATS (Night sweats) and MYALGIA (Muscle pain). At the time of the report, ALCOHOL PROBLEM (very sensitive to alcohol), CHILLS (Severe chills), NIGHT SWEATS (Night sweats) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-071835 (Patient Link).   Reporter did not allow further contact
Patient states phlegmy cough and headaches began within a few hours and continue through today, eczema reaction on hands appeared about 1 week later and is ongoing.
Since the second injection, menstrual cycle has become unpredictable and too frequent. Closer to every three weeks.
March 26 first vax, no prob except tired and no energy. a week and 2 days later she went to hospital could not even change clothes , went to Dr. , then ER.  they did MRI, and found out she had a stroke on right side of brain. but right side was showing weakness.  Week and half later weakness in right hand. 2nd MRI left side stroke on brain, inflammation on spinal cord, short term rehab.  They found UTI  after going back to ER. Son got call from The 2nd ER doctor and said she was diagnosed with  neuromyelitis optica  very rare disease. They said she had transverse myelitis  (May,  14 2021) Returned to rehab then found out she had high white blood cell count ,  On May 16, 2021  readmitted to hospital  and did not return to Rehab until June 18 2021 . Then returned and is still in on July 2, 2021.  (Inflammation of gallbladder, 4th diagnose  of Shower strokes, diabetes, On July 12, 2021 in hospital was diagnosed  with Covid 19 and is still in hospital
Patient lost consciousness for a couple seconds and hit his head on the ground. Patient got up right away. No CPR provided.
Within 20-30 minutes of the vaccination on October 21, I began experiencing intermittent chest pains. I had experienced this previously with my first 3 doses of the vaccine but it always went away quickly.  October 21 and 22 consisted of this on and off chest pain.  On October 23 , I began having heart flutters at rest in addition to the chest pain. I went to the ER where I had an abnormal EKG and troponin in my blood. I stayed in the hospital overnight. On the 24th, I had a nuclear stress test (abnormal), echocardiogram (abnormal) and a cardiac catheterization procedure (showed no blockages). I was diagnosed with myocarditis due to the covid vaccine. I was put on a blood pressure medication and sent home to rest for the next 6-8 weeks.
Sudden sensorineural hearing loss in the left ear. 60 MG prednisone seems to have improved symptoms so far
Local T-Cell rxn to DT. Swollen, red, indurated left upper arm with heat & tenderness.
Two to three hours after receiving the second dose of COVID-19 Pfizer-BioNTech vaccine, the patient began to have generalized rash erythematosus with hives.  The patient was transferred to the Emergency Room and following the evaluation the patients was treated with Solu-medrol 125 mg IV single dose and Benadryl 25 mg IV. single dose.
Pt recvd vax & devel redness & soreness in the arm of inject; next day was also sick to stomach; 2 days later arm cont to be swollen red & sore below the elbow; these local sx resolved 10 days p/inject;
Report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment medications provided.
rashes inside of arm, rashes outside of breast and down a little bit/rashes flare ups; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes inside of arm, rashes outside of breast and down a little bit/rashes flare ups) and PRURITUS (Itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rashes inside of arm, rashes outside of breast and down a little bit/rashes flare ups) and PRURITUS (Itchy). At the time of the report, RASH (rashes inside of arm, rashes outside of breast and down a little bit/rashes flare ups) had not resolved and PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment details were provided. Crosslinked to original case. MOD21-073281   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Fallow up received and contains no new information.
Minor but persistent GI issues (over two weeks), with diarrhea.  GI discomfort and frequent bowel movement.
This is a spontaneous report from a contactable physician via Pfizer sales representatives. A female patient of an unspecified age and ethnicity received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient felt fatigue and malaise for a week after the immunization with TRUMENBA. The outcome was unknown. Follow-up (15-MAY-2016): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 10-DEC-2018, when the patient was 14-year-old, was vaccinated with the first dose of with GARDASIL 9 injection (exact dose, strength, frequency and lot# with expiration date were not reported) for prophylaxis. On 17-SEP-2018, when the patient was 18-year-old, was vaccinated with the second dose of GARDASIL 9 injection, lot# N025428 with expiry date 19-JUN-2020 (exact dose, strength, frequency and lot# with expiration date were not reported) for prophylaxis. No adverse events were reported. The outcome of inappropriate schedule of product administration and no adverse event was unknown. This case was considered non-valid due to lack of the patient's identifiers.
Patient was at hospital 12/27/2020 after having a fever between 101-103, which started on 12/25/2020.  The doctor there felt she might have had an allergic to her COVID vaccine. She was then diagnosed with a UTI, and sent home on antibiotics. She had a rapid test at the hospital which was negative, and a PCR ,results also negative, they also did a chest x-ray. 12/28/2020 she went to a pulmonologist who diagnosed her with a severe reaction to the vaccine, and sent her home with stronger antibiotics. Her temperature  on 12/28/2020 remains at 101 and is not coming down even with Tylenol. MD told her she cannot return to work until she goes 24 hours without a fever and Tylenol.
8 days later on 1/21/21 rash started developing on left arm at injection site. Arm is sore, red, bumpy, indurated, and itchy. Rash is getting bigger the next morning.
Rash to anterior chest and posterior back and generalized itch that worsened over 10 minutes.  Was monitored post vaccine by blood pressure and pulse ox and medicated with Prednisone 20mg, Benadryl 25mg po  and Pepcid 20mg. Monitored for 3 hours with improvement in rash and symptoms of itch.  No SOB, NO wheezing or angioedema during course of event. Was released home without further adverse events
Patient experienced tingling in left fingers which began about 1 hour after receiving vaccine and sore arm at injection site.  No other symptoms.  Patient requested going to emergency room due to high anxiety and history of anxiety disorder
Fever of 103, extremely cold, headache and very tired. also some nausea. Rested in bed all day and took tylenol for the fever.
Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched; Swollen lymph node in left armpit with pain radiating down arm; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 08Jan2021 08:45 at single dose at left arm for COVID-19 immunization. Medical history included osteopenia, vitiligo, known allergies: Demerol and Vicodin. The patient's concomitant medication received in two weeks included Vitamins. The patient previously took the first dose of bnt162b2 intramuscularly on 18Dec2020 20:45 (lot number: EH9899) at single dose at right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine received in four weeks. The patient experienced swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched on 09Jan2021 07:00. No treatment received for the events. No COVID prior vaccination. COVID test post vaccination: Nasal Swab Negative on 05Jan2021. The outcome of the events was not recovered.
One day after her 2nd dose of vaccine, patient experienced tingling in both hands. She did not experience this side effect after dose #1.
chills After the first and second doses; feverish After the first and second doses; body ache After the first and second doses/muscle ache/pain for 2 days; sick for 2 days After the first and second doses; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 2 days After the first and second doses), CHILLS (chills After the first and second doses), PYREXIA (feverish After the first and second doses) and MYALGIA (body ache After the first and second doses/muscle ache/pain for 2 days) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 2 days After the first and second doses), CHILLS (chills After the first and second doses), PYREXIA (feverish After the first and second doses) and MYALGIA (body ache After the first and second doses/muscle ache/pain for 2 days). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ILLNESS (sick for 2 days After the first and second doses), CHILLS (chills After the first and second doses), PYREXIA (feverish After the first and second doses) and MYALGIA (body ache After the first and second doses/muscle ache/pain for 2 days) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.   This case was linked to MOD-2021-402913, MOD-2021-402894 (Patient Link).
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L001326, expiration date: 13-JAN-2017 and lot# L006384, expiration date: 25-FEB-2017), dose and route were not reported. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
On 6/28/22, I became symptomatic with flu like symptoms such as chills, fever, raspy throat. I tested positive for COVID-19 that day. I spoke with my doctor that evening who advised that I begin taking Paxlovid which I began taking that day. For the next 2-2.5 days I was still experiencing a sore throat and a fever with chills on and off, and some body aches, but nothing major. By the end of the third day, I was feeling significantly better. The following Sunday was my last dose of Paxlovid, which I took but I was still experiencing head cold symptoms with impacted sinuses but was feeling much better. However, I had a rebound around day 9 and was having chills and fever again and my head cold symptoms got worse, my throat soreness also went from mild to moderate. My doctor diagnosed me with a rebound case of COVID-19. On 07/08/2022, I was also diagnosed with a secondary sinus infection and was prescribed a round  of amoxicillin antibiotics. I continue to test positive for COVID-19. I have been testing myself since day 6 and have been positive for 8 days in a row. Today my symptoms are very minor with some congestion and scratchy throat but no other symptoms. Other than the 2 days of relief I experienced, I have been symptomatic for 12 out of the 14 days.
Hives rash around neck, between and under breast. Slight elevation of temp. Big red ring slightly off center from injection point. Scalp crawled, some slight chills, cough. My opinion I have never reacted to a flu vac, so I think I reacted to the pneumonia one. It stung while being injected.
could not put weight on non-surgical knee, could not get up from couch, unable to stand; hand and arm also hurt; had pain in the non-surgical knee, severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (could not put weight on non-surgical knee, could not get up from couch, unable to stand), PAIN IN EXTREMITY (hand and arm also hurt) and ARTHRALGIA (had pain in the non-surgical knee, severe joint pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement on 12-Feb-2021.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRALGIA (had pain in the non-surgical knee, severe joint pain). On 04-Mar-2021, the patient experienced DYSSTASIA (could not put weight on non-surgical knee, could not get up from couch, unable to stand) and PAIN IN EXTREMITY (hand and arm also hurt). On 06-Mar-2021, DYSSTASIA (could not put weight on non-surgical knee, could not get up from couch, unable to stand), PAIN IN EXTREMITY (hand and arm also hurt) and ARTHRALGIA (had pain in the non-surgical knee, severe joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 04-Mar-2021, the patient had severe joint pain. Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked.
Information has been received from a physician concerning a female (age unknown) with history of about one outbreak of "herpes simplex" a year, who on 06-FEB-2008 was vaccinated with a first 0.5 mL dose of Gardasil (Lot # unknown). After receiving the vaccination the patient now has outbreaks more frequently. Unspecified medical attention was sought. No product quality complaint was involved. Outcome unknown. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a physician concerning a 25 year old female with history of about one outbreak of "herpes simplex" a year, no illnesses at the time of vaccination, who on 06-FEB-2008 at 11:45 am was vaccinated intramuscularly in the left deltoid with a first 0.5 mL dose of GARDASIL (Lot # 655154/1210U). Concomitant therapy included BENADRYL, TYLENOL, REXAN and doxycycline. After receiving the vaccination the patient now has outbreaks of genital herpes more frequently. Unspecified medical attention was sought. No product quality complaint was involved. Subsequently, on an unknown date the patient recovered. Additional information is not expected.
16 days post vax maculopapular rash on face & neck, fever, nausea, diarrhea;rash sore to touch;vesicular rash on both legs-itchy;MD referred pt to infect control MD who felt it was varicella;
Pt received 1st HPV vaccination 11/14/18. Later the evening in the 14th began to noticing generalized itchy feeling, isolated hives on forearm. States forearm hives have resolved, but today 11/16/18, more hives have cropped up on her neck and she is still feeling itchy. Denies wheezing, shortness of breath. Has used hydrocortisone cream with good relief to relieve hives. Information relayed to clinician via telephone encounter. Continued monitoring and PO BENADRYL recommended for comfort. Pt instructed to RTC if symptoms worsen or do not resolve. Pt instructed to seek emergency care for any respiratory symptoms.
This spontaneous report was received from a health care professional concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. Since the beginning of November 2016 through 17-NOV-2016, the patients were vaccinated with improperly stored doses of VAQTA lot # L015460, Expiration date: 20-JUL-2017 and Lot# M036459, Expiration date:18-JAN-2018 for prophylaxis. The vaccine doses were exposed to a temperature of 48.1F for 20 minutes. The reporter stated that the vaccine doses had previous temperature excursions of 35.6F for 1 hour, 35.5 (units not provided) for 40 minutes and 35 (units not provided) for 30 minutes. The temperature excursion was detected by a data logger. There were no adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014191: US-009507513-1612USA014190: US-009507513-1612USA014189.
24 hours after injection had fever really high(temp not taken) lethargic, nauseous, for 24 hours.mom felt it was due to the mercury in the shots.
Stroke in 2022; Frozen shoulder; Shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 08:00 as dose 3 (booster), single (Lot number: Ewa53721) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0171821, Location of injection: Arm Left), administration date: 13May2021, when the patient was 45-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: 3302680, Location of injection: Arm Left), administration date: 13Apr2021, when the patient was 45-year-old, for COVID-19 Immunization. The following information was reported: PERIARTHRITIS (disability) with onset 01Dec2021, outcome "not recovered", described as "Frozen shoulder"; ARTHRALGIA (disability) with onset 01Dec2021, outcome "not recovered", described as "Shoulder pain"; CEREBROVASCULAR ACCIDENT (disability, medically significant) with onset 01Dec2021, outcome "not recovered", described as "Stroke in 2022". The events "stroke in 2022", "frozen shoulder" and "shoulder pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident, periarthritis, arthralgia.  Clinical course: Patient has no Known allergies.