chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever chills Narrative: Per supervisor report: "took 2nd COVID injection on 3/30/2021. Symptoms fever, chills."  Other Relevant History:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:19 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 27.42 for dose administered on 28-Feb-2021.  No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 degrees Fahrenheit at 09:00 AM and 26 degrees Fahrenheit at 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported. .
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). The patient was treated with CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) for UTI, at a dose of 1 dosage form. At the time of the report, URINARY TRACT INFECTION (UTI) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received on 14-JUL-2021 contains significant information. The event outcome was updated from unknown to recovered/resolved.
Client received the [2nd] COVID vaccine (Pfizer lot # EW0179 and expiration date  08/2021). Reconstitution time 10:34 am. Client reported to, EMT that client was feeling nauseated. EMT guided client to private observation room. EMT reported to to Lead RN. RN responded. Client sitting in semi-fowler's position complaining of nausea, headache, left arm numbness and pain at the injections site. Client rates headache 1/10 and left arm pain a 6/10 on a 1 to 10 severity pain scale. Client denies radiation of pain or numbness in left arm. Denies urticaria, hives, throat or facial swelling, chest pain, shortness of breath wheezing, weakness, palpitations or dizziness. Vital Signs at 12:18 HR 86, BP 110/72, SpO2 99% RA, RR 18. Upon examination, client appears in NAD and alert and oriented to person, date, place, and event. Left upper extremity with in normal limits. No bruising, swelling, bleeding, or redness notes. Client reports history of migraines and asthma as a child. Denies recent history of seasonal allergies, migraines and no longer uses an albuterol for treatment of asthma. Denies taking prescribed medications at this time. Education provided on side effects of vaccine and when to call a doctor for worsening or continuing arm pain. Pt reports symptoms of left arm numbness and nausea resolved at 12:32pm. Pt reports pain has improved to a 4/10. Vital signs at 12:40pm are HR 84, RR 14, SpO2 99% RA, BP 110/72. Client encouraged to follow up with PCP within the next week regarding symptoms experienced after vaccination.  Client verbalized understanding. ER precautions were given for throat or face swelling, difficulty breathing, palpitations, chest pain, dizziness, weakness or bad rash all over body. Client walked out of site with a steady gait. VAERS completed. VAERS confirmation number
Following injection pt had soreness, Pain, numbness and swelling at site of injection to extreme degree. Felt unable to move arm fully and at times would have to move arm to alleviate pain. Swelling and associated symptoms lasted 2 wks in spite of use of anti-inflammatories, heat, and ice.
Patient states that 2 days after the covid vaccine (administered in his left arm) he began experiencing right sided weakness and muscle spasms/contractions. States that due to history of cerebral palsy, he has baseline left sided weakness and contractions. The symptoms are slowly progressive as per patient. Denies any headache, vision changes, cough, SOB, chest pain, or sore throat.  Does complain of abdominal pain and loose stool daily since. Symptoms are not improving and are continuing to worsen slowly.  No improving or worsening factors. No similar symptoms in the past.  Does have a hx of Bipolar d/o on Lithium and has not had Li levels checked in over  6 months. Does forget lithium dose 1-2x/week
Pt awoke 3:00am, 1/19, with a dull headache, covering front & top of her head & "stuffy" feeling. By the end of day, she hurt all over. States she had a fever but did not take temp. Says she was in bed for 2 days.
Tire very easy fatigue. Feel cold or chilled. Get winded very easy. Heart rate seems increase without much exertion. Left leg has discomfort when walking. Not able to walk as fast or as long. "Feel" my heart in my chest. One time experienced a pain in the jaw line and discomfort of the heart area. Experienced a 30 minute coughing* episode while feeling my heart flutter. *Cough was associated with loss of breathe it seemed. Feel slight pains in the chest area.
Passed out 12 hours after receiving the vaccine.; This is a spontaneous report from a contactable consumer(patient). This 16-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0175) at single dose via an unknown route in left arm on 04Jun2021 08:30 at 16-year-old for Covid-19 immunization. Medical history included Paramyotonia-congenita. Prior to vaccination, was the patient diagnosed with COVID-19. Patient had no known allergies. Concomitant drug included fluticasone propionate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 08:00 PM, patient passed out "12 hours" (as reported) after receiving the vaccine. No treatment was received.  Outcome of the event was resolved. Since the vaccination, the had not patient been tested for COVID-19.   The report was assessed as non-serious.
The injections site was small and red with a golfball site bump on day 2, by day 4 the large bump was gone. The injection site started getting more red swollen and larger. It is currently the size of a softball.
hypotonic episodes w/cold sweat x 3; 7MAR92 lasting approx 1 hr then acting nl; 8MAR92 lasting few minutes, then acting nl; 10MAR92 lasting few minutes, then acting nl;
Tested positive for Covid 19; Tested positive for Covid 19; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Lot number: ER8729) at the age of 44 years as dose 2, single and administered in arm left, administration date 07Apr2021 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 02Dec2021, outcome "recovering" and all described as "Tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has been tested for COVID-19 since the vaccination.
This is a spontaneous report from a contactable physician that reported three cases of severe cellulitis for three patients. This is the third of three reports. A patient of an unspecified age, gender and ethnicity received the first dose of intramuscular PREVNAR 13 0.5 ml, single dose. The physician stated that injection was given at a pharmacy on 23Oct (year unspecified). Relevant medical history and concomitant medication were unknown. On an unknown date, the patient experienced severe cellulitis. Clinical outcome of the event was unknown at time of this report.
Patient had bleeding and immediate knot and soreness at injection site. Bleeding stopped within seconds and bandaid applied. Observed for 30 minutes.
I started getting bad headache, it got worse and when I got back to office I could barely see. General fatigued, I got nauseous. This lasted 21 days until second dose, my headaches cleared.
Significant ringing in ears got worse with second vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 29Mar2021 at 11.00, (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left  on 08Mar2021 at 11:00, (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient medical history included mild hypertension. The concomitant medications include Chlorthalidone (MANUFACTURER UNKNOWN) for an unknown indication from an unknown start date and unknown if ongoing. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date (after receiving first dose of COVID-19 vaccination), patient experienced significant tinnitus (ringing in ears) and the clinical outcome of the event significant tinnitus was unknown. On 29Mar2021, (after receiving second dose of COVID-19 vaccination) the patient experienced significant tinnitus (ringing in ears) which had become worse after second dose. No therapeutic measures were taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event aggravated tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FH8021) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Topical class B steriods" (unspecified if ongoing), notes: Known allergies: topical class B steriods. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Not sleeping; heart rate up; difficulty in breathing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 82-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Batch/Lot Number: El9269) as dose 2, single for covid-19 immunization (at the age of 82-years-old). Medical history included chronic CLL slight (lymphocytic leukaemia), A fib long time no effects (atrial fibrillation) and some COPD (chronic obstructive pulmonary disease) no effect till now all were from an unknown date and unknown if ongoing. The concomitant medications included blood pressure and blood thinner all new (other medications in two weeks). The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 20Jan2021 at 01:30 Pm (Batch/Lot Number: El3249) as single dose for covid-19 immunization (at the age of 82-years-old). Patient had not received any other vaccine in four weeks. Patient had no covid prior vaccination. Patient had not been tested for covid post vaccination. Patient had no known allergies. It was reported that after receiving the second dose of vaccine on 15Feb2021 at 12:00 am the patient was not sleeping, heart rate up difficulty in breathing about half his normal breaths have been to doctors they seem to think it is to do with heart. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received Moderna vaccine instead of Pfizer vaccine for dose #2 in vaccine series of COVID-19 vaccine series.
patient collapsed and taken to emergency department; low blood pressure; becoming depressed; difficulty sleeping due to rash; felt itchy on the inside of the body; rash that covered his arms, upper torso, shoulders and went down the back/rash developing on face and neck; nausea; dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (patient collapsed and taken to emergency department) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided.).    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nausea). On 31-Mar-2021, the patient experienced DEPRESSION (becoming depressed), INSOMNIA (difficulty sleeping due to rash), PRURITUS (felt itchy on the inside of the body) and RASH (rash that covered his arms, upper torso, shoulders and went down the back/rash developing on face and neck). On 01-Apr-2021, the patient experienced SYNCOPE (patient collapsed and taken to emergency department) (seriousness criterion medically significant) and HYPOTENSION (low blood pressure). At the time of the report, SYNCOPE (patient collapsed and taken to emergency department), HYPOTENSION (low blood pressure), DEPRESSION (becoming depressed), DIZZINESS (dizziness), INSOMNIA (difficulty sleeping due to rash), PRURITUS (felt itchy on the inside of the body), RASH (rash that covered his arms, upper torso, shoulders and went down the back/rash developing on face and neck) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   A pharmacist suggested the patient take Children's Benadryl followed by Zyrtec to help with the itching. These medicines have not helped alleviate his intense itching. On 1Apr2021, the patient collapsed and was taken to the emergency department. The patient was treated at the emergency department after he collapsed from low blood pressure. He was prescribed Hydroxyzine HCI 10mg for the itching by the emergency room physician, but the medicine has done nothing to alleviate the patient's symptoms.  Based on the current available information which includes a temporal association between the use of the product and onset of the reported events of vaccination site reaction, a causal relationship cannot be excluded. Ras and nausea are consistent with the known safety profile of the vaccine.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events of vaccination site reaction, a causal relationship cannot be excluded. Ras and nausea are consistent with the known safety profile of the vaccine.
Broke out in a rash; This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. A contactable consumer reported for a female patient that:  Description: The Office Manager reported that "a female patient received a PREVNAR 13 shot in her left arm and broke out in a rash the same day". Manufacturer information for PREVNAR 13 is Pfizer. No PQC involved. No further AE information provided.  Product: Product: Prevnar Product Circular#: Not Applicable Lot Number: X13882 Expiration Date: 30Sep2020 Dose/Frequency: Refused to Answer Manufacturer (if available): Pfizer  The information listed above is all data we have received. Please do not contact Merck & Co., Inc. for additional information. Any follow-up information received by Merck & Co., Inc. regarding this case will be forwarded to you upon receipt.  Please note that this information has not been reported to the FDA.  No follow-up attempts are possible. No further information is expected.
No adverse effects noted. Pt called and informed of event, possible side effects and to call immediately if he has any side effects.
Shortness of breath, cough, headache, diabetes out of control  - began on 12/31 and lasted until now 1/5/10 - Several visits to ER and admission to hospital.
Arm is red & warm to the touch. When I first noticed it there were 2 red swollen lumps that have now merged into 1 big red rash. Lumps are larger in size & slightly painful. It's still warm
large ecchymosis @ inj site (35mm) w/dependent erythema distal to site;hot & inflamed to touch outer aspect of upper arm above elbow;
Nausea lasting up to 8 plus hours per day. Persistent for 3 days starting 4 days after injection.
A big red, painful blotch patch on the back of right calf with blue/purplish/yellow ring around it the size of a baseball and warm to the touch.
Left shoulder very swollen, sore, red and hot to touch. The swelling went down but Area is still bright red and now has raised patches and hurts. I also have red spots and splotches in my face and scalp that are painful. It actually feels like the vaccine gave me shingles.
pt exp rasied rash on chest, neck & waistline area for 3-4 wks; no itch assoc w/rash;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-JAN-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, lot, and route # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 10-NOV-2015 (note that this is before the reported vaccination date), the patient was treated by a physician for a vesicular rash which was diagnosed as trigeminal neuralgia and peripheral neuropathic pain. He was prescribed fentanyl for management of his painful symptoms. On or about 09-FEB-2016, the patient sought subsequent treatment from the same physician for a painful rash which was diagnosed as trigeminal neuralgia and peripheral neuropathic pain. He was prescribed fentanyl for management of his painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. The date of vaccination was noted to be after the initial onset of events. Upon receipt of follow-up, this date will be updated/clarified. Additional information has been requested.
Extremely tired for 3 days and loss of appetite. Started eating better 7 - 10 days later.
Case number PHEH2012US012969 is an initial spontaneous report received from a nurse on 22 Jun 2012 and a follow up received from the nurse on 16 Jul 2012. This report refers to a 16-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11075) intramuscularly into her left deltoid muscle on 20 Jun 2012. On 21 Jun 2012 she experienced tingling in extremities, headache, fever, mild photophobia and fatigue. On 24 Jun 2012, she had recovered completely from these events. The causality was not reported. Follow up information received from the nurse on 16 Jul 2012: Updated site of vaccination, additional events (fever and photophobia), start date and end date of events, outcome.
I got the vaccine on Saturday. Starting on Sunday I had mild flu like symptoms. I was tired and achy. Following that it felt like the flu like symptoms were getting better but it started to feel more like bronchitis symptoms. I had a cough. My doctor prescribed an inhaler for me. I just had a physical a couple of weeks before that and I was healthy. I still have some flu like symptoms and I still have the cough.