chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 06Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension, controlled; hyperlipidemia, arthritis; "controlled hyperlipidemia" (unspecified if ongoing), notes: Other medical history: Hypertension, controlled; hyperlipidemia, arthritis; "arthritis" (unspecified if ongoing), notes: Other medical history: Hypertension, controlled; hyperlipidemia, arthritis. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (30May2022) Positive, notes: about 5 days after the end of the Paxlovid, the symptoms began again, and I tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment with Paxlovid started on 21May2022 and stopped on 25May2022. After completing the course of Paxlovid and having my symptoms resolve, about 5 days after the end of the Paxlovid, the symptoms began again, and I tested positive again. These symptoms consisted primarily of significant congestion, fatigue, and low-grade fever, and resolved in about a week. Adverse event started on 31May2022 and recovered on 05Jun2022. Treatment taken for adverse events ephedrine, Afrin nasal spray, rest. No known allergies. No other medication taken in 2weeks.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from an unspecified reporter and refers to a currently 1-year old patient of unknown gender and race. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, lot # S038702, expiration date 01-DEC-2021 for prophylaxis (frequency and route of administration not reported) (product storage error).  The improperly stored suspect vaccine experienced a temperature excursion of - 9.5 Celsius degrees (°C) for 8 hours and 53 minutes, and -10.1°C for 6 hours and 40 minutes. The call was made due to a digital data logger. No previous temperature excursion was reported.; Sender's Comments:  US-009507513-2009USA008377: US-009507513-2009USA008353: US-009507513-2009USA008397: US-009507513-2009USA008398: US-009507513-2009USA008449: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008533: US-009507513-2009USA008553: US-009507513-2009USA008555: US-009507513-2009USA008557: US-009507513-2009USA008746: US-009507513-2009USA008761: US-009507513-2009USA008780: US-009507513-2009USA008804: US-009507513-2009USA008870:
Death due to brain bleed, per wife's message left with agency. Obituary located at:
received dose 1 on 1/28. Tested for asymptomatic surveillance screening with his unit, found to be positive on 2/4/2021
Chills and headache for about 16 hours straight starting about 8 hours after shot.
Fever; Tachycardia; Feeling lousy; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 05Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, She received her first dose on 18Dec2020 and "did not experience anything with that dose".), administration date: 18Dec2020, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; TACHYCARDIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tachycardia"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Feeling lousy"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache". The events "fever", "tachycardia", "feeling lousy" and "headache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, tachycardia.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
No adverse event; an expired ZOSTAVAX was administered to a patient.; This spontaneous report was received from a pharmacist (conflicting information also reported as physician) referring to a patient of unknown age and gender. The patient concurrent conditions, pertinent medical history, concomitant therapies, drug allergies or reactions were not reported.  On 23-JUN-2021, the patient was vaccinated with an expired dose of zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route of administration and lot # were not reported), expiration date 22-APR-2022) for prophylaxis. It was reported that, prior to the administration the product had no prior temperature excursions, and the patient did not experience an additional adverse event (reported as no supported disclaimer was provided). At the time of the report, the outcome of the events was not reported. The action taken with zoster vaccine live (ZOSTAVAX) regarding the events were not reported. No product quality complaint involved.  The causal relationship between the events and the suspect vaccine was not reported.
Six hours after the vaccine I got chills, headache, stomach upset and swelling in my lower face and throat. I had body aches all over my body but no fever or pain at the injection site. Those symptoms lasted for ten days. I went to ER. I was given medication for the nausea and pain. The chills were a little better by then. The medication helped with everything but the headache. The headache is constant at the back right of my head. I then get other head pain at the same time in my temples on the left. It is a sharp shooting pain. I get flashes of light in my eyes and my eyes start twitching at the sides. I also get pain at the top of my head on the left hand side on occasionally which comes after the temple pain. I sometimes get head pain on the right side with deep concentration. I have recently started to get tremors in my right hand. Sometimes the headache wakes me up at night. I wake up every day with a headache and it has been thirteen weeks. I can not drive or concentrate. I have seen a neurologist but I am still having trouble scheduling scans. I have tried some prescription pain medication and it did not work. I have taken two courses of steroids.
Appr 3 hrs p/immun, parent woke pt & pt began to scream uncontrollably for appr 3 hrs;
1w 1 day severe local reaction; swelling day 2-4 severe fatigue and muscle pain ended up in ER
Resident was checked on at 1515 to give 1500 med, resident was noticed to be unresponsive at that time. TMA called this nurse into room, assessment started, eye not tracking, mumbled speech noted, right side mouth droop, not following commands. 911 called. VS taken and charted. Resident was to lunch at noon walked with walker to dining room, received ride in wc back to room which is her normal routine, last checked on at 1300, no concerns at that time.   Assessment / Plan Active Problems:   *CVA left-sided with right-sided paresis -Not a candidate for thrombolytic given significant comorbidities as well as age -Patient will be admitted We will repeat CT scan in the morning She will have a 2D echo She will be given aspirin 325 per rectum Patient is not able to swallow
Myalgias,nasal congestion, clear runny nose, nonproductive cough, sore throat
This spontaneous report as received from a licensed vocational nurse via a company representative refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2016 (reported as "starting on or after 29-APR-2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L033343, expiration date: 13-SEP-2017 (exact dose, dose number and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.26 degrees Celsius for 1 hour and 25 minutes and 21.04 degrees Celsius for 26 hours and 25 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
MMR 16JAN91 exanthem development 28JAN91. Seen 29JAN91 & lt parotid gland tenderness, sl. enlargement but those sx's are resolving.
Injection site reaction. red rash, itching, hot to touch. Lasted 4 hours. Returned next day. Resolving itself.
Information has been received concerning a pt who was vaccinated with MMRII. Concomitant therapy included streptococcus pneumonia vaccine (PREVNAR) administered IM. Subsequently, the pt experienced a febrile convulsion. The febrile convulsion was considered a "Significant Medical Event". Follow-up was received which indicated "event did not occur". This information was originally received from an RN. No further information is available.
Moderna COVID-19 Vaccine EUA 2/2/21  2:30am. - 7a.m.  severe shaking chills 2/2/21 7a.m. - 2/3/21  4:30pm  elevated temp 101.4 ( with peak 101.9)  with progressing body aches. Tylenol 1000mg helped w/aches for about 2 hours but not temp.  2/3 muscle/body aches compounded by joint swelling/ pain generalized but knees, feet, hands were the worst. 2/3/21  4:30pm 2/4 2:30 pm elevated temp ranging 100 - 100.7 muscles aches.  late in the day 2/4 was the first time I could climb stairs (joint pain) and Friday 2/5  was the 1st day I didn't have to use a tool to open my milk jug.  Then suddenly Fri evening everything seemed to suddenly resolve except muscle aches in gluteals and flanks bilaterally.
Aching joints of the wrists, knees and ankles. Fever, chills and dull headache. Fatigue. By the second day, symptoms had disappeared and I felt fine! Temperature was normal, just slight fatigue.
Large egg size hard lump at injection site. Red and sore, painful to touch. Noticed about 5 hrs. after injection.  Got larger around 3 am. 24hrs later still  hard and red. Painful to touch.  3 days later lump is smaller and not as hard. Still red and not as sore Muscle aches  and fatigue lasted about 36 hrs.
Bad ringing in her ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Bad ringing in her ears".  No follow-up attempts are possible. No further information is expected.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/27/2021. PATIENT FULLY VACCINATED ON 02/28/2021.
Lymphadenopathy in left axilla.  Treatment: Tylenol and cold compresses.
My left arm immediately became very very sore and inflamed. I was unable to lift my arm, sleep on it. I had to sleep on my back and not move my left arm. My arm was hot to the touch and red to the elbow. This condition remained for several weeks. The muscle is still sore to the touch. I had high fever and chills for four days following the shot. Then I had diarrhea for at least 3 days. Then the fever and chills came again perhaps they did not leave me. I also had bad headaches. I was sick in my bed for a week, I could not get up. My friends brought me food, soup mostly and toast. It took about 3 weeks before I felt well enough to leave my house. It has been a while so I might not have included everything that happened to me. I was very ill. I filed a complaint with Pharmacy against the Manager wig gave me the shot as she was very rude and in my opinion no medical trained to administer shots. She just stabbed my arm then told me not to cry. She has since called me and apologized. I will never go there again. I saw my doctor she hasn't decided if I should have the booster shot however we are waiting for 6 months. I will she her prior to that time.
Severe flu-like symptoms. Muscle pain, fatigue, lethargy, severe headache.
pericarditis diagnosed by EKG symptoms of chest pain and tightness constant for 48 hours, then improving but persist at night on day 5
This spontaneous report was received from a back office lead and refers to a patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-DEC-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: June 2017, dose reported as 1 mg, intramuscularly, in left deltoid (dose number was not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever with Tmax of 103 with onset within 24 hours;  this was 5th dose of Prevnar using new Prevnar 13;  3 months between 4th and 5th dose;  no previous adverse reaction to Prevnar
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 07Jan2023 to 12Jan2023).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax & 3min p/inj site devel hives, pain/burning p/5min;devel hives across chest down to abd;pt c/o feeling hot & dizzy;
injection site was very painful; whole body was aching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site was very painful) and MYALGIA (whole body was aching) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A, 027L20A and 034F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (injection site was very painful) and MYALGIA (whole body was aching). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection site was very painful) and MYALGIA (whole body was aching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported. The patient experiencing side effects same after doses 1 and 2, but not as painful.   This case was linked to MOD-2021-377195, MOD-2021-377282.
A rash and hives ever since getting the vaccine if the environmental temperature is above 75 degrees Fahrenheit inside or out of doors. Cannot go outside during summer months at all.
Flu like symptoms for 48 hours; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in high school was not a fun time).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said beware the 2nd shot, he/she had flu like symptoms for 48 hours. No contact details were available.
My lips got swollen after 24 hour of vaccine, took Benadryl but lips are still swollen after takin it.
Pt c/o redness, patchy looking skin, and swelling of arm where injection was placed. She also c/o extreme fatigue.
2nd vaccine caused red raised non itchy or painful rash in 2days vs #1  was 7 days raised red itchy painful disappeared in several days
This case was considered as serious, i.e. an important medical event. Unsolicited case received on 25-JAN-2014 from a consumer through internet. A female patient (age and age group unknown) with an unknown medical history and no reported concomitant medication had received a flu shot (manufacturer, batch number, route and administration site were not reported) on an unspecified date. On 22-JAN-2014, the patient had a positive flu culture and an ear infection. No information was reported on any corrective treatment given. At the time of the report, the patient recovered (recovery date not reported).
Pt wife came into pharmacy on 2-2-13 and said that after her husband received a flu shot he had a severe reaction. She said pt got shot on 1-10-13 & on 1-17-13 pt went to hospital where they discovered that he developed Guillain- Barre after performing a spinal tap. Pt has MS but has had flu shots before no reaction. Pt has been in hospital about 16 days. Pt wife says pt is paralyzed from waist down & will need rehab.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 23Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 2022, outcome "recovering", described as "Rebound case of Covid"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound case of Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: Patient had no known allergies. Patient received Paxlovid from 18Aug2022 to 22Aug2022 for COVID-19 treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was around someone who had later tested positive for COVID. Then I started to feel sick and caught COVID. I had myalgia, arthralgia, and fatigue. I am a doctor so I prescribed myself PAXLOVID. My symptoms lasted for about 3 days. On the third day I just had a slight cough and a slight sore throat.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 06-APR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a pharmacist, concerning a 4 month patient of unknown sex. On 26-SEP-2012, the patient was vaccinated with a dose of MMR II (dose, and route were not reported). No symptoms were reported. Additional information has been requested.
Patient sat in waiting area after immunization for 15 minutes to make sure no reaction. She came to the counter and said she did experience some blurry vision.
Client received the 2nd COVID vaccine (Moderna Lot #021C21A and expiration 05/26/2021) at 1544. At 1552 client started to touch her head and lean forward. EMT and PHN responded. Client stated that she was feeling "lightheaded and queasy." Client transferred to zero gravity chair by EMT and PHN. Client was pale and had goosebumps. PHN asked if she was feeling any other symptoms. The client stated that she was "freezing." Vital signs were taken at 1558 (blood pressure 112/60, Oxygen 96%, Heart rate 80). Client started to shake and cry and breath rapidly. PHN called EMS at 1558. Client stated that she had a similar reaction to the flu vaccine last year and it the symptoms lasted for "12ish hours." She stated that she laid in bed the whole time until they subsided. Client stated that she has a history of anxiety, no medical conditions, no allergies, and is not taking any medications. Client advised to follow up with primary care provider and allergist before receiving her second vaccine. EMS arrived at 1602. EMS took patient outside to the ambulance to assess her at 1604.
I experienced exhaustion, what usually takes an hour to do takes me four hours to do, the last 11 years of boating it takes me 15-30 minutes to do the anchor it takes me 4 hours to do. I have little to no energy
Headache started within a few hours of vaccine.  Started feeling achy, fatigued, feverish by mid-afternoon.  By evening, I had cold-chills, body aches.  Saturday morning (4/3), my fever was 101.5.  I took OTC cold/flu pills, which helped some with the body aches/chills/fever.  My fever ended up spiking at 101.9 Saturday afternoon, and the fever broke Saturday night.  Sunday I still had a slight headache, I took OTC Tylenol which eased the symptoms.  As of Sunday, this was my only remaining symptom.