chrisvoncsefalvay/vaers-outcomes huggingface dataset:
generally not feeling well; Headache; tiredness; nausea; constipation; chills; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Aug2021 19:30 (Batch/Lot number was not reported) (at the age of 52 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The 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 experienced generally not feeling well, headache, tiredness, nausea, constipation, and chills on 09Aug2021 at 09:00. The adverse reactions resulted in doctor or other healthcare professional office/clinic visit. The patient received Cortisone shot and Z-pack for the adverse events. The patient underwent Covid-19 test Nasal Swab on 10Aug2021: negative. Outcome of the events was not recovered.    The lot number for BNT162b2 was not provided and will be requested during follow-up.
This is a spontaneous report from a contactable consumer (the patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, in left arm on 10Feb2021 as a single dose for COVID-19 immunisation. Medical history included intracranial pressure increased. Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT62B2 for COVID-19 immunization on 20Jan2021 and Valtrex for cold sores (which the patient had that through childhood but the patient had not had it for like 10 years. Doctor set patient on Valtrex and then when patient stopped Valtrex it started up again). On an unspecified date, the patient experienced flair out or outbreak of cold sores. It was reported that the patient had seen some article saying that It could be like that a Pfizer vaccine could be a trigger for someone that had that in the past, and wanted to get some information on it. The patient underwent lab tests and procedures which included full blood count: unknown result on an unspecified date. Therapeutic measures were taken as a result of flair out or outbreak of cold sores (oral herpes) with Valtrex. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient experienced redness and inflammation at injection site. Patient also reported limited mobility, and overall feeling of fatigue, dizziness, as well as difficulty maintaining focus the day after having received the vaccine. Patient was seen by physician and instructed to inform us as the immunizing facility to report adverse reaction appropriately. Patient still instructed by MD to receive second dose.
4-5 days p/inject swelling bright red well circumscribed, hot & more painful than itchy;
As soon as I got the shots and was going to put my arm back in sleeve I felt a sharp pain shoot down my arm. Arm was ok but later that evening about 9:00 pm my arm was very painful. By the morning I couldn't move my arm at all. I was in SEVERE pain for 2weeks. I can move it now. The pain is still going on. But tolerable.
I was very cold but no fever,   my hands and arms started shaking..  my body would tense up during these shakes then stop for about a minute and begin again... this lasted about 45minutes to an hour,  even after I went to bed and was under several blankets. My arm at injection site is very sore.
Strong pain in the left arm decreasing the movement of the arm.   Treatment of ice and Tylenol
feeling tired; fever; pain left arm; weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced fever, pain in arm and weakness. On an unknown date, the patient experienced tiredness. On an unknown date, the outcome of the fever, pain in arm, weakness and tiredness were recovering/resolving.   It was unknown if the reporter considered the fever, pain in arm, weakness and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient himself. The age at vaccination was not reported. The patient received dose of Shingrix in the left arm. The patient reported that, currently had fever, pain in the left arm, weakness and also felt tired. The patient did not provide any additional information and disconnected the call before date of birth and address could be obtained. The patient did not consent to follow up. There was discrepancy in the event outcome reported in source document (recovering and resolving) and in system (not recovered and not resolved).
UTI; passing a lot of blood; This is a spontaneous case received from a contactable consumer. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ1688), dose 2 via an unspecified route of administration on 17Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Feb2021 at Single dose for COVID-19 immunization. The patient received both doses of the Pfizer-BioNTech COVID-19 Vaccine (first dose last 24Feb2021 and second dose on 17Mar2021). On the 18Mar2021, patient had UTI (Urinary Tract Infection) and was admitted in the emergency Room on the 19Mar2021. She was passing a lot of blood and was put on heavy duty antibiotic (cefuroxamine Possibly cefuroxime). The patient experienced uti on 18Mar2021 and passing a lot of blood on Mar2021. The event was assessed as medically significant. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Skin was rashy, blotchy and itchy about 12 hours after the vaccine. This has persisted for 12 hours
On 09/21/2005 patient phoned office, advised that her arm was sore and swollen and had a knot and was puffed up, no redness, not warm to touch, states felt like I had the flu for a few days.  Still feels tired, had no fever but was chilled and had sweats.
This spontaneous report as received from a nurse practitioner refers to a 3 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had a temperature excursion. No information on patient's concomitant medication was provided. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
felt hot for a day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt hot for a day) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (felt hot for a day). At the time of the report, FEELING HOT (felt hot for a day) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-054593 (Patient Link).   Reporter did not allow further contact
I'm dizzy a lot. It comes and goes through out the day. Sometimes I'm dizzy all day long. Sometimes I'm not dizzy at all. But it's more often than not. This started a few days after the vaccine and I'm still experiencing it.  It's kind of a floaty, unstable feeling. I didn't put two and two together at first. I've been to my doctor two times.
Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX vaccine (Merck). Subsequently the patient experienced shingles. At the time of the report, no outcome was reported. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Follow up information was received from the physician who reported that the 62 year old female patient on 15-JUN-2007 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). On 16-APR-2008 the patient developed a shingles on "one side of the trunk". On 30-SEP-2008 the patient developed her second case of shingles on "the other side of the trunk". The patient contacted the physician for medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/24/2008; 12/23/2008. Follow-up information received from a physician via a HZ questionnaire concerning a 62-year-old female patient with an allergy to lisinopril and a past medical history of chickenpox at age 3. On 15-JUN-2007 she was vaccinated in the left arm with a dose of ZOSTAVAX vaccine (Merck) (lot# 6576/0618U). Concomitant medication included amlodipine. On 16-APR-2008 the patient developed herpes zoster in the right thoracic dermatome, the patient reported pain of an 8-9. The lesions were reportedly papular and vesicular. It was reported that there was no recent exposure to chickenpox or herpes zoster. Unspecified medical attention was sought, no specimen was submitted. The patient recovered. Then on 30-SEPT-2008, the patient developed lesions in the left lumbosacral dermatome. She reported pain of a 5 out of 10 for this episode. The patient sough medical attention. It was reported that the patient recovered. Additional information is not expected.
8/15/2021 25 mins post vaccine - hard time swallowing and throat felt swollen, as if closing. Took 75 mg of diphenhydramine and water. About 1 hour later able to swallow without difficulty.  8/22/2021 mid-day felt excessive drowsiness followed by intense pain at injection site. Took a 1 hour nap and when I woke up my arm was swollen, sore, red, hot to the touch, and a few minutes became a bit itchy at the site of injection. Took diphenhydramine and used cold-pack to reduce swelling. Also moved arm, some stretches, and massaged the site to reduce soreness and increase circulation.  8/23/21 Site is still warm to the touch, sore, and red around the site of injection. It has reduced since 8/22/2021 but still present.
INITIALLY HAD RASHES AND BUMPS ON BOTH HT AARMS AND LES. ON 5/29. 2021 SUFFERED HEART ATTACK. ANGIO SHOWED CLOTS IN CORONARY ARTERIES
This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a patient who received BEXSERO (batch number 16D501, expiry date unknown) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced adverse reaction, injection site pain, injection site erythema, fever and injection site swelling. On an unknown date, the outcome of the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling were unknown. It was unknown if the reporter considered the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced injection site pain, redness, swelling, and fever were beyond typical reactions the reporter had seen in the past and with other products. The reporter stated that, they noticed that it stems from Lot 16D501 from the Vaccines program. At the time of this report the reporter was choosing to not use BEXSERO until they receive further information from Vaccines program and manufacturer medical team. The reporter agreed to be followed up. This is 1 of the 8 cases (8 out of 20 patients reported adverse reactions) reported by same reporter for same event.
Sudden onset vertigo, nausea, vomiting followed by facial swelling and red blotches went to ER given o2 and Phenergan.
Information has been received from a woman in a medical office concerning a 8 year old white male patient with no allergies, no past medical history and no adverse events following prior vaccinations who on 06AUG1999 was vaccinated in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently, the patient was exposed to chickenpox. In November, the patient "broke out with disease". Medical attention was not sought and laboratory tests were not performed. Subsequently, the patient recovered. The reporter also mentioned three other patients who had similar experiences following vaccination with varicella virus vaccine live. Additional information is not expected.
Pt stated his left arm felt "tight" about 21:00 on 1/11/01. No complaint of pain or fever but did have some difficulty raising left arm to face. Left elbow area was red, ward to touch and swollen approx. 3/4 larger than the right elbow. Checked by doctor, who recommended Benadryl. Also advised to take Tylenol if needed. Keep left arm elevated when in bed and use warm compresses.
Became sleepy, hyporesponsive, hypotonic (wouldn't lift head up) before leaving office after vaccine on 9/23/05. Decreased feeding, poor lifting head x 2 days or so. Quite better by 3-4th day, still less active on Day 5 but tone excellent.
Ringing of both ears (tinnitus) started about 2 hours after the shot and hasn't stopped as of the date/time of this report (5/17/21 5:30pm)
The patient reported that she has missed her 3rd dose of GARDASIL 9 in which she received her last dose in March 2018; No adverse reactions; This spontaneous report was received from a female patient of unknown age referring to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in March 2018, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly, (dose, site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had missed her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse reactions were reported.
seems like patient is having the flu; swelling in the hole upper arm; fever of 99.9; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (seems like patient is having the flu), PERIPHERAL SWELLING (swelling in the hole upper arm) and PYREXIA (fever of 99.9) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (patient has a heart disease and went under many surgical procedures.). Concurrent medical conditions included Heart disease, unspecified.    On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (seems like patient is having the flu). 27-Aug-2021, the patient experienced PERIPHERAL SWELLING (swelling in the hole upper arm) and PYREXIA (fever of 99.9). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (seems like patient is having the flu), PERIPHERAL SWELLING (swelling in the hole upper arm) and PYREXIA (fever of 99.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Body temperature: 99.9 (High) High fever of 99.9.         concomitant medications include medication for heart disease.  Treatment information not provided.
Pt recv vax on unknown day;  post vax pt exp swollen/ red vax site
Patients states that vaccination was given very high on the arm. Patient reports pain started very early the next morning, with difficulty lifting arm. This morning patient visited Urgent Care office because pain has not subsided. Patient states that the practitioner said the vaccination aggravated the tendon.
woke up  15 hours after vaccine with throat swelling, drank warm water and symptoms relieved I 6-7 hour with out any medications He has a history of anaphylactic reactions to peanuts and kiwi so she does have an Epi Pen handy
I had the normal headache, fatigue, and joint pain in my knees with the first and second dosage of Pfizer.  But something different occurred after the second dosage.  I experience knee pain daily from surgery a few years ago.  My right knee is always a bit swollen and painful.  After the second dose of Pfizer, I experienced shooting pains in my knees, especially the right knee.  This pain was unlike anything I had ever experienced before.  It was almost like a hot poker was intermittandly being held to my knee, and a sensation radiated down my leg.  It sensationn occurred the evening after the shot was administered, and lasted only that evening.  After this experience, I can report that the swelling and pain in my knee has drastically reduced.  I feel that the inflammation in my right knee has noticeably decreased, and the swelling has almost completely subsided.
first dose 3-5 years ago, not received second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 to 5 years prior to the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix, 3 to 5 years ago from the date of reporting, according to the patients claim. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.  No further events were reported. The reporter consented to follow up.
I had vaccination on 02/14/2022. About 24-48 hours later I did not feel good. I had really bad coughing, congestion in chest, and a headache. It was upper respiratory infection and I was provided 2 different antibiotics with cough syrup due to being immunocompromised. I had this upper respiratory infection for about 6 weeks. I do still presently still get week on 02/15/2023. I do not know if residual, back injury or immune system.
PRURITUS AROUND EYE, MILD SWELLING AROUND EYES Narrative:  Patient is a 70 yo MALE with PMHx significant for PTSD, mood d/o, HTN, and HepC. Pt received Pfizer COVID-19 vaccine dose #1 on 1/30/2021 and dose #2 on 2/20/2021. On 2/20/21, during the observation period for dose #2, pt reported pruritus and swelling around eyes 5 days after first vaccination on 1/30/21; stated it is the same before and after the second dose and has been treating with Benadryl 5x/day, which alleviates itching but not swelling. Due to elevated BP, eye swelling, and agitation, clinic provider recommended patient go to the emergency department for observation, but pt refused as he wanted treatment. Pt later revealed recent "deep facial with laser" treatment by private MD around the same time as COVID-19 vaccine dose #1. A couple days prior to COVID-19 vaccine dose #2, pt reports that private MD instructed him to stop facial cream . Per clinic provider assessment, believes reaction of pruritus and mild swelling around eyes is unlikely to be an allergic reaction to the vaccine since there were other potential causes (preceding facial laser treatment near the eyes, and a new face cream used near the eyes); elevated BP likely d/t pt being upset about lack of tx of symptoms. Patient sent home with prednisone rapid taper (6-day course) after risk/benefit discussion with plan to f/u with laser tx MD & same-day clinic on 2/22/21. During 2/22/21 visit, pt reported " about 25%" improvement in symptoms s/p 2 days prednisone use.
TIA approximately 2 days later. PT had unilateral facial paralysis, dysarthria, and arm/leg paralysis. Non-ambulatory, unable to use right arm or right legs. Could not lift. Admitted to hospital. CT scan negative for acute stroke. Pt had complete resolution of all symptoms with 6 hours of admission. Felt to represent TIA.
16 hours after the vaccination I experienced flu-like symptoms. Body aches. Headaches. Tiredness. Joint pain. 2 days after the vaccine, I felt better but tired. However my teeth have been very sensitive. Cold causes pain. I have to take anti-inflammatory medication for it to be tolerable.
This spontaneous report was received from a Licensed Vocational Nurse concerning multiple unspecified patients of unknown age or gender. The patients' concurrent conditions, medical history or allergy/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses (24 hours) of ROTATEQ (Lot # L013203, exp. 28-JAN-2017) (dose and frequency were not provided). There was no concomitant medications reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Headache; This is a spontaneous report from a contactable consumer. This consumer reported that a female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Age at the time of vaccination was not provided) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated he had a female friend, who had the Pfizer Covid 19 vaccine, and had a headache on an unspecified date, after the vaccine, and recovered. The reporter declines to complete a safety report for his female friend. The outcome of the event was reported as recovered on an unspecified date. Reason for no lot number: of Pfizer Covid 19 vaccine: Caller unwilling to complete the report.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100930708 same reporter/product/event, different patient
PATIENT CALLED 10/13/2020 0815 (APPROX 72 HORS POST IMMUNIZATION) MAIN COMPLAINT PAIN AT INJECTION SITE AND ARMPIT. PAIN SCALE 5-6 OUT OF 10
Morning of 03/05/2021, pt reported body aches, temperature taken on 03/05/2021 @ 12:30 and read 100.7F.Pt was instructed to take Tylenol every 4-6 hours, rest, and stay hydrated. Pt was advised if fever did not go away by tomorrow morning, to seek medical care.  1st Dose-  01/28/2021 @ 13:00 2nd Dose- 03/04/2021 @ 13:30 Moderna 1st Dose- 007MZ0A                2nd Dose- 014MZ0A