chrisvoncsefalvay/vaers-outcomes huggingface dataset:
report side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (report 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) at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (report side effect). At the time of the report, ADVERSE REACTION (report side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided.
Beginning approximately Day16 after vaccine dose, noted "woozy"/sort of lightheaded & "off"/off balance sensation I have never experienced before...solid frontal headache for first few days but that is now gone, but "off" sensation persistently continues (now @ Day32). Went to the pharmacy 4/26 for Covid test, to rule out mild covid case (awaiting results).
patient's blood pressure went up to 186/patient's blood pressure wasn't going down; Nausea; Dizzy; patient's head hurts/huge headache; had pain in left eye/Patient's eyes were sore; in every part of patient's body, patient's skin and joints were in "very so much pain"; in every part of patient's body, patient's skin and joints were in "very so much pain"; in every part of patient's body, patient's skin and joints were in "very so much pain"; patient couldn't get warm/patient got very cold again; patient started to have twitching and then patient's body started to move involuntarily; patient started to have twitching and then patient's body started to move involuntarily; just absolutely exhausted; patient's cough went up again; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 on 08Feb2021 for COVID-19 immunisation. The patient had the COVID vaccine, patient's second vaccine this morning (01Mar2021), patient had the first one three weeks ago. After half an hour, patient's blood pressure went up to 186 and the patient still cannot understand if that happen after the vaccine and the patient ended up in the ER and stayed with the nurse at the COVID location but the patient's blood pressure wasn't going down and patient's pulse was 100. The patient ended up at the ER and had pain in left eye, nausea, patient was 'striving' (not clarified), patient couldn't get warm. Patient was dizzy. The patient started to have twitching and then patient's body started to move involuntarily and then they released the patient at 2 (unspecified). The patient got home and just absolutely exhausted, which the patient thought was from the symptoms patient had, so the patient got very cold again, the patient's cough went up again and huge headache, in every part of patient's body, patient's skin and joints were in "very so much pain". Patient's eyes were sore and patient's head hurts. Patient took Neorelax (treatment). Patient had 4 times problems with the colonoscopy. On unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: 186 (half an hour patient's blood pressure went up to 186), colonoscopy: unknown result, heart rate: 100. Therapeutic measures were taken as a result of patient's head hurts/huge headache (headache) which included Neorelax. The event patient's blood pressure went up to 186/patient's blood pressure wasn't going down resulted in emergency room visit. Outcome of the events was unknown.  Information on the batch/lot number has been requested.
Patient went to receive her 2nd COVID-19 vaccine on 1/28/2021 and during administration only a partial dose was given. It was advised by physician that client receive another full dose, which she did on 2/3/2021.
Rash/redness without hives on arms and legs bilaterally, nose developed 2-3 hours after receiving flu shot. Recommended to take Benadryl. Patient stated rash on nose went away prior to taking Benadryl. Gave vaccination according to standard operating procedures. Will follow up with patient later today and tomorrow. Advised patient to call 911 for an anaphylaxis/anaphylactic shock if it occurs. Patient is not experiencing any itching.
pt recv vax 27OCT97 & w/in a few hr T103.3, chills, shaking, inc temp cont for 2 days on 29OCT:T106.3 color pale blowing resp exp green sputum transferred to hosp;
This spontaneous report was received from a registered nurse, who refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-JUN-2018, the patient was inadvertently vaccinated with one expired dose of RECOMBIVAX HB lot # M010671 and expiration date on 02-JUN-2018, for prophylaxis (route of administration and dose were not reported). The reporter stated that no adverse effects reported.
Warm red swelling at injection site about 2" in diameter. Self described as itchy.
Rash - All over body - worse in the morning hours Swelling of the hands and feet Joint pain High BP and Shakes Started on week after shot- rash just on the hands and arms, then spread to date all over body
Around 11/03/2021 - I started feeling terrible, could not stop coughing, sore throat head congestion, and earache.  After I had these symptoms for over a week, I went to an urgent care. the strep test, c-19 test, listened to my lungs. And put me on erythromycin, z-pack for 5 days. My symptoms did not resolve at all. I went back to the urgent care because I could not hear, especially left ear. They said I had ear wax and they cleaned it out. It did not help. I went to a different urgent care a week later. They said I have an ear infection and they gave me ear drops, ciprofloxacin. My ear is still completely blocked. So then week later I went to my primary care. My PCP told me I still have an ear infection and put me doxycycline 100 mg for 8 days. My PCP also put me on high blood pressure medication, Amlodipine 10 mg once a day. I have never been on high blood pressure in my life. My ear infection did not resolve. Then my PCP sent me to an ENT doctor on 12/08/2021. She looked at my left ear and said I have a middle ear infection and she put me on fluticasone spray, to take twice a day every day and they gave me an audiology test. and she said my left ear wasn't hearing much of anything. My ear problem and a little congestion still remains. Like a little mucous in my nose. Nothing to complain about. If my ear problem does not resolve in 2 months, I have an appointment to go back again. If it is not better in 2 months, they are going to do another procedure, they did not say what it was.
Patient got sick over the weekend. Went to facility on 03/02/2021 and then passed on 03/18/2021
Tired and Chills for about 12 hours  Bruising, redness and swelling lump 3?x4? under skin Lump the size of ?half boiled egg? under skin on left arm Holding heat   **I would like to note I have NEVER had a reaction to any immunization prior and have received flu vac every year, Series of Hep B vac, pneumonia and shingles
Raised rash on tops of hands, forearms, tops of feet, around ankles Non itchy Began 1 week after vaccination as small red rash, grew to raised rash with small fluid filled bumps, beginning to vanish 2 weeks after vaccination
Administered 0.5mL instead of 0.25mL for booster dose.
Apparent breakthrough varicella rash about ten months after vaccination. About 10 lesions total.
lymphadenopathy in left lower neck area above clavicle/swelling of lymph nodes; sick; sore throat; This is spontaneous report from a contactable other-healthcare professional (patient). A 45-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: lot number Eh9899), via an unspecified route of administration on 16Dec2020 19:00 at single dose at left arm for immunization. Medical history included known allergies/shellfish. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 21Dec2020 07:00 AM, the patient experienced lymphadenopathy in left lower neck area above clavicle. Patient had never had this before but had felt sick since patient took the vaccine mainly the first day but sore throat not sure if related, then the swelling of lymph nodes. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered non-serious.
Pt recvd 1 dose of Engerix-B 13NOV91 & 1 to 2 hrs p/vax exp vertigo & h/a; pt went to ER where events were treated w/1 dose of antivert; sx resolved;
This spontaneous report as received from a physician refers to a 6 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. Approximately on an unknown date in December 2014 (reported as vaccination at 2.5 months of age), the patient was vaccinated with first dose of ROTATEQ (lot number, dose and frequency unspecified), orally. Concomitant medications were not reported. On 05-MAR-2015, the patient will receive second dose of ROTATEQ (lot number, dose and frequency unspecified), which was longer that the recommended interval (inappropriate schedule of drug administration). No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ROTATEQ was not reported. Product quality issue was not involved. Additional information has been requested.
Immediately the next day for a couple of days I had pain everywhere. I was weak. I couldn't get out of bed. I had pain everywhere for about 3 days then that went away. May 1st 2021 I got really bad chest pain. I ended up going to the hospital and was admitted at University Hospital. I had high troponin 1 levels.  I was hospitalized again for high troponin levels. The doctors think this happened because they think I have a coxsackievirus. Next week I will be getting another cardiac MRI.
Flat red rash developed around vaccination site 8 days after inoculation.  Not itchy or painful at this point, feels warm. After inoculation only minor arm soreness for 2 days.  Putting  Aquaphor Healing Ointment on. Already take nightly small dosage of Atarax generic.
Patient received immunization on 07/25/2005 and 5 minutes later developed rash on lower legs and described by Mother as red and elevated.  Went to ER but rash went away.  Cam to office on 07/28/2005, but no rashes anymore, no difficulty breathing, no other symptoms
Patient stopped talking, had slight twitching. Slouched over, & was unresponsive for 45-60 seconds. I prevented her from falling, she came to slowly & we talked to her to make sure she knew who she is & where she was. She then knelt down & rested her head on the chair. Her state improved gradually. Then EMS took over.
On June 16 when I got the shot, about an hour later I started getting a headache that started in the back of my head. When I woke up on June 17 at 7:45AM I had a slamming headache that again started from the back of my head and radiated both upward and downward into my neck and shoulders. The headache was there all day and all of the following day, June 18. Then on June 19 I woke up at 7:45AM with the headache significantly decreased. In place of the headache I had numbness on the left side of my face. I was unable to move the left side of my face at all. The left side of my tongue was numb. The numbness and tingling goes to my left ear and the left side of my neck. On June 20 I had all the same symptoms with the left side of my face. I called my PCP who told me it sounded like Bell's Palsy and that I needed to go to the hospital. At the hospital they ruled out any neurological issues. I was diagnosed with Bell's Palsy (which I have NEVER had before). They ordered Prednisone which I will start taking tomorrow since my pharmacy was already closed. They also took bloodwork testing for lyme disease which there are no results for yet.  As for pregnancy, there is no history to share beside me being 23 weeks pregnant and I am due October 15.
Patient received ZOSTAVAX 9/27/14, had symptoms of pain and redness 9/29/14 at injection site. Was told by urgent care that it was infected and given antibiotics for 1 wk course.
Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; Soreness in her left arm; Chills; Not feeling too well/flu-like feeling; Not feeling too well/flu-like feeling; Slight headache / headache; This is a spontaneous report from a contactable consumer (patient).  This 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unknown route, on 10Jan2021 at 15:00 at single dose in the left arm for COVID-19 immunisation. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ0140) administered in the upper left arm on 20Dec2020 (at 14:45-15:00) and developed a little headache, soreness and was tired (reported under AER 2021026236). Relevant medical history included thyroid, cholesterol and blood pressure (as reported). The patient was taking concomitant medications for underlying medical history. No other vaccine was received in four weeks. In the evening yesterday she was not feeling too well. She had a slight headache; body aches and she could get rid of the headache. She clarified that last night she felt chilly, she had the chills. By 10am this morning she did not feel well, she had a pretty bad headache and felt like she had a temperature. Her temperature earlier today was 99.4 degrees F and now her temperature was 101.2 degrees F. Her whole body feels like she was having aches, stated it is like a flu-like feeling, she had heaviness in her chest, her pulse will not go out of the 90s. She took her oxygen level and it was between 97-99%. She had also soreness in her left arm. She asked if these are common side effects, or something to be concerned about. Therapeutic measures taken as result of the events included ibuprofen (ADVIL). The outcome of the events was unknown.
Pink eye; Red face; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 26Apr2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included diabetes, non-alcoholic steatohepatitis (NASH) cirrhosis and a known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), allopurinol (MANUFACTURER UNKNOWN), famotidine (PEPCID), atorvastatin (MANUFACTURER UNKNOWN) and empagliflozin (JARDY); all for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 28Apr2021 at 01:00 the patient experienced pink eye and red face. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with eye drops and diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pink eye and red face were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
rt upper below deltoid (arm) & spreading some under arm-red swollen & extremely warm;
Symptoms: c/o ?chest tightness immediately after shot?, subsided after a few minutes later, c/o headache,  Intervention: VS stable. Stayed an additional 15 minutes, total 30 min. Symptoms subsided.
This spontaneous report was received from nurse regarding approximately 175 unspecified patients of unknown age and gender. There was no information on medical history and drug reactions or allergies. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (strength, dose, route not reported) that were exposed to temperatures outside of the recommended storage range. No adverse effect reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
HCP reporting having mixed and administered two of the diluent portions of Shingrix.; HCP reporting having mixed and administered two of the diluent portions of Shingrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: HCP reporting having mixed and administered two of the diluent portions of Shingrix.) and inappropriate preparation of medication (Verbatim: HCP reporting having mixed and administered two of the diluent portions of Shingrix.). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 15-May-2023 The reporter did not have any additional adverse vent information available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The reporter reporting that mixed and administered two of the diluent portions of Shingrix to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of blurred vision in a 35-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 8 August 2013 at 13:30 the subject received 1st dose of BOOSTRIX (0.05 ml unknown route, left arm) and experienced underdose. The indicated dose for BOOSTRIX is 0.5 ml. On the morning of 9 August 2013, 1 day after vaccination with BOOSTRIX, the subject experienced blurred vision. The nurse practitioner reported that the subject woke up with blurry vision. After some time passed, the blurry vision had not subsided. Extensive medical history was not gathered. At the time of reporting the event was unresolved.
two days after receiving the number two vaccination the muscle from my elbow to my shoulder started hurting very badly.  and the next day the muscle in my back on the same side from the bottom of my shoulder blade to my waist started hurting badly.  it has never quit or lessened to this day.   it hurts especially bad when I reach back or up with my arm or when I first get out of bed in the morning in my back..
Second dose not scheduled >40 days; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Second dose not scheduled >40 days) and FATIGUE (fatigue) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0072C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Second dose not scheduled >40 days). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Second dose not scheduled >40 days) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was on an antibiotic as she had a dental procedure.  Treatment information was not provided.
13 yr male got the VARIVAX on the (LA). Has his arm red with no pain only when they touch it hurts.
kind of unsteady on her feet; dizziness; her head was feeling peculiar; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 09:20 (Batch/Lot Number: EL5318) (at the age of 78-years-old) as a single dose for covid-19 immunisation. The patient medical history included blood pressure issue from an unknown date and ongoing. Concomitant medication(s) included atenolol (ATENOLOL) 25mg take once daily by mouth and benazepril (BENAZEPRIL) 20mg take once daily by mouth taken for blood pressure for years (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she got the vaccine on saturday (30Jan2021 09:20) and she didn't have any side effects except dizziness. Mention she didn't see that as one on the list. Adds she was dizzy when she wakes up and feels dizzy right now if she moves her head just right. Patient was asking is are we aware of this side effect. Patient further stated that after vaccination she was sitting in the car waiting for 15 minutes she was laughing with her family and she noticed her head was feeling peculiar. Adds that may have been the start of it (dizziness). Adds the peculiar feeling was kind of right in the center of her forehead. States she thought maybe she was dehydrated and slammed water all day long yesterday and as she was going to bed she felt dizziness. Today she noticed she was still dizzy and kind of unsteady on her feet. Patient was scheduled for the second dose of the vaccine on 20Feb2021. At the time of this report head was feeling peculiar (feeling abnormal) and dizziness were not recovered and the event kind of unsteady (Unsteadiness) on her feet was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 19-APR-2016, the patient was vaccinated with am improperly stored ROTATEQ 2 ml oral injection (lot # L008997, expiry date 04-DEC-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second one lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality involved. This is one of several reports from the same reporter. Additional information has been requested.