chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed brain fog; slurred speech; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. A 35 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: FEELING ABNORMAL (non-serious), outcome "recovered", described as "developed brain fog"; DYSARTHRIA (non-serious), outcome "recovered", described as "slurred speech". Therapeutic measures were taken as a result of feeling abnormal, dysarthria.  Additional information included: Verbatim Question: What is the feasibility of getting only half of the 2nd COVID vaccine? My patient of 35-year-old is a university professor who had no comorbidity but developed brain fog & slurred speech within a wk after getting the 1st shot. She tried salt pills and high-intensity exercises and her symptoms resolved within 6 wks. She is very concerned about having recurrent or worse symptoms, if she gets the full dose of the 2nd shot. Would love to seek your guidance. Can she just receive half of the 2nd shot?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Elevated Red area 2in x 1in on right thigh. Warm to the touch. No treatment needed at this time.
Muscle pain in arm at injection site; This is spontaneous report received from a contactable consumer. A 24-year-old non pregnant female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: el3247) via an unspecified route of administration on 01Mar2021 at 02:15 PM (at 24-year-old) on left arm as dose 1, single for COVID-19 immunization. The patient's medical history and allergies to medications, food, or other products were reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not have covid prior vaccination and was not tested for covid post vaccination. On 01Mar2021 at 09:00 PM the patient experienced muscle pain in arm at injection site. No treatment was received for event. The patient was recovering  No follow-up attempts were needed. No further information was expected.
noc of vax pt was vomiting, had not been at all sick prev to this; pt arm's for 3 day's very swollen,, red & very hot to the touch in a large area on up arm;
Case PHEH2016US025851, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to an adult female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618521) at a dose of 1 ml intramuscularly on 03 Oct 2016. The nurse stated that, she discovered that 9 patients received 1.0 ml of FLUVIRIN rather than 0.5 ml. No adverse event was reported after this maladministration (accidental overdose). The case was lost to follow up at initial.
Normal after vaccination shot. Played basketball with friend 1hr. But then not hungry for dinner. Violent vomiting at about 6:45 pm. No fever. Fell asleep at about 8:15pm. Another round of violent vomiting at about 9pm. Slept all night after that. Pale and listless the next day. Slept a lot. Fever of 100+ starting at about 12pm. Able to eat dry cheerios but not hungry. Disoriented after afternoon nap. Gave 300 mg Motrin junior at about 5pm. Started feeling better. Slept all night. Seemed back to normal the next day (3/22), although ate cautiously for several days. Raised bumpy rash appeared on 3/23 or 3/24 (can't remember which). Round patch on front torso, upper abdomen, roughly 8 in. in diameter. Not hives, or at least not like any hives he's had before. ONLY on that one spot. Rash faded over 2-3 days. Then all back to normal.   Nobody else in the family got sick, so we don't think the vomiting was from a stomach virus.
Patient presented to pharmacy requesting dose of Janssen vaccine without disclosing previous administration of a dose of Pfizer vaccine. Error was discovered upon reporting to IIS. Upon follow up, the patient did admit to receiving a dose of Pfizer. He originally made an appointment for the Janssen vaccine at  and was not made aware of the vaccine product change until he was reviewing his paperwork at home. He also reported having no side effects from either injection, not even a sore arm.
This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M041768, expiration date 25-JUN-2018 (dose was not reported)  for prophylaxis. No adverse effects were reported. The temperature involved was 9 to 25 degrees Celsius for 15 minutes. No previous temperature was reported, and a data logger was involved.
Nausea; Dizzy when standing, versus within normal limits; This is a spontaneous report from a contactable nurse. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an intramuscular route of administration in the left arm on 22Apr2021 at 11:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient had no known drug allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 22Apr2021 at 11:45, the patient experienced nausea and dizzy when standing, versus within normal limits (wnl). The events resulted in emergency room/department visit or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events nausea and dizzy when standing, versus within normal limit was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Passed out; Abdominal pain; Trouble breathing; Sweats; Didn't feel well; Fatigue; death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (death) and LOSS OF CONSCIOUSNESS (Passed out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Trouble breathing), HYPERHIDROSIS (Sweats), VACCINATION COMPLICATION (Didn't feel well) and FATIGUE (Fatigue). The patient died on 26-Apr-2021. The reported cause of death was Passed out. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (Passed out), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Trouble breathing), HYPERHIDROSIS (Sweats), VACCINATION COMPLICATION (Didn't feel well) and FATIGUE (Fatigue) outcome was unknown.            No treatment information provided by the reporter and no history of concomitant medication was reported  Regarding the events of loss of consciousness, malaise, abdominal pain, dyspnea, hyperhidrosis and fatigue, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However regarding the event of death, Very limited information regarding this event has been provided at this time.  Further information has been requested; Sender's Comments: Regarding the events of loss of consciousness, malaise, abdominal pain, dyspnea, hyperhidrosis and fatigue, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However regarding the event of death, Very limited information regarding this event has been provided at this time.  Further information has been requested; Reported Cause(s) of Death: passed out
9/3 - Received ZOSTAVAX. 9/4 - Rash; trouble breathing; burning pain; itchy; Bright Red and swollen. 9/4 - 8pm went to Pt first and they gave BENADRYL and Abx; hands numb/face numb/tight throat. 9/5 - Not worse but rash still there; blisters worse.
pt recv vax 21DEC95 & 28APR97 pt devel chickenpox consisting of a rash w/10-20 lesions;no fever was reported;pt recovered;
Patient's mom took him to ER for rash on his bilateral arms and forehead. Mom described rash to be inflamed and bumps all over. Patient was given Keflex and Benadryl for reaction. Mom says that the rash hasn't worsened since his visit at the ER on 10/24/2020
The day after receiving the vaccine my trunk has broken out in a bumpy/red and swollen rash. It starts mildly at my neck and moves to the breast, stomach area and all over my lower to mid-back.
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 2 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 12-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
About a week after the first dose I experienced muscle pain in my neck then it moved to my shoulder blade. It's been over a month and I'm still feeling pain in my shoulder blade near my spine.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 08-OCT-2104 the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route not reported). The patient received the second dose of GARDASIL on 05-NOV-2014 (Inappropriate schedule of vaccine administered) and the third dose on 25-FEB-2015. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 17-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K009192 with an expiration date on 27-JUN-2016; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
This spontaneous report was received from a registered nurse and refers to a 23 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 17-JAN-2018, the patient was vaccinated with improperly stored VARIVAX, lot # N021719, expiration date 10-AUG-2019, by subcutaneous route in the right arm, (dose, dose number, and frequency were not reported), for prophylaxis. Concomitant therapies included sterile diluent (MERCK, lot number N020144 Expiration date 01-NOV-2019). No adverse reactions were observed. The temperature excursion occurred possibly from 22-DEC-2017 to 02-JAN-2018, when no temperature was recorded and also possibly due to the "power was turned off and the freezer door was open". No previous temperature excursion. The digital data logger was not involved. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1802USA006871.
Swollen feeling armpit on right side; Right arm feels tingly or swollen, as if blood has rushed to it or it has woken up from being an asleep limb; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 15Apr2021 at 09:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient was pregnant. The patient did not have any medical history and known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included pantoprazole (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 25Mar2021 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 21:15, the patient had swollen feeling armpit on right side and right arm felt tingly or swollen, as if blood had rushed to it or it had woken up from being an asleep limb. It was not numb and the patient could still move and function normally. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen feeling armpit on right side and right arm feels tingly or swollen, as if blood has rushed to it or it has woken up from being an asleep limb was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from the pharmacist and refers to a 56 year old male patient. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 31-OCT-2018, the reporter stated that when he was attempting to vaccine the patient with PNEUMOVAX 23 lot # R018735, expiration date: 06-APR-2020 (dose was not reported) for prophylaxis, the "finger flange" on the syringe broke (it was clean break and no cracks noted to the syringe). The pharmacist removed the broken syringe and vaccinated successfully the patient with a new PNEUMOVAX 23, (dose, indication, route of administration, lot # and expiration date were not reported) for prophylaxis. It was also reported that the product would not be collected by the reporter, as it was hazardous and he did touch the patient. The outcome of the syringe broke was reported as recovered/resolved. Relatedness between the breakage of syringe and PNEUMOVAX 23 was not reported.
Redness at site within 2-3 hours, down to elbow, with hot to touch. Itching started 10 hours later and lasted 30 hours. Put ice on it.
client stated she felt nauseous and had 1 episode of vomiting. After client vomited returned to baseline. observed for 10 more minutes and evaluated by MD. Client advised of follow up care and declined transport to ER for further evaluation. Patient noted to be back at baseline and father drove client home.
CONGESTIVE HEART FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series-1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced congestive heart failure, and shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of congestive heart failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211266112.; Sender's Comments: V0: 20211266078 - congestive heart failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
severe reaction the day after 2nd shot.  I have had 5 separate joint replacements d/t severe arthritis.  I had severe pain in all of the replacements especially the 2 most recent.  Even the 3 dental implants hurt.  No Temp but severe fatigue, headache.  Unable to get out of bed. It took 4 days to begin to start getting back to  normal for me.
The vaccination was given at noon on 9/9/2020. At 4:30 PM that evening, I noticed a slight nausea and weakness. I ate normally, and by bedtime at 8 PM my skin was very hot, and this continued for at least 24 hours. By 6 AM the next morning, I felt too weak to lift more than a glass of water, but my temperature (taken orally) was normal.   During the course of the day 9/10/2020, I did not eat or drink, laid in bad all day, but vomited twice. Today (9/11/2020) I feel 50%, and have started to eat and drink.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Diabetes, Blood pressure high, Glaucoma, Thyroid disorder, Nervous system disorder and Drug allergy (Allergic to some allergy pills.). Concomitant products included POTASSIUM and METFORMIN for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included chronic obstructive pulmonary disease medications, diabetes Medications, high blood pressure medications, nerve medication, stomach medication, water medication, thyroid medication, blood thinner medication, eye drops for glaucoma.  Treatment medication was not provided   This case was linked to MOD-2021-132126 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received updated outcome of the event.
Confused; Dizzy; Short term memory loss; This spontaneous case was reported by a pharmacist and describes the occurrence of CONFUSIONAL STATE (Confused), DIZZINESS (Dizzy) and AMNESIA (Short term memory loss) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 16-Apr-2021, the patient experienced CONFUSIONAL STATE (Confused), DIZZINESS (Dizzy) and AMNESIA (Short term memory loss). At the time of the report, CONFUSIONAL STATE (Confused), DIZZINESS (Dizzy) and AMNESIA (Short term memory loss) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medicines were not reported.
Patient received one dose of the Janssen COVID vaccine on8/23/2021 after previously receiving two doses of the Pfizer vaccine on 4/8/2021 and 4/29/2021.
Patient received 2nd dose at 10:50am. At 10:52am patient stated that she was felling hot and started flushing, unable to speak, unable to swallow, had weakness, and unable to breath. Code Blue was called by nurse and provider responded along with medical assistant. O2 started at 3L via NC. IM Benadryl administered at 10:56am. Patient noted to be cold and diaphoretic. IM Benadryl received patient started returning to baseline. patient was able to speak and stated that the tingling sensation improved in her face. she was able to swallow without difficulty. repeated vital signs every 5 mins for the next 10 mins. she was observed for a total of 45mins and discharged home with ER precautions and stable. Patient was picked up by sister who was driving her home.
01: 47 PM Pfizer Covid-19 Vaccine administered in left deltoid- mother and sister also in room.  Patient left room ambulatory without any issues or distress to go sit in waiting room.  01: 52 PM Sister  stated patient didnt feel well and alerted PCT . Mother present and witnessed patient have syncopal episode. He was lowered to floor but was arousable after 10-15 seconds. Patient sat upright and drank few sips of water. Patient was noted to be pale and sweating. He reports he has had similar episodes when receiving flu vaccine in the past.  Mother and PCT remained with patient in lobby.   2:00 PM Patient did vomit x 1 in trash can and reports he is feeling some better 2:20 PM Patient remained in lobby with mother until feeling much better. He left ambulatory in no apparent distress.
Fever 102F; headache; extreme fatigue; nausea; loss of appetite.
Information has been received from a nurse practitioner concerning a female patient with no pertinent medical history and no drug reactions/allergies who "10 years ago", in approximately 2000 was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown). After the first dose of vaccination, the patient had a local reaction. On an unknown date, the patient was vaccinated with the second dose of RECOMBIVAX HB (manufacturer unknown). After the second dose of vaccination, the patient experienced arm pain, swelling, and couldn't move the arm. The patient was hospitalized for 5 days (hospital name unknown). On an unknown date, the patient was recovered. Arm pain, arm swelling and couldn't move the arm were considered to be immediately life-threatening and disabling events. Additional information has been requested.