chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy; This is a spontaneous report from a contactable consumer or other non hcp.    A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in left arm on 15Mar2021 15:00 (Batch/Lot number was not reported, age at vaccination 44-year-old) as single for COVID-19 immunisation. Medical history was reported as none and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in left arm on 22Feb2021 03:00 pm as single dose for COVID-19 immunisation. On 17Aug2021 13:00, the patient experienced bell's palsy. He received treatment medications as prednisone and valacyclovir. The seriousness of event considered as disability. It was reported that patient had emergency room visit and physician office visit. He had no known allergies. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine in four weeks and no other medications in two weeks. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
hives started around ankles, then arm became red & swollen & hot; several; episodes of profuse sweating, cool to touch, no fever; mom gave DPH; hives spread to hand & became red, would appear in little bits & this cont until following Weds;
RED, SLIGHTLY SWOLLEN AREA ON R ARM SUBCUTANEOUS AREA. KEFLEX 500 MG BID X 10 DAYS.
lt deltoid sl swollen w/hard area about size of a egg;no redness to area;no warmth to arm;
Pt. states that after receiving the 3rd dose of Phizer 01/18/2022, started experiencing symptoms 01/19/2022 of severe anxiety, panic attacks, and shortness of breath. No noted Primary visit/communications.
Initially started as fever and teething. Then diagnosed with RML PNA and AOM. Then was hospitalized twice for severe viral croup/ stridor /tracheomalacia on 4/6/2010. This initial hospitalization included an PICU stay.
Within the first 18hrs I developed the expected chills, achiness, headache, fatigue but that went away.   The entire next week I was nauseous on and off, then noticed that the nausea has been lingering around for the past 4 weeks, not every day and not all day. I vomited on 5 different occasions and have had a headache on and off. Today I have diarrhea in addition to the nausea.
COVID infection following COVID vaccine series 01/13 COVID vaccine dose#1 02/04 COVID vaccine dose #2 09/30 Pre-procedure COVID test positive, remained asymptomatic 10/21 COVID vaccine dose #3
Sore stiff neck, headache started 8 hours after injection. Restless sleep. 6 am muscle aches arms, neck, back, hips. Chills and fever thru out the day reaching up to 101. Took ibuprofen alternating with acetaminophen. Went to bed at 8pm, slept good. Woke up at 6:30 slight headache. Most of the aches gone. No fever. Had vaccine at 11:15am. 2nd vaccine
cold; tachycardia; cramping; flu; body aches; low back pain; diarrhea; chills; fever; joint pain; fatigue; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu) and PAIN (body aches) in an 8-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Pfizer (all prior doses were Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Hypometabolism (sensitive person to medication, meaning slow metabolizer of medication.).    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Nov-2023, the patient experienced NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu), PAIN (body aches), BACK PAIN (low back pain), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Nov-2023, NASOPHARYNGITIS (cold), TACHYCARDIA (tachycardia), MUSCLE SPASMS (cramping), INFLUENZA (flu), PAIN (body aches), BACK PAIN (low back pain), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient had received Spikevax around 2 PM on Friday, 17-Nov-2023  4 hours after vaccination she experienced extreme chills, never felt this cold before, tachycardia which she attributes to her fever, achy, body aches, low back pain, which caused her to worry as she was a Registered NP. Joint pain, pronounced fatigue, didn't want to move at all, terrible headache, diarrhea and cramping, a 103 which went down to 102 after taking Tylenol. Reported that back ache, terrible headache, lasted until Sunday evening. HCP stated that it felt like I had a bad Flu.  Concomitant medications were not reported.
Fever 24 hours later, resolved. Redness, heat, swelling, cellulitis, seen 6 days later, started on antibiotic.
patient took a flu shot every year and was sick for days.; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer/non-hcp.  This case involves a patient who took a flu shot every year and was sick for days (illness), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history of the patient were not provided. Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient took a flu shot every year and was sick for days (illness), (Unknown latency) following the administration of INFLUENZA VACCINE.   Final diagnosis was illness.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown.
redness at injection site; fever; pain at the injection site; hard time sleeping; tired; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HT5J, expiry date 26th January 2022) for prophylaxis.   On 24th October 2019, the patient received Shingrix 1 ml. On 24th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, difficulty sleeping and tiredness. On 25th October 2019, the patient experienced injection site erythema and fever. On an unknown date, the outcome of the injection site erythema, injection site pain, difficulty sleeping, tiredness and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, difficulty sleeping, tiredness and fever to be related to Shingrix.  Additional details were provided as follows: The day before the reporting date, the patient received Shingrix. The patient felt painful at the injection site and also felt tired last night. The patient had time sleeping because it was painful at the injection site. On the reporting date, 1 day after receiving Shingrix, the patient saw that it was red at the injection site and she had fever about 100.3 degree F. The reporter consented to follow up.
Pt received flu shot, and spiked a temperature. Due to fever from flu shot patient had a febrile seizure. Pt. had no prior illness when receiving shot. Temperature was 98 degrees Ax.
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 10th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown. It was unknown if the reporter considered the fever and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On an unknown date, the patient received 1st dose of SHINGRIX. A day before reporting, the patient received 2nd dose of SHINGRIX. The patient asked how long does the fever and headache usually last and could she take something for it or just wait. The patient reported that she did not felt like this after receiving 1st dose.
Pt developed pain and erythema in the Right  leg. Mother called to report on 6 days after administration.  Pictures that mother provided showed 3-4 vesicles around the injection site.  Pt came to the office the day after mother contacted us and the vesicles had crusted over less than 24 hours after the picture.  Per Mother patient reported pain in both legs starting the day after she received vaccinations, to the point it was difficult to put on pants, for over a week.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 29-APR-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot # 0628AE, expiration 26-JAN-2015 (dose and route unknown). The Healthcare worker reported that VAQTA had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
20 Minutes after MD/ office visit developed puffiness around site and open up / urticartial lesions all over body given Benadryl / Epinephrine, steroids, Albuterol - resolution of site.
Fever as high as 102 lasting more than 12 hours Chills lasting more than 48 hours.
No adverse response at time of administration and 48 hours after administration. Vaccine was given beyond 6 hours after initial puncture of vial.
This spontaneous report was received from a registered nurse regarding a patient of an unknown age. Information on the patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 07-DEC-2018, the patient was vaccinated with M-M-R II that was reconstituted with expired sterile diluent (lot# M009800, expiration date: 12-SEP-2018) for prophylaxis. No adverse effects was reported (no adverse event). There was no product quality complaint. Sender's Comments: US-009507513-1901USA009966: US-009507513-1901USA009968: US-009507513-1901USA007603.
fever upto 104 within 1hr of vaccine, fever still present at 24hrs- otherwise normal exam on 4/14/2023
4th day after vaccine. Shortly after waking up in the morning I had a heart attack. Afterwards I entered the ER and stayed overnight for 2 days.  I had a series of blood work done. CT scan, Chest X-ray, Angiogram/Hearth Catheterization.
kidney stones; kidney stone blocked the tube; Did not get second dose; sepsis; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (kidney stones), SEPSIS (sepsis) and URINARY TRACT OBSTRUCTION (kidney stone blocked the tube) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (kidney stones) (seriousness criterion hospitalization), SEPSIS (sepsis) (seriousness criterion hospitalization prolonged), URINARY TRACT OBSTRUCTION (kidney stone blocked the tube) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose). At the time of the report, NEPHROLITHIASIS (kidney stones), SEPSIS (sepsis), URINARY TRACT OBSTRUCTION (kidney stone blocked the tube) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included unspecific transfusion. No concomitant medications provided.   The patient reported that due to being hospitalized, she was unable to get the second dose of the Moderna COVID-19 vaccine.  This report refers to a case of incomplete course of vaccination (second dose) for mRNA-1273,  with associated AEs of Nephrolithiasis, sepsis and Urinary tract obstruction. Further information is requested.; Sender's Comments: This report refers to a case of incomplete course of vaccination (second dose) for mRNA-1273,  with associated AEs of Nephrolithiasis, sepsis and Urinary tract obstruction. Further information is requested.
did not get the flu until got the shot; Initial information regarding an unsolicited valid non-serious social media case received from a consumer (patient) via social media on 20-Oct-2020.  This case involves a patient of an unknown age and gender who did not get the flu until got the shot (Influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (batch number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the patient did not get the flu until got the shot (Influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was unknown for the event of influenza, at the time of reporting.  There will be no information available on the batch number for this case.
monthly cycle was off for this month; blood pressure went up after first dose/Has been getting readings of 170/110, which are not within her historical range where she was regularly 120/80; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration, administered in arm on 13Sep2021 as dose 1, single for COVID-19 immunization (at the age of 24-year-old). The patient medical history and concomitant medications were not reported. No vaccines in 4 weeks prior, and no problems in past. Only has had her childhood vaccines, like HPV in her teen-age years. Historical vaccine included Flu. On an unspecified date in Sep2021, the patient blood pressure went up. Has been getting readings of 170/110, which are not within her historical range where she was regularly 120/80. It has been persistent since she received the shot and she has only had this first dose. States she received the first dose on 13Sep2021. Noticed blood pressure increase between the 20th and 27th, 1-2 weeks post vaccination. The initial reading was 170/110. Patient just went to the doctor today and it's about 160/100 and is going to schedule to get an echocardiogram on Saturday to look at her heart. On an unspecified date, the patient's monthly cycle was off for this month. She was in good health and normal weight and no issues prior to this. No visit of emergency room (ER). Patient visited physician office. On an unspecified date in Sep2021, the patient underwent lab tests and procedures which included blood pressure measurement: 170/110, blood pressure measurement: 120/80 and blood pressure measurement: went up. On 06Oct2021, blood pressure measurement: 160/100. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
menstrual cycle has increased; menstrual cycle has increased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 22Nov2021 (Lot number: EW0171) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer,, Previous dose brand unknown: False,, Previous dose lot number: EN0153,, Previous dose lot unknown: False,, Previous dose administrator route: Intramuscular, Previous dose administration date: 01May2021, Previous dose number: 2), administration date: 01May2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer,, Previous dose brand unknown: False,, Previous dose lot number: ER8730,, Previous dose lot unknown: False,, Previous dose administration date: 10Apr2021, Previous dose number: 1), administration date: 10Apr2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 2021, outcome "recovered with sequelae" and all described as "menstrual cycle has increased". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, oligomenorrhoea.  Upon follow-Up 04Feb2022: Follow-up attempts are completed. No further information is expected.
HPV 9 IM given in the right deltoid. Lot number M009116. Patient Reaction: Patient states she "sees stars" then passed out for approximately 5 seconds. Patient in sitting position. Father present. Patient roused and immediately states "I am okay." Cool rag obtained and applied to forehead and base of neck. Vital signs obtained. Temp 98.7, Pulse: 62, O2: 98, Blood pressure 100/66. Patient states "I just passed out, I have done this before when I tore my ACL." Patient given water to drink and monitored for 30 additional minutes. 10 in clinical area and 20 in lobby. Patient drank 16 ounces of water and told her father she felt fine. Father told her it was alright to go before I came back to check on patient. Father and patient have copy of VIS forms and instructions for "after the shots," VIS forms state what to do for additional symptoms, including when to seek medical help. Patient left with Sister, no distress noted by Secretary who was in the lobby when patient left. Follow up call made to father @ 1651 who states patient is well with no adverse reactions nor distress noted at this time.
Aches, fever, extreme night sweats for about 4 weeks, very ill.  Thought I would have to quit my job.
Sore arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for a couple of days) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm for a couple of days). At the time of the report, PAIN IN EXTREMITY (Sore arm for a couple of days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided    This case was linked to MOD-2021-110199 (Patient Link).
Not sure if this event is related or not.  I had a ischemic stroke on 7/4/2021:  I was standing making dinner and the right side of my body stared going numb and weak.  I started slurring my words.  I was taken to the ER, they ran CT scans and did not see a major hemorrage.  I had a follow up MRI which confirmed a lacunar stroke in my pons (left side?
Emergency C-section; received Moderna vaccine while pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of CAESAREAN SECTION (Emergency C-section) and MATERNAL EXPOSURE DURING PREGNANCY (received Moderna vaccine while pregnant) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received Moderna vaccine while pregnant). On 08-May-2021, the patient experienced CAESAREAN SECTION (Emergency C-section). The cesarean delivery occurred on 08-May-2021, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. On 08-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (received Moderna vaccine while pregnant) had resolved. At the time of the report, CAESAREAN SECTION (Emergency C-section) outcome was unknown.      No treatment and concomitant medications were reported
Relapse of Multiple Sclerosis symptom; Extreme vertigo; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6204, Expiration Date: unknown), via an unspecified route of administration on right arm on 15Mar2021 10:00 AM at single dose for Covid-19 immunization.The patient historic vaccine included first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL9267, Expiration Date: unknown), via an unspecified route of administration, on right arm on 22Feb2021 9:00 AM at single dose for Covid-19 immunization. Patient medical history included Multiple Sclerosis. No Allergies to medications, food, or other products was reported. Concomitant medications included other medications were received in two weeks. On 16Mar2021 at 03:00 AM patient experienced Extreme vertigo and aches in her bones concentrated in her hips and lower back. It also triggered a relapse of Multiple Sclerosis symptom as and she had significant difficulty walking. The pain has continued for days. She had been taking high doses of Aleve for days for the pain. Facility type vaccine: Pharmacy or Drug Store. he patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to vaccination, the patient was not diagnosed with COVID-19. The outcome of event was not recovered. .
Pt should have received the Gray Cap Moderna Booster Vaccine. Instead got a booster dose 0.25ml of the Original Moderna Pediatric. Parent and pediatrician were contacted. No adverse event reported with this medication error. Parent instructed to get little one revaccinated with the correct Moderna booster in 2 months.
Positive chicken pox, less than 50 vesicles, no fever. The patient received Varicella immunization on 03/15/01. The mother broke out approximately 03/24/01, 2 other siblings broke out, then the patient, then 1 other sibling, and a housemate.