chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash and itchiness appeared   at the injection site 4 days later,  on Tuesday night patient begin to experience sharp pinching pain around the heart area, patient called the pharmacy on 12/02/2021 around 7 pm and was advised to have the chest pain check up, rash is normal and she can take benadryl  but chest pain need to be check out. patient then went to urgent care and is awaiting examination, follow up with patient at 8:30pm  but she has not been seen by  the doctor yet, only put in the room.
first dose three years ago, second administered today; first dose three years ago, second administered today, expiry date 15-Sept-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number GJ549, expiry date 15th September 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose three years ago).   On 19th September 2022, the patient received the 2nd dose of Shingrix. On 19th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long and expired vaccine used. On an unknown date, the outcome of the drug dose administration interval too long and expired vaccine used were unknown.   Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received second dose of Shingrix (on the day of reporting) later than the recommended interval after the expiration, which led to lengthening of vaccine schedule and expired vaccine used.
This report was received from Novartis and was assigned manufacturer report number PHEH2017US016177_OS for a pneumonia shot (manufacture unknown). Information has been received from a currently 60 year old female patient concerning herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2015 the patient was vaccinated with pneumococcal vaccine, (23-valent) (manufacture unknown) for prophylaxis (dose, frequency, route, lot# and expiration date were not reported). However, it did not work. The outcome of vaccination failure was not reported. Causality between vaccination failure and the product was not reported. Additional information has been requested.
BRUISE AT THE INJECTION SITE; This spontaneous report received from a patient via a company representative 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 (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced bruise at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise at the injection site. This report was non-serious.
This is a spontaneous report from a contactable pharmacist received via a Company representative. The pharmacist reported for two patients. This is the second of two reports. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient had a red circle on the administration site on an unspecified date, and it lasted for a week. The outcome of the event was recovered on unspecified date.
Severe hives/urticaria with extreme burning/itching erupting in various parts of the body. The hives started 8 days after administration of the Moderna booster. Now, 25 days after the booster and 17 days after the initial appearance of the hives, the intensity has subsided but they still flare up off and on throughout the day and night.
After dinner, seated at table, feeling of dizziness, lightheadedness, nausea like I might faint. I'm told I actually fainted for about 30 seconds. Came back to consciousness, needed to lie down, pushed back chair from table, realized I released some urine, went to bathroom, laid down and went to sleep.
vaccinated with booster; Fully vaccinated with booster and was a confirmed positive for COVID on 05Jan2022; Fully vaccinated with booster and was a confirmed positive for COVID on 05Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "Fully vaccinated with booster and was a confirmed positive for COVID on 05Jan2022"; IMMUNISATION (non-serious), outcome "unknown", described as "vaccinated with booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in my left side of my arm, Shoulder; Dizziness; Very tired; Sleepy; Anxiety; Not knowing where she was; This is a spontaneous report from a contactable healthcare professional (patient). This 53-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) on 22Jan2021 at 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included anemia, gastritis, and peptic ulcer. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient previously received penicillin from an unknown date for an unknown indication and experienced allergy. On 23Jan2021 at 21:00 the patient experienced severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month. The patient went to a doctor or other healthcare professional office/clinic visit as a result of the events. The patient did not receive any treatment for the events. The outcomes of severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month were recovered with lasting effects. It was also reported that since the vaccine the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Initial misuse report received from a healthcare professional on 14 January 2014. A child patient (demographics unknown) had received PENTACEL. The patient received only the DtaP/IPV component. Although not licensed, DTaP-IPV is immunogenic when administered without first reconstituting the ActHib component. Because the child was not given the ActHib component of PENTACEL, he/she needs to be given a separate injection of ActHib reconstituted with saline diluent. Since not administered together, chart lot numbers and vaccine name/component appropriately. No adverse event was reported. List of documents held by sender: none
Heavy and tight chest. My chest was so heavy that it was hard to lay down or get up to walk. It was tight all day but worsened when lying down resulting in me staying propped up at night.  It was very scary. I contemplated going to the ER but knew how busy they are these days. My chest continued to feel pressure from July 9, 2021 until August 2. I was able to get a CT scan completed during this time and was able to schedule an appointment with a pulmonologist but symptoms had disappeared before I was able to see the doctor due to how far out I had to make the appointment.
Presented with a 2 cm area surrounding area where immunizations given in left leg. Advised cold compress and BENADRYL 3/4 tsp every 6hrs prn.
Exagerate local reaction. Painful with patient asking to be carried. Swelling of left quadricep with loss of knee landmarks, erythema and warmth at injection site measuring 12X7 cm. Still able to walk. Supportive care, ibuprofen. If spreading will give keflex for presumed cellulitis.
Fever of 101. Felt cold and achy joints. Fatigue. Headache. Slept most of the day wrapped in a blanket. Fever broke about 5:00 pm and started feeling better.  Felt normal by 10:00pm. No treatment.
Stiffness, numbness, tingling sensation throughout entire left arm from injection site (upper arm) to hand.
Headache, ARM & FINGER NUMBNESS, LEFT-SIDED WEAKNESS Narrative:
Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL (Lot # not reported) and experienced all over body tingling. At the time of the report the outcome of the patient was unknown. No further information is available.
Vasculitis rash treated with triamcinolone 0.025% ointment.
ACHES; FELT OUT OF IT; CHILLS; PROBABLY A SLIGHT FEVER; TIRED; FELT LIKE A MINOR FLU; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced aches. On APR-2021, the subject experienced felt out of it. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced probably a slight fever. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced felt like a minor flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, and probably a slight fever on APR-2021, had not recovered from tired, and felt out of it, and the outcome of felt like a minor flu was not reported. This report was non-serious.
Had left arm discomfort after vaccine that continued for about 17 days. Started to message my arm one day to help with the pain and noticed a  pea sized lump on my upper arm medial side. Have not had arm pain in the last 3 days but the lump is still there - size is the same I believe. Received second dose of Pfizer yesterday (8/23/21) on opposite arm.
HEADACHE, STIFF AND ACHING NECK, LOWER BACK PAIN, NIGHT SWEATS, DIARRHEA, PAIN DOWN ARM
Tenderness pain, swelling size of a tennis ball, pain and muscle soreness same after 72 hours itching, warm to the touch
red, raised rash that began @ inj site & spread to abd, neck, head w/some itching noted by parents;rash started on rt thigh;
Loss of balance 6:50a when heading to the shower. Sat down on the toilet, room spinning. Laid back in bed and everything still spinning. The worst of it lasted about 30-45min. Currently laying in bed and eyes are heavy. Have a headache and fatigued.  Dizziness comes and goes but not nearly as bad as this morning. It is currently 10:19am.
Arm was slightly sore the first night, but felt worse the next day. Slight headache, more tenderness at injection site, slight fever (99.6 at 15:00), moderate nausea, and moderate vomitting.
The patient came to the pharmacy and request a Flu shot for her and her family.  Her vaccine was administer at 5:45pm approximately, after 15 minutes her husband tell to the pharmacy tech that her wife was not feeling well. She has dizziness, nausea, her body was trembling and her hands were cold.  She also feel some itching on her face and throat.  Pharmacy tech call 911 at 6:04 pm  and  stay with the pharmacist to take notes. The patient's husband call her physician and they refuse to administer to her epinephrine 0.3mg inj.  They accept to received diphenhydramine inj. 50mg/1ml, the pharmacist  administer 0.5 ml equivalent  to 25mg of Diphenhydramine intramuscular.  The paramedics arrived at 6:36pm and took the vitals, the oxygen saturation was 98, temperature 36.2, pulse 72, blood pressure 110/80.  The paramedic recommend to go to Emergency room but she refuse to go with them.  When she leaves the pharmacy was calm, she does not show any trembling, was not cold and do not feel itching anymore, she was a little drowsy.
Swelling of arm and lymph in the axilla 12-13-21 in PM Headache 12-13-31 in AM Dizziness and lightheadedness 12-13-21 1100 Nausea and vomiting 12-13-21 1400
Area of erythema and slight rising above skin right deltoid area 4 to 5 cm- instructed to use ice pack and Benadryl.
Patient is complaining of high fever that started yesterday after vaccine. Not relieved with Tylenol or Ibuprofen.
Hives all over back and sides of stomach, dizziness, fever, muscle aches and fatigue.
Patient developed a fever, headache, stomach ache, lethargy and loss of appetite approx. 40 hours after receiving vaccination.  The fever lasted for 3.5 days, spiking at 103.4 degrees F 4.5 days after vaccination.  Headache, stomach ache and loss of appetite lasted 3 days; lethargy lasted 4 days.
Case number PHEH2013US021981 is an initial spontaneous report received from a consumer (nursing student) on 18 Oct 2013. This report refers to a female patient whose age was not reported. Her medical history included anaphylactic reaction to latex in the past and egg allergy which was further explained as hurting of stomach when she ate egg. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that she experienced fevers as high as 103 to 104 degree F after flu vaccination. The outcome of the event was not reported. The reporter stated that the fever might be possibly due to her egg allergy.
This spontaneous report was received from a registered nurse and refers to unspecified multiple patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB injection, lot# M007762, expiration date: 07-DEC-2018, lot# M036612, expiration date: 19-MAY-2019 (dose and route of administration were not reported). The temperature excursion ranged from 32 to 35 degrees Fahrenheit for 24 hours. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013069: US-009507513-1703USA009342.
This spontaneous report was received from an Office Manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-AUG-2017, the patients were vaccinated with improperly stored doses of M-M-R II injection with lot number: M036543 and expiry date: 15-AUG-2018 (exact dose, route of administration, were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot number and expiration date not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit on an unspecified date, for a time frame of 16 hours. A digital data logger was not involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005224: US-009507513-1708USA005225.
chest pain; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer sponsored Program. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FS8841), via an unspecified route of administration, administered in left arm on 21Oct2021 (at an unspecified age) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chest pain on 22Oct2021. On afternoon of 22Oct2021 the patient started having complaints of chest pain. She went to the Emergency Room on 23Oct2021 where a chest X-ray and blood work was done and everything was "normal" with pateint's heart. She was given a TYLENOL drip in the Emergency Room and had been taking oral TYLENOL but it has not touched the chest pain and has stopped taking the oral Tylenol. Patient did not want to get the second dose of the Pfizer Covid-19 vaccine because she was scared due to her complaints of chest pain. Reporter contacted primary care or physician, took the patient to emergency room all day Saturday and they did all kind of test on her and everything was negative her heart was fine but still she has the chest pain. The outcome of the event was not recovered.
pt states that about 8 hours after the vaccine her blood sugar spiked for about 36 hours.  It was 255 which is extremely high for her since she is on insulin and has been a diabetic for 50 years.  She had dramatic breathing improvement since having a severe breathing problem.  It improved for about 5 days then started to go back to normal.  After getting her 3rd vaccine Lot # 037F21A at pharmacy (got full dose not booster) she experienced a slight breathing improvement but not as substantial as 2nd dose.  She had a sinus infection that immediately improved.  She had severe aching in her lower teeth as well as flu like symptoms.  Her infusion sight/portal became very sore.  Her blood sugar would spike after eating food.  This lasted for 3 days.  When her blood sugar elevated her breathing would get better.  She  had some positive reactions happen after 2nd and 3rd dose.   She no longer has any of the other symptoms.
within about 15hr after vaccine: headache, nausea, low grade fever 99.6, chills, body aches. about 32hrs after vaccine: rash on legs and arms - red, bumps, itchy.
7 year old male with no significant past medical history who was admitted for tachycardia in the setting of 7 days of fevers, bloody stools (gross blood seen 1/25), NBNB vomiting, and decreased PO intake and urine output. S/p both doses of his COVID vaccine, second dose at end of December 2021. A CAT was called 1/29 due to decreased urine output, low BPs in the 80s systolic and HR persistently 120s-140s despite pain management. He received a total of 4 NS boluses over his first 2 hospital days and CXR was obtained with atelectasis vs L sided PNA. POC US done by PICU fellow showed mild-mod cardiac dysfunction. Labs were notable for increased troponin and markedly increased BNP, leukocytosis with left shift, and persistently elevated inflammatory markers. He was subsequently transferred to the PICU.  On arrival to the PICU, patient was hypotensive with fluid overload clinically (peripheral edema, pulmonary edema on CXR), consistent with cardiogenic shock. Epinephrine was started and milrinone added given ECHO with diminished biventricular function. Epi was discontinued 1/30 and milrinone continued. Nicardipine was added for afterload reduction and lovenox added given poor cardiac function. Lasix gtt was started 1/30 for diuresis, and diuril added 1/31 (though discontinued 2/1 due to adequate diuresis). Given continued hypertension, nicardipine drip was d/c'ed as amlodipine was started.  For treatment of MISC, patient received IVIG on 1/30, pulse dose steroids on 2/1 and 2/2, and continued on BID steroids with wean plan outlined by rheumatology. His inflammatory markers down-trended appropriately and his cardiac function normalized on ECHO 2/2. Given patient age and anxiety with medical therapies, he was intubated 1/30-2/3. Dex and midaz drips were started for sedation and anxiolysis. Patient remained stable on RA. Given fevers and retrocardiac opacity on CXR 1/30, patient completed 5 days of CTX for pneumonia.  Patient  developed worsening abdominal distension and emesis, requiring intermittent pauses in feeds. Abdominal xray showed ileus with significant gaseous distention. Feeds were paused 2/3 for extubation, briefly resumed, then paused again in the setting of multiple episodes of emesis (one heme occult positive emesis likely due to coagulopathy + mallory weiss tear). Distension improved with NPO/sump suctioning, and patient was able to tolerate clear liquids and meds starting 2/4. Bowel regimen was continued with small, non-bloody stool output. Patient had no further episodes of bloody stool or emesis. Hgb and coags were trended and improved. Anti-xa remained within goal while on lovenox. At the time of transfer patient was tolerating a regular diet and off all IV medications. Patient's bowel regimen was held in the setting of loose stools. Patient continued to tolerate PO and was meeting maintenance goals at the time of discharge.   Patient hospitalized from 1/28/22 to 2/8/22 with 7 days spent in ICU.
This spontaneous report as received from a pharmacist refers to a 55 year old female patient. The patient had no known drug allergies. No information on her medical history or concomitant drugs was reported. On 09-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (site of administration, lot# and expiration date not reported). On 09-NOV-2014, the patient experienced redness and a slight bump at the injection site, after receiving ZOSTAVAX. The patient sought medical attention by seeing the pharmacist. No treatment was given to the patient and no lab diagnostic studies were performed. The outcome of the adverse events was unknown. The relatedness between use of ZOSTAVAX and the adverse events was not reported. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 9th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th January 2019, 60 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX in the left deltoid. On 8th January 2018, the patient was diagnosed with shingles her local physician's assistant. The physician assiastant prescribed antivirals and antivirals creams this morning. The consent for follow up with the pharmacy was given to obtain additional details.
I got a 101 fever for a day (woke up with it the next day and it broke that night) and I also got severe fatigue (noticed within a couple hours of the vaccine). It hasn't gotten worse, it just hasn't gone away. No treatment. Severe fatigue, still experiencing it.