chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She stated it hurt a lot yesterday; Booster; lump underneath the site of the injection; itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 05Jan2022 (Lot number: FL3197) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALIUM taken for lower limb fracture; GABAPENTIN taken for lower limb fracture. Vaccination history included: Bnt162b2 (Dose 1, she was taking a muscle relaxer, Valium and gabapentin for her leg), administration date: Mar2021, for Covid-19 immunization, reaction(s): "She broke her leg severely in Sep"; Bnt162b2 (Dose 2, she was taking a muscle relaxer, Valium and gabapentin for her leg), administration date: Apr2021, for Covid-19 immunization, reaction(s): "She broke her leg severely in Sep". The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022, outcome "unknown", described as "Booster"; VACCINATION SITE MASS (non-serious) with onset Jan2022, outcome "unknown", described as "lump underneath the site of the injection"; VACCINATION SITE PRURITUS (non-serious) with onset Jan2022, outcome "unknown", described as "itchy"; VACCINATION SITE PAIN (non-serious) with onset 06Jan2022, outcome "unknown", described as "She stated it hurt a lot yesterday".  Additional information: She broke her leg severely in September. Now she was taking a muscle relaxer, Valium, and gabapentin for her leg. She stated she has not had a reaction in the past so she was not sure if she should take those medications today. The caller stated she had her 3rd dose of the Pfizer-BioNTech COVID-19 vaccine and it was a little sore.
The first event was the next morning I had flu like symptoms. I had hives on the trunk of my body including my stomach back chest. I had swelling on my left arm that was purple, white and red. It was at the site of the shot and was the size of a cantaloupe. It was also hot to touch and tender. The swelling went down within a few weeks and I called the health office and my provider who told me to monitor it at that time. I was advised to get the 2nd vaccine which I did. It was in my right arm. It was an even worse reaction, I got hives everywhere with labored breathing fever aches chills and joint pain. I called my doctor and he advised me to take ibuprofen and monitor my breathing. I physically went to see the doctor as I still had hives months later. I still have them on the back of my body. Some pop up and go away. The doctor prescribed Zyrtec 2 times daily. I was switched to Claritin and Singulair which worked better. I still have hives.
experienced chills for the day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (experienced chills for the day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (experienced chills for the day). At the time of the report, CHILLS (experienced chills for the day) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
brain bleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBRAL HAEMORRHAGE (medically significant), outcome "unknown", described as "brain bleed". Clinical course: Reporter's husband, had brain bleed in January, she had read up on the COVID vaccine and had been told by a physician that brain bleeds were directly related to the COVID vaccine.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
rash on injection site arm 1 week after vaccine. resolved in 2-3 days
Within 15 minutes of injection developed severe pain in area of injection. Next day (11/4/16) arm from neck to fingers was in pain. Two different courses of oral cortisone followed by injection of cortisone over the next month. No relief.
Pt reported feeling dizziness and vision problems shortly after receiving COVID-19 vaccine. VSS throughout incident. Pt reported that symptoms resolved after 15-20 minutes. Pt coherent and talking throughout incident. No s/s of allergic reaction observed or reported during or after incident. Pt denied any SOB and in was in no apparent distress once symptoms resolved. Pt left clinic after 30 minutes.
Rash- started 09/20/02 am, Rash than spread to trunk, No cough, No fever, No nausea, No vomiting,Benadryl 1/4 tsp qid
27 y/o patient expressing concern re primary SPV site never forming a scab. Received primary SPV (LUE) on 28OCT13, as well as AVA #3, MMR#2, Seasonal Influenza, and MGC ACYW- 135 Diptheria Conj (RUE). Pt states that the SPV site (LUE) formed a papule, then a blister, then a pustule, as expected. He was not aware of a scab forming or falling off. He kept the area covered and dry and removed the Bandaid while in shower. Patted dry and covered with clean Bandaid. Has kept area covered with Bandaid till present. Skin at SPV injection site is completely healed with keloid about size of dime at injection site (LUE).
patient called today complaining of new adverse reaction: ringing in the ears and not being able to "get up (stand up)".
cannot move; cannot open eyes; dizzy; really tired; weak; pain in upper back; sticking out tongue to get a deep enough breath; tingling in feet and hands; itching in feet and hands; swelling in feet and hands; pressure on chest; shallow breathing; wheezing; throat closed up; whole body swelled up; ears ringing; easily agitated; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in feet and hands), PRURITUS (itching in feet and hands), PERIPHERAL SWELLING (swelling in feet and hands), CHEST DISCOMFORT (pressure on chest) and HYPOPNOEA (shallow breathing) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No Adverse Events. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Product used for unknown indication, ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced PARAESTHESIA (tingling in feet and hands), PRURITUS (itching in feet and hands), PERIPHERAL SWELLING (swelling in feet and hands), CHEST DISCOMFORT (pressure on chest), HYPOPNOEA (shallow breathing), WHEEZING (wheezing), OROPHARYNGEAL DISCOMFORT (throat closed up), SWELLING (whole body swelled up), TINNITUS (ears ringing) and AGITATION (easily agitated). On 02-Jun-2021, the patient experienced HYPOKINESIA (cannot move), OCULAR DISCOMFORT (cannot open eyes), DIZZINESS (dizzy), FATIGUE (really tired), ASTHENIA (weak), BACK PAIN (pain in upper back) and DYSPNOEA (sticking out tongue to get a deep enough breath). On 20-May-2021, CHEST DISCOMFORT (pressure on chest), HYPOPNOEA (shallow breathing), WHEEZING (wheezing), OROPHARYNGEAL DISCOMFORT (throat closed up), SWELLING (whole body swelled up), TINNITUS (ears ringing) and AGITATION (easily agitated) outcome was unknown. At the time of the report, PARAESTHESIA (tingling in feet and hands), PRURITUS (itching in feet and hands), PERIPHERAL SWELLING (swelling in feet and hands), HYPOKINESIA (cannot move), OCULAR DISCOMFORT (cannot open eyes), FATIGUE (really tired), ASTHENIA (weak), BACK PAIN (pain in upper back) and DYSPNOEA (sticking out tongue to get a deep enough breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Significant follow up appended
About 5pm the day of my vaccination, I had slight discomfort in my right arm where I received my vaccine. As the evening progressed, the pain got worse; I called my daughter who's a doctor who came and inspected my hand. I couldn't bend my fingers or open a bottle of Advil. About 5 in the morning, I had body chills and body sweats and the pain had spread throughout my hand. My fingers were swollen and my arm felt terrible, my husband called an ambulance. Once the ambulance arrived, the pain went away like someone flipped a light switch. The EMTs thought it could've been a blood clot and wanted me to go to the emergency room. My daughter presumed it was a bad reaction to the shot and to just monitor the pain. The pain left my arm but stayed in my hand for some days. I've had off and on issues with pain in my hand. The pain still hasn't settled completely; I have to see a rheumatologist now due having rheumatoid arthritis and after receiving bloodwork done on 01/13//2022 to see if there can be a solution found to settle the pain.
after vaccine developed sensation of tongue swelling.  No objective signs of swelling.  Recieved 25 mg of benedryl with no improvement in 15 mins.  She was very nervous and we decided to monitor her in ED.   Also recieved famotidine there.  Felt better and was discharged after an hour
caller reported administered MMR II that was improperly sotred; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 24-JUL-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA))(M-M-R II) lot # S020161, expiration date 30-JUN-2021 (dose and route of administration were not reported), for prophylaxis. Administered dose of the suspect vaccine experienced the temperature excursion of 10F. There was previous temperature excursions reported. The administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) experienced temperature excursion below 36 Fahrenheit degrees (10F) for 50 minutes. The digital data logger was involved to capture the temperature excursion.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2008USA001689: US-009507513-2008USA001787:
Pain; knee swelling; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain, and knee swelling after getting the first dose of the vaccine on an unspecified date. Outcome of the events was unknown.  Information about Lot/ Batch has been requested.
Pt was given a Tdap injection when he should have received a DTaP no adverse reaction had.
Patient received Pfizer 1st dose and asked the patient to wait for 30 minutes post vaccination to observe for any sort of adverse reactions. 30 minutes later  patient complained of having sore throat and her voice sounded hoarse. Patient asked to wait to see if symptoms improved. 15 minutes later  patient complained of short of breath and throat tightness. Given albuterol nebulizer and benadryl.  Patient further monitored and vital signs were stable.  5 minutes later patient remained short of breath and rapid response was called and patient was taken to ER. Given Benadryl 25 mg IV and famotidine 20 mg IV. In ER, given 125mg methylprednisolone and 0.3mg of epinephrine. Patient discharged from ER.
Sore arm for 3 days; For the two weeks after receiving the vaccine, I would have recurring injury pain for 24-36 hours in prior injury sites (wrist, shoulder, allergic bite on back, wrist again).  One site at a time with a day of no symptoms in-between.  Symptoms stopped occurring exactly two weeks from vaccination.  Some pain strong enough that ibuprofen needed.
Patient's family called us on 03/18/2021 to report vomiting for 3 days starting after her vaccination. They took her to hospital where the family reports she was diagnosed with bowel obstruction. She declined surgery because of her age and underlying comorbid conditions including breast cancer and diabetes. She passed away on 03/22/2021.
pt recv vax 12NO97 & approx 4-6hr later devel a diffuse, pruritic, fine papular rash on chest, back, arms, mild temp 100.6, myalgia;
Client states she has had a low grade, fever since being vaccinated, fever has been as high as 100 degrees F. Client reports rash, redness and swelling to injection site. Client visited dr 6/12/14 for an allergic reaction and was given an injection steroids and TYLENOL at the visit and told to contact the facility where she received her vaccinations.
Dec 29 upon awakening: Chills, body aches slight nausea, lower abdominal cramping. Which lasted throughout the day- Temp of 100.2. Dec 30-felt better.
needle was not properly on the syringe and some of the vaccine leaked out; needle was not properly on the syringe and some of the vaccine leaked out; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case from a Pharmacist via Regulatory authority (Reference number- 00812910).  This case involves a 69-year-old female patient who was vaccinated with suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] experienced needle was not properly on the syringe and some of the vaccine leaked out (underdose and syringe issue).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 14-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA and expiry date: 30-Jun-2022) (Frequency = once) (Solution for injection in pre-filled syringe) via intramuscular route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to vaccine underdose and syringe issue. (latency on same day).  It was reported "Caller is asking if the patient will need another injection."   At time of reporting, no adverse event was reported.
Left sided facial myokymia/Started in orbicularis oculi muscle for a few days then spread to all facial muscles on the left side/idiopathic facial myokymia; mouth deviation to the left due to continuous muscle twitching; This is a spontaneous report from a contactable HCP reported for herself that. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 20Jan2021 12:00 (Batch/Lot Number: Unknown) as DOSE 2 SINGLE for covid-19 immunization(Age at vaccination 35 years). The patient past Medical history included hypothyroidism from an unknown date and unknown if ongoing and optic neuritis from Jun2013 to an unknown date. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, probiotics (PROBIOTICS) taken for an unspecified indication and vitamin d no's (VITAMIN D NOS) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 02Feb2021, the patient experienced Left sided facial myokymia/Started in orbicularis oculi muscle for a few days then spread to all facial muscles on the left side/idiopathic facial myokymia and mouth deviation to the left due to continuous muscle twitching. No sensory issues. No weakness. Had evaluation by neurologist who ordered brain MRI to rule out MS and brainstem lesions, MRI report normal. The patient is treated with oral gabapentin and currently titrating dose up without benefit. Only precipitating event he can think of was getting the vaccine. The event outcome was not recovered.  Follow-up attempts completed. No further information expected.
TOES ARE STIFF; COULD NOT WALK FOR MORE THAN 2 BLOCKS; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DISCOMFORT IN STOMACH; PAIN IN LEGS; DISCOMFORT IN LEGS; STOMACH WAS SWELLED UP AND WAS VERY BIG AND FELT LIKE WAS 6 MONTHS PREGNANT; PAIN IN STOMACH; COULD NOT STAND UP FOR MORE THAN 2 MINUTES; This spontaneous report received from a consumer concerned a 66 year old female. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, 3 days after the vaccination, the patient felt discomfort and pain in legs and in stomach. The patient's stomach was swelled up and was very big and felt like the patient was 6 months pregnant. The patient had a lot of pain in legs and could not stand up for a long time, not more than 2 minutes. The patient went to a PCP (primary care physician) for a check-up. Patient's legs were in a very bad condition and after 2 months and a half, patient could not walk for more than 2 blocks. When patient squad on the floor, it became very difficult to stand up as legs hurt. Patient's leg discomfort was better but still legs from knees down sometimes felt bad and toes were stiff and it hurt. The patient's stomach was less swollen and was recovering. Physician of the patient ordered an antibodies test on unspecified date in Apr-2021, after a month and a half of vaccination and it was negative (confirmed immunological vaccine failure). On 06-AUG-2021, the patient again underwent the antibody test and the result was negative. The patient did not know what type of antibody test the doctor preformed but it was a blood test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach was swelled up and was very big and felt like was 6 months pregnant, and discomfort in legs, and the outcome of toes are stiff, pain in legs, confirmed immunological vaccine failure, pain in stomach, could not stand up for more than 2 minutes, could not walk for more than 2 blocks and discomfort in stomach was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210826244-COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Patient called reporting blurred vision and eyelid droop within 24hrs of vaccine administration. Three to four days later started getting neck, joint, and back pain, weakness, dizziness and insomnia, which hes continued without improvement since 5/8/13. Similar to past experience with actual shingles virus.
Vaccine exposure during pregnancy; This is a spontaneous case, initially received from other non-health professional via Med Communications (reference number: SEQ19-02824) on 17-Sep-2019, concerning a female pregnant patient of an unknown age.  The patient's medical history and concomitant medications were not provided.  On unspecified date during her first trimester, the patient was administered INN Flu Vaccine [Influenza vaccine, brand name, dose, route of administration, batch number, expiry date and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy')  for an unknown indication.  It was unknown if the patient experience any adverse event after administration of Flu vaccine.
Patient received dose at 1:19pm walked to OBs area, sat in chair.  Started texting, noted weakness, c/o sweaty feeling, alerted staff.  Placed in WC, back to Med Eval tent where he was diaphoretic, pale.  Did not lose consciousness.  Patient admits to not eating or drinking today at all, very stressed about vaccine.  Drank a bottle of water, and gatorade, fan for air circulation.  Patient recovered well on cot in supine position, walked out without incident.  Likely vasovagal response without syncope. NP
In my arm pit of my left arm it swelled up; In my arm pit of my left arm it swelled up and was very painful; Dose 1 Start date: 20210203/ Dose 2 Start date: 20210218; This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 18Feb2021 at 13:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included low thyroid. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation (The vaccine was administered outside the range of 19-42 days (15 days) resulting in Inappropriate schedule of vaccine administered and medication error). The patient past drug therapy included lisinopril (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021 at 03:00, the patient's arm pit of the left arm swelled up and was very painful. Her doctor put her on steroids and the pain went away but the swelling has not totally gone away and is sometimes painful. The patient went back to her doctor 6 weeks later with the complaint that it was still swollen and sometime painful. The doctor ordered an ultrasound and blood test but all was negative. It was still swollen and sometimes painful that has not gone away yet. On an unknown date, patient underwent lab tests and procedures which included ultrasound and blood test and the results were negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with steroids. The clinical outcome of the events arm pit of the left arm swelled up and was very painful was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.