chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seen 3/22/17 - given Tdap, HPV-9 #1, MCV4 #1 and RX for EPIDUO for acne before 12 noon. Late afternoon per child face a little puffy. Used EPIDUO for 1st time later that day.
Swelling on lt side under arm & under chin, lethargy x 1 wk, weakness, extreme, fatigue, p/24hrs upon rising, fast heart, difficulty breathing x 1 sec; swelling lasting x 1 wk; also shooting pain in side;
Nausea/vomiting the day after the vaccine administered but patient did inform me of the event until 1/20/13, almost 3 months later & the hospital wouldn't release any info on her stay b/c they stated, "I'm not HIPPA certified".
Patient was given PNEUMOVAX 23 and within 10-15 mins started feeling shaky, pain all over, chest pain. Patient sat for about 30 mins. and ambulance was eventually called.
Sore muscles/ Muscle aches; Chills; Headache; Little bit of fever; This is a spontaneous report from a contactable consumer (patient) reported himself.A 38-Year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on 31Mar2021 ( at the age of 38-Year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number and expiry date: not reported) via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization.The patient reported that events experienced on next day. On 01Apr2021, he had chills, a little bit of fever, muscle aches, headache and he got sore muscles. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse practitioner concerning a 65 year old female patient with hypertension and osteoporosis, who on 15-DEC-2008 was vaccinated with 0.65 ml of a dose of ZOSTAVAX (Oka/Merck) (Lot not reported). Concomitant therapy included lisinopril-HCTZ, alendronate sodium and CYMBALTA. On 16-DEC-2008 the patient developed headache and flu like symptoms. As of 16-DEC-2008 the patient's symptoms persisted. Additional information has been requested.
8 days after the vaccine I woke up to a large, hot, itchy bump at the vaccine site.
Shoulder joint uncomfortable; Arm hot; Arm itchy; Arm with little bumps; Rectangular patch on arm; Arm sore; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), MUSCULOSKELETAL DISCOMFORT (Shoulder joint uncomfortable), SKIN WARM (Arm hot), PRURITUS (Arm itchy) and PERIPHERAL SWELLING (Arm with little bumps) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Shoulder joint uncomfortable), SKIN WARM (Arm hot), PRURITUS (Arm itchy), PERIPHERAL SWELLING (Arm with little bumps), RASH (Rectangular patch on arm) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm sore), MUSCULOSKELETAL DISCOMFORT (Shoulder joint uncomfortable), SKIN WARM (Arm hot), PRURITUS (Arm itchy), PERIPHERAL SWELLING (Arm with little bumps), RASH (Rectangular patch on arm) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
Patient was given FLUZONE HD on 9/19 - patient states arm felt uncomfortable shortly after getting shot but pain really increased on Monday 9/21. Pain was localized to area around injection site. Patient states she was unable to lift arm or rotate arm without having discomfort. Patient sought treatment from pharmacist while visiting another country. Pt was given itami 140mg patch. Pt still having pain and discomfort in upper arm and ROM limited.
Fever; Body aches; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the 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 07Apr2021 at 04:30, the patient experienced fever, body aches and vomiting. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, body aches and vomiting was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(R) arm red, warm to touch, tender, radiating pain, 4 inches by 3 inches in size. Instructed to ice area for 20 minutes and take ibuprofen every 6 hrs for pain & swelling.
Came to ER with abdominal pain and vomiting, states is vaccinated, is poor historian. Discharged 9/2/2021 Vaccine date is unknown
After 24 hours after getting booster I started getting fatigue, headache, aches and pains in shoulders, arms, upper legs, and fever. I had to take off work then the next day my urine was dark and a reddish color. I went to the doctor get urine tested and it tested positive for blood in urine. Urine blood went day in 3 days. And that's still an ongoing issue since I got COVID.
Fever; Chills; Dull headache, which wasn't severe, like a London fog; Tried to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Caller states she has a history of cancer and just finished 6 chemotherapy treatments, and now she is taking a pill for treatment.; "chemotherapy treatments" (unspecified if ongoing), notes: history of cancer just finished 6 chemotherapy treatments, now taking a pill for treatment. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer: Unknown, Caller states she has never had any problems before with any vaccines.), for Covid-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer: Unknown, Caller states she has never had any problems before with any vaccines.), for Covid-19 immunization; Covid-19 vaccine (Dose 3; Manufacturer: Unknown (First booster), Caller states she has never had any problems before with any vaccines.), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset Oct2021, outcome "unknown"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Dull headache, which wasn't severe, like a London fog"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "Fever"; SOMNOLENCE (non-serious) with onset Oct2021, outcome "unknown", described as "Tried to sleep".  Additional information: Consumer stated she was calling about the Pfizer Covid vaccine, second booster. Consumer stated she wanted to report right away, her experiences after the second booster. Consumer stated she had fever, chills, and she tried to sleep. Consumer stated the next day she had a dull headache, which wasn't severe, like a London fog. Consumer stated her great nephew who works for Pfizer told her to report the event as soon as possible, so she was doing as he requested. Consumer stated she has never had any problems before with any vaccines. Consumer stated she has a history of cancer and just finished 6 chemotherapy treatments, and now she is taking a pill for treatment. Consumer does not provide the name of the medication or the product information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediately after vaccines were give (R) deltoid became red and redness spread up into neck and face. Child said her throat felt a little itchy, and she started wheezing but was not in resp. distress. Given 2 tsp BENADRYL (25 mg), oral steroid 38mg and albuterol neb with good result. Observed for 1 hour.
15 hours after first Moderna vaccine shot given at 3:30 pm on 4/14/21, I awoke at 6:30 am and noticed difficulty swallowing and tongue feeling "FAT".
This spontaneous report was received from a physician (also reported as a healthcare student with MD degree) refers to a patient of unknown age and gender. On 16-OCT-2013 the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date and route not reported). On an unknown date, the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). On 16-OCT-2013, about an hour after administration, the patient developed pharyngolaryngeal pain. The patient came to the physician's office on and the pain had decreased some but was still present (recovering). Treatment was not rendered for the event. Laboratory diagnostic studies were not performed for the event. The patient sought medical attention. Causality was not reported. Additional information has been requested.
After receiving my TDAP vaccine, I experienced the expected soreness in my left arm at the injection site. But in the early morning of the 3rd day I began feeling extreme pain, which only increased daily to the point where my husband insisted on taking me to the ER.  The pain feels as though my arm is being ripped out of it's socket. It is a constant pain that is only increasing over time. My left arm is completely useless. It is not paralyzed or anything, but is immobile unless I am willing to endure extreme, excruciating pain. The ER sent me home with instructions to follow up with my clinic when they opened that morning (I checked into the ER shortly before 04:00am on the morning of September 25, 2019). My clinic suggested Motrin for 48 hours and to see them if after 48 hours the pain did not decrease. The pain increased again overnight and my clinic was able to see me today, September 26th, around 11am. They suggested 72 hours of Motrin as needed, and told me if the pain is still there on Monday they will send me to a neurologist. Therefore, we are assuming there has been nerve damage.  There was never any swelling, redness, or signs of fever. I am 28 weeks pregnant, with 2 living boys whom have both been fully vaccinated with no issues. My due date is Dec 17, 2019.
Red rash; hives; Very bad arm pain; Left armpit had pain; Could not lift arm; lef shoulder pain; Skin rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very bad arm pain), AXILLARY PAIN (Left armpit had pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm), RASH ERYTHEMATOUS (Red rash) and URTICARIA (hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (Skin rash). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Very bad arm pain), AXILLARY PAIN (Left armpit had pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm) and ARTHRALGIA (lef shoulder pain). On 23-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and URTICARIA (hives). On 22-Jan-2021, RASH (Skin rash) had resolved. At the time of the report, PAIN IN EXTREMITY (Very bad arm pain), AXILLARY PAIN (Left armpit had pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm), RASH ERYTHEMATOUS (Red rash), URTICARIA (hives) and ARTHRALGIA (lef shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 4 month old male patient who turned blue and subsequently experienced a generalized seizure on 11-Jan-2006. On 06-Jan-2006, at 4 months of age, the patient received the second dose of Prevnar, along with a dose of Pediarix (diphtheria/tetanus/acellular pertussis/hepatitis B vaccine/polio virus inactivated) and a dose of Act-Hib (haemophilus B conjugate vaccine (tetanus)). The patient's concurrent illness includes hemangioma of skin (port wine stain on face). Indication for Prevnar was immunization. Product was administered on 06-Jan-2006. dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. Th child's mother reported that on 11-Jan-2006, her infant son turned blue (skin discoloration) and was resuscitated by her. The infant was then seen by the physician and later admitted to the hospital for a generalized seizure (convulsion). Laboratory tests were performed: EEG and MRI results were negative. The child was hospitalized for 2 days. No medications were administered to the infant while hospitalized. The physician noted that the infant "had no reaction with first Prevnar dose" and no previous neurological issues were known. No additional information was available at the time of this report.
Info has been received from a physician concerning a 5 year old female who on approximately 8/27/05, (one month prior to the report) was vaccinated with a 0.5ml dose of varicella virus vaccine live. It was reported that on month prior to this report, in August 2005, the pt developed 15-20 lesions. Unspecified medical attention was sought. Subsequently, the pt recovered. No product quality complaint was involved. The physician also reported that the pt's 1 year old sibling who has not received varicella virus vaccine live developed chickenpox. Additional info has been requested.
Hiccups; This is a spontaneous report from a contactable other health care professional (patient himself). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: En6205), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 15:00 (at the age of 49-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included Htn, sleep apnoea and low testosterone. The patient had no known allergies. Concomitant medication(s) included gabapentin (GABAPENTIN); lisinopril (LISINOPRIL); sildenafil (VIAGRA [SILDENAFIL]); anastrozole (ARIMIDEX) and testosterone (TESTOSTERONE). The patient had no other vaccine in four weeks. The patient not had covid prior vaccination. On 05Mar2021 at 17:15, the patient experienced Hiccups began shortly after injection and have now continued for 36hrs. The patient had not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
Feeling burn and itching behind the ears and under the back hair line; I have redness around those areas and a bit peeling; I have redness around those areas and a bit peeling; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 06Feb2021 at 18:15 (Batch/Lot number was not reported) (at the age of 23-year-old) as single for covid-19 immunisation. The vaccine facility type was others. The patient medical history and concomitant medication were not reported. Patient received birth control was received within 2 weeks of vaccination. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Feb2021, the patient stated that "feeling burn and itching behind the ears and under the back hair line and had redness around those areas and a bit peeling". The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events was unknown. Post vaccination, the patient was not tested with COVID-19. The outcome of the events was resolving.  Information about batch/lot number has been requested.  Follow-up attempts completed. No further information expected.
Patient was given TDaP vaccine thru VFC even through patient has a private insurance which requires private vaccine supply. Clinician informed and verbalized that is fine as long as we chart and file report. RN supervisor reported medication error.
Sore muscle at injection point; Slightly swollen throat; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jan2022 at 10:00 (Lot number: unknown) at the age of 68 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications included: DULOXETINE; NAPROXEN and TEMAZEPAM.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Jan2022 at 20:00, outcome "recovered" (an unknown date in Jan2022), described as "Sore muscle at injection point"; PHARYNGEAL OEDEMA (non-serious) with onset 13Jan2022 at 20:00, outcome "recovered" (an unknown date in Jan2022), described as "Slightly swollen throat". Therapeutic measures were not taken as a result of vaccination site pain and pharyngeal oedema.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Cardiac symptoms(irregular heart beat/abnormal EKG) decreased O2 saturation rash and malaise
Like with my first shot, I woke up at 11:30 p.m. with extreme chills (shaking because of being cold) but I'm sure I had a fever also.  After 2 hours the chills stopped.  I did not sleep much because of this.  I was awake 4 hours, then slept 1 hour, then got up to let my dog out.  I have been in bed much of this next day.  I still feel like I have a temp.  Also headache and I felt a little nauseous this time.
Beginning 10/15/22 I experienced symptoms of COVID-19 with cough, congestion, and headache. I was diagnosed with COVID-19 on day 2 of my hospital stay for Preeclampsia. I was given MUCINEX, acetaminophen, benzonatate, I was given oxygen, I was already on IV fluids. I was ill for 7 days before my symptoms began to resolve, and a slight cough that lingered for an additional 5 days. I delivered my baby girl, 4lb 13 oz at 33 weeks 6 days. I am fully recovered from COVID-19.
After first shot severe fatigue for about 3 weeks; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 (Batch/Lot Number: EW0170) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing Asthma as a child but no adult issues or treatment. Patient did not have covid prior vaccination. covid tested post vaccination no. On an unspecified date the patient experienced after first shot severe fatigue for about 3 weeks. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Red, swollen area 3" x 3" left upper deltoid area. Tylenol and warm compresses advised. No fever.
MYOCARDIAL  INFARCTION; CORONARY ARTERY OCCLUSION; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, fever, and left anterior descending artery blockage, and concurrent conditions included increased triglyceride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 at 13:00 to left arm for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included eicosapentaenoic acid ethyl ester used for unknown indication. On 24-MAR-2021 19:10, the patient experienced myocardial infarction, and was hospitalized (date unspecified). On 24-MAR-2021 19:10, the patient experienced coronary artery occlusion. It was reported that on 11-MAR-2021 at 17:00, the patient played basketball for 50 minutes and he had no medical issues. On 25-MAR-2021 at 19:10 the patient played basketball for 30 minutes and he had heart attack with a coronary artery LAD 100% blockage and was treated with a stent procedure right after a visit to the emergency room.  Laboratory data (dates unspecified) included: Triglycerides (NR: not provided) Increased (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from myocardial infarction, and coronary artery occlusion. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s-Myocardial infarction, coronary artery occlusion. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
This case was reported by a consumer via call center representative and described the occurrence of cold in a 68-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included CRESTOR. On 25th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th May 2018, less than a day after receiving SHINGRIX, the patient experienced cold, influenza-like symptoms and muscle ache. On an unknown date, the outcome of the cold, influenza-like symptoms and muscle ache were unchanged. It was unknown if the reporter considered the cold, influenza-like symptoms and muscle ache to be related to SHINGRIX. Additional information was received as follows: At 14:30, the patient received SHINGRIX on the left arm. The patient gave permission to contact his health care provider. No further details were provided by the caller. Referred the patient to his health care provider for further follow up.
Per mom, "right deltoid red and swollen". Parent took her in to urgent care clinic and was prescribed antibiotic and prednisone.