chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 15Apr2021 at 10:45 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), vitamin b complex (VITAMIN B), ascorbic acid, colecalciferol, zinc citrate, allium sativum bulb, sambucus nigra fruit, piper nigrum fruit, echinacea purpurea whole plant (IMMUNETI), fexofenadine hydrochloride (ALLEGRA) and probiotic (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 25Mar2021 at 15:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced sore arm and slight headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and slight headache were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient received DTaP when provider order Tdap based on patient age he did not receive the required dose of his recommended vaccine
The patient was given a booster/3rd dose of pediatric pfizer on 12/3/21 by the provider.  The patient tolerated the injection well and was able to leave after allotted wait time.  There were no reported side effects reported.
Developed several red areas on chest & neck.  0 hives, 0 sob, 0 coughing, 0 wheezing.  Pt states she has routine undiagnosed allergies & not unusual for her to develop frusney when nervous also.  Refused BENADRYL.  Pt states she's allergic, but did not list as allergy on screening.  Refused epinephrine.  Areas resolved within 30 minutes. 0 further signs/symptoms.
Erythema, swelling and itching in a 4 cm area immediately below the site of injection.
This 4 year old child had a 12"length x 5"width red, painful, hot swollen lump on his left side thigh. It was hard to the touch and it was getting progressively larger. A 10 day antibiotic, amoxicillin, regiment was given to prevent any infection on site.
Severe swelling in left arm at the site of inoculation with redness and  rash
I woke up with four am and I had diarrhea from that time until about noon. I was lethargic and had chills but no fever. I had the chills and a headache the next day. Saturday, I started feeling better with just a very mild headache. On the 11th, though, I called the doctor in the later afternoon. I went to Urgent Care - where I saw Dr.  at 06:00 that night. No treatment. By Sunday, I was okay.
Hypertension. Severe swelling of hands feet. Nausea diarrhea headache cognitive impairment
Got vaccine & still got Shingles/Suspected vaccination failure; Bells Palsy; Got Shingles on right-side of my face and head; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, bell's palsy and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, bell's palsy and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got shingles vaccine and still got shingles on right-side of his/her face and head along with bell's palsy. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Severe gout in left knee that is not responding to nsaids indomethacin, ibuprofen, aleve or colchicine or cortisone injection.  Have been unable to walk for almost 2 weeks now and have not been able to go to work.
approximately 24  hours after administration, I had vertigo and nausea lasting for approx 6 hours. I was treated with  zofran with some improvement. I was able to get to sleep and in the morning the symptoms had resolved
Noticed swelling, pain, redness at site of KINRIX. Area approx 1 1/2" diameter. Continued to swell and turn more red. Returned to Clinic on 10/8/09 site approx very swollen, c/o sore throat, body aches.
Anxiety and  Pyrexia . Negative all other symptoms. Pt held for observation and provider released
School noticed redness around left arm injection site on Tuesday morning notified mom and applied ice to the area. Redness started to spread down (L) arm on Tuesday afternoon. Child was seen in Dr. office on Thursday am. Treatment included MOTRIN and cool compress.
Flu symptoms--body aches, low grade fever, headache, fatigue. Flu, COVID  RSV test negative. Was treated with Tamiflu. Symptoms resolved in 48 hours.
UTI; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. Consumer mentioned currently taking antibiotics for her UTI on an unspecified date. Consumer wanted to know if it is okay for her to take the second dose while on antibiotics therapy. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
pt brought to ED via EMS after a fall at home; weakness and SOB (x 3dys), productive cough; found to be positive for COVID and flu; pt's condition worsened and he required CPR (x20min); pt died in the ED
4/23/21-Chills, Feverish, Nausea, Back Muscles Aching, 4/25-same except no feverish or chills, 4/26-21-Felt worse, no appetite, back muscles aches worse, headache, low energy, fatigue, sleepless, 4/27/21-Same except back muscle aches worse, 4/28/21-Same, Rapid covid test-negative, urinalysis-negative, prescribed muscle relaxer chlozoxazone, 4/30/21-Same, switched meds from chlozoxazone to ETODOLAC, 5/3/21-Same, more muscle aches all over, anxious, increased dosage of ETODOLAC, 5/3/21-Same, more muscle aches all over, anxious, added cyclobenzaprine, 5/5/21/21-Same, Lab work, urinalysis abnormal, 5/7/21-Primary Doctor, Waiting on lab results, 5/12/21-Doctor, more lab tests, received lab results,  Elevated absolute eosinophils (599)  and low sodium (132).  Referred to Allergist, Nepherologist, Rheumatologist.  As of day 61 (6/20/21) I am still unable to work due to chronic fatigue, muscle aches, headaches, brain fog, not able to concentrate or focus, etc.  Repeating lab work to see if results have changed.  As of today, 7/14/21 (Day 82) I am still on medical leave.  Absolute eosinophils have been reduced to 399.  More tests from Rheumatologists.  I have not worked since 4/23/21.
flu like virus; may have got a bad lot from the pharmacy or maybe it is just my body; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Jul-2021. The most recent information was received on 26-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like virus) and FEELING ABNORMAL (may have got a bad lot from the pharmacy or maybe it is just my body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included Flu like symptoms.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like virus) and FEELING ABNORMAL (may have got a bad lot from the pharmacy or maybe it is just my body). At the time of the report, INFLUENZA LIKE ILLNESS (flu like virus) and FEELING ABNORMAL (may have got a bad lot from the pharmacy or maybe it is just my body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 antibody test negative: negative (Negative) negative.         On an unknown date, post vaccination, the patient reported that he experienced symptoms of flu like symptoms.   No treatment information was provided  No Concomitant information was provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant : Patient Details provided
He developed a rash. He was "not feeling well".  "He had pain and listlessness and said he was tired."
She received the vaccine the morning of 17 Sept 09 and was well at the time. By the next morning she had rhinorrhea, nasal congestion and cough. 48 hours after the vaccine she developed fever and chills and headache and then as the week progressed she developed wheezing, and temps to 103.5.  She did not seek treatment until 23 Sep 09 when her hands and feet began to swell. By this time the temp and wheezing had subsided but she could not wear her rings and her shoes were tight due to edema. She states she gained > 10 lb of fluid weight. She received conservative tx and 72 hours quarters. Will do full evaluation before she is given the H1N1 vaccine. Symptoms: Fatigue; malaise > 60 days, chills, dry, bronchospasm, nasal drainage, fever, headache, migraine.
Bad headache (and I rarely get headaches), whole body aching, especially right arm, chills, stomach ache. My students complained they were hot, but I was wearing my coat and freezing.
Hard and red right deltoid with 5 hive like bumps and bad body aches for 3 days.
I developed a blood clot.  I went to an urgent care and was directed to the emergency room.
Pt was diagnosed with hypertension on 5/21/03 after 3 days of a consistent severe headache. BP was noted to be elevated 149/110 by pt then she presented to MD with BP 140/108. Pt was started on Diovan MCC 160mg. Pt was seen 3/6/03. She complained of headache, mild 3/9, moderate 3/10, turning to illness (feverr, diarrhea, headache, chills) on 3/11-3/12. Had moderate headache 3/11, then mild headache 3/12 and 3/13. On BP meds.
On 04/06/2023, I had exercised for an hour and was about to go shopping. I was in a store, and I suddenly felt like I was going to black out. Everything went black before my eyes briefly. I went to my car until I felt ok to drive home. On my way home, I could tell my heart was out of rhythm. When I got home, my pulse was at 185. I tried some maneuvers that I've been taught to get my pulse down myself. When that was unsuccessful, I called an ambulance. I was transported to a local hospital. From there, I was in the emergency room for a long time. They decided on my blood work, to admit me. My cardiac enzymes were rising, so they admitted me on an observational basis. I was discharged the next day and saw my cardiologist who said that I had a type 2 myocardial infarction based on the elevated heart rate. He did some medication changes, and I will follow up with him to discuss further options.
cannot currently walk without assistance; no sensation from the waist; This spontaneous case was reported by a consumer and describes the occurrence of PHYSICAL DISABILITY (cannot currently walk without assistance) and HYPOAESTHESIA (no sensation from the waist) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHYSICAL DISABILITY (cannot currently walk without assistance) and HYPOAESTHESIA (no sensation from the waist). At the time of the report, PHYSICAL DISABILITY (cannot currently walk without assistance) and HYPOAESTHESIA (no sensation from the waist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter  Treatment information was not provided.   Reporter did not allow further contact
Mom states t104 was taken to Er & given APAP; States was Ok p/that;
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (used expired vaccine) in a 52-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006C21A) for COVID-19 immunization. No medical history reported. On Sep 13, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 13, 2021, patient administered expired product (used expired vaccine). On Sep 13, 2021, administered expired product  (used expired vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vaccine was administered after 3 days from time from first puncture. Most recent follow-up information incorporated: On Sep 28, 2021: Follow-up received contained relevant information. The vaccine was administered after 3 days from time from first puncture added in narrative.
10/4/21: 10 mins post-dizziness for a few minutes.  10/8/21: 4 hrs vertigo/slurring words 10/8/21-4/2022: Severe Vertigo, confusion, Shortness of Breath, numbness tingling of hands, legs and feet, dizziness with normal movements (standing up, turning head, turning around, when getting too hot or tired), fatigue, headaches every morning, nausea, vomiting and diarrhea.  10/15/21: Went to Emergency room for pressure on chest, shortness of breath, pain in sternum, vomiting, pain between shoulder blades, lower back pain, abdominal pain.  10/16/21: Emergency Surgical Procedure to remove gallbladder. MRI showed problem with liver and kidneys were struggling per Surgeon and surgeon stated that have no explanation as to why my organs were having complications. Stated in hospital for observation and IV.  Present day: Dizziness, fatigue and nausea.  All labs and head MRI shows normal results.  Gave birth, no complications, labs showed no concerns to OBGYN.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 56-year-old female patient who received SHINGRIX (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis. On 1st March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd March 2019, 1 days after receiving SHINGRIX, the patient experienced fever and chills. On 4th March 2019, the patient experienced swollen mouth, difficulty breathing, unable to swallow, pain and tingling of extremity. The patient was treated with BENADRYL. On 4th March 2019, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the swollen mouth, difficulty breathing and unable to swallow were recovered/resolved and the outcome of the pain and tingling of extremity were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, swollen mouth, difficulty breathing, unable to swallow, pain and tingling of extremity to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On 2nd March 2019 and 3rd March 2019, the patient experienced chills and fever. Three days after vaccination, the patient experienced mouth swelling, difficulty breathing and swallowing, aches, pain, and tingling in her left arm. On Monday morning, 4th March 2019, she felt fine. However, in the afternoon, her mouth began to swell, causing her to have difficulty breathing and swallowing. She took BENADRYL and the symptoms resolved. Then, after an unknown time on the same day, she began to experience aches, pain, and tingling in her left arm that has not resolved. The reporter did not consent to follow up. The reporter was unable to obtain additional information.
positive for COVID 19; positive for COVID 19; SHE WAS NOT TRUTHFUL WHEN I ASKED her if she was feeing well and meeting the site requirements to be at work and then she felt worse on 23Dec; did have a ST; Dose Number:3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 21Dec2021 (Lot number: FF2589) 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: IMMUNISATION (medically significant) with onset 21Dec2021, outcome unknown, described as Dose Number:3; DRUG INEFFECTIVE (medically significant) with onset 23Dec2021, outcome unknown, COVID-19 (medically significant) with onset 23Dec2021, outcome recovering and all described as positive for COVID 19; MALAISE (non-serious) with onset 21Dec2021, outcome recovering, described as SHE WAS NOT TRUTHFUL WHEN I ASKED her if she was feeing well and meeting the site requirements to be at work and then  she felt worse on 23Dec; OROPHARYNGEAL PAIN (non-serious) with onset 21Dec2021, outcome recovering, described as did have a ST. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive. It was unknown if therapeutic measures were taken as a result of covid-19, malaise. At Workplace clinic facility where the most recent COVID-19 vaccine was administered. The patient receives any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient has been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events immunization, drug ineffective and covid-19 and the suspect drug BNT162B2.
developed congestion, cough and low grade fever 1 day later. cough persisted > 11 days.
Individual started complaining of an itch in her throat and felt some degree of lymph node swelling on the right side. Collective symptoms include: anxiety, flushing, short term paresthesia, right sided facial swelling, difficulty swallowing, right sided facial droop, medicinal taste. some slurring.  Individual was taken to the ed in house, triaged, treated and released. Reporter is not privileged to details of treatment, but aware of release within hours of being seen.
Golf ball sized lump at injection site, body aches, fever, headache behind right eye, throbbing severe every day since vaccine 24 NOVEMBER 08. Nausea during headache, dizziness, sharp pain for 2-3 hours on right side of face. Limited vision and light sensitivity.
Pt died after being diagnosed with COVID concurrently with a devastating left thalamic IPH with extensive IPH and ventricular blood.
Information has been received from a clinic worker, concerning a patient with an unknown medical history, who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck), instead of zoster vaccine live (MSD). It was unknown if medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Patient became limp unresponsive,pale,slumped in chair, ammonia ampule used to gain responsiveness.Positioned verticle on exam table, vital signs taken.  Responded quickly to ammonia ampule. No history of fainting with other vaccines. discharged from DOH alert, talking, walked to car. Episodelasted about 8 seconds.
pt developed persistent severe hives 48 hours after second covid vaccination that has continued.  she has no previous history of urticaria or adverse reactions to vaccinations in the past. hives have not resolved with courses of systemic steroids, high dose oral antihistamines, or h2 antagonists
Sweating; tenderness on the arm where the vaccine was administered; Chills; Injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (tenderness on the arm where the vaccine was administered), CHILLS (Chills) and INJECTION SITE PAIN (Injection site tenderness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (tenderness on the arm where the vaccine was administered), CHILLS (Chills) and INJECTION SITE PAIN (Injection site tenderness). At the time of the report, HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (tenderness on the arm where the vaccine was administered), CHILLS (Chills) and INJECTION SITE PAIN (Injection site tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
the vaccine was not strong enough; diagnosed with shingles; This spontaneous report was received from a 63 years old female patient referring herself. The patient's concurrent condition was not reported. The patient's drug reactions/allergies included, antibiotics, sulfa drugs, Bacitracin. On an unknown date in May 2017 (reported as mid May of 2017) the patient was vaccinated with zoster vaccine live (ZOSTAVAX), subcutaneously in upper arm (strength, dose, lot/batch number, expiration date was unknown) for shingles.  On an unknown date in April 2019 (reported as a month ago), the patient experienced severe headache on the left side of the head. On an unknown date in May 2019 (reported as about a week ago), the patient experienced itching, pain, puffiness, redness, watery eyes, flu like symptoms, and blisters on face and underneath the eyes. The patient visited the physician and was diagnosed with shingles (herpes zoster). The physician stated that the patient got the shingles as the vaccine was not strong enough (therapeutic response decreased). On an unknown date in May 2019 (reported as weekend of holiday), the patient visited the urgent care and was prescribed with antiviral medicine Valacyclovir to help with itching and pain. No product quality complaint was involved. The outcome of therapeutic response decreased and herpes zoster was reported as not recovered/not resolved. Causality assessment was not provided.  Upon internal review the event shingles (herpes zoster) was determined to be medically significant.