chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After seeing reports of pericarditis/myocarditis, we contacted pediatrician and were advised that it sounded like a textbook reaction; After seeing reports of pericarditis/myocarditis, we contacted pediatrician and were advised that it sounded like a textbook reaction; Patient started complaining of chest pain on 4th day following 2nd vaccination. Pain made worse by certain movements.  (like leaning forward to pick something up.) It didn't bother him enough to seek; This is a spontaneous report from a contactable consumer (patient).   A 13-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: EW0178,) via an unspecified route of administration on 03Jun2021 at 03:30 pm (age at vaccination: 13 years) on the right arm as single dose for COVID-19 immunisation at Pharmacy or Drug Store. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: EW0185) via an unspecified route of administration on 13May2021 at 12:00 pm on the right arm as single dose for COVID-19 immunisation. On 4th day following the 2nd vaccination on 07Jun2021, the patient started complaining of chest pain. The patient stated that the Pain was made worse by certain movements (like leaning forward to pick something up). The patient stated that the chest pain didn't bother him enough to seek medical care and gradually resolved without treatment by 8th day. After seeing reports of pericarditis/myocarditis, the patient contacted pediatrician and was advised that it sounded like a textbook reaction and that we should report it here. The patient stated that he will have a checkup next week. Device Date was reported as 11Jun2021. The case was considered as serious (medically significant).  The patient did not receive any treatment for the events. The outcome of the events was resolved  Follow up needed, further information has been requested.
This is a spontaneous report from a Non-Contactable Physician via Pfizer Sales Representative.  A patient of unspecified age and gender received TRUMENBA, 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 experienced high fever of 103/104 and headache on an unspecified date with outcome of unknown. Description of Event: Physician reported a patient who experience a high fever of 103/104, headache and had to call for help while in the shower in fear of passing after being given the immunization. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This was a localized reaction with swelling down the left arm and bruising. She also felt very poorly on 9/06 and 9/07. She also felt weak. She went to see her MD, 9/7/12, who felt that she should be of work until he cleared her to return.  She missed work 9/10 and 9/11 and was cleared to returen 9/12/12. MD advised pt. to not take flu shot next year.
This is a spontaneous report from a Pfizer-sponsored program, received from a contactable physician. A male (pediatric) patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had trouble sleeping two nights after receiving meningococcal group b rlp2086. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
unspecified symptoms; Dizziness when lying on her back; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness when lying on her back) and UNEVALUABLE EVENT (unspecified symptoms) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (Dizziness when lying on her back). On an unknown date, the patient experienced UNEVALUABLE EVENT (unspecified symptoms). At the time of the report, DIZZINESS (Dizziness when lying on her back) and UNEVALUABLE EVENT (unspecified symptoms) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.   No treatment information was provided.
Red papulo-vesicular rashes all over trunk and buttocks, some are extra-pruritic since yesterday; some of the lesions are now crusted. Supportive measures and monitor temperature.
This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in her lips) and LIP SWELLING (lips were completely swollen) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling in her lips) and LIP SWELLING (lips were completely swollen). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Tingling lips and Lip swelling, at an unspecified dose and frequency and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Tingling lips and Lip swelling, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (tingling in her lips) had resolved and LIP SWELLING (lips were completely swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided.
Felt SOB, felt cold and sweaty. Headache. Backache, generalized muscle soreness. Redness, tenderness warmth at injection site (L) deltoid.
Multiple lesions on trunk, ankles, neck erythema with central vesicle, itchy (total of 15)
Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non healthcare professional (office staff) by phone. This case involves a 4 months old female patient who was vaccinated with a one time dose (also reported as 0.5 ml) of PENTACEL (Batch number: UJ065AA, expiry date: 16-Oct-2020) via intramuscular route in the left thigh on 12-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because PENTACEL had undergone a temp excursion during delivery. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Influenza vaccine administered. Patient got up and walked across room and fainted; several minutes later. She woke up 2-3 seconds later and became alert.
rash on the legs feet & palms of the hands & same on the face; mom instructed by MD to take DPH 3 times a day; mom told nurse on 5MAR93 that pt was taking PCN the prev wk;
Pt received TD on 6/17/01 due to a laceration on left middle finger. Pt returned on 7/2/01 complaining of left arm pain that radiates down to fingers. Describes pain as sharp and throbbing. Pt had been in for further exam and evaluation. Also, complained of loss of ROM of left arm. Pt had been treating with Motrin and Valium. Pt seen on 7/30/01 with symptoms of brachial neuritis.
Guillain-Barre Syndrome, Burning in feet, hands, and face, Tingling in feet, hands and face. Pain in feet & hands. Numbness in fingers.
Information has been received from a health professional concerning a 14 year old female who on 12-MAR-2007 was vaccinated with Gardasil (Lot 653736/0014U). On 13-MAR-2007 the patient experienced a rash on her chest, back and face. On 14-MAR-2007, the patient experienced fatigue. On that same day, the patient went to see her pediatrician who placed her on therapy with hydrocortisone (manufacturer unknown) and BENADRYL. The patient did not improve and hydrocortisone and felt to be ineffective (WAES#0703USA04721). On 16-MAR-2007, the patient experienced vomiting and diarrhea. The patient's rash, fatigue, vomiting and diarrhea persisted. Additional information has been requested.
COVID AFTER RECEIVING THE JANSSEN COVID 19 VACCINE; This spontaneous report received from a patient concerned a 42 year old male. 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: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced covid after receiving the janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after receiving the janssen covid 19 vaccine was not reported. This report was non-serious.
Cold sores outbreak on 2 occasions. 49 years old and I have never had a cold sore previously in my entire life.
Chills, fever, hive like rash all over body a week after, and smells and tastes are no longer the same. There is a certain taste and smell (which are the same) that quite a few foods and other things taste and smell like.
Patient describes ongoing Left shoulder pain swelling and soreness since the date of vaccination on 10/12/2016. Patient noticed "a little bump which went away but the soreness continued."
Patient got a SHINGRIX vaccination and she developed dizziness, sweating and weakness and lost bladder control.  She did not lose consciousness but I called 911 because she wasn't feeling any better. After paramedics examination it WAS found out that her vitals are ok but she felt dizzy while standing up so they took her to the ER.
Patient became glassy eyed and pale. She was completely non-responsive. She lost muscle control in her body (like a ragdoll). This time I video taped her reaction. I decided to continue to vaccinate given the current whooping cough outbreak and because my pediatrician said there are no CDC reports of a child who had an adverse reaction having subsequent reactions to vaccines!!!!!!  She also said there are no reports of permanent damage, but since her vaccines she has lost skills, particularly motor-planning and imitation skills such as being able to stick her tongue out (motor planning and imitation). I can see that she tries to move her tongue inside her mouth but is no longer able to stick it out. She was doing this consistently before the vaccines. She is now waking up every 2 hours at night (previously woke up once at 4 am and 6:30 am and then slept until 9). Now will shriek and not be able to self-soothe and put herself back to sleep. She also is overly active and fussy. I can only describe it like she is driven by a motor for the past 5 days. Her heart beats fast and she literally pants out of exhaustion from kicking and moving. She no longer is consolable and pleasant. She cries most of her waking hours and seems unhappy. This is a different child than what she was before these vaccines. Dr. spent almost an hour with her and SAW what a pleasant happy baby she WAS!!!!
My grandson was force vaccinated against my daughter's consent. My daughter has a severe learning disability and has authorized me to advocate on her behalf, so I'm helping her submit this report.  We've observed seizures, muscle freezing, problems with constipation and diarrhea, and high pitched screaming starting spring of 2016. He was taken from her at birth and her now ex-husband, a convicted pedophile only allowed her to hold him twice. They were rescued from their predator, but father was able to manipulate 50/50 custody. Patient was force vaccinated without her consent on two additional dates in 2016. We will fill out separate forms for the other two dates.
Foot soreness; A spontaneous report was received from a consumer on 29 Dec 2020. This case concerns a 68 year old female patient. The patient is a participating in the mRNA-1273 Emergency Use Program and experienced foot soreness with the use of mRNA-1273.    Relevant medical history included foot soreness. There were no concomitant medications provided.  On 29 Dec 2020 the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the non-serious event foot soreness. It was noted the patient experienced the event of foot soreness prior to vaccination and she went to the urgent care seeking treatment on 30 Dec 2020. She was prescribed cephalexin for treatment. It was also noted the reporter did not believe the urgent care visit had anything to do with his wife getting the vaccine.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event of foot soreness was not reported.   The event of a little soreness was not recovered/not resolved at the time of this report.; Reporter's Comments: Based on the current available information the event is unrelated to vaccination (started prior to the first dose of the vaccine).
13AUG94 pt temp nl auxillary; no localized react; slept a lot; appetite poor; 14AUG94 fussy & irritable; t99.4 330PM ax; temp in ER 105 R; IV therapy started; APAP suppositories; adm to hosp; treated w/IV's APAP & ATB;
Received the Shingles vaccination yesterday around 11. Arm was very sore - I applied ice and took ibuprofen. Around 12 hours later developed fever, chills, shivering, achy joints, slight nausea. Woke up at 22 hours post-vaccination feeling achy and a little light headed, and low energy. Took more ibuprofen. Not recovered at 24 hours post injection, but assume will resolve within a day or so.
T103 4AUG98 noticed lt arm swollen below arm pit 5AUG or 6AUG;recv APAP 2-3X;19AUG98 swollen area remains below lt arm pit;referred to PMD;
Within 2 weeks of my second COVID-19 Pfizer vaccine (my vaccine was 04/22 and my reactions started around 05/05), my scalp started itching regularly. Through patch tests, it was discovered that I became allergic to propylene glycol during this period, which was in my hair products. This progressed over the months to full-blown hives, which will now extend all the way down my body if I come into contact with propylene glycol or ingest it through pills. This will likely be a lifetime allergy.
I was very tired during the day.  More so, as the day went on. Sometimes, I am tired during the day.  It was only obvious that this might be a side effect later in the day. 1-2 cm blisters at antecubital site on left arm, which was the extremity of vaccine injection. My neck was sore.  At first, I thought I had just slept so long that first night, that I was sore from that.  It was more sore than from an odd sleeping position.  My left neck/trapezius muscle at insertion in neck.
the child woke up around 3am that same night with a nosebleed (only had one once his whole life, years ago) and stating that there were bugs on the bedroom walls. I made sure child was fully awake before asking what he was pointing out at the wall for, child stated again, there are bugs like spiders all over the walls. The next night patient also stated the same, and a few more nights since then. That had never happened before the vaccine. 2 weeks later patient had fever for 3 days.
8 days after vaccination pt noted a 1.5 - 2 in diameter pale red area with speckled dots around her injection site. 4 days later on 2/22/2021 area was larger at 2.5in x 3in area that was pale red with red dots dispersed around the injection site. Pt did take antihistamine on 2/21/2021 for headache and sinus. Reported very minor itch or irritation to the area but not pain, warmth or swelling. Pt saw her primary provider on 2/24/2021 due to area still present. No treatment course given per her primary provider. Pt reported on 2/25/2021 that the area was not a pale pink color and less noticeable but the size was the same. She feels it is starting to subside. No other s/s of reaction reported.
keeps smelling sulfur but sulfur smell was not constant and not persistent; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in right arm, administration date 10Mar2021 12:30 (Lot number: EN6207) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAROSMIA (non-serious) with onset 13Mar2021, outcome "not recovered", described as "keeps smelling sulfur but sulfur smell was not constant and not persistent".  No follow-up attempts are possible. No further information is expected.
Information has been received from a 63 year old female patient with an allergy to MINOCIN. The patient was vaccinated with .65ml of ZOSTAVAX on 28Oct2011. Concomitant medications reported included: prednisone and anti-inflammatory medications. The patient had pain in her left hand which started right after the injection. In mid November the left hand had gotten worse. The patient felt tired and feverish as well. The patient went to a rheumatologist where blood work and rheumatoid arthritis test (unspecified) was completed. The patient was diagnosed with arthritis and was placed on methotrexate. The patient continues to experience pain with tiredness and lack of energy (considered to be symptoms of arthritis). The patient believes the ZOSTAVAX is directly responsible for her arthritis. It was reported the patient sought medical attention and was treated with a cortisone shot. The claimed event has improved some on methotrexate. It was reported the patient could not work. The patient is recovering. Arthritis was considered disabling. Additional information has been requested.
approx 1 hr p/vax crying incontrollable temp 103.6 R 3PM inject; would not take formula; seen by MD 22OCT93; both legs were quite sore; had otitis;
Fever with great weakness.  Bedridden for several days.  Gained mobility and strength over the next 8 weeks with 6 weeks of physical therapy.  Visits by home health care including a nurse.
This spontaneous report was received from a 60 year old female patient who was referring to herself. The patient concurrent conditions were allergies, allergy to ragweed, oak, mold, dust and mildew. The patient's concomitant medications included allergy shots, NEXIUM for acid reflux, LYRICA for neuropathy and vitamins. On 08-NOV-2017, the patient was vaccinated with ZOSTAVAX to prevent shingles (dose, route, lot number and expiration date were not provided). Other suspect therapies included sterile diluent. On 09-NOV-2017, the patient's arm from the injection site down to the elbow was red and felt hot. The patient put ice on it, however it did not help. The patient stated there was no rash. On 10-NOV-2017, she went to the pharmacy where she had vaccine administered and was advised to talk with her physician. There was no laboratory diagnostic studies performed. The patient present status was not recovered. The relatedness between the event and suspect therapies was not reported.
PATIENT REPORTS DIZZINESS, FLUSHING / REDNESS ON FACE / ITCHY RASH ON FACE AND ON ARM AROUND THE INJECTION SITE.  PATIENT SAID SHE FELT FINE AND SHE LEFT THE STORE.  PHARMACIST CALLED PATIENT LATER AND SPOKE TO PATIENT.  PATIENT SAID THE REDNESS ON THE FACE IS GONE ALREADY.  ONLY HER ARM -THE INJECTION IS RED.  PATIENT CONSULTED AND KNOWS TO MONITOR FOR SIGNS OF ALLERGIC RXN AND WILL TAKE ANTIHISTAMINE IF NECESSARY.  PT WILL MONITOR AND GO TO ER IF START TO FEEL TIGHTNESS OF THROAT AND HAVE TROUBLE BREATHING.  AT THE END OF THE CONVERSATION ON THE PHONE, PATIENT SAID SHE FELT WELL AND WILL WAIT TO TAKE  ORAL ANTIHISTAMINE  AND WILL MONITOR HERSELF.
Heart attack; Irregular heartbeat; This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat). The patient was hospitalized on 24-Mar-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and HEART RATE IRREGULAR (Irregular heartbeat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Beta blocker (unspecified) and statin (unspecified) for an unknown indication. Treatment included few stents inserted for the heart attack.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
A couplle af days after shot hard sore lump about a couple inched below injection site occured. Then 2 weeks later a Red rash below injection site about the size of 2"x2" appeared.  Sharp pain like porqupine quills. Rash was red dots like broken blood capilaries and very itchy. Lasted a few days. Kind of scabed over. Reminded me of a shingles rash and pain. Very tired for the following month.
As I was driving home after my vaccine, pain and heat started to radiate from the injection site up my left shoulder to the site of a previously torn rotator cuff.  The pain and heat then traveled across my back to my right shoulder which also has a torn rotator cuff.  The pain increased and I felt the need to keep rotating my arm/shoulder.  The intense pain continued for the next 2 weeks.  Then the pain also moved up into my neck on the left side and up across my head and down my face  There was and is a slight numbness on the left side of my face.  After a week (or so) I contacted my primary care physician to see if she'd heard of similar reactions with other patients which she had not.