chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of rash in a 57-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number FH9NA, expiry date unknown) for prophylaxis. Co-suspect products included BOOSTRIX (batch number K5F5R, expiry date unknown) for prophylaxis. Concurrent medical conditions included meat allergy (Allergy to pork). On 18th February 2019, the patient received FLUARIX QUADRIVALENT 2018-2019 season and BOOSTRIX. On 18th February 2019, less than a day after receiving FLUARIX QUADRIVALENT 2018-2019 season and BOOSTRIX, the patient experienced rash and tingling. On 18th February 2019, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the tingling was unknown. It was unknown if the reporter considered the rash and tingling to be related to FLUARIX QUADRIVALENT 2018-2019 season and BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received one vaccine in the right deltoid and the other in the left deltoid. Withinn about 15 min , patient stated feeling a tingly feeling all over. The reporter stated she saw nothing visual (no hives etc.), however. Provider assessed the patient, there was a slight rash, no hives, and provider considered her fine, no other side effects. The patient rubbed area and rash went away quickly. Then the patient was released. No follow-up issues at the time of reporting. The reporter agreed to follow up from GlaxoSmithKline.
7-10 cm erythematous circular lesion to the area of injection site of L thigh
Day 2-4 swollen glands in left side of neck Days 6-8 104 fever, chills, extreme body aches, vomiting, diarrhea, headache, cough, abdominal pain when I cough.
Pt reports received covid vaccine on 3/6/2021 to R deltoid. The next day (3/7) she woke up and R side of cheek was bright red. No warmth/swelling. No bumps or sores. No difficulty breathing or swallowing. Feels completely fine, just the redness noted. She call PCP on 3/8 to report.
sx began approx 5hr p/vax;rt arm became sore, red & swollen down to fingers;progressed to generalized pain on whole rt side of body;pt thinks also had fever (didn't take temp);sx subsided w/in 24hr;
pt recv vax;gen red rash, slightly raised w/ itching & bruising;fever up to 102;
Waves of extreme nausea, along with chills; Waves of extreme nausea, along with chills; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient (unknown if pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 07Apr2021 at 11:00 (at the age of 35-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. 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. On 07Apr2021 at 18:00, the patient experienced waves of extreme nausea, along with chills. Terrible for first 24 hours. It was reported that the second 24 hours had been milder, but still nauseated. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the reported events. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache, nausea-vomit, restless-can't sleep, body aches, heavy feeling.
Severe headache for days since vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache for days since vaccination) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     None.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Severe headache for days since vaccination). On 30-May-2021, HEADACHE (Severe headache for days since vaccination) had not resolved.            On 25may2021, post vaccination, the patient reported that she experienced symptoms of severe headache.  No treatment information was provided No conmed information was provided
approximately 6-7 hours after receiving the Prevnar 13 vaccine, mother reported baby (patient) having bulging fontanelle, fussiness, decreased feeding- lasted all night. Improved about 20 hours after. Mother had wanted pt to get vaccines spaced out since pt had bulging fontanelle, fussiness with his 4mo WCC vaccines (was taken to ER for this),  and was hoping that by giving one vaccine at a time, this would be avoided.
Patient felt dizzy after seeing a small amount of blood at the injection site. She was advised to sit down for 10 to 15 minutes. After a few minutes the patient got up and tried to go to her car to wait it out, but lost her balance and went to her knees. We brought her a chair and gave her water. She was feeling better after a few minutes but had her husband pick her up so she didn't have to drive.
Fever, Malaise, Fatigue, Shortness of breath.  Symptoms started on 06/07/2022, Received positive test on 06/08/2022.
J and J vaccine 7 days of HA, tiredness and swollen lymph nodes in neck and under left arm with generalized alopecia for several week, given in April 2021. Moderna vaccine 10/28/21: HA, fatigue, hair lossmus and nerve pain in both feet. tinnitus, shortness of breath, frequent urination and waking in night to urinate, dizziness, light headed. All continuing until now.
Patient states she has a swollen, painful, pink lump approximately 1/2 apple in size at injection site.
beginning 30AUG96 pt had fever of 102-103;broke out w/rash couple of days later which was bumpy, maculopapular, red, confluent, itchy, began on back & abd then travelled to face & legs;emesis x2;earache, sl cough;rash faded as of 10SEP96
Pt recv vax on 12/16/98; 5.5 hr post vax pt exp headache, vomited x2, cold sweat/clammy, medicine taste in mouth, heightened senses
Covid vaccine monitoring documentation. PT with positive Covid who was vaccinated. PT was not tested here, patient tested at hospital and positive 111/21. Admission 11/1/21 ? 11/6/21. PT vaccinated with Janssen Lot 042A21A on 5/4/21.  Primary diagnosis documented as Acute hypoxic respiratory failure, COVID-19 pneumonia.
Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25May2023 at 14:30 as dose 6 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cataract surgery", start date: 23May2023 (not ongoing). Concomitant medication(s) included: METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID] oral (ongoing); GLUCOSAMINE oral (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , Lot number and expiration date not provided.), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE , Lot number and expiration date not provided.), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE , Lot number and expiration date not provided.), for COVID-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE , Lot number and expiration date not provided.), for COVID-19 immunisation; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE , Lot number and expiration date not provided.), for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 26May2023 at 06:30, outcome "unknown", described as "Dizzy". Therapeutic measures were taken as a result of dizziness.  Additional Information: It was reported that she noticed when she first got up. It was about 6:30 in the morning. Treatment/ Intervention was only lying down. There were no prior vaccinations within 4 weeks. Indication for use of metamucil was reported as regularity and for glucosamine it was reported as to give flexibility. The report was not related to study. No investigations reported.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Dizziness, vertigo. It is worse when I am lying down or if I lean over or bend down.
14x15cm indurated, blached. erythematous rash on the left upper arm. No drainage, site warmth upon palpitation. + TTP +neurovascularity intact.
Pt fainted after immunes given, woke right back up. Vital signs stable. Patient kept back for 15 mins and drank water.
Myalgia & Fever Narrative:  onset of body aches and feeling warm overnight after shot, now feeling febrile.
HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache. This report was non-serious.
pt recv vax 25JUN96 & 26JUN96 pt devel hardness & redness @ the inj site which was also hot;pt screamed in pain when the area was touched;area seemed to inc size over a 12hr period;
7/31/05 arm started to swell. 8/1/05 arm per parent swollen size/length of baseball, purple and red. Took to family Dr who advised Tylenol, Benadryl. That evening ER Benadryl, antibiotic rx. Improved 8/3/05.
I had headache and nausea for the rest of the day that I got the vaccine. After that I was fine.  As a result I didn't feel like doing anything but laying down. Also as expected, I had pain at the injection site.
vision loss; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: 183599) solution for injection, via an unspecified route of administration in left arm on 20Jan2021 at a single dose for Covid-19 immunization. Medical history included pacemaker, vitiligo, psoriasis, blood pressure, and autoimmune disorder. Concomitant medications included blood thinners and blood pressure medications. The patient experienced vision loss on an unspecified date. It was reported that patient went for an office/clinic visit to a doctor or other healthcare professional. Also went emergency room/department or urgent care. Patient did not receive any treatment. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 since vaccination. Covid-19 virus test: negative. The event was reported as non-serious however it caused disability. Outcome of the event was not recovered.  No follow-up activities are needed. No further information is expected.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On 26-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported) at an unspecified hospital. The pharmacist noted that the patient reported that after receiving ZOSTAVAX he experienced an injection site reaction. On 28-JUL-2013, the patient experienced general malaise, tenderness and warmth at the unspecified injection site. No treatment was given for the events. No medical attention was sought. The outcome of general malaise, tenderness and warmth at the unspecified injection site was reported as recovering. Additional information has been requested.
Pt received Pneumococcal vaccine (Pneumovax 23 Merck) Lot 0486U on 7/15, Sunday while she was an inpatient at this institution. Pt was dismissed on 7/16. On Tues 7/17, she called the pharmacy to report hives, " little red bumps", which had appeared that morning at the injection site and that she had had a 100.2 fever overnight. Suggested she take Benadryl if the hives were uncomfortable and to report to her primary care physician
PATIENT DEVELOPED A RASH ON THE AREA OR A LITTLE BELOW THE AREA WHERE SHE RECEIVED THE SHOT. PT STATED IT DOES NOT ITCH BUT WAS TENDER THE NEXT DAY.
Bilateral arm and hand pain, numbness in fingers. Arms go completely numb when driving or holding grandson. Only time they are not numb is when he is standing up. It started the same time he got his COVID vaccine.
IMMEDIATELY AFTER ADMINISTERING THE SHINGRIX AND FLU SHOT PATIENT STATED HE WAS NOT FEELING WELL. I NOTIFIED THE PHARMACIST ON DUTY. PHARMACIST REPORTS PATIENT IS NOT FEELING WELL AND STARTS SHAKING ALMOST LIKE A TREMOR ,HE KEELED OVER IN THE BENCH CHAIR SIDEWAYS LOST CONSIOUSNESS VERY BRIEFLY AND ASKED TO CALL EMS. PATIENT SAT UPRIGHT REGAINED CONSIOUSNESS AND SAID FELT BETTER. PATIENT SAID WAS COLD AND SWEATY. HE ASKED FOR WATER . PARAMEDICS TOOK HIS VITALS AFTER ARRIVAL DID NOT SAY WHAT VITALS WERE BUT SAID WERE LOW SUGGESTED GOING TO HOSPITAL AND DECLINED . PATIENT WALKED OUT OF HERE AND SEEMED FINE.
This spontaneous report as received from a registered nurse via a company representative refers to a female patient of unknown age. On an unknown date in 2008 the patient was vaccinated with a dose of ZOSTAVAX (route and lot# unspecified). On18-FEB-2013 ("today") the patient came into the nurse's office with shingles around the eye area. The outcome of event was unknown. Additional information has been requested.
Pt came in for third dose of Toddler series. Updated guidelines states that pt should have received Bivalent dose. Mom states no adverse reaction from vaccine. Notified parents to return in >8 weeks for bivalent vaccine.
Patient was given 0.5ml of vaccine instead of 0.25ml, called patient and she denies any problems since vaccination. Letter also sent to patient notifying of dosage received.
Site: Pain at Injection Site-Mild, Additional Details: syringe was faulty , med dripped out of syringe, pt has to be given dose again after original dose dripped and patient did not get first dose "injection"---choose pain to continue but pt did not complain of pain (it was the only closest option so that we can proceed)
This spontaneous case reported by a consumer, describes the occurrence of nausea (her son received the Moderna COVID-19 vaccine and felt a little queasy) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nausea (her son received the Moderna COVID-19 vaccine and felt a little queasy). At the time of the report, nausea (her son received the Moderna COVID-19 vaccine and felt a little queasy) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not provided.
diagnosed with myasthenia gravis; This is a spontaneous report from a contactable consumer reported for a female patient in her 80s that who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Caller stated the person that also was diagnosed with myasthenia gravis was a friend of her cousin and her cousin went home to pick up the cousin's medications and met someone who worked with her and was telling the caller that it was really odd that this friend or her friend's sister came down four weeks ago and had her two vaccines and her age was in the low 80s and she did not know what vaccine this lady received but thought it was the Pfizer COVID vaccine but stated she has no other patient information and has no lots, expiry dates or NDC numbers for this patient's vaccine and did not know this person but the person is a friend of her cousin's. Stated the patient was diagnosed 4 weeks ago in Sep2021. Outcome of the event was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Low grade fever; body aches; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (Age of vaccination: Unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced low grade fever and body aches. The patient underwent lab tests and procedures which included body temperature: low grade on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
weak, confused, Temp 102.9, 2 large emesis, decreased SA02, pale, chills
Patient complained of dizziness 5 minutes post vaccination. Her BP was 150/99 mm/Hg after 10 minutes her BP decreased to 134/88 mm/Hg then to her baseline after 15 minutes of 126/85 mm/Hg. She had a prolonged observation of 30 minutes and was discharges feeling better, not dizzy.
Almost identical to first dose - sore arm and interrupted sleep first night due to feeling too hot (not sure if actual fever).  Sore arm developed about 4-6 hours after injection and resolved around 40-48 hours. Soreness/stiffness was significant enough during about first 24-36 hours after onset to inhibit common daily acitivities, and  injection area was quite tender to touch.   About 12 hours after injection (around 2 AM), possible low fever (? actual temperature was not taken) or at least a subjective feeling of being too hot/unable to properly regulate body temperature began, with some sweating, plus minor headache and nausea, that interrupted sleep for about 5 hours.    The following day had bothersome muscle stiffness/aches, although this might have been caused by poor sleep without usual movements. This resolved within about 24 hours.
High grade fever 101-102, chills, body aches, nose bleeds; took Tylenol.
Patient states that she has experienced dry cough, muscle pain in stomach area, hot and cold spells and a headache. She did not state taking anything for these reactions.
Patient has localized redness, swelling, itching, and increased warmth at site that began after 3 days and is still present today.
The symptoms I started feeling the following day, January 26, were nausea, and fever. Ibuprofen was used to deal with the symptoms.  The fever reduced over time but the nausea persisted. I decided to rest in bed to avoid worsening it. The following day, January 27, I woke up with the headache and body aches. I no longer felt nauseous but my temperature was still slighty high.
Within 5 minutes I started to have flank pain on the rightside. Was having a panic attack so couldn't breathe well. Flank pain started spreading to my side and mid to lower back. Then it started in the left side. Then it went across my whole mid back and got extremely stiff. Part of my top lip is numb. Over 4 hours and I still can't breathe properly despite the use of my anti anxiety medicine hours ago. Neck pain. Legs walking in slow motion no matter how hard I tried to push them. Hyperventilating after coughing 2 or 3 separate times. Shooting pain in my back when I lay down. Can't catch my breath laying down.
Opposite side of face face swelled; headache; got a "frozen shoulder" from vaccination side on same side.; got a "frozen shoulder" from vaccination side on same side.; This is a spontaneous report from a non-contactable Other HCP reported (herself). A 26-year-old (Non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via unspecified route of administration in left arm on May2021 (at age of 26-years old) as 1st dose, single dose for COVID-19 Immunization. Patient medical history includes Asthma from unspecified date to unknown till ongoing. Patient had known allergies of lot- latex, nickel, avocados, kiwis, peaches, etc. Patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On 21May2021 18:00, patient experienced opposite side of face swelled, headache, and got a "frozen shoulder" from vaccination side on same side. Treatment received by patient for adverse events is BENEDRYL. The Clinical outcome of events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
flu like symptoms; shortness of breath, smoker but hasn't been smoking; more and more mucous; Coughing; cold and hot; Chills; Headache; splitting up all day; arm was hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting really bad), INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (shortness of breath, smoker but hasn't been smoking), SECRETION DISCHARGE (more and more mucous) and COUGH (Coughing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting really bad). On 01-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (shortness of breath, smoker but hasn't been smoking), SECRETION DISCHARGE (more and more mucous), COUGH (Coughing), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), CHILLS (Chills), HEADACHE (Headache) and VOMITING (splitting up all day). On 01-May-2021, PAIN IN EXTREMITY (arm was hurting really bad) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (shortness of breath, smoker but hasn't been smoking), SECRETION DISCHARGE (more and more mucous), COUGH (Coughing), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), CHILLS (Chills), HEADACHE (Headache) and VOMITING (splitting up all day) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant  Rheumatoid Arthritis Medications   Treatment Cough Drops Cough Syrup Cold Shower
Right thigh - swelling, induration 10.2cm x 6.5cm, tender, erythematous at 48 hours presentation.