chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen Left Arm after the third shot; Red Left Arm after the third shot; Booster dose was taken outside the window period; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen Left Arm after the third shot), ERYTHEMA (Red Left Arm after the third shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was taken outside the window period) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swollen Left Arm after the third shot), ERYTHEMA (Red Left Arm after the third shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was taken outside the window period). On 17-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was taken outside the window period) had resolved. On 19-Aug-2021, PERIPHERAL SWELLING (Swollen Left Arm after the third shot) and ERYTHEMA (Red Left Arm after the third shot) had resolved.            Treatment information was not provided.   Patient had no side effects after first and second doses of vaccine.  She stated to have a colonoscopy done(outine and not related to vaccine).
The night I got the second dose my feet started tingling. Five days later my legs and hands started tingling. I went to the urgent care and they told me to wait. Today I still felling my right hand and my left foot tingling.
This prospective pregnancy case was reported by a physician via call center representative and described the occurrence of erythema in a 29-year-old female patient who received INFANRIX (batch number H7S99, expiry date 17th MAY 2017). Concomitant products included prenatal vitamins. On 21st AUGUST 2015, the patient received the 1st dose of INFANRIX (intramuscular). The patient's last menstrual period was on 22nd DECMBER 2014 and estimated date of delivery was 28th SEPTEMBER 2015. The patient received INFANRIX at week 34 of the pregnancy and during the third trimester of pregnancy. On 21st AUGUST 2015, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age of vaccine administration. On an unknown date, the patient experienced erythema, pain and vaccine expose during pregnancy. On an unknown date, the outcome of the erythema, pain, wrong vaccine administered, inappropriate age of vaccine administration and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing. It was unknown if the reporter considered the erythema and pain to be related to INFANRIX. Additional details provided were as follows: The case was not previously reported to anyone. On 21st AUGUST 2015, a pregnant patient received 1st dose of INFANRIX instead of Tdap vaccine, which led to wrong vaccine administered and an inappropriate age at vaccination. On an unknown date, less than a month after receiving 1st dose INFANRIX vaccine, the patient experienced redness and soreness (pain).
Acute mild anaphylactic like reaction may have been due to nuts consumed and unrelated to vaccine. This child received varicella vaccine in this office this afternoon. The father left after a few minutes, and almost as soon as he got into his automobile, the child began to cough, more than would be expected with just clearing his throat. The father gave him a food bar-containing figs. Almost immediately after receiving this he developed very prominent congestion. The father noted that he began to develop a rash on the face and had significant redness of the eyes and profuse rhinorrhea. Father immediately returned to the office for evaluation. This child does have a history of having had a positive very weak RAST test to eggs, but tolerates eating eggs without difficulty. He has not had difficulties with influenza vaccine. He had very similar reaction in the past to contact with a latex balloon, developing the nasal symptoms, cough and rash.
Tender, erythematous area around injection site right deltoid 3cm around site of DTAP #4 injection.
30-60 seconds after injection redness, 2 min after inj hives. 10 min. after inj. gave BENADRYL PO. 10 min after oral BENADRYL, Hive gone and redness decreasing.
MILD FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unknown) dose was not reported, administered on 17-MAY-2021 11:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 17-MAY-2021, the subject experienced mild fever. The action taken with covid-19 vaccine  was not applicable. The outcome of mild fever was not reported. This report was non-serious.
I had cough and a running nose.  Then, I lost my taste and smell.  I had fatigue.  The cough got really bad with a tight chest.  I went to get tested for COVID-19, positive results.
Heart Rate dropped from 120 to 59 in less than 5 minutes at time of vaccination- I left as heart monitor was reading 65 BPM. Blood pressure remained lowest ever experienced. When I experienced double vision,  rather in fact: quadruple vision and had not been able to urinate AT ALL from time of injection 2:00 pm Monday until 5:00 pm Tuesday. Dizzy, stumbling, slurring words, confused and panicked, I saw Dr. who IMMEDIATELY referred to to ER. ER was full. EMPLOYER MANDATED THIS SHOT FOR CONTINUED EMPLOYMENT, I had no money for ER; so i declined $$$ambulance$$$ told Dr. I would get a ride, then laid on the ground to die for 3 days. I did not die and returned to work only to be met with reprimandation for having to take 3 days off for my kidneys to start working again. Dr. wanted to check for blood clots in lungs; heart congestion, and clots in muscles. This costs money. My health post-vaccine is now uncertain. Prior to this I was 100% well and healthy physically. I previously had Covid and  *had natural antibodies prior to this.
ALTERED TSH, HAY FEVER, BRONCHITIS, DOUBLE PNEUMONIA, CUT GLASS, INFLAMED LYMPH NODES, CANCER.
Swollen arm; Red arm; Hardness to touch on the arm; Tenderness to touch on the arm; Itchy arm; A knot on the arm; Warm arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE INDURATION (Hardness to touch on the arm), VACCINATION SITE PAIN (Tenderness to touch on the arm) and VACCINATION SITE PRURITUS (Itchy arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE INDURATION (Hardness to touch on the arm), VACCINATION SITE PAIN (Tenderness to touch on the arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE NODULE (A knot on the arm) and VACCINATION SITE WARMTH (Warm arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE INDURATION (Hardness to touch on the arm), VACCINATION SITE PAIN (Tenderness to touch on the arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE NODULE (A knot on the arm) and VACCINATION SITE WARMTH (Warm arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Area around injection edematous, warm to the touch, erythema measuring 10cm x 5cm. Area on left thigh of LE.
immed p/ pt recv vax pt ``complained of stinging pain w/hematoma & redness of one inch in diameter'' lasting 24 hr & by 4/21 pt recovered
Day 9 after vaccine felt slight itchiness at vaccine site off & on during day; Day 10 after vaccine woke up to itchy red circular rash around vaccine site approximately 1 1/2"x2".  Day 11 after vaccine rash site increased to 2" x 2 1/2" & itchy around edges. Rash slightly lighter in color except around edge.  Day 12 after vaccine rash @ 2 1/2" x 2 12" but much lighter-pinkish- in color & very little itching.  Day 13 rash very light pink & no itching.  Day 14, rash hardly visible. No itching and each day after visibly disappearing.
3 incredibly itchy fluid filled blisters / on my pinky on my right hand / on my thumb on my left hand / 2 on my chest; 3 incredibly itchy fluid filled blisters; fever; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2021, the patient received the 2nd dose of Shingrix. On 12th January 2021, less than a day after receiving Shingrix, the patient experienced fever. On 15th January 2021, the patient experienced blister and pruritus. On an unknown date, the outcome of the blister, fever and pruritus were unknown.   It was unknown if the reporter considered the blister, fever and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient had my 2nd Shingrix vaccination on 12 January 2021. The patient developed 3 incredibly itchy fluid filled blisters one on my pinky on right hand, one on thumb on left hand, and on chest. The night of the Shingrix vaccination the patient had a fever. The patient wanted to know why 3 fluid filled blisters after the 2nd Shingrix vaccination.
1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo.  ER later that day; blood work. Declined IV fluid. Monitored vitals.  Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back.  1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain.  still experiencing dizziness, 'disorientated'
Patient received vaccine approx 10:25 am, and had slight itchiness during the observation period but said it was not bad and left the clinic location. She returned approx 50 mins later(11:15am) when symptoms became worse. C/O increased itchiness, started in neck area, then spread to arms, hands, legs, then top of head. No hives noted but patient was scratching skin. Skin cool and dry, no hot/red areas, A&Ox3. Vitals normal, BP 120/80, 126/82, P 72 Regular. Lung sounds clear. No tingling to throat or mouth area. 50 Mg BENADRYL administered(4 12.5 mg chewable tablets). tolerated well, but made her very drowsy. 11:25 stated had relief from itching but still remained very sleepy. Vitals normal, BP 120/74, 122/70, P 70. 12:51 BP 122/70 P 70, Patient was sent home with daughter after symptoms improved and she felt much better.
Lump on back of head day of injection that she spoke to hematologist about and thought to be lymphadenopathy (now resolved), then 1 week after injection on 1/13 has developed itching and redness at injection site that she has applied topical benadryl cream for.
Pain in left shoulder region radiating down left arm. Pain when lifting arm above shoulder. Burning sensation in left shoulder. Overall pain at injection site and in left shoulder and arm. Due to lack of health insurance I've not followed up with a physician.
Gout.   Never had prior.  Pain/swelling, inflammation.  Steroid pack and Colchicine for treatment.  Issue persists at time of this report.
The first two vaccines resulted in sore are for a few days. The 3rd vaccine caused 36 hours of 102.4 - 103 temperature with malaise and body aches. On day 5 following the vaccine, I developed 3 cold sores on my lower lip, with elevated temperature, mucus in both eyes, and body aches from the herpes simples outbreak. On day 7 - January 4th, following the 3rd vaccine I traveled to visit with family. On day 9 - January 13, I had a nurse home visit for several days, very sore throat, productive cough, 102 temperature, malaise and dehydration. On day 16th - January 20, I broke out with 3 more cold sores that are still noticeable February 4th. Right jaw pain, and blood shot eyes with mucus.
one day of not feeling good; achey arm/ felt nothing horrible just sore; elevated temperature; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (one day of not feeling good), PAIN IN EXTREMITY (achey arm/ felt nothing horrible just sore) and PYREXIA (elevated temperature) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation and Rheumatoid arthritis. Concomitant products included METHOTREXATE, PRAVASTATIN and WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (one day of not feeling good), PAIN IN EXTREMITY (achey arm/ felt nothing horrible just sore) and PYREXIA (elevated temperature). On 03-Mar-2021, VACCINATION COMPLICATION (one day of not feeling good), PAIN IN EXTREMITY (achey arm/ felt nothing horrible just sore) and PYREXIA (elevated temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 99.8 (High) high.         Patient's additional concomitant drugs included, atrial fibrillation medication.  Treatment information was not provided by the reporter.
Patient  is a 66 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EN6208 on 3/11/2021. The patient experienced the following reaction(s) during the immediate of observation: 1:33pm Patient c/o "tingling feeling to tongue." Report PMH of anxiety and HTN. Patient takes hydrochlorothiazide, norvasc, xanax, and paroxetine at home. Patient reports seasonal allergies.  Patient was treated/managed as follows:  1:35pm No swelling noted to face, mouth, and tongue. Denies shortness of breath and chest discomfort. VS: BP 170/90, HR 74, RR 20, O2 sat 96% on room air. Patient reports not taking morning BP medications.  1:37pm: VS BP 160/78, HR 75, RR 20, O2 sat 95% on room air. Patient states "tingling is a little better." Denies shortness of breath. No swelling noted. 1:53pm Patient escorted to car by RN leaving private car with husband. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 21-AUG-2015, the patient was vaccinated with an unknown dose of VAQTA that was improperly stored (lot # L009445, expiry date 01-JUN-2017, route was not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
ABDOMINAL PAIN; A spontaneous case report was received from a physician on 28-Jun-2019 for two consumers.  Based on the information obtained from the physician, two individual case safety reports PVX201907-000549 (husband) and PVX201907-000550 (wife) were created and cross-linked in the database.  This case describes a female consumer who had abdominal pain, after administration of first dose Vivotif for an unknown indication.  Action taken with Vivotif with respect to the event was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that a female consumer had abdominal pain, after administration of first dose Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer had abdominal pain, after administration of first dose Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201907-000549:
Vaccine was administered at 11 years of age. 2nd dose will be delayed until patient is 12 years old.
Approx. 3-4 hrs after vaccination, the pt awoke from a nap with fussiness, pulling legs up, them limp and pale, no shaking, breathing normally. This lasted for about 30 mins.
This spontaneous report was received from a licensed practical nurse and refers to a 5 months old female patient. There was no information about the patient's pertinent medical history, and drug reactions or allergies provided. On 09-JAN-2017, the patient was mistakenly vaccinated with a dose of PROQUAD injection (lot# M009745, expiration date 23-AUG-2017; dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested.
Provider called in to ask if they had to re-administer vaccines to patients if a vial was doses were given at >12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Provider called in to ask if they had to re-administer vaccines to patients if a vial was doses were given at >12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 EXPIRED PRODUCT ADMINISTERED (Provider called in to ask if they had to re-administer vaccines to patients if a vial was doses were given at >12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Provider called in to ask if they had to re-administer vaccines to patients if a vial was doses were given at >12 hours) had resolved.        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.   No concomitant medication was mentioned. No treatment medication was mentioned.
Beginning 1/11/2020, I began experiencing an uncomfortable sensitivity in my left axilla. I have a history of  inflamed lymph nodes that occurs 1-2 times a year under the arm and in the groin, and this felt similar to those episodes. The lymph node is hard to touch and the sensitivity continues today. Today (1/13/2020), I noticed an inflamed, red patch of skin that is hot to touch over the region where the injection occurred. Additionally, I have experienced diarrhea 1-2x/day for the past two days.
Approximately six to seven months after receiving his last booster, he developed blood clots in his leg; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, (received the primary series and two boosters of the Pfizer Covid vaccine)), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Approximately six to seven months after receiving his last booster, he developed blood clots in his leg". She stated it was so severe, he (her dad) almost had to have his leg amputated.  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.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the event Thrombosis and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt was given Moderna booster. She recieved primary series - Pfizer but requested and was given Moderna for the booster. Moderna is not currently approved for boosters under age 18.
Red, swollen, sore at injection site. Fever. Aches, painful muscles. She took Tylenol and rest. Recovered in 2-3 days per husband.
Pfizer vaccine was stored incorrectly, it was stored in a regular freezer instead of a sub-zero freezer. Mother of patient is informed and will decide later if she wishes to have patient revaccinated.
Fatigue, fever, nausea, headache. Fatigue started about 4 hours after shot. Got out of bed the next morning with a 100.4 fever and nausea. Headache may have been due to caffeine withdrawal (no coffee due to nausea). Symptoms lasted the entire day. Woke up feeling fine on the 25th (headache went away after a cup of coffee!!).
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: patient developed symptoms about 5 minutes after receiving vaccine.  She started looking very pale and looked like she was about to faint.  pt started having seizures soon after.  paramedics were called.