chrisvoncsefalvay/vaers-outcomes huggingface dataset:
minor reaction to the Moderna booster vaccine; had a minor skin reaction about 24 hours after the vaccine; Rash; It is red; broke out in hives pretty bad all around that area in their top of their arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (minor reaction to the Moderna booster vaccine), SKIN REACTION (had a minor skin reaction about 24 hours after the vaccine), RASH (Rash), VACCINATION SITE ERYTHEMA (It is red) and VACCINATION SITE URTICARIA (broke out in hives pretty bad all around that area in their top of their arm) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (minor reaction to the Moderna booster vaccine), SKIN REACTION (had a minor skin reaction about 24 hours after the vaccine), RASH (Rash), VACCINATION SITE ERYTHEMA (It is red) and VACCINATION SITE URTICARIA (broke out in hives pretty bad all around that area in their top of their arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (minor reaction to the Moderna booster vaccine), SKIN REACTION (had a minor skin reaction about 24 hours after the vaccine), RASH (Rash) and VACCINATION SITE ERYTHEMA (It is red) outcome was unknown and VACCINATION SITE URTICARIA (broke out in hives pretty bad all around that area in their top of their arm) had resolved.            No concomitant medications were provided.  Reporter claim that the clinic didn't clean their arm before giving vaccine with anything and they administered the vaccine in a second degree bum scar spot, also stated that they had no reaction after the first two doses of the Moderna Covid-19 Vaccine.
Patient was notified when error was discovered, approximately 4 hours later. No adverse events reported at this time. Patient will received the bivalent vaccine in 2 months.
Onset of 1st chicken pox lesion on 8/3/01 appeared on his back; on 8/4/01, 6 lesions on back and stomach; on 8/5/01, 15 lesions on back, stomach and both arms; on 8/6/01, 20 lesions on back, stomach, both arms and forehead with conjunctivitis in both eyes; on 8/7/01, 30 lesions on back, stomach, both arms, forehead, inside of mouth, inside of ears, on and around scrotum and 1 on bottom of right foot, on 8/10/01, had yeast infection around scrotum and lesions appeared crusty and began to fall off. He is still recuperating from this episode and is currently fighting a mild upper respiratory tract infection that is not associated with vaccine or prior series of illness'. I feel that his immune system was suppressed by the chicken pox and became more susceptible to the conjunctivitis and yeast infection. The nurse inserted the syringe into small glass bottles and set them on the exam table. I did not see her draw the serum or remove the syringe from these bottles; at which point I was holding my son in position to be immunized.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent  conditions and concomitant therapies were not provided. On multiple dates between 20-APR-2016 and 20-MAY-2016, the patients were vaccinated with incorrect stored doses of ROTATEQ, for prophylaxis. The doses of ROTATEQ underwent temperature excursion from 47 Fahrenheit degrees to 77 Fahrenheit degrees along 32 minutes. The call was placed because of a Digital Data Logger. The ROTATEQ had not experienced previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-: US-009507513-1709USA008179: US-009507513-1709USA008180: US-009507513-1709USA004302:
Pt recv vax on 10/7/98; 7 hr later pt exp indurated & warm rx on Rt arm
headache; suddenly blacked out for a couple of seconds; suddenly dizzy; very bad nausea; very fast heart beat; tightness in her chest to her heart like she is going to have a heart attack; tightness in her chest to her heart like she is going to have a heart attack; This is a spontaneous report from a contactable consumer reporting for herself.     A 43-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 10:40 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation  .  Medical history included ongoing depression, ongoing anxiety.  There were no concomitant medications.  The patient  suddenly blacked out for a couple of seconds  on 13Apr2021 16:40 with outcome of recovered on 13Apr2021 , suddenly dizzy  on 13Apr2021 16:40 with outcome of recovered on 15Apr2021, very bad nausea  on 13Apr2021 16:40 with outcome of recovered on 13Apr2021, very fast heart beat  on 13Apr2021 16:40 with outcome of recovered on 13Apr2021, tightness in her chest to her heart like she is going to have a heart attack  on 13Apr2021 16:40 with outcome of recovered on 13Apr2021,  headache on 14Apr2021 with outcome of not recovered. The event loss of consciousness was considered an Important Medical Event. The remaining events were non serious.  The patient underwent lab tests and procedures which included heart rate: fast   on 13Apr2021.  Follow up information has been requested. Lot number was already received.
Very sore arm, shoulder and armpit immediately after dosage, continuing 48 hours after dosage.  Chills and headache 12 hour after dosage, lasting 4 hours.
Localized pain/swelling at injection site.  Headache, neck pain, fever last night (11-16-07).  11-17-07 ER visit.
Had a rash breakout about 2 months after receiving vaccine for chickenpox. Has had chickenpox for 8 weeks now. I would consider it a medium severity case. Took him to four doctors while the areas were scabbed over and was wrongly advised that it was eczema twice and scabies twice. Took him to ER at hospital before it was diagnosed as chickenpox. Currently treating with calamine lotion and Aveno baths. This is a follow up report since I didn't have all the information for the original.
Negative antibody test after receiving both doses of Covid-19 vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the second of three reports. A 69-year-old elderly female received the first and second doses of BNT162b2 (solution for injection; Lot reported as unknown) as single doses via unspecified route on unspecified dates in 2021 for COVID-19 immunization. There was no medical history, concomitant medications or past drug history reported. The reporter was inquiring about the efficacy of the COVID-19 vaccine. The reporter stated that on an unspecified date in Feb2021, the patient had a negative antibody test after receiving both doses of the Covid-19 vaccine. The outcome of event negative antibody test after receiving both doses of Covid-19 vaccine was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296623 same reporter/drug/AE, different patient.;US-PFIZER INC-2021293985 same reporter/drug/AE, different patient.
Pt recvd 1 dose of Engerix-B & devel numbness & tingling around mouth, a rash on the rt side of face, abdominal cramping & diarrhea;
arm @ inj-from shoulder to elbow-swollen, itchy, inflamed & discolored
4/14 - pt's son reports that the patient has had diarrhea, stomach pains, loss of appetite and confusion. He described her as incoherent. He had to "physically make her eat." By afternoon, she had improves some. Advised watching and monitoring - seeking help if the condition worsens.
Pain and swelling, erythema at site of injection; area of erythema measured 15 x 18 cm. Pt also had systemic sx with chills, myalgias. Treated with Benadryl 50mg PO q 4-6 hours prn.
Felt sick; Arm starting having pin and needle sensation in it; Lost grip and strength in arm and hand/ the feeling is mostly on the under part of right arm, pinky and ring finger on the right side where got the shot and right side of hand; Lost grip and strength in arm and hand; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 06May2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and 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-19 vaccine. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 15Apr2021 at 16:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient reported that he got his first shot on 15Apr2021 and was fine then went back for his second shot on 06May2021 and after the second shot on an unknown date in May2021, he felt sick and was sick for a few days and the patient didn't think much about it. Within a week, the patient's arm started having pin and needle sensation in it and he had the same feeling ever since then. The patient lost grip and strength in his arm and hand and the feeling was mostly on the under part of his right arm, pinky and ring finger on the right side where he got the shot and right side of his hand. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt sick, arm starting having pin and needle sensation in it and lost grip and strength in arm and hand/ the feeling is mostly on the under part of right arm, pinky and ring finger on the right side where got the shot and right side of hand was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Received 1st dose COVID-19 Vaccine and experienced COVID-19; COVID-19; This is a solicited report from a non-Pfizer sponsored program based on the information received by Pfizer. A contactable consumer (patient) reported that a 65-year-old female patient received bnt162b2, intramuscularly in 2021 (Batch/Lot number was not reported) as first dose, single for covid-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from Jan2021 (Batch/Lot number was not reported) to 2021, at 40 mg, cyclic, (1 in 2 week) for moderate to severe adult crohn's disease. The patient medical history and concomitant medications were not reported. The patient received 1st dose COVID-19 Vaccine and experienced COVID-19. It was also reported that the patient experienced an event of non-serious COVID-19 with ADALIMUMAB (HUMIRA). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number and expiration date was unknown. In 2021, the patient experienced COVID-19. In 2021, the COVID-19 resolved. On 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number and expiration date was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: covid-19 on 2021. The action taken in response to the event(s) for adalimumab was permanently withdrawn in 2021. The reporter's causality for the event(s) of COVID-19 with adalimumab and bnt162b2 was not provided. The outcome of the events was recovered in 2021.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  No follow-up attempts are possible. information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, a causal relationship between events Drug ineffective / COVID-19 and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)  cannot be completely excluded.
One week after receiving vaccine my right deltoid was swollen, red and warm to the touch with heavy arm and discomfort down whole arm. This lasted several days. Treatment was antihistamine and ibuprofen.
Blisters in mouth and on tongue, swollen, red at shot site and sweating with no activity.
patient was administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   2 vials from same lot number 1st vial Lot number: 050E21A , Administered on 05Nov2021 2nd vial Lot number: 050E21A, Administered on 12Nov2021. No concomitant medication was provided by the reporter. 34 patients were administered from an expired vaccine. 16 staff members were administered from the expired vaccine. 2 patients have passed  away. No treatment was provided by the reporter.
Pain at injection site seemed to worsen 3 days post vaccination. Arm became stiff in certain positions, certain positions caused pain and stiffness. Sometimes hurts to sleep on this side. Sometimes just hurts (2 months later) while arm is at rest at side.
Initial unsolicited report received from a non-healthcare professional on 13 December 2016. This case involves a 16-year-old female patient who was vaccinated with booster doses of Menactra (batch number, expiry date, dose, route and anatomical site of administration were not reported) in an unknown site on an unknown date. Patient's medical history was reported as vitiligo which was also mostly resolved in the past 4-5 years. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified time following the vaccination, the patient had developed new patches around her eyes. Laboratory investigations were not reported. Corrective treatment was reported as unknown. The outcome of event was reported as unknown. List of documents held by sender: none.
Fatigue; Vaccination site pain; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via an unspecified route of administration in left arm on 22Mar2021 at 15:00 hours (at the age of 29-Year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient had allergy to goat cheese. Concomitant medication included citalopram (MANUFACTURER UNKNOWN) since an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced fatigue and vaccination site pain on 23Mar2021 at 17:00 hours. The therapeutic measures taken as a result of fatigue and vaccination site pain was none. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fatigue and pain at the injection was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.
Was unconscious for about 20-30 seconds; Fainted; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was unconscious for about 20-30 seconds) and SYNCOPE (Fainted) in a patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Was unconscious for about 20-30 seconds) (seriousness criterion medically significant) and SYNCOPE (Fainted) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Was unconscious for about 20-30 seconds) and SYNCOPE (Fainted) outcome was unknown.            No concomitant medications were provided. No treatment information was provided. COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old patient with no clinical history who experienced the unexpected event of LOSS OF CONSCIOUSNESS and SYNCOPE  The events occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old patient with no clinical history who experienced the unexpected event of LOSS OF CONSCIOUSNESS and SYNCOPE  The events occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Large lump and bright red skin rash at injunction site apprixmately 2" inches out from site in all directions. Subsiding by 8/05 PM.
2 days post vax pt devel an erythematous papular rash w/a few on legs, arms & cheek;
Information has been received from a physician concerning the physician's 15 year old niece with a history of seizure disorder who on an unspecified date was vaccinated intramuscularly with a dose of GARDASIL. It was reported that the patient "got very ill". The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Therapy with human papillomavirus vaccine was discontinued. Additional information has been requested.
High pitched screaming or persistent crying for hours x 3 plus days.---  Took to Dr. office on Sat after vaccinations et was told it was probably colic!! Extreme sleepiness; Restlessness, hyperactivity or inability to concentrate; Sleep disturbances that change wake/sleep pattern.
Patient complained of recurring pruritic erythematous lesion at right arm inoculation site-resolved in 1-2 days.  Has recurred several times since 08/25 immunization.  Asymptomatic today.
Multiple fever blisters; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 13Apr2021 at 02:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. On 15Apr2021, the patient experienced multiple fever blisters. The patient did not have a fever blister in 20 years or more. He had three since the shot. No therapeutic measures were taken for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the multiple fever blisters was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist and refers to a 61 year old female patient with none drug reactions or allergies. On 15-SEP-2014 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot # K008079, expiration date: 03-SEP-2014). Concomitant therapies included pravastatin, ACIPHEX, PROPRANOLOL ER, SINGULAIR, PROAIR, piroxicam and estrogens,  PREMARIN. On 16-SEP-2014, the patient experienced an injection site reaction of redness, pain, itching and swelling. The area was not to the touch. There was no treatment given for the adverse events.  None lab diagnostics studies were performed. The patient sought medical attention via visiting the pharmacy. The outcome of events was reported as not recovered. The relatedness between events and ZOSTAVAX was not reported.  Additional information has been requested.
Headache, fever, chills, shaking, hot flashes.  Duration:  12 hours.
severe cramps; chiils; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (severe cramps), CHILLS (chiils), HEADACHE (headache) and MYALGIA (body ache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2EA) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced MUSCLE SPASMS (severe cramps), CHILLS (chiils), HEADACHE (headache) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (severe cramps), CHILLS (chiils), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Patient is eleven years old but given adult dose (0.3mg) of Pfizer vaccine. Pt. observed 15 minutes per protocol, no adverse event occured.
Gave shot about 9:19 pm on 11/1/10. At about 9:20 pm pt said she felt dizzy and began grabbing her chest and asked for a cold wet paper towel. Brought the pt a towel and glass of water, asked if she was having trouble breathing. Husband stated that "she sometimes has these small episodes where she can't breathe. Give her a few minutes and I'll come get you if I need you". About 2 minutes later the husband came to the window and said she can't breathe. Took EPI-PEN to the lobby, asked pt if she could breathe, shook her head no. Gave pt an EPI-PEN in the left leg and told techs to call 911. After about 5-10 minutes but was still grabbing chest, gasping for breath, vomiting and saying she couldn't breathe. Gave second EPI-PEN in right leg. After about 5 minutes EMTs arrived, gave them a list of patient's medications and allergies.