chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Varicella eruption noted on 10/9/08 per APRN. Pt  presented day #3  illness with 18 lesions on trunk only. No fever, tired, runny nose.
pt to observation s/p vaccination. pt began to feel dizzy and thirsty. on eval, pt become syncopal and ems notified and on scene with medical staff on site. Pt had LOCx2. Vitals taken. BS checked and EKG completed.  IV started. pt then taken to local hospital for further eval.
Approximately 10 minutes after receiving the injection, I started to feel a pain in my chest like a weight was placed on my heart.  I could feel my blood pressure rising.  My heartrate jumped from 62 to 102 in 6 minutes. After approximately another 30 minutes the pain lessened however it did not go away for another 24 hours.
Information has been received from an approximately 62 year old patient via company reprehensible referring to himself/herself. Patient's concurrent conditions, concomitant medication and medical history were not provided. In approximately June 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route and frequency were not provided). Six months later, in early December 2011, the patient  suffered an outbreak of the herpes zoster virus. The rash started at the top of his/her head at the hairline and extended into his/her left eye. The pain could only be described as if a knife were driven into the eye, easily the worse pain the patient had ever experienced in his/her life. The patient's doctor told him/her that the outbreak would have been worse if he/she didn't have the vaccine. At the time of the report, the patient still took Gabapentin 400 mg three times a day for the post Shingles neuralgia(onset date unspecified) and four types of eye drops. Because of the affect to his/her eye the patient suffered corneal abrasions and was on a course of heavy steroids for a year. His/her optic nerve had deteriorated(onset date unspecified) in the affected eye but his/her vision was still intact. At 66 years old(at reporting time) the patient expect his/her treatment would continue for life, with no guarantee he/she wouldn't suffer another outbreak. No product quality complaint (PQC) was reported. The patient also provided feedback on the ZOSTAVAX commercials, and suggested they should contain information regarding the potential dangers of the shingles virus to the eye. The outcome of the events was considered as not recovered. Additional information has been requested.
On Friday, March 10, 2023, during the day I began to feel a tickle in my throat and a fever of about 100. I tested negative for that day. I still had fever on Sunday, and I took medication for that. I stayed in bed all weekend. Monday morning my fever was 101. I just rested. That afternoon my fever broke. I haven't had a fever since then. I took another COVID-19 test Tuesday night and tested positive. Thursday, I called my doctor and was Paxlovid for three days. During this whole time, I have been treated also for a fungal infection and taking Terbinafine. Since late last week I have felt much better. I still tested positive yesterday.
Patient received COVID Booster which had exceeded the recommended 12 hour open time within 24 hours of vial being opened. There was no obvious adverse effect and there still is not. Vaccination had minimal room temperature exposure.
Don't feel well; Run a fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Don't feel well) and PYREXIA (Run a fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Don't feel well) and PYREXIA (Run a fever). At the time of the report, MALAISE (Don't feel well) and PYREXIA (Run a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.   Reporter did not allow further contact
Information has been received concerning a pt who post vaccination experienced a severe local reaction, the entire upper arm was very swollen,red, hot, tight and severely painful. On 11/17/00 it was reported the pt had dizziness and unspecified medical attention was sought.  The pt recovered from her experience on 11/20/2000.
anterior STEMI admitted on 5/11/21 with left chest and arm pain. Underwent stent to LAD pt stated he developed chest discomfort and SOB  a few days after his 1st moderna vaccine in Mid April
I am not able to secure the details requested above. I have phoned the pharmacist and to date, no reply.   After an expected 2-3 day soreness, these symptoms did not dissipate; instead increasingly worsened. Range of motion is limited with overhead or front to back movement. Pain is traveling from shoulder thru upper arm and experiencing a stiffness in neck. I am right dominant and have lost strength due to discomfort.  Sleep is disrupted since the injection. I have taken Aleve 220 mg. with little to no relief. Pain and ache is constant.
Home tested positive.  Some chills/fever first 24 hours.  Extremely "runny" nose for a few days.  Cough for several days, probably due to sinus drainage.
large dark spot under lash line of lower eye, then 48 hours after small white bumps in dark spot.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-OCT-2016, the patient was inadvertently vaccinated with an expired dose of (wistar ra 27-3) M-M-R II (lot # K018965, expiration date: 15-OCT-2016, dose and injection site were not provided). No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from an adult female consumer, who was referring to herself, a patient of unknown age. The patient's current conditions, drug reactions or allergies were not reported. On 30-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (dose number, strength, route of administration, lot # and expiry date were not provided). Concomitant medications were not reported. After vaccination, the patient experienced pain at the injection site. Additionally, at the time of reporting, the injection site was still painful and the patient could barely move her arm. There was no product quality complaint involved. Additional information has been requested.
Flu vaccine rcvd 10/7/09 910 am. At 500 on 10/7/09 patient c/o fever, bad headache, body aches, sneezing, sore throat, runny nose and swollen arm at the location site. PMD seen 10/8/09.
pt recv vax & pt awoke from nap flushed, temp 103 ax;mom contacted clinic;PHN recommended contacting pvt MD;MD recommended tepid sponge bath & APAP;T100 8OCT97;
Information has been received from a physician concerning a patient who unspecified date was vaccinated with GARDASIL (lot # not reported). On unspecified date the patient had generalized body aches and pain. No further information is available.
Patient complained of headache, dizziness, nausea about 5 minutes after receiving dose. Original BP 182/113. Patient was brought to exam room to lay down, given hydration. After 15 minutes, BP dropped to 170/103. Patient instructed to continue waiting. After 30 more minutes, patient reported cessation of symptoms. BP checked - 170/89. ER precautions given. Patient walked out of clinic in stable, alert condition with husband and son.
Headache, Myalgia, Arthralgia, Nausea Vomiting, Pain at injection site Narrative: N/A
No adverse effects were reported; The physician reports that on 5/31/2019, one dose of improperly stored PROQUAD) was administered; This spontaneous report was received from a physician concerning unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 31-MAY-2019, the patient was vaccinated with one dose of improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant Human albumin (rHA) for prophylaxis (lot number R020677 with expiration date on 15-JAN-2020, route of administration, strength and frequency were not reported). Other suspect therapy included sterile diluent, for prophylaxis (lot number N032755 with expiration date on 04-AUG-2020, route of administration, strength and frequency were not reported).  Administered doses of vaccine experienced temperature excursion between 15 degrees Fahrenheit up to 46 degrees Fahrenheit (36 Fahrenheit) for 8 hours and temperature excursion between 6 degrees Fahrenheit up to 14 degrees Fahrenheit (14 Fahrenheit) for 15 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA001160: US-009507513-1906USA001161:
Arm which vaccine was administered became red, hot and swollen. Swelling went below elbow and above shoulder and to chest. Patient complained of minor itching and pain. Mother reports similar reaction after patient received 1 year old vaccines.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 66 out of 189 adult patients described by the reporter. No concomitant information was reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
patient complained of soreness in his left shoulder the evening of the day he got the vaccine and it was swollen a little. the next evening  his left bicep was turning red and started to swell.  The next day he stated the lymph nodes under his arm hurt badly and he didn't feel well.
hives started coming up on multiple places of the body; they are painful and they don't seem to go away/This hive is all over the body/The hives are red urticaria all over the body; they are painful; itchy and they don't seem to go away; her hands are swollen; She can sense heat on the body part that the hives appear next; throat tightness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives started coming up on multiple places of the body; they are painful and they don't seem to go away/This hive is all over the body/The hives are red urticaria all over the body; they are painful), PRURITUS (itchy and they don't seem to go away), PERIPHERAL SWELLING (her hands are swollen), FEELING HOT (She can sense heat on the body part that the hives appear next) and THROAT TIGHTNESS (throat tightness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (hives started coming up on multiple places of the body; they are painful and they don't seem to go away/This hive is all over the body/The hives are red urticaria all over the body; they are painful), PRURITUS (itchy and they don't seem to go away), PERIPHERAL SWELLING (her hands are swollen), FEELING HOT (She can sense heat on the body part that the hives appear next) and THROAT TIGHTNESS (throat tightness). The patient was treated with PREDNISOLONE for Throat tightness, at an unspecified dose and frequency. In December 2021, THROAT TIGHTNESS (throat tightness) had resolved. At the time of the report, URTICARIA (hives started coming up on multiple places of the body; they are painful and they don't seem to go away/This hive is all over the body/The hives are red urticaria all over the body; they are painful), PRURITUS (itchy and they don't seem to go away), PERIPHERAL SWELLING (her hands are swollen) and FEELING HOT (She can sense heat on the body part that the hives appear next) had not resolved.            The patient was a Pediatrician.  Concomitant medication of the patient was not reported.  The patient was on Prednisolone, for the last 6 days and the throat had calmed down, but the hives did not seem to went away. All symptoms had been persistent. The urticaria still came, then in 20 to 30 minutes it went away and reappeared somewhere else.  Treatment information for rest of the events were not reported by the reporter.   This case was linked to MOD-2021-427781, MOD-2021-427793 (Patient Link).
pt received 0,.3 ml of undiluted Kids Pfizer vaccine (ndc 59267-1025-04) instead of adult RTS vaccine. checked in with pt at 8pm and she was doing fine other than a sore arm.  She was unconcerned by the mixup
Information has been received through the Merck pregnancy registry from a registered nurse concerning a 28 year old pregnant female with allergy to iodine who on 06-FEB-2007 was vaccinated intramuscularly in the right deltoid with the first 0.5 mL dose of Gardasil (lot# 654741/1208F). On 24-APR-2007, the patient was vaccinated intramuscularly in the right deltoid with the second 0.5 mL dose of Gardasil (lot# 655205/1426F). It was reported that the patient was 4 weeks into her gestation period and has a delivery date of 24-JAN-2008. The patient sought unspecified medical attention. The registered nurse reported that the patient did not have any weight gain in the last 10 week. There was no product quality complaint involved. Additional information has been requested. 07/08/2008 Follow-up information was received from the nurse on 27-MAY-2008 which indicated that the patient had delivered a healthy, normal, newborn. Both mother and baby are fine. No additional information is expected.
First dose administration on 19Dec2020 and second dose administration on 12Jan2021; Dyspnea; Rash; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; This is a spontaneous report from a contactable healthcare professional (the patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283, expiration date not reported), via an unspecified route of administration (left arm) on 12Jan2021 at a single dose, for COVID-19 immunization. Medical history was not reported. Concomitant medication included cefalexin monohydrate (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC ALLERGY), and triamcinolone. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5760, on right arm, on 19Dec2020, and experienced urticaria and folliculitis with severe exacerbation after both vaccination. It was reported that on Jan2021, the patient was under successful treatment for urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; experience of rash and dyspnea on Jan2021 required steroids and epipen. Treatment included Prednisone course, epipen, and H2 blockers. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. It was also reported that the patient had first dose administration on 19Dec2020 and second dose administration on 12Jan2021. The patient was recovering from all events, except for "First dose administration on 19Dec2020 and second dose administration on 12Jan2021" with outcome of unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
pt recv vax 22JUL96 & 11SEP96 pt devel three non-vesicular lesions located on chest & arm;pt examined by MD on 11SEP96;also devel a fever & a vesicular rash;exp truncal ataxia;gait was unsteady;
This spontaneous report was received from a licensed practical nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter mentioned that on an unknown date, this indeterminate number of patients received a dose of GARDASIL 9 (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) for prophylaxis; which had been exposed to excursion temperatures of 8.6 Celsius degrees on two different occasions (one for 15 minutes and the other for 3 hours). No adverse effects were reported. There was no product quality complaint involved. This is one of four reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA001795: US-009507513 1704USA014014: US-009507513-1704USA014013.
severe, incessant vomiting for nearly an hour with dry heaving thereafter and inability to keep down fluids for a couple of hours
PATIENT REPORTS DROWSINESS AND FEELING TIRED AFTER VACCINE.  PT WAS MONITORED FOR AN  ADDITIONAL 30 MINS. UPON DISCHARGE REPORTS FEELING BETTER
pain in the intestines; fever; colic in her intestines; fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (colic in her intestines), PAIN (pain in the intestines), the first episode of PYREXIA (fever), VOMITING (vomiting) and the second episode of PYREXIA (fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B4A and 023M20A) for an unknown indication.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 05-Mar-2021, the patient experienced ABDOMINAL PAIN (colic in her intestines), the first episode of PYREXIA (fever) and VOMITING (vomiting). On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (pain in the intestines) and the second episode of PYREXIA (fever). At the time of the report, ABDOMINAL PAIN (colic in her intestines) and VOMITING (vomiting) had resolved and PAIN (pain in the intestines) and the last episode of PYREXIA (fever) had not resolved.
Client stated that 1 week after she received the nasal mist vaccine on 11/10/2010 she had chills with no fever and developed hoarseness. No sore throat. For the past month she has had hoarseness off and on.
Small, itchy bump appears on the same arm vaccine was administered (but not directly at injection site) about 11 days later. Spread to larger rash that is slightly swollen and itchy on right arm.
dose of PENTACEL was given to a child on a catch up schedule and due to it being a combination vaccine she received a extra polio dose, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 25 months old female patient who was vaccinated with 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ260AAA Expiration date:14-May-2021) on a catch up schedule and due to it being a combination vaccine she received a extra polio dose (PT: extra dose administered) via unknown route in the left vastus lateralis  for prophylactic vaccination on an unknown date.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) ; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination on an unspecified date.  It was an actual medication error case due to extra dose administered. The patient has received 4 doses of IPV, 4 doses of DTaP and 3 doses of Hib.    No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Pt was vaxed w/1st dose of Hep B & 1 wk later was found to be HBsAg pos; No further details were provided;