chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Outbreak of oral herpes/first cold sore developed; feeling tingling in mouth;blisters on the inside of her lips, cold sores covering the exterior of lips; Painful, blistering lesions on chest, arms, and legs; Developing a light rash on her legs; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Outbreak of oral herpes/first cold sore developed; feeling tingling in mouth;blisters on the inside of her lips, cold sores covering the exterior of lips), BLISTER (Painful, blistering lesions on chest, arms, and legs) and RASH (Developing a light rash on her legs) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, PREGABALIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced ORAL HERPES (Outbreak of oral herpes/first cold sore developed; feeling tingling in mouth;blisters on the inside of her lips, cold sores covering the exterior of lips), BLISTER (Painful, blistering lesions on chest, arms, and legs) and RASH (Developing a light rash on her legs). The patient was treated with DOCOSANOL (ABREVA) at an unspecified dose and frequency; FLUOCINONIDE at an unspecified dose and frequency; TRIAMCINOLONE at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Outbreak of oral herpes/first cold sore developed; feeling tingling in mouth;blisters on the inside of her lips, cold sores covering the exterior of lips), BLISTER (Painful, blistering lesions on chest, arms, and legs) and RASH (Developing a light rash on her legs) had not resolved. Not Provided          The patient had a scheduled hip surgery on 14-Apr-2021 which might be postponed due to patient condition. The patient reported that blistering lesions on chest some are tiny blistering when appearing; two on shoulder under bra strap are roughly the size of a quarter and ache on exposure to air. The patient has regular physician contact and was given a steroid injection at her appointment on the day of the call, 05-Ap-2021. The patient received the treatment fluocinonide for inside of mouth. It was reported that the patient was actively experiencing symptoms; remain severe at the time of the call.  Action taken with mRNA-1273 in response to the events was not applicable.
Pain across her chest when she breathes; shoulder blade under her arm she developed pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis (had trouble with arthritis). Concomitant products included infliximab (Remicade).   On 28th October 2019, the patient received the 1st dose of Shingrix. On 29th October 2019, 1 days after receiving Shingrix, the patient experienced pain. On 1st November 2019, the patient experienced chest pain. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the chest pain was unknown.   It was unknown if the reporter considered the pain and chest pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The next morning near her right shoulder blade under her arm, she developed pain. On the day of reporting, she reported it had moved to the left side in her back she also felt referred pain across her chest when she breathes. Caller reports having trouble with arthritis and was unsure of pain causality. The reporter consented to follow up.
Fever of 101.8 Lethargy Muscle aches  Patient is around 16 weeks pregnant and is due in October 2021
No Adverse Reaction. Pt to come to clinic on 9/19/2023 for DTap vaccine.
Patient states she received a flu shot at the ICHD on 10/28/05 at 4:00-4:30 pm. She states that she felt "weird" after getting the shot. State weird means her face felt tight but she didn't pay attention. She was visiting her sister who was a patient at medical center that evening. While at hospital she laid down between 8-9 pm, preparing to spend the night with her sister. States she immediately began to have swelling of her lips, tongue, eyes and neck. She states that her eyes were very bloodshot. She was taken down to Emergency Department, where she was given an IV. She was sent home on prednisone for 5 days, 3 days of Tagamet and 3 days of Benadryl. Symptoms resolved. Medicine course was completed and symptoms returned 2 days later. Patient went to hospital, where she states she was given a prednisone shot and was sent home with 7 days of Benadryl, Tagamet and prednisone. Today she is on day 3 of the 2nd medicine course and feels well. Requested medical records from hospital and IRMC ER on 11/08/05.
Patient received second dose in series at 0730 today began developing itching and hives several hours post administration. Also complained of runny nose and sneezing. Was given Zyrtec 10mg and Benedryl 25mg orally at 1530 on the same date.
This is a spontaneous report from a contactable physician via a sales representative. This physician reported similar events for two patients. This is the first of two reports. A adolescent male patient of an unspecified ethnicity received single dose of TRUMENBA (Lot # S26962), via an unspecified route of administration on an unspecified date at an unspecified dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe vomiting within an hour of meningococcal group b rlp2086 and went to ER for assistance. The outcome of event was not reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017359849 same reporter/drug/event, different patient.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age with diabetes. On 02-MAR-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous. Concomitant therapies included Metformin. On an unknown date in March 2014, the patient developed red rash on her arm near the injection site and swollen lymph node. No treatment was rendered. There was no lab tests performed. The outcome of the events were reported as not recovered. The patient sought medical attention. Additional information has been requested.
Pt was given monovalent vaccine rather than bivalent, pt returned and got bivalent the same day
Pain/soreness at injection site, worst on 9/20, better on 9/21. 101 degree fever lasting one day, all day, on 9/20. Small splotchy rash starting around injection site 9/21.
Patient received pneumococcal vacine on 9/24/05.  Patient developed erythema to the site.  Site developed into cellulitus.  MD notified.  Patient ordered cephalexin for the celluitus.  Report from care coordination notes that the site had improved and swelling decreased.
Had to wait a month between shots; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too short (Verbatim: Had to wait a month between shots). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 15-MAR-2023 The case was received from the patient interactive digital media. The patient stated that he/she only had to wait a month between shots. The follow-up could not be possible as no contact details were available. The patient received 2nd dose of Shingles vaccine, later than the recommended interval, which led to lengthening of vaccination schedule. This case is linked with US2023AMR047839, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR047839:Same reporter
Sudden chest pain radiating toward armpit; Dizzy; Sweaty; Rapid pulse rate; Nausea; This is a spontaneous report received from a contactable consumer (patient). A 13-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administered in left arm on 21May2021 13:30 as single dose for COVID-19 immunisation at School or Student Health Clinic. Medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. Patient had no allergies. On 21May2021 22:30, the patient experienced Sudden chest pain radiating toward armpit, dizzy, sweaty, rapid pulse rate, nausea. The symptoms resolved after about 10-15 minutes. This repeated a second time on Saturday 22May around 4 pm. Repeated a third time on Sunday 23May around 3 pm but was less in severity. Lot number on card not clear but appears to be EN0185 or EW0185. The events assessed as non-serious. No treatment was received for the events. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) (batch number YE53N, expiry date 7th November 2021) and (batch number QE4SZ ?, expiry date 26th November 2021) for prophylaxis.   On 7th October 2019, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The healthcare professional declined to provide patients initials and date of birth. The vaccine lot number and expiration date provided in report fields were for the powder portion of Shingrix. The patient experienced a rash following a dose of Shingrix. No onset date of rash was provided. The reporter noted the patient went to his doctor and a skin biopsy was sent for review. The results did not returned at time of reporting. No additional information was there to provide. The reporter consent to follow up
Neurological Disorder(s); Prior to the second inoculation of the Pfizer COVID-19 vaccination, the recipient was a healthy 44yo female, with an unremarkable medical history. Seven days following the inoculation, the recipient sustained severe headache, neck pains, body aches, fever, blurred vision, dizziness, unsteadiness, and the inability to walk due to initial onset of inoculation side effects. The recipient continues to now suffer chronic blurred vision, unsteadiness, and other vestibular system problems due to the Pfizer COVID-19 vaccine. Continued medical treatment is still being conducted, all while the recipient has been unable to work due to disabling side effects.
Pt was given 7 days of Valacyclovir for shingle tx. & Outbreak of Shingle VALACYCLOVIR
Pt complained of pain in (L) arm at site of injection on same day of injection. On the following day, pt felt his stomach was "warm" and vomited at school. Also complains of "scratchy throat". Denies shortness of breath or chest pain although mother treated with Albuterol and ZYRTEC because she thought he was "breathing funny". School nurse reported temp = 96.4. Vitals on exam WNL in clinic on 4-20-2016 at 11:50 AM. Child denies any symptoms other than "scratchy throat". Strep A culture and viral respiratory panel sent on 4-20-2016. Pt to follow up in clinic on 4-21-2016.
Initial and follow up information has been received from a physician and an other health care professional concerning a 71 year old white female with hypertension and no known allergies who on 13-AUG-2007 at 13:00 was vaccinated SC with a 0.65 ml first dose of Zostavax (Lot#656858/0356U). There was no illness at the time of injection. On 14-AUG-2007 the patient developed injection site redness, swelling and mild pain. The patient contacted the physician's office. No lab studies were performed. The patient was prescribed AVELOX 400mg for 7 days accompanied by warm compresses as a precaution. The patient did not have an infection. As of 20-AUG-2007 the patient recovered. No further information was provided. There was no product quality complete involved. Additional information is not expected.
Fever, body aches started about 12 hours after administration. Took ibuprofen. About 8 hours after that dose, took another ibuprofen for same symptoms. About noon (24 hours after vaccine) fatigue and loss of appetite. Approximately 6p on 11/13 diarrhea started. Fevers and chills were ongoing. Started alternating acetaminophen with ibuprofen every 6 hours. Fevers became less frequent on 11/15. Diarrhea persisted for 48 hours. Labs were ordered. All liver enzymes were elevated.
Information has been received from a certified medical assistant (CMA) concerning a 9-week-old breast fed white female who on 12-APR-2007 was vaccinated PO with the first dose of rotavirus vaccine (human-bovine) (lot # 655406/1114F). On 12-APR-2007, the patient experienced projectile vomiting when "a little" of the vaccine was administered into her mouth. The CMA tried again to administer the dose and the patient vomited again. The dose was then mixed with Pedialyte, but the patient vomited again. Unspecified medical attention was sought. On that same day, the patient recovered. No further information is available.
The patient stated that she experienced the following side effects directly after vaccination: lost of mobility in her neck, pain and loss of mobility from both shoulders down to her elbows, pain in her chest, and she stated could barely move her arm.
Developed generalized hives on 7/15/21 at 18:00 (78h post second COVID vaccine dose). No respiratory distress, no uvula or lip swelling. Given dose of benadryl 7/16/21 at 09:00 when seen in primary care office with significant improvement in itching. Discharged home with scheduled benadryl until hives resolve. Most likely cause in general is viral/idiopathic  but reporting due to timeframe in relation to second COVID vaccine.
his vision was blurry/Felt like his vision was getting blurry in both eyes; with eye floaters that are catching the light more often/Eye floaters and they are catching the light more often which is creating a flashing light every now and then/The floaters are happening more in his left eye; with eye floaters that are catching the light more often/Eye floaters and they are catching the light more often which is creating a flashing light every now and then; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 36-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 23May2021 12:40 (Batch/Lot Number: EW0178) as 1st dose, single for covid-19 immunisation. The patient medical history prior to vaccinations included headache, stomach ache and arm pain. Concomitant medications were not reported. History of all immunisation list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine or additional Vaccines Administered on Same Date of the Pfizer were reported as none. On 23May2021 after receiving a first dose of vaccination, a couple hours after the vaccine patient felt like his vision was getting blurry in both eyes and that had continued. He also had eye floaters before receiving the Covid 19 vaccine but now the eye floaters are catching the light more often which is creating a flashing light every now and then. It was happening in both eyes, the floaters are happening more in his left eye. He reported the ophthalmologist said his eyes were fine. He reported he was borderline on his eye prescription and according to the ophthalmologist the Covid 19 vaccine might impacted his eye muscles a little bit and pushed him over to the next prescription. The ophthalmologist said the blurred vision should go away in a few days. The ophthalmologist also said he had not heard of any vision side effects with the Covid 19 vaccine, and he should be fine a day or two. It was reported that patient was not visited to emergency room of physician office. At the time of report, patient was not recovered from the events. Additional information has been requested.
Apparent cellulitis/possible abscess 17x17 cm. Ant. Lt thigh Adjacent to injection site.
Vertigo; Area in left cheek about an long was hard/stiff and the cheek was misshapen/Cheek was enlarged/Enlargement also spread to forehead, left lower jaw; Area in left cheek about an long was hard/stiff and the cheek was misshapen/Cheek was enlarged and face and facial features were asymmetrical; Double vision; Blurry vision in one eye; Severe light sensitivity; Left side of face felt very heavy and numb; Left side of face felt very heavy and numb; Eyelids not being open evenly/Enlargement also spread to eyelids; Sudden pain behind left earlobe; Could not properly smile or create facial expressions; Fall; Severe memory issues; Lack of cognitive function; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIOINTECH COVID-19 VACCINE; solution for injection; lot number: EW0150), via an unspecified route of administration, administered in the left arm on 05Apr2021 16:30 (at the age of 23-years-old) as dose 1, single for COVID-19 immunization. Medical history included Ehlers-Danlos syndrome, postural orthostatic tachycardia syndrome (POTS), dysautonomia, Sjogren's syndrome, pelvic floor dyssynergia, and asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) immediate release (IR) and extended release (XR), atenolol, lamotrigine, and testosterone enanthate (XYOSTED). The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and metronidazole benzoate (FLAGYL) and experienced drug allergy with bot drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 05Apr2021, the patient experienced severe memory issues and lack of cognitive function which persisted and was still occurring at the time of the report. On 07Apr2021 00:15, the patient experienced sudden pain behind the left earlobe lasting a few seconds and sudden vertigo causing her to fall over towards the left. Shortly after, the patient noticed an area in her left cheek about an long was hard/stiff and the cheek was misshappen. The cheek was enlarged and her face and facial features were asymmetrical. The patient had double vision/blurry vision in one eye, possibly due to her eyelids not being open evenly. The patient also experienced severe light sensitivity. The left side of her face felt very heavy and numb. The patient could not properly smile or create facial expressions. Later that day, the enlargement also spread to her forehead, left lower jaw, and further to her eyelids. The events resulted in emergency room/department or urgent care visit. Therapeutic measures were not taken as result of the events. The outcome of the events was not recovered.
headache; 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 HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Nine days after injection a slightly itchy, red rash appeared around the injection site. About 3 inches in diameter. The area was sore and after a couple days was hot to the touch. Lasted for about 7 days before it faded.
Patient is an 80-year-old male with history of arthritis, Early dementia, sleep apnea, COPD and hyperlipidemia along with a recent abdominal ex lap due to a perforated gastric ulcer presenting to the emergency department via EMS from home for confusion and combative behavior.  Patient was recently admitted at hospital from 7/19-8/10 for abdominal issues where he underwent an exploratory laparotomy.  He was then discharged from hospital to a nursing facility as he was diagnosed with COVID in the hospital and this was the only facility that was able to take COVID-positive patients.  Per patient's daughter who is power of attorney and lives in another state, she told us over the phone that patient was then discharged from the nursing facility and was to go to another nursing home, however they did not have any beds available, so he ended up back home.  He is currently living with his wife who is also disabled and unable to take care of him.  He recently has become combative towards his wife.  He does have a wound in the center of his abdomen, and he will not let anybody touch this anymore either.  Upon arrival, patient is alert to self and place, however he thinks it is 1940s. Patient's wife is unable to come up to the hospital due to her disability. Associated Symptoms: skin lesions