chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in area where she received her shot; Not feeling well; Headache; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2023, the patient received the 1st dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced injection site pain, feeling unwell, headache and tiredness. On an unknown date, the outcome of the injection site pain, feeling unwell, headache and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, feeling unwell, headache and tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's comments: The patient self-reported this case.  The patient received her first dose of Shingrix on the left arm, one day before reporting and was not feeling well, had pain in the area where she received her shot, had a headache and was experiencing tiredness. The reporter did not consent to follow-up.
On December 7th I developed shingles on my face and it also went into my eye. The treatment that I received was that I was put acyclovir, prednisone, gabapentin Tegretol, Benadryl, prednisolone eye drops, Tylenol, Ibprophen, Flexeril,  and amino lysine. I'm still dealing with the shingles and it's going on 3 months.
pt recvd vax & devel fever, chills, shakes & cellulitis;pt presented to ER for eval & was treated w/Rocephin & Cipro;MD had a concern about the particular lot of vax;
Sore arm, movable but paid lifting it above my head. Fever on  day after vaccination of 99.2-100.2. Minor chills, minor fatigue.
After the booster shot, I felt the typical flu like symptoms for 2 days of chills, hot flashes, and soreness. Then 8 days later on 12/25/21 my scalp started itching. I woke up at 4am covered in red hives and welts and was extremely itchy. From Saturday through Tuesday the hives migrated to different areas reaching everywhere. By Tuesday 12/28/21, My right eye started to see some swelling and a visible bump over my right eyebrow. Wednesday 12/29/21 my hands, and feet started swelling and toes started to turn grey/purple. At this point I went to Urgent Care.
Mom stated pt had fever of 102.8 & was listless for approx 12 hrs & 2nd DTP/HIB/OPV; pt was limp; APAP given; no sz noted;
9/16/21: Patient arrived to ER due to shortness of breath for the past day. He stated he thought he had a cold for a few days. He reports he and his wife testing positive for Covid yesterday and complaints of progressively worsening shortness of breath with 70% pulse ox reading on room air at home. He reports receiving 3 doses of the Covid vaccine as well as receiving Regeneron yesterday. He denies N/V/D, CP, abdominal pain, syncope, fever, chills, cough, HA or any other symptoms currently.   Pertinent abnormal laboratory findings include neutrophils 72, bands 14, lymphocytes 10, D-dimer 1.47, glucose 110, BUN 46, creatinine 2.52, AST 58, LD 537, BNP 1495, procalcitonin 1.45 & CRP 153. Please note: Patient received first dose Pfizer vaccine on 1/13/2021 Lot # EL1283 and the second dose on 02/10/2021 Lot # EL9265 and the third dose on 9/9/2021 Lot # FF2587
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot  number: not reported) dose: not reported, on Apr 28, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. Apr 2021, patient experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of fever: not reported.
Redness is spreading down her arm and up across her back/At her injection site was a 3 inch raised red circle; Hive type stuff across her back; Arm  became swollen; Arm  became hot to the touch; Right arm was also itchy/Itchiness is spreading down her arm and up across her back; Arm soreness in the vaccination arm; A spontaneous report was received from a boyfriend concerning a 27-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness in the vaccination arm/ Pain in extremity, at her injection site was a 3 inch raised red circle/ redness spreading down her arm and up across her back/ Injection site erythema, arm became swollen/ Peripheral swelling, arm became hot to the touch, right arm was also itchy, itchiness spreading down her arm/ Pruritus and hives type stuff across her back/ Urticaria.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 via unknown route in the right arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, after receiving her vaccination, the patient experienced one day of arm soreness in the vaccination arm, which resolved after one day.  On 09 Jan 2021, the patient noticed a 3 inch raised red circle at her injection site. Her became swollen, hot to the touch and was also itchy.  On 10 Jan 2021, the redness and itchiness spread down her arm and up across her back. There also appeared to be hive type stuff across her back. The patient called her HCP who recommended taking 25-50 mg of diphenhydramine every 6 hours, which the patient had been doing.   Action taken with mRNA-1273 in response to the events was not reported.   The event, arm soreness in the vaccination arm, was resolved on 01 Jan 2021. The events, at her injection site was a 3 inch raised red circle, arm became swollen, arm became hot to the touch, right arm was also itchy, redness spreading down her arm and up across her back, itchiness spreading down her arm and up across her back, and hive type stuff across her back was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient has has influenza immunization (FLUZONE HD) on 9/22/11. Started to complain about symptom: constant painful upon movement of shoulder, swollen and limited range of motion. Feels like there is something constantly poking inside shoulder.
Information has been received from a registered nurse concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who on 14-AUG-2006 was vaccinated subcutaneously with "the standard dose" of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653736/0689F).  There was no concomitant medication.  ON 15-AUG-2006 the  patient developed a rash on her face and experienced itching on her face.  It was reported that the rash was only on the patient's face and not at the injection site or any other part of her body.  The patient was instructed to take diphenhydramine hydrochloride (BENADRYL).  On 17-AUG-2006, in the morning, the patient was instructed to take diphenhydramine hydrochloride (BENADRYL).  On 17-AUG-2006, in the morning, the patient called her physician's office and reported that "it was responding to diphenhydramine hydrochloride (BENADRYL) but had not fully recovered".  The patient was scheduled to be seen by her physician on 17-AUG-2006.  Additional information has been requested.
Patient received her vaccination in her left arm. (Janssen Covid-19). About 1-2 minutes after vaccination, the patient began to black out for about 10-15 seconds.  She woke up and water was provided. 911 was called and the patient began to black out again for about 10-15 seconds. She refused medical attention from 911, and began to drink more water and electrolytes.  She remained on site for 30 minutes for observation.  She stated she was dehydrated and has a history of fainting after vaccines and piercings.  She did not disclose this information prior to vaccination.  A follow up call was placed on 07/28/2021, and the patient stated she was feeling much better and only experiencing slight pain at the injection site.
pain at injection site; fatigue; fever reemerged; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and PYREXIA (fever reemerged) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and PYREXIA (fever reemerged). On 09-Feb-2021, VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and PYREXIA (fever reemerged) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included acetaminophen.
Numbness in groin and rectal area / Numbness in feet; Dfficulty urinating; difficulty defecating; feel numbness in rectal area; Skin became sensitive to touch; Skin was painful to the touch; rash; Difficulty walking; Flu like symptoms; Chills; Achy all over; Headache; May have multiple sclerosis; This case was reported by a consumer via call center representative and described the occurrence of multiple sclerosis in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, 1 day after receiving Shingrix, the patient experienced multiple sclerosis (serious criteria GSK medically significant). On 20th October 2019, the patient experienced influenza-like symptoms, chills, pain and headache. On 24th October 2019, the patient experienced sensitive skin, skin pain, rash and walking difficulty. On 25th October 2019, the patient experienced numbness in feet, urination difficulty, defecation difficult and anal numbness. On an unknown date, the outcome of the multiple sclerosis, sensitive skin, skin pain, rash, walking difficulty, numbness in feet, urination difficulty and defecation difficult were not recovered/not resolved and the outcome of the influenza-like symptoms, chills, pain and headache were recovered/resolved and the outcome of the anal numbness was unknown.   It was unknown if the reporter considered the multiple sclerosis, influenza-like symptoms, chills, pain, headache, sensitive skin, skin pain, rash, walking difficulty, numbness in feet, urination difficulty, defecation difficult and anal numbness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received Shingrix on left arm. The patient experienced flu like symptoms, described as achy all over and chills and headache.  The patient's skin became sensitive to touch, primarily on the left side above the waist but below the underarm. The skin was painful to the touch. The patient also experienced difficulty walking. The patient then began to feel numbness in his groin and rectal area. and had difficulty urinating and defecating due to not being able to have feeling. On 29th October 2019,the patient went to the emergency department. The patient did not remain overnight and was advised to see a neurologist the next morning.  On 31st October 2019, the patient was dianosed with multiple sclerosis. The neurologist said that the patient might have multiple sclerosis. The neurologist performed an MRI of the spine and brain, which were unremarkable.   The patient was also tested for Lyme disease but results are not known at the time of reporting. The reporter consented to follow up.
On 11/13/01, the child's aunt called triage nurse regarding his arm being swollen and having a fever. He came to ER on 11/14/01 with right arm red and swollen from elbow to upper to upper arm. Rx'd ibuprofen, Benadryl and cool compresses. He had no fever or systemic symptoms.
1st dose in November 2016, 2nd dose 3-4 months later and 3rd dose in March 2017.; brain is in a fog; has cognitive impairment, is anxious and withdrawn; has cognitive impairment, is anxious and withdrawn/teenage angst; has cognitive impairment, is anxious and withdrawn; He mumbles when he talks/When he talks, he says he doesn't know what to say; This spontaneous report was received from a consumer referring to a 15 years old male patient. The patient had no concomitant medications, pertinent medical history and drug reactions/allergies.     In November 2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot # and expiration date were not provided) intramuscularly for prophylaxis. The second dose  was administered 3-4 months later and the third dose  was administered in March 2017 (via intramuscular; dose detail, lot number and expire date were unknown) (inappropriate schedule of product administration).        In 2017 (reported as after 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)), the patient was noticed different and had cognitive impairment, was anxious and withdrawn. The patient felt the shot going through his veins. He mumbled when he talked. When he talked, he said he didn't know what to say since he said his brain was in a fog. His teachers at school said he was like a different person. At first the reporter thought it was teenage angst. The patient sought for medical attention. The patient went to a mental therapist who prescribed fluoxetine hydrochloride (PROZAC) and sertraline hydrochloride (ZOLOFT). That didn't help so they were discontinued. He went to a Neurologist who did lab panel for aluminum which didn't show anything. The patient tried probiotics, changing diet to fruits and vegetables, yogurt, lemongrass, elderberry, epsom salt baths, cilantro, fish oil supplements, Cannabidiol (CBD) oil and deep tissue massage. Nothing seemed to help. The outcome of the events was not recovered. The causality assessment was not provided.  Upon internal review, brain was in a fog was determined to be medically significant.
erythema, warmth, lymphadenopathy, pain, swelling, fevers 101
Information has been received from a physician concerning a 96 year old female who on 15-NOV-2007 was vaccinated with a 0.65 ml subcutaneous dose of Zostavax (Oka/Merck). Concomitant therapy included KLONOPIN and LEXAPRO. "About 13 days later", on 27-NOV-2007, the patient experienced a severe case of shingles around the eyes. No product quality complaint was involved. No other information was provided. Additional information has been requested.
On  Monday the 28th I was handing a patient a piece of paper and I got really dizzy. I felt dizzy through the morning and then went to lunch. Saw Dr. and told her what happened. She looked at my eyes and asked me a few questions. She checked me again after lunch. She also checked me again at 3:30 pm...my dizziness came and went throughout the day. The dr also walked me to my car at the end of my shift to make sure I was safe to drive. It was okay for me to drive. I took Dramamine for the dizziness and nausea when I got home. Symptoms had resolved the next morning.
Difficulty breathing, severe chest pain, fast severe chest pain, increasing and fast heart beat, shortness of breath, weakening of entire body, feel of fainting, shaking, trembling, severely high fever, skin tone changes to red/violet or veins showing through skin, nausea, vomiting, feeling heart will stop or explode.
awoke 3AM crying, inc temp, irritable;tepid bath;second dose of APAP;12hr later still inc temp, irritable;
"not sure if the vaccine was administered properly"; at times fingers go numb; excruciating pain that radiates down left arm; "shoulder problems" and pain of left shoulder; still feel the injection site where the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR ("not sure if the vaccine was administered properly"), HYPOAESTHESIA (at times fingers go numb), PAIN IN EXTREMITY (excruciating pain that radiates down left arm), ARTHRALGIA ("shoulder problems" and pain of left shoulder) and VACCINATION SITE PAIN (still feel the injection site where the vaccine was given) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 040B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), MELATONIN and FISH OIL for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR ("not sure if the vaccine was administered properly"), HYPOAESTHESIA (at times fingers go numb), PAIN IN EXTREMITY (excruciating pain that radiates down left arm), ARTHRALGIA ("shoulder problems" and pain of left shoulder) and VACCINATION SITE PAIN (still feel the injection site where the vaccine was given). At the time of the report, PRODUCT ADMINISTRATION ERROR ("not sure if the vaccine was administered properly"), HYPOAESTHESIA (at times fingers go numb), PAIN IN EXTREMITY (excruciating pain that radiates down left arm), ARTHRALGIA ("shoulder problems" and pain of left shoulder) and VACCINATION SITE PAIN (still feel the injection site where the vaccine was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were reported by the reporter.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported..
Received 1st injection GARDASIL. C/o Flu-Like symptoms immediately. Fever/chills, achiness, watery eyes, cough, nasal congestion, headache, fatigue, sore throat, hoarseness.
injured knee; pain significant enough that it makes it difficult to sleep some nights; injured knee starts to hurt; muscle pain in his shoulder; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (injured knee), INSOMNIA (pain significant enough that it makes it difficult to sleep some nights), ARTHRALGIA (injured knee starts to hurt) and MYALGIA (muscle pain in his shoulder) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   On 07-Feb-2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced JOINT INJURY (injured knee), INSOMNIA (pain significant enough that it makes it difficult to sleep some nights), ARTHRALGIA (injured knee starts to hurt) and MYALGIA (muscle pain in his shoulder). At the time of the report, JOINT INJURY (injured knee) and ARTHRALGIA (injured knee starts to hurt) had not resolved and INSOMNIA (pain significant enough that it makes it difficult to sleep some nights) and MYALGIA (muscle pain in his shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter Reporter causality: related for joint injury and arthralgia; unassessable for rest of the events
mild case reported by mom;3 lesions noted on back, one above lip, ear & knee;temp f 101 preschool attended by child reported outbreak of varicella during that time;
Seizure - went to ER. Received 4 doses of ATIVAN and 1 dose of DILANTIN. Admitted to PICU.  Medical records and ICD9 codes received for DOS  9/18/09.    FInal DX:Altered mental staus, focal seizure Vaccines given 9/13/09. C/O child sitting up in bed and staring. Tried to talk. Focal seizure witnessed in ED with L eye shift and L extremity movement/stiffness. (+) urinary incont. Lethargy. Previous GI virus with vomiting. Head CT/MRI abn. PICU admit.  ICD9 Codse:  780.39, 780.02, 789.02, 767.6
received 2 doses of the Moderna Covid-19 Vaccine after which they both caught Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received 2 doses of the Moderna Covid-19 Vaccine after which they both caught Covid) in a male patient of an unknown age 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 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. On an unknown date, the patient experienced COVID-19 (received 2 doses of the Moderna Covid-19 Vaccine after which they both caught Covid). At the time of the report, COVID-19 (received 2 doses of the Moderna Covid-19 Vaccine after which they both caught Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-456336 (Patient Link).  Company comment: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the second dose of mRNA-1273. As reported, the patient received 2 doses of the Moderna Covid-19 Vaccine after which he caught COVID. No exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the second dose of mRNA-1273. As reported, the patient received 2 doses of the Moderna Covid-19 Vaccine after which he caught COVID. No exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.