chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID booster injection in left arm.  Patient experienced onset of pain and limitation of range of motion.  Pain has improved but continues to have limitation of range of motion.  There is concern for shoulder injury after vaccine administration
Patient received PNEUMONAX 23 on 10/4/18 around 10am, patient noticed some redness, some itching and soreness and tenderness in evening time. Her right arm was little bit warm also. Patient took extra strength TYLENOL, that helped little bit. Patient called pharmacy on 10/5/18 in morning. Patient also came to pharmacy to show her arm. I (Pharm. D) looked her right arm. Her arm was somewhat swollen, red and tender to touch. But it was not much severe allergic reaction. I also recommended to take one or 2 dose of TYLENOL if needed. And to take BENADRYL for itching. Patient also went to Urgent care just to make sure. Nurse practitioner recommended taking BENADRYL and steroid. But patient didn't want to take steroid. And assured patient that she will be okay in 1-2 days. Patient was very pleasant in nature.
migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208415.
Hives that resolved with Benadryl.   Injection site soreness, large swelling and mild warmth
pt became very diaphoretic & was found unresponsive; BP 80/40;
10 dyas after DTaP, Polio, MMR and Varicella were given on 3/1/06, child developed SOB and painful breaths, hospitalized with diagnosis of Pericarditis.  Mother states doctors do not say it was related to vaccines. 9/15/06 Received medical records from hospital which revealed patient experienced ASD w/surgical repair 1/2004 at CHOP who presented to ER with fever, chest & abdominal pain & easy fatigue since 3/8/06, 1 week s/p vax.  Admitted to hospital from 3/10/06-3/15/06 w/final diagnosis of viral pericarditis & s/p ASD repair.  CXR showed LLL pneumonia & that 2nd sternal wire was broken.  Echo revealed septal pericardial effusion.  ID consult done & antibiotics started along with NSAIDs.  Throughout hospitalization WBC decreased but ESR increased from 46 to 74.  All cultures were neg.  Patient was d/c to home with peds cardiology follow up arranged/ss
a patient who received both doses of the Pfizer COVID vaccine and then came down with COVID; a patient who received both doses of the Pfizer COVID vaccine and then came down with COVID; This is a spontaneous report from a contactable physician from a Pfizer sponsored Program. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Batch/Lot number was not reported) on an unspecified date as dose 1, single and on an unspecified date as dose 2, single both via an unspecified route of administration for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporting physician wants to know if it was unusual for a patient having two vaccines to get COVID. The physician wants to know how common it is for a person who has two vaccines to get a COVID infection. The physician reported that they have a patient who received both doses of the Pfizer COVID vaccine and then came down with COVID. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 in this patient cannot be completely excluded.
This spontaneous report was received from a 65 year old female patient, regarding herself. The patient's medical history and concurrent conditions were not reported. On 15-FEB-2015, the patient was vaccinated with ZOSTAVAX in the left arm (administration route, lot number and expiration date were not provided). Concomitant therapies included trazodone hydrochloride, acyclovir and tramadol hydrochloride (+) ketorolac tromethamine as needed. On 23-FEB-2015, the patient experienced a "break out on an unspecified area of her body" it was not specified what kind of breakout did the patient experienced. On 04-MAR-2015 the patient had a new "outbreak". The outcome of the events was unknown at the time of this report. Additional information has been requested.
Information has been received from a nurse concerning a female patient who on an unspecified date, at the age of twelve months, was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). A few years later, the patient developed shingles. The physician decided not to give her a second dose. At the time of this report, the patient's outcome was not reported. Additional information has been requested.
Pain, erythema around injection site, induration. Lesion approx. size of a goose egg.
This spontaneous report has been received from a pharmacist concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with doses of PNEUMOVAX23, (lot #, exp. date, strength, route of administration and dose were not provided). There was no concomitant medication reported. On an unknown date, the patients experienced "redness and swelling" at the injection site while using PNEUMOVAX23. The pharmacists reported that a number of patients sought medical attention the day following the vaccination. Additionally, she stated that the adverse experience improved within a few days following the injection. Therefore, the patients status was reported as recovered. The causal assessment of redness and swelling at the injection site to PNEUMOVAX23 was not reported. Additional information has been requested.
Case number PHEH2015US026958 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 21 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 19 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
9/8/21: 3:42 pm - 5:30 pm: tightness in jaw, dry mouth, lethargic and weak, much soreness deep within left arm site of injection. 9/9/21, 4:30 am, deep pain injection site, legs heavy, like lead. 6:24 am, Nausea. 7:30 am fever 101 degrees, chills; 8:22 am; Pain site of prior hysterectomy (across all interior stitches, wide area, felt like fire); firey pain at area of biopsy of where ovaries were, fatigue, sleep till 11:20 am, then metallic taste in mouth. 4:30 pm, aches, sweaty clamy feeling, top of feet were very achy. Fever lasted through the night. 9/9/21 - 9/12/21 pains in chest over heart and down left arm.  9/10/21 7:00 am no more fever. Swelling side of breasts, particular left breast. 3:30 pm and for rest of day, fatigue.  9/11/21 7:30-9 am stomach cramps; 3-4 pm gassy stomach and from 3 pm and on feelings of fatigue.  9/12 /21 fatigue; constipation. Swelling at side of left breast began to dissipate at or about September 23, 2021. Fatigue lasted through until September 27, 2021. There was no changing of color of hair from brown to gray as with the previous Moderna injection No. 1 of 08/11/2021 with occurred about 3 days after in which the entire top layer of hair turned gray.  Lasted for 2 days and then color started to return to normal. At or about November 22, 2021 swelling under arms and side of breasts dissipated. November 28, 2021, legs finally relieved of the heavy feeling, able to move the legs freely without pain or feeling of being weighed down.
Case number PHEH2012US013248 is an initial spontaneous report received from a nurse on 02 Jul 2012: This report refers to a patient of unknown age group and gender. This patient was given only the CYW-135 liquid component of MENVEO vaccine (batch number: unknown) intramuscularly on 29 Jun 2012. No other adverse reaction was reported following this administration error.
High fevers between 104+ and 102 for 10-20  days, 101-99 with fever meds until 5/18 or thereabouts. Afterwards, still fevers in 99s without fever meds (normal temperature is low 97).  From about day 5, severe hives on arms and buttocks. Also  migratory joint pains.   Acetaminophen until 5/7, switched to ibuprofen afterwards.  Used Claritin  10mg, Pepcid AC 40 mg daily. Some steroid ointment (but the hand pain made it difficult to squeeze, so discontinued after a few days)
Patient developed persistent pruritic urticaria which is sometimes generalized, and sometimes focal on arms, legs, back, chest and abdomen. Pt was on fluconazole for vaginal yeast infection at the time.  It was discontinued  on 3/7/2022 or 3/8/2022.  Urticaria continues to erupt as of today (3/16/2022).
at injection site: area of redness, mild warmth, mild discomfort that took approximately 10 days to resolve completely
The patient answered all screening questions and received the appropriate flu vaccination. After receiving the vaccination, the pharmacist instructed the patient to stay seated until they were ready while their documentation was printed. The patient stood up and proceeded to faint backwards into the partition dividing the immunization area. The pharmacist and technician rushed over to assist the patient and the patient's partner. The patient was conscious the entire time and both he and his partner denied repeated requests to contact 911. We offered other services to the patient, including blood pressure checks but all were denied except an ice pack and cold fluids. The pharmacist stayed with patient while they recovered and helped him to a sitting position when he was ready. This took about 10 minutes. After continuing to observe, the patient was assisted to a chair where they sat and drank more fluids and recovered. Repeated requests to call 911, the physician or perform blood pressure checks were denied as the patient stated they "were fine and just embarrassed". When the patient was ready after another 10 minutes, they asked to leave. The pharmacist assured the patient was stable and would not be driving or performing any other taxing duties. The patient was instructed to contact his PCP or 911 should he have any other symptoms.
Immunization DTAP and IPV given in right thigh on 1/3/03. On 1/4/03, had small, red/purple lump on right thigh and irritable. On 1/6/03, had decreased redness but still had hard lump.
Patient developed chest pain, confirmed as myocarditis. He was managed with high dose steroids and IVIG.
Patient received vaccine at 09:45 am, at 9:50 am  he fainted and fell out of chair that he was seated in. Within seconds he recovered. He appeared pale, nauseous, disoriented briefly. His blood pressure at 10 am was 88/45. He drank some orange juice and put his head between legs. By 10:10 am his blood pressure was 117/74.
Patient began to feel faint within 2 minutes after receiving vaccine.  Became pale and diaphoretic.  Patient was brought to floor and began to show improvement immediately.  Patient remained in observation until 9:05 AM (25 minutes after vaccine administration) and was cleared to discharge home with father at that time.
Nausea, light headed, vision loss, hearing loss, rapid heartbeat, sweating, chills, headache, difficulty breathing, clammy skin, low blood pressure, fatigue (in chronological order)
Fever, Chills, Body Aches, and Fatigue began about 7 hours after the vaccination and lasted for a period of about 36 hours. Used Tylenol and ibuprofen to reduce fever and help relieve body aches.
Tinnitus - has been nonstop 24/7 since day after 2nd COVID vaccine
Fever 102 degrees chills nausea 1 day weakness - 5 days.
Red, swollen, itchy rash all over her body the morning/day after vaccination.  Pt reports this also happened after first dose, but much milder.  Pt had not treated with anything yet, recommended Benadryl and hydrocortisone applied to the reddest/itchiest areas.
Pt vaccinated with Engerix-B developed edematous ocular orbits, irritation eye area both sides, eyes were puffy, swelling eye on both sides, eyes became itchy.
One week after receiving vaccine, I was standing at kitchen sink washing dishes and felt my back just go out. Saw an orthopedist two days later. X-rays where performed and they came back normal. Ortho doctor prescribed FLEXERIL, steroid pack, and physical therapy. After 1.5 weeks of prescribed therapy symptoms mostly resolved. I am still in PT and have follow up with ortho doctor on Friday. I experienced an almost exact event following my first dose.
Initial report received on 16 September 2014 and follow up information received on 19 September 2014 from an investigator participating in a study. A 25-month-old male subject was diagnosed with left submandibular abscess on 07 September 2014 i.e. 18 days after receiving first intramuscular 0.25ml dose of the study vaccine FLUZONE quadrivalent in right thigh on 20 August 2014 (batch number: U4978AB). The event appeared after visit 01. No medical history was reported. The subject had no concomitant therapies. The subject had symptom fever from 07 September 2014. Subject presented to the emergency department on 07 September 2014 with left mandibular abscess and fever. He was admitted to the hospital on the same day and was given one dose of Morphine, IV Ceftriaxone and Clindamycin. The abscess was drained. Culture grew MSSA and subject was changed to Cefazolin. Pain well controlled with TYLENOL or MOTRIN. Subject was transitioned to PO AUGMENTIN and was discharged. Subject was afebrile for more than 24 hours prior to discharge. The lab data was not reported. The subject had corrective treatment with Morphine - 1 dose on 7 September 2014, IV Ceftriaxone from 07 September 2014 to 10 September 2014, IV Clindamycin from 07 September 2014 to 10 September 2014, IV Cefazolin from 10 September 2014 to 13 September 2014, PO AUGMENTIN 13 September 2014 to 18 September 2014, TYLENOL from 07 September 2014 to 13 September 2014 and MOTRIN from 7 September 2014 to 13 September 2014. The symptom of fever was resolved on 16 September 2014. The subject was discharged from the hospital on 13 September 2014. The event of left submandibular abscess was ongoing at the time of the report. According to the investigator, the event was not related to the study vaccine or trial procedures. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 30 October 2014: It was updated that the subject presented to the emergency department on 07 September 2014 with left submandibular (previously reported as left mandibular) abscess and fever. Follow up information received on 10 December 2014: It was reported that the subject had no ongoing illnesses, medical history or risk factors. There were no complimentary investigations. At the time of reporting the event was still ongoing.
This spontaneous report was received from an unspecified reporter via Novartis company representative (manufacturer control # PHEH2018US022678_OS), concerning a 73-year-old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (strength, dose #, route, lot # and expiration date were unknown). Concomitant medications were not reported. On an unknown date, the patient experienced allergy to vaccine (reported as "drug allergy"). It the time of reporting, the outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).
Localized swelling and pain, bright red skin, and itching at location of shot for about 1 week. Lasting pain/soreness where needle entered arm over 1 month later.
cough; Sore throat; acute bronchitis; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), BRONCHITIS (acute bronchitis), COUGH (cough) and OROPHARYNGEAL PAIN (Sore throat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 047B21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included ESTRADIOL, PROPRANOLOL, ATORVASTATIN, VITAMINE C and CALCIUM for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced SINUSITIS (sinus infection). On 02-Apr-2021, the patient experienced BRONCHITIS (acute bronchitis). On an unknown date, the patient experienced COUGH (cough) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with DEXAMETHASONE 13-Apr-2021 at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; BENZONATATE for Cough, at an unspecified dose and frequency and AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. On 19-Apr-2021, BRONCHITIS (acute bronchitis) had resolved. At the time of the report, SINUSITIS (sinus infection), COUGH (cough) and OROPHARYNGEAL PAIN (Sore throat) had resolved. Not Provided          Patient took steroid shot for sinus infection   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: completed ADR form
This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), DYSPEPSIA (Bad digestive problem) and ABDOMINAL DISCOMFORT (Had a bad bowel movement) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis (Arthritis joint). On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced CONSTIPATION (Constipation), DYSPEPSIA (Bad digestive problem) and ABDOMINAL DISCOMFORT (Had a bad bowel movement). At the time of the report, CONSTIPATION (Constipation), DYSPEPSIA (Bad digestive problem) and ABDOMINAL DISCOMFORT (Had a bad bowel movement) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication list was not provided. Treatment information was not provided. This case was linked to MOD-2021-190999.
RN administered COVID shot to patient, then patient verbalized to nurse that they had received the flu shot about 8 days prior to the COVID vaccine. The patient had filled out ?NO? to question number 5 on the screening document in regards to having received a vaccine in the last 14 days. Patient informed the nurse and supervisor that they had not brought their glasses and could not properly read what the screening document was asking them.
No adverse event/ no known pt adverse events; Indavertently administered improperly stored GARDASIL 9/ Vaccines went out of temp range. Vaccines given despite the temp excursion; This spontaneous report was received from a licensed practical nurse (LPN) regarding to a 15-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.  On 09-NOV-2021, the patient was vaccinated inadvertently with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) second dose, intramuscularly in left deltoid lot number T028929, with an expiration date of 08-MAR-2023 (dose, strength and formulation were not reported) for prophylaxis (product storage error). There were no additional adverse event details and no known patient's adverse events (no adverse event). Administered dose of vaccine experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. Digital Data Logger was involved.  This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007812: US-009507513-2202USA002574: US-009507513-2202USA007813:
exactly 1wk following vax pt devel fever of 105 w/mottling of the skin;MD exam revealed concurrent ear infect;
3 h - start of arm pain 5 h - upper arm non functional from severe pain. could not be moved in any direction 6h - start of nausea, mild chills and tiredness 8h - temp of 99.3 (usually at or below 98.6), chills, headache. Pain from arm made sleeping almost impossible. 13h - temp and chills ended. arm still very painful 40h - arm pain started to subside. 18-56h - on and off nausea, dizziness and evening tiredness 48h - slight nose bleed, on and off.  64h - arm fully functional with slight lingering discomfort  ongoing - slight nose bleed, slight nausea, dizziness
blood clots in neck, then developed into a stroke which was caused from getting the vaccine shots prior. had to get admitted to the emergency room