chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm twitching; arm is kind of hurting; This is a spontaneous report from a contactable consumer (patient's wife). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in left arm at the age of 47-year-old on 12Apr2021 11:45 (Lot Number: EW0158) as single dose for COVID-19 immunisation. Medical history included none. Family Medical History reported Diabetes, heart disease, high cholesterol. There were no concomitant medications. The patient previously took first dose bnt162b2 (Lot Number: EN6199, Route IM, Anatomical Location: Left)) at the age of 47-year-old on 22Mar2021 for COVID-19 immunisation. Caller reporting side effects from Pfizer COVID vaccine that her husband is experiencing. Caller states that her husband had 2nd dose on Monday 12Apr2021 and he is generally ok, his arm is kind of hurting in Apr2021. Caller states her husband arm started twitching today 15Apr2021 (twitching started today around 11AM this morning) and would like to know have other people been reporting this, what this is. Caller states that he caller her about 10:50am this morning so it seems like it has been 72 hours, that the arm twitching started, after the Pfizer COVID vaccine that her husband had on Monday 12Apr2021. Caller states that she is feeling guilty because she had no reaction to the vaccine but her husband is having problems and she made the appointment and made him go get the Pfizer COVID vaccine. No any AEs require a visit to Emergency Room or Physician Office. The outcome of event arm twitching was not recovered. The outcome of event arm is kind of hurting was unknown.  No follow up attempts are needed. No further information is expected.
None - patient has no aderse reaction or response, and is doing well (per MOC)  - COVID booster was given too early
My daughter woke up to feeling nauseous vomiting and was having effects of her stomach hurting. I tried to give her some clear liquids and she could not hold any liquids down constant vomiting throughout the a.m. in the morning
No adverse event; the patient first dose of ROTAVIRUS vaccine was ROTARIX and today the patient received their second dose of the series as ROTATEQ; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine live oral 1v (ROTARIX) instead of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (interchange of vaccine products). On 10-APR-2023, the patient was vaccinated with the second dose of the series as rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event reported (no adverse event).
Pt presents with complaints of left shoulder pain for past month since getting Flu shot at AMP flu event on Oct. 4.  She notes having greater than usual pain after shot, and poor use of left arm.  Since then, difficulty sleeping on L side until now.  Unable to paint due to pain when reaching forward.  Pain during taking off shirt and bra, bathing (unable to reach behind back and R shoulder, reaching out to side.    Pain was rated at 8-9/10  for first week or two, and is slightly better this week, starting week 4.    Pain was severe; 8-9/10 and radiating to anterior, posterior and lateral L shoulder; Currently rated at 4/10 at rest and pt is scared to move shoulder.   Pt will benefit from skilled PT services in order to reach established goals. Pain medication   Has not had A follow-up since Oct 26 th
When she was ten, patient received the three-shot course of quadrivalent HPV vaccine. Please note, it was quadrivalent, not Gardasil 9 which was not yet available at the time. She experienced severe pain in her arm and a massive headache with each shot. As middle school started in the Fall, we noticed her getting more frequent headaches and not having as much energy as usual. PE class became a struggle for her as well, and she had trouble concentrating on her homework. Patient developed feelings of anxiety. She also started to have a disordered sleep schedule, often unable to sleep at night but exhausted enough to need naps during the day to function. She started spending less and less time outside as she felt overly sensitive to the noise, direct light, and heat. She progressively spent more time in her room where it was dark and quiet. She spent much of her time in bed feeling fatigued. She started requesting to take personal days off from school because of her frequent migraines and exhaustion. She would often start to black out (lose vision and hearing, feel dizzy and nauseous, and drop to the ground) after getting up from bed. She noticed pain in her joints, especially in her shoulders, back, and lower extremities. Any time she would have to stand for more than a few minutes, her legs would get splotchy red or purple coloring and her knees would feel sore. Warm showers and baths made her feel lightheaded and would induce shooting pains in her calves and feet. She experienced gastric stasis with nausea, bloating and intermittent constipation. Eventually, she developed a hand tremor that would manifest any time she used her hands for eating, painting, drawing, or carrying things.
Redness, swelling from shoulder to forearms on both shoulders which resolved in 48 hours. Also developed a mild red rash on the chest. Treatment was cool compress and Ibuprofen.
3 hours after injection, developed severe local pain around injection site.  By 24 hours later, has 4cm round area of erythema and swelling around injection site but is very tender to palpation, out of proportion to exam, from right elbow up to right clavicular region.  Arm movement is significantly limited by pain.
Father reports rash started on neck 9/29/02. Also noticed redness, swelling and blisters on R arm at site of injection. Rash on neck has progressed down back over shoulder blades and now has small blisters. Child also complaining with leg pain. Father states they applied Calamine lotion today. Referred to private MD.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2022 at 11:00 as dose number unknown, single (Lot number: IM0698) at the age of 47 years, in left arm for covid-19 immunisation. The patient's family history included: "Hear disease history on patient father and brothers" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (25May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in 2 weeks. Rebound of Covid 19. Tested positive on 25May2022. Symptoms never went completely away since patient originally tested positive on 09May2022. COVID 19 Treatment included Paxlovid, Treatment start date: 09May2022, Treatment stop date: 14May2022. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sore arm, slight swelling and redness at injection site, red circle slightly bigger than a quarter at injection site all starting day after vaccine. Redness and swelling has started to go down
Patient complained of left arm weakness and sensation that arm was "asleep", palpitations, headache.  Escorted to the Emergency Department
Patient came to pharmacy on Monday 11/19/18 with complaint of difficulty raising left arm. Said difficulty raising left arm began around 3 days after receiving flu shot, approx 11/4/2018. Following completion of this form...phoned patient. Contacted patient to verify if any other vaccines/treatments in last several months...No. Told him, that after we met today around 4:00 PM 11/19/18, I contacted his physician and left verbal message with his staff, including all details about the event. Patient mentioned that he took dog for a walk, and was out of house when MD office called him back and left him a message. Patient plans on returning MD's call tomorrow 11/20/18 at 9:00 AM. Asked him if the difficulty raising left arm was getting better or worse, he said neither.
1005-Called to 30 minute observation; MD and EMT responded. 1st vaccine 1008-hard to swallow, dizziness, feeling "unwell"; fullness in ear, flushed BP 187/118; tolerating water 1011- 164/90BP no chest pain, shortness of breath, numbness, dizziness, blurry vision, n/v 1017-Feeling better, have dry throat, MD sitting with patient 1020- Pt stated she is feeling great, denies any symptoms, elected to leave pit with her husbands.   Treatment/Outcomes: Allergies: seasonal; sulfa  MHx: Hashimoto's, gallbladder removed Meds: 'hormones" and thyroid
Redness at the injection site, it had increased in size, and little less lighter / red spot at injection spot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at the injection site, it had increased in size, and little less lighter / red spot at injection spot) in a 121-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history were reported.     On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at the injection site, it had increased in size, and little less lighter / red spot at injection spot). At the time of the report, INJECTION SITE ERYTHEMA (Redness at the injection site, it had increased in size, and little less lighter / red spot at injection spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants and treatment medicines were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information was received on 26-MAY-2021 and it contains No New information
Employee received TD vaccine in ER 10/15/04 and returned to ER on 10/18/04. Complained of painful joints and injection site (right deltoid) and malaise. Also complained of redness on injection site. Treated with Keflex 500 mg at 6 hours x 1 week. Prednisone 20 mg po once a day x 5 days.
no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use 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)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jan-2023, 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 13-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      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 (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant products reported.  Nurse supervisor reported that they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date. The beyond use date was 08 Jan 2023. The patient was 12 years and above but HCP did not have the information if some of them were below 17 years old.   This case contains information for patient 13th out of 15 patients who were administered bivalent dose on 13 Jan 2023, 1 out of 3 reported by the reporter.  No treatment products reported.   This case was linked to MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698566: Master case
Received 12 mo. immunizations on 7/19/11; per mom, developed hives next day - intermittent x3 days. Seen in office 7/23/11. No rash noted ; positive urticaria on exam. Tx= BENADRYL every 6h x 48h; then prn. Mom requesting VAERS report be filed; concerns hives secondary to vaccine (no local site reaction(s) noted).
Approx at 3pm had headache & felt lethargic then later that evening felt nauseated - no vomiting. All symptoms resolved by noon next day.
Immediately after the shot the first evening, symptoms came on strong with severe chest pain and shortness of breath. Also fever, aches and chills which I was not as concerned about. In bed for 5 days with these symptoms. Not relieve by Advil.
Information has been received from a healthcare worker, medical assistant who reported that 6 doses of improperly stored GARDASIL were administered to 6 patients on unspecified dates (lot# K007264 expiration date 02-MAR-2017, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Redness radiating down patient's arm from injection site (half arm is red). Patient received prescriptions for BENADRYL, ZANTAC, ibuprofen. Just started on medications.
12/28/21 for "Altered Mental Status". PMHx of "HTN and L eye blindness".
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic allergic sinusitis" (unspecified if ongoing). Patient had no known allergies. There were no concomitant medications. He did not receive any other medication within 2 weeks of vaccination.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.   The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Received a 0.25mL dosage for a 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a 0.25mL dosage for a 1st dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received a 0.25mL dosage for a 1st dose). On 23-Dec-2021, ACCIDENTAL UNDERDOSE (Received a 0.25mL dosage for a 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Patient was rejected to have the 2nd dose.  No treatment details were reported.
Behind their knees, the back half of our legs are cramped and swollen with pain; Behind their knees, the back half of our legs are cramped and swollen with pain/ hands are swollen; His face is swollen as well; He's been using a walker for about 1 week; He fell on Friday; they went to the orthopedic clinic who told them it was arthritis.; joint pain; muscle and back pain; muscle and back pain; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed unknown manufacturer.), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), MYALGIA (non-serious) all with onset 2022, outcome "unknown" and all described as "muscle and back pain"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Behind their knees, the back half of our legs are cramped and swollen with pain"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Behind their knees, the back half of our legs are cramped and swollen with pain/ hands are swollen"; SWELLING FACE (non-serious), outcome "unknown", described as "His face is swollen as well"; WALKING AID USER (non-serious), outcome "unknown", described as "He's been using a walker for about 1 week"; FALL (non-serious), outcome "unknown", described as "He fell on Friday"; ARTHRITIS (non-serious), outcome "unknown", described as "they went to the orthopedic clinic who told them it was arthritis."; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201309624 same reporter/ product/event, different patient;
Information has been received from a nurse practitioner and a registered nurse concerning a female  who on an unspecified date was vaccinated with a dose of GARDASIL.  Shortly after receiving the vaccine the patient experienced syncope and went to the emergency room because she had fallen and hit her head.  The patient "did improve".  Additional information has been requested.  This is one several reports from the same source
Developed redness, inflammation and lightheadedness around smallpox site. As overall swelling decreased, multiple small papules emerged around area in approx 4x4inch space.
This spontaneous report was received from a nurse concerning to a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided This is one of several reports received from the same reporter. Additional information has been requested.
Pt was c/o redness and swelling from (L) arm. Recommended to ice to arm 4x/day.
mild fevers, some enlarged on lt, which slowly resolved; pt now 28SEP94 has some enlargement on lt side of jaw & mild sore throat; dx of parotitis;
Patient received vaccine on left deltoid. While in the required 15 minute waiting period patient began to get dizzing. Patient visibly looked a little pale and was told to breath slowly and put her head between her legs if she gets more dizzy. Patient never lost consciousness. While patient was waiting again she threw up and after throwing up she said she felt a lot better and visibly regained her color again. Patients BP was within normal range of 110/80. Patient stayed in the waiting room for a longer time and left when she felt fine again.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 20-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.