chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm swelling; Sore arm; Headache; Vaccine given to adolescent; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to adolescent), PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to adolescent). On 07-May-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On 06-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to adolescent) had resolved. On 08-May-2021, PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved.        The action taken with 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 concomitant medications were provided. No treatment medication was reported.
Got vaccine 5/18. Pain started 5/20-waist to thigh severe pain. Rash started 5/21 on thigh leg/thigh pain. BP-159/91-hurts to touch, dry mouth.
2 hours after rec vaccine, welts developed on Rt neck, between breasts + underneath breasts, Rt + Lt outer arm proximal to elbows. C/o headache, relieved by Aspirin 2 tabs every 6 hours x 24 hours. Shea butter to welts which are brown color. Referred to family clinic.
Pt called 10-14-21 and complained of sore arm.  She felt  that she should not be having pain after 1 week and wanted it recorded.
Pain at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient's demographic details were not provided. The age at vaccination was not reported. The patient experienced pain at the injection site. The patient had not experienced any other symptoms. The patient asked how long would the event persist and asked if there was anything specific that could help alleviate it. The reporter consented to follow up.
a big lump on the side of her arm between the arm & breast; A bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a big lump on the side of her arm between the arm & breast) and HEADACHE (A bad headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (a big lump on the side of her arm between the arm & breast) and HEADACHE (A bad headache). At the time of the report, VACCINATION SITE MASS (a big lump on the side of her arm between the arm & breast) and HEADACHE (A bad headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported. Two lot no. given for booster dose were given as lot # 017A21A or 017F21A.   This case was linked to MOD-2021-381116 (Patient Link).
inappropriate age at vaccine administration; This spontaneous report was received from a medical assistant via company representative  referring to a female patient of unknown age.  The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient ingested Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot, strength, frequency, dose and expiration date were not reported) during her grandchild's visit (Product administered to a patient of inappropriate age).   No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA001251 :  US-009507513-2102USA001245:
Sore shoulder, overnight developed ashiness across shoulder blades and throughout body. Fatigue, nausea and diarrhea. Puffy red area adjacent to site of shot about 5" circumference.
Hypertension of 162/118 with heart rate of 130 being at 1335. Normal blood pressure is around 120/80 & resting heart rate of 70. Swimmy headed. But laughing and joking.  Observed for 10 minutes, transferred to ER from vaccine site on campus. Triage bp was 145/100, hr of 112. Time elapsed between  vitals taken was 17 minutes. EKG performed. Was not informed of results. Monitored for next several hours. Was asked to drink approximately 32 oz of apple and water. Given crackers to eat. Discharged from ER at approximately 1800. Bad headache same night into next day.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VAQTA lot # L015460, 20-JUL-2017 exposed to 0.4'C for 231 hours, L015460 20-JUL-2017 exposed to 30F for 684hours, M017982 13-SEP-2017 exposed 30F for 325 hours. There were no prior excursions. No adverse effects were reported. Additional information has been requested.
First shot on March 20, next period following first shot experienced a  heavier than usual period lasting 10 days.   Second shot received on April 17, very light period lasting 2 weeks.   No period in May or June.
This spontaneous report as received from a healthcare worker refers to a 20 year old female patient with a pertinent medical history of Shingles. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On an unknown date the patient experienced recurrence of shingles. The outcome of recurrence of shingles was unknown. Additional information has been requested.
sever chest and shoulder pain  /  difficulties in breathing crating more chest pain       fever100.5on Monday     on Tue temp102.7 Pain has diminished  /  breathing returned to more normal P.S. Sat and Sunday i moved at least six tons of freight each nday
Date and time adverse event started: 1st dose 2-3 days post-vac at unk time. 2nd dose 4/30/2021 immediately after injection.  Date and time of vaccination: (list both if they received both shots): 1st dose 4/9/2021 ~1100. 2nd dose 4/30/2021 ~1300.  Brand and lot of vaccine: Pfizer 1st dose LOT#: E(E/U)50151. 2nd dose LOT#: EW0171 . Caller reports that with 1st dose her mother felt very tired, and she was achy and had pain all over her body for couple of days. 2nd dose, caller reports her mother had immediate pain during injection (pt felt like the the person who gave her the shot injected too high up on her left arm) bc she felt instant pain. 5/1/2021 pt cannot move her left arm, her neck is swollen (does not hurt when touched or swallow) and there's pain to the left side of her neck when she turns her head to the right.    What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): 1st dose pt took Tylenol, this helped per symptoms went away on the 4th day post-vac. 2nd vaccine, pt have not tried anything.   Ever have a reaction to a previous vaccine?  If yes, what? None.   ***NOTE*** Recommend caller the pt can take Tylenol or Ibuprofen to see if that will help with the pain; also recommend to stay hydrated. Advised the swelling in her neck may take up to 10 days to resolve. Recommend if her symptoms does not get better in a couple of days to take her to hospital to be evaluated since pt does not have health insurance. 5/5-Patient has taken Tylenol to alleviate symptoms, swelling in the neck has decreased, minimal pain as of now. Reports feeling much better.
Pt returned to clinic on 3/21/2016 at 8:45am. Parents reported swelling and redness in the L thigh that was first appreciated in the evening on 3/18/16. Pt received DTaP and Hib in the L thigh on 3/18/16. Swelling and redness started to resolve on 3/20/16. Pt did not complain of pain and movement was not impaired. No fever noted. NP assessed patient. This RN discussed with parents what a local reaction meant and that a VAERS report would be filled out. RN instructed parents to notify pediatrician before patient is to receive DTaP again.
This consumer spontaneous report (an uinitial receipt 06-NOV-2014) concerns a 66 year-old male patient. On unknown date, the patient received influenza vaccine (manufacturer and batch number not provided), TDAP (manufacturer and batch not provided), pneumococcal vaccine (manufacturer and batch not provided), and ZOSTAVAX (batch number not provided). On an unknown date, following the administration of ZOSTAVAX, the patient experienced chest pain and felt like he was going to die. Outcome was reported as recovered.
pt recived 1st dose at 1:17pm. proceeded to observation area , no complications.  1:19- RN observer rounds on pt who sts heart is racing.  RN grabs bp tree and patient proceeds to pass out.  Rapid response called  patient A&O when response team arrives  Pt passes out for second time  pt taken to Trauma Room in ER
numbness in arm that goes all over body; chills; dizziness; shortness of breath; losing balance; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in arm that goes all over body), CHILLS (chills), DIZZINESS (dizziness), DYSPNOEA (shortness of breath) and BALANCE DISORDER (losing balance) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 17-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in arm that goes all over body), CHILLS (chills), DIZZINESS (dizziness), DYSPNOEA (shortness of breath) and BALANCE DISORDER (losing balance). At the time of the report, HYPOAESTHESIA (numbness in arm that goes all over body), CHILLS (chills), DIZZINESS (dizziness), DYSPNOEA (shortness of breath) and BALANCE DISORDER (losing balance) outcome was unknown.
had a throat problem; he just had many of the classic symptoms; he just had many of the classic symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Lot number: 32030BD) at the age of 81 years as dose 3 (booster), single, administered in arm left, administration date 01Mar2021 (Lot number: EN6202) as dose 2, single and administered in arm left, administration date 08Feb2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Over weight" (unspecified if ongoing), notes: over-weight he lost 16lbs last time he went to the doctor. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 31Jan2022, outcome "unknown" and all described as "he just had many of the classic symptoms"; PHARYNGEAL DISORDER (non-serious), outcome "unknown", described as "had a throat problem". Clinical course: Reporter doesn't know if her husband ever got tested for COVID. He just thought he had covid, he had a throat problem, then found out the caller, his wife had covid, he just had many of the classic symptoms. Patient Height: he has shrunk, before having COVID, he has had back surgeries, spacers in disks. Concomitant meds was no medications, remarkably healthy. Description of Product Complaint, patient thought he had Covid after his Covid-19 Vaccines. Reporter clarifies she does not know if patient ever got tested for Covid, but patient had the classic Covid symptoms.   No follow-up attempts are possible. No further information is expected.
Pt recvd vax & 5 hrs later exp sudden onset of lightheadedness, aching sensation, malaise & felt cold; denied fever, nausea or vomiting; sx persisted the following day although the pt had returned to work;
Rigors, fever/chills into the morning. Arm soreness, difficulty raising or bending arm, swelling at site, nausea, last temp at 9AM 10/28 99.8 degrees.
No adverse event; 5 doses administered after expiration date. Doses administered today. Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) 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 16-Jun-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 16-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Dosage text was reported as unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information of 1st patient out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-729609, US-MODERNATX, INC.-MOD-2023-729611, US-MODERNATX, INC.-MOD-2023-729613, US-MODERNATX, INC.-MOD-2023-729614 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729613:(Pt 4 of 5) US-MODERNATX, INC.-MOD-2023-729611:(Pt 3 of 5) US-MODERNATX, INC.-MOD-2023-729609:(Pt 2 of 5) US-MODERNATX, INC.-MOD-2023-729614:(Pt 5 of 5)
Pt states slight itching at injection site L arm, noticed raised red rash, and warm to touch approximately 24 hours after immunization. Rash increased in redness and warmth over next 12 hours. Symptoms lasted approximately 6-7 days. PPatient self medicated with tylenol OTC.
No additional AE details were provided and no additional AE's were reported.; a patient was administered a dose of MMR-II on after it expired; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information of the patient's medical history, concomitant medication and concurrent condition was not reported.  On 18-OCT-2022, the patient was administrated a dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) subcutaneous injection 0.5ml (lot # 2034391 was evaluated and changed to the valid Lot #T034391, expiry date was reported as 08-OCT-2022, strength, route of administration and anatomical location were not provided) for prophylaxis after it expired (expired product administered). No additional AE details were provided and no additional AE's were reported (no adverse event).
Localize redness, edema, pain at injection site; Lymphedema of neck area.
Resident began to have facial edema and bilateral edema to upper extremities.  Resident also began having difficulty with swallowing.
Patient received ZOSTAVAX vaccine on 06/30/2011. On 08/22/2011, she called pharmacy and reported that day after receiving vaccine she developed red blistery rash under her armpit. The same arm. She followed with MD & was prescribed antibacterial wipes. Rash is still there, purplish and little residual.
Approximately 6 hours after the vaccination I started to experience minor flu-like symptoms including low grade fever & chills. By 12 hours after vaccination my symptoms were more severe and included fevers 101.5, headaches, severe body aches, chills, dizziness, nausea, and hearing sensitivity. By 36 hours after vaccination my symptoms had mostly subsided with just minor dizziness and nausea remaining.
Pt received 3rd HPV stayed at HD 15 min to 20 min after vaccine no problem. Got a call from school around 11 saying she had chills and then approx. 30 min to 45 min school called c/o SOB. Went to ER. But still complained of nausea.
Grandfather brought grandson in for pharmacist on duty to look at his arm.  He had received a flu shot from us on Friday evening and was concerned the child had an infection from the shot.  It could be a localized reaction as listed in the package insert (lump/swelling, redness, warm to the touch, itchiness) or it could be cellulitis.  The grandfather reports on Saturday afternoon, child's arm had a bump and his arm was red around the area.  By Sunday, the area was very red but had flattened.  Today, I saw child's arm was red from the top of the shoulder to half way to the elbow.  He had a slight white edge going around the red area.  The grandfather reports the red area is not as red as before but the red area has grown in size.  He did call a physician but did not want to make an appointment and instead came to the pharmacy for me to view it.  I went over possible reactions in the package insert but also recommended a consult with a physician, especially if the area worsens.  The only complaint child reports is itchiness.
Headache everyday for 20-30 minutes intervals, then it will go away for several hours and then return.
Pt recvd 1st dose of Hep B vax 15JUN91 & 15JUL91 pt recvd 2nd dose of vax & 7AUG91 to MD w/malaise, congestion, fever, chills, gastric upset, adenopathy, fatigue synd, joint pains & nausea;  vomiting, chest tightness, lost 7 pounds;
general body ache; exhaustion; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Essential tremor" (unspecified if ongoing); "Allergy: walnuts" (unspecified if ongoing), notes: Mild oral allergy to walnuts &, eggplant; "Allergy: eggplant" (unspecified if ongoing), notes: Mild oral allergy to walnuts &, eggplant. Concomitant medication(s) included: ADVIL [IBUPROFEN]; ALEVE; LITHIUM; PROPRANOLOL; LEVOCETIRIZIN; FLUCELVAX QUADRIVALENT, administration date 30Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: I don't have the number right now), when the patient was 54 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "general body ache"; FATIGUE (non-serious), outcome "not recovered", described as "exhaustion"; CHILLS (non-serious), outcome "not recovered", described as "chills". It was unknown if therapeutic measures were taken as a result of pain, fatigue, chills.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications she received within 2 weeks of vaccination was Advil, Aleve, Lithium, Propranolol, Levoceterizine. She was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, she has been not tested for COVID-19. Device Date was 02Nov2021.  Follow-up attempts completed. No further information is expected.
Patient was administered Moderna COVID Vaccine dose 1 on 4/27/2021. It was not identified that the patient was not of recommended age for the vaccine until the vaccine was administered to the patient. Moderna Medical  Information agency was contacted which recommended to administered second dose 28 days from when the first dose was administration. Patient will be contact for second dose appointment.
Developed an eczema-type rash around the perimeter of my face. Extremely itchy. It did not respond to typical hydrocortizone cream; however, antifungal cream provided some relief, but did not cure it. Condition persisted for approximately ten weeks, sometimes getting better but then getting worse. I could not find an environmental cause. The condition seems to be gone now; however, several areas remain sensitive and feel as though they could break out again.
contracted COVID; contracted COVID; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: was not reported, Expiration Date: was not reported), via an unspecified route of administration, administered anatomical location was not reported, on an unspecified date in Feb2021, as dose 2, single for COVID-19 immunization and the patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: was not reported, Expiration Date: was not reported), via an unspecified route of administration, administered anatomical location was not reported, on an unspecified date in Jan2021, as dose 1, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient stated, she received her first dose of the vaccine in Jan2021 and her second dose in Feb2021. The patient mentioned that she contracted COVID-19 in Aug2021. The patient asked if she is allowed to take a booster dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.